What is Cosentyx?

Cosentyx (secukinumab) is a prescription medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory autoimmune conditions.

Cosentyx helps reduce skin lesions, joint pain, swelling, and spine inflammation by blocking interleukin-17A (IL-17A), a protein involved in immune and inflammatory responses. Cosentyx is a monoclonal antibody that acts as an interleukin-17A antagonist.

Cosentyx is administered once a month as a subcutaneous injection (under the skin), after an initial loading period. It can also be given as an intravenous (IV) Infusion for adults with psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis (nr-axSpA).

What is Cosentyx used for?

Cosentyx is FDA-approved to be used for:

• Plaque psoriasis: Moderate to severe, affecting large or multiple areas of the body, in patients 6 years and older who are candidates for systemic therapy or phototherapy.
• Psoriatic arthritis (PsA): Active disease in patients 2 years and older.
• Ankylosing spondylitis (AS): Active disease in adults.
• Non-radiographic axial spondyloarthritis (nr-axSpA): Active disease in adults with objective signs of inflammation.
• Enthesitis-related arthritis (ERA): Active disease in patients 4 years and older.
• Hidradenitis suppurativa (HS): Moderate to severe disease in adults.

Cosentyx FDA approval was first granted on January 21, 2015, for plaque psoriasis, and since then, its use has expanded to include these listed conditions.

How does Cosentyx work?

Cosentyx is an IL-17A antagonist. 

In autoimmune diseases, the immune system becomes overactive and produces excessive IL-17A, a cytokine (protein) that promotes inflammation, pain, and tissue damage.

Cosentyx works by binding to and blocking IL-17A, preventing it from triggering the inflammatory response. This helps calm the immune system, reduce inflammation, and relieve symptoms associated with these chronic conditions.

Cosentyx targets the underlying cause of inflammation rather than just masking symptoms.

Cosentyx side effects

Common Cosentyx side effects may include diarrhea and cold symptoms such as a stuffy nose, sneezing, and sore throat.

Serious Cosentyx side effects

Get emergency medical help if you have signs of an allergic reaction to Cosentyx with symptoms of hives, chest tightness, difficulty breathing, feeling like you might pass out, swelling of your face, lips, tongue, or throat.

This medicine can cause serious bacterial, viral, and fungal opportunistic infections. Call your doctor right away if you have signs of infection, such as

• redness, warmth, or painful sores on your skin;
• cough, shortness of breath, cough with red or pink mucus;
• increased urination, burning when you urinate;
• sores or white patches in your mouth or throat (yeast infection or “thrush”);
• new or worsening diarrhea or stomach pain; or
• fever, chills, sweating, muscle pain, weight loss.

Cases of Hepatitis B virus reactivation have occurred using this medicine.

Further doses may be delayed until your infection clears up.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

You may get infections more easily while using Cosentyx, as it lowers your immune system’s ability to fight infections. Call your doctor right away if you have signs of infection such as fever, chills, sweats, muscle aches, skin sores, stomach pain, diarrhea, burning when you urinate, weight loss, cough, shortness of breath, or a cough with red or pink mucus.

Tell your doctor if you have an active infection or have ever been diagnosed with tuberculosis or inflammatory bowel disease before using this medicine.

Before using this medicine

You should not use Cosentyx if you are allergic to the active ingredients, secukinumab, or any of the inactive ingredients contained in the medicine.

Latex allergy. You should not handle the needle cap of the Cosentyx Sensoready pen, or the 75 mg/0.5 mL or 150 mg/mL prefilled syringes if you are sensitive to latex.

Tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure you can safely use Cosentyx, tell your doctor if you have ever had:

• an active or chronic infection;
• inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• an allergy to latex; or
• if you currently have signs of infection such as fever, sweats, chills, muscle pain, cough, shortness of breath, cough with bloody mucus, weight loss, skin sores, stomach pain, diarrhea, or painful urination.

Make sure you are current on all vaccines before you start using this medicine. You should not have any vaccinations during your treatment with Cosentyx without first talking to your doctor.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Cosentyx can harm your unborn baby. You and your healthcare provider should decide if you will use this medicine.

Breastfeeding

Tell your doctor or healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Cosentyx passes into your breast milk.

How should I use Cosentyx?

Subcutaneous Cosentyx

Cosentyx subcutaneous injection can be self-administered or administered by a caregiver in your own home. Pediatric patients should not self-administer this medicine; an adult caregiver can inject this medicine after proper training in subcutaneous injection technique.

Subcutaneous Cosentyx instructions

• Take the injection pen out of the refrigerator and let it reach room temperature for 15 to 30 minutes before use. Give the injection within 1 hour after removing the medicine from the refrigerator.  Do not try to warm the medication by heating it in a microwave, placing it in hot water, or using any other method. 
• Prepare an injection only when you are ready to give it. You may need to use 2 injections to get your total dose.
• The solution should be clear or light yellow. Call your pharmacist if the liquid in your vial, pen, or syringe looks cloudy, has changed colors, or has particles in it.
• Do not shake the syringe or dosing pen.
• The injection can be given anywhere on the front of your thighs (upper leg), upper outer arms, or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. Do not inject into the same place two times in a row. Avoid injecting into the skin that is hard, red, bruised, swollen, tender, or affected by psoriasis. 
• Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside.
• Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of them following state or local laws. Keep out of the reach of children and pets.

Intravenous Cosentyx

Cosentyx can also be administered as an intravenous infusion by your healthcare professional (HCP) for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS), or non-radiographic axial spondyloarthritis (nr-axSPA). Cosentyx intravenous infusion should be administered over a period of 30 minutes

General information

You may get infections more easily, even serious infections. You will need frequent medical tests.

Use Cosentyx exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Cosentyx Dosing Information

Cosentyx is supplied as a Sensoready pen, UnoReady Pen prefilled syringe, or single-dose vial.

Intravenous dosing (administered by a healthcare provider)

Intravenous dosing can be used for psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis. Dilute before use. Administer infusion over 30 minutes.

• With a loading dose: 6 mg/kg initially at week 0 followed by 1.75 mg/kg every 4 weeks thereafter (maximum 300mg per infusion).
• Without a loading dose: 1.75 mg/kg every 4 weeks (maximum 300mg per infusion).

Subcutaneous dosing

Usual Adult Cosentyx Dose for Plaque Psoriasis

Dose:

• 300 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks.
• Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.
• For some patients, a dose of 150 mg subcutaneously may be acceptable.

Use: Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Usual Pediatric Dose for Plaque Psoriasis (6 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.
• Body weight less than 50kg: recommended dose is 75mg.
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• Safety and effectiveness of Cosentyx in pediatric patients with plaque psoriasis below the age of 6 years have not been established.

Use: Moderate to severe plaque psoriasis in pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.

Usual Adult Dose for Psoriatic Arthritis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks; if the patient continues to have active psoriatic arthritis, consider increasing the dose to 300 mg subcutaneously every 4 weeks.

Comments:

• For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosage for plaque psoriasis.
• This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis.

Usual Pediatric Dose for Psoriatic Arthritis (2 years and older)

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.
• The safety and effectiveness of Cosentyx in pediatric patients below the age of 2 years and with a body weight of less than 15 kg (33 pounds) have not been established.

Comment: This drug may be administered with or without methotrexate.

Use: Active psoriatic arthritis in patients 2 years and older.

Usual Adult Dose for Ankylosing Spondylitis

Dose:

• With a loading dose: 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
• Without a loading dose: 150 mg subcutaneously every 4 weeks.

Comment: If a patient continues to have active AS, consider a dosage of 300 mg every 4 weeks.

Uses: For active ankylosing spondylitis.

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Dose:

• The loading dosage is 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Without a loading dosage is 150 mg every 4 weeks

Use: Active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients who have objective signs of inflammation.

Usual Dose for Enthesitis-Related Arthritis 

Dose:

• Dose is based on body weight, given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks.
• Body weight 15 kg to less than 50kg: the recommended dose is 75mg
• Body weight is greater than or equal to 50kg: recommended dose 150mg.

Use: Active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Usual Adult Dose for Hidradenitis Suppurativa

Dose:

• Recommended dosage is 300 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter.
• If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. 

Use: moderate to severe hidradenitis suppurativa (HS) in adults

Cosentyx products

Subcutaneous Injection

• Cosentyx Sensoready pen: 150 mg/mL single dose.
• Cosentyx UnoReady pen and single-dose prefilled syringe: 300 mg/2 mL.
• Cosentyx prefilled syringe (for pediatric patients less than 50 kg): 75 mg/0.5 mL single dose.

Intravenous Infusion

• Cosentyx injection: 125 mg/5 mL in a single-dose vial (healthcare professional use only)

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Cosentyx.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Cosentyx?

Avoid receiving a “live” vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Cosentyx?

Cosentyx may interact with other products, so tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take and keep a list to show your healthcare provider and pharmacist when you start a new medicine or stop a regular medicine.

When starting or stopping this medicine, patients who are receiving a CYP450 substrate medicine, particularly those with a narrow therapeutic index,  your therapeutic effect or drug concentration monitored, and you may need to have a dosage adjustment of the CYP450 substrate. To check for interactions with Cosentyx, click on the link below.

Cosentyx Package Insert 

HCPs and patients often use the Cosentyx Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interactions, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Cosentyx Prescribing Information (PI) or FDA label.

Cosentyx J code

Cosentyx J code is J3247 (1 mg, intravenous).
J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

The J code is only required for the intravenous infusion.

Your physician will need the Cosentyx J code when filling out forms for your intravenous infusion treatment.

Storage

• Store this medicine in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze this medicine.
• Keep this medicine in the original carton until ready for use to protect it from light.
• If necessary, the Sensoready pen, Unoready pen, and prefilled syringes may be stored at room temperature, up to 86°F (30°C), for up to 4 days.   
• Write the date the medicine was removed from the refrigerator in the space provided on the carton.
• If unused and stored below 30°C (86°F), the Sensoready pen, Unoready pen, and prefilled syringes may be returned to the refrigerator only one time. Throw them away if they have been kept outside of the refrigerator and have not been used in over 4 days.
• Do not shake this medicine.
• Keep all medicines out of the reach of children.

Ingredients

Active ingredient: secukinumab.

Inactive ingredients:

Cosentyx Sensoready pen and prefilled syringe: L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for injection.

Cosentyx Vial: L-histidine/histidine hydrochloride monohydrate, polysorbate 80, and sucrose.

Latex: Do not handle the needle cap of the Cosentyx Sensoready pen, or the 75 mg/0.5 mL or 150 mg/mL prefilled syringes if you are sensitive to latex.

Consentyx Manufacturer

Cosentyx manufacturer Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.

Cosentyx Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Cosentyx.Cosentyx (secukinumab) – Novartis Pharmaceuticals Corporation

What is guselkumab?

Guselkumab (Tremfya) is an injectable medication used to treat inflammatory, autoimmune conditions plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, in certain patients. Guselkumab helps reduce inflammation, pain, swelling, and skin, joint and gastric symptoms. 

Guselkumab works by blocking the action of interleukin-23 (IL-23) at its receptor. IL-23 is a naturally occurring small protein called a cytokine, which plays a role in your normal inflammatory and immune responses. Blocking the action of IL-23, guselkumab inhibits the release of small proteins called chemokines and cytokines that cause inflammation. Guselkumab is a biological drug from the drug class known as interleukin inhibitors, it is also called a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody

Guselkumab can be self-administered as an injection under the skin (subcutaneous injection) using pre-filled syringes or pens or may be given as an infusion by a healthcare professional, depending on your condition and stage of treatment. Guselkumab is given every 4 to 8 weeks as maintenance treatment, after initial doses.

Guselkumab was first approved by the US Food and Drug Administration (FDA) in 2017. It comes in the form of a prefilled syringe and a One-Press injector.

No biosimilars of guselkumab have been approved. Biosimilars are highly similar versions of a biological drug that are designed to work in the same was as the original version of the drug, but they are not identical.

What is guselkumab used for?

Guselkumab is an FDA-approved prescription medicine (indications) to treat:

• Plaque Psoriasis in adult patients with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light)
• Psoriatic Arthritis in adult patients with active psoriatic arthritis.
• Ulcerative Colitis in adult patients with moderately to severely active ulcerative colitis
• Crohn’s Disease in adult patients with moderately to severely active Crohn’s disease.

It is not known if guselkumab is safe and effective in children under 18 years of age.

How does guselkumab work?

Guselkumab mechanism of action (MOA) is by binding selectively to the p19 subunit of interleukin-23 (IL-23) which is a naturally occurring cytokine (protein). Cytokines are substances released by cells of the immune system that influence other cells and play a key role in promoting inflammation and immune response, in chronic immune-mediated diseases.

By blocking the effects of IL-23, guselkumab helps to regulate the immune system and control inflammation so that symptoms of these conditions improve.

Guselkumab is an interleukin-23 antagonist.

Guselkumab side effects

Common guselkumab side effects

The most common side effects of guselkumab include:

• Infections (23%)
• Upper respiratory tract infection (14.3%)
• Headache (4.6%)
• Injection site reaction including pain, itching, swelling, redness, or bruising where the medicine was injected (4.5%)
• Joint pain (2.7%)
• Elevated liver enzymes (2.6%)
• Diarrhea (1.6%)
• Gastroenteritis, inflammation of your stomach into your intestines, causing pain, vomiting, and diarrhea (1.3%)
• Fungal skin infections (1.1%)
• Herpes simplex infections (1.1%)

These common side effects occurred in 1% or more of plaque psoriasis patients being treated with Guselkumab for 16 weeks in clinical trials Ps01 and Ps02.

Serious side effects and warnings

Hypersensitivity reactions

Get emergency medical help if you have signs of an allergic reaction to guselkumab a: hives, rash, itching; chest tightness, difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Infections

This medicine can weaken (suppress) your immune system, and you may get an infection more easily.

Call your doctor at once if you have signs of infection, such as:

• fever, chills, body aches, night sweats;
• weight loss, feeling very tired;
• cough (may contain blood or mucus), shortness of breath;
• pain or burning when you urinate;
• severe diarrhea or stomach cramps; or
• skin redness, tingling, blisters, oozing, or sores that look different from psoriasis.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

Allergies

You should not use guselkumab if you are allergic to it, polysorbate 80, or any other of the inactive ingredients in this medication

Tuberculosis

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis. Also, tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Before starting treatment with guselkumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

To make sure guselkumab is safe for you, tell your doctor if you have:

• an active or chronic infection;
• active tuberculosis infection that is not being treated; or
• if you have recently received or are scheduled to receive any vaccine.

Vaccines

Make sure you are current on all vaccines before you start treatment with guselkumab.

Avoid the use of live vaccines while being treated with this medicine.

Hepatotoxicity

Medicine-induced liver injury has been reported with this medicine. When being treated for Crohn’s disease or ulcerative colitis your liver enzymes and bilirubin levels will be monitored at baseline, and for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. If drug-induced liver injury is suspected your treatment will be paused until this diagnosis is excluded.

Pregnancy

It is not known whether guselkumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry called MotherTOBaby to track the effects of guselkumab on the baby. You can enroll in this registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. Breastfeeding

Breastfeeding

It is not known whether guselkumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breastfeeding.

How should I use guselkumab?

Patients with plaque psoriasis or psoriatic arthritis will receive guselkumab as an injection under the skin (subcutaneous injection). 

Patients with ulcerative colitis will receive their initial (induction) doses through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the induction doses, patients will receive maintenance treatments as a subcutaneous injection which may be self-administered.

Patients with Crohn’s disease may receive their beginning (induction) doses as a subcutaneous injection or an intravenous infusion in a healthcare facility by a healthcare provider. After completing the induction doses, patients will receive maintenance treatments as a subcutaneous injection (subcutaneous injection) which may be self-administered or given by a carer.

Guselkumab injection

• Use guselkumab exactly as your healthcare provider tells you to use it.
• See the detailed “Instructions for Use” that comes with guselkumab for information on how to prepare and inject a dose of guselkumab, and how to properly throw away (dispose of) used guselkumab prefilled syringes or One-Press injectors.
• Prepare for your injection
  • Remove your guselkumab prefilled syringe or One-Press injector carton from the refrigerator.
  • Keep the prefilled syringe or One-Press injector in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
  • Do not warm the prefilled syringe or One-Press injector any other way.
  • Check the expiration date (‘EXP’) on the back panel of the carton.
  • Do not use your prefilled syringe or One-Press injector if the expiration date has passed.
  • Do not inject guselkumab if the perforations on the carton are broken. Call your healthcare provider or pharmacist for a refill.
• Choose injection site
  • Select from the following areas for your injection:
    • Front of thighs (recommended)
    • Lower stomach area (lower abdomen), except for a 2-inch area right around your navel (belly-button)
    • Back of upper arms (only if someone else is giving you the injection)
      Do not inject into skin that is tender, bruised, red, hard, thick, scaly or affected by psoriasis.
• Clean injection site
  • Wash your hands well with soap and warm water.
  • Wipe your chosen injection site with an alcohol swab and allow it to dry.
  • Do not touch, fan, or blow on the injection site after you have cleaned it.
• Inspect liquid
  • Take your guselkumab prefilled syringe or One-Press injector out of the carton.
  • Check the guselkumab prefilled syringe or One-Press injector liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles. You may also see one or more air bubbles. This is normal.
  • Do not inject if the liquid is cloudy or discolored, or has large particles. Call your healthcare provider or pharmacist for a refill.
• Inject. guselkumab
  • Using prefilled syringe
    • Remove needle cover.
    • Hold your prefilled syringe by the body and pull needle cover straight off. It is normal to see a drop of liquid.
    • Inject guselkumab within 5 minutes of removing the needle cover.
    • Do not put needle cover back on, as this may damage the needle or cause a needle stick injury.
    • Do not touch needle or let it touch any surface.
    • Do not use a guselkumab prefilled syringe if it is dropped. Call your healthcare provider or pharmacist for a refill.
    • Position fingers and insert needle.
    • Place your thumb, index and middle fingers directly under the finger flange, as shown.
    • Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
    • Use your other hand to pinch skin at the injection site. Position syringe at about a 45 degree angle to the skin.
    • It is important to pinch enough skin to inject under the skin and not into the muscle.
    • Insert needle with a quick, dart-like motion.
    • Release pinch and reposition hand
    • Use your free hand to grasp the body of the prefilled syringe.
    • Press plunger
    • Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.
    • Release pressure from plunger
    • The safety guard will cover the needle and lock into place, removing the needle from your skin.
  • Using a One-Press injector
    • Twist and pull off bottom cap
    • Keep hands away from the needle guard after the cap is removed.
    • Inject guselkumab within 5 minutes of removing the cap.
    • Do not put the cap back on, this could damage the needle.
    • Do not use a One-Press injector if it is dropped after removing the cap. Call your healthcare provider or pharmacist for a new One-Press injector.
    • Place on skin
    • Position the One-Press injector straight onto the skin (about 90 degrees relative to injection site).
    • Push handle straight down
    • Medication injects as you push. Do this at a speed that is comfortable for you.
    • Do not lift the One-Press injector during the injection. The needle guard will lock and the full dose will not be delivered.
    • Complete injection
    • Injection is complete when the handle is pushed all the way down, you hear a click, and the teal body is no longer visible.
    • Lift straight up
    • The yellow band indicates that the needle guard is locked.

• After your injection
  • Dispose of your prefilled syringe or One-Press injector
  • Put your used guselkumab prefilled syringe or One-Press injector in an FDA-cleared sharps disposal container right away after use.
  • Do not throw away (dispose of) your guselkumab prefilled syringe or One-Press injector in your household trash.
  • Do not recycle your used sharps disposal container.
  • For more information, see “How should I dispose of the used prefilled syringe or One-Press injector? under Storage below.
• Check injection site
  • There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
  • Do not rub the injection site.
  • If needed, cover injection site with a bandage.

Guselkumab dosing information

Usual Adult Dose of Guselkumab for Psoriatic Arthritis:

Induction dose and Maintenance dose: 100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter.

Comment: This drug may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)

Usual Adult Dose of Guselkumab for Plaque Psoriasis:

Induction dose and Maintenance dose: 100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter.

Usual Adult Dose of Guselkumab for Crohn’s Disease

Induction dose: 

• 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8, or
• 400 mg administered by subcutaneous injection at Week 0, Week 4, and Week 8

Maintenance dose:

• 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
• 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.

Usual Adult Dose of Guselkumab for Ulcerative Colitis

Induction dose: 200 mg administered by intravenous infusion over at least one hour at Weeks 0, 4, and 8.

Maintenance dose: 

• 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
• 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.

Guselkumab formulations

Guselkumab (Tremfya) injections are available as:

• One-Press patient-controlled injector single-dose 100 mg/mL Injection:
• Tremfya Pen single-dose prefilled pen 200 mg/2 mL
• Prefilled syringe single-dose 100 mg/mL 
• Prefilled syringe single-dose 200 mg/2 mL (100 mg/mL)

Guselkumab infusion is available as:

• Single-dose vial  200 mg/20 mL (10 mg/mL) 

What happens if I miss a dose?

If you miss your guselkumab dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.

What happens if I overdose?

If you inject more guselkumab than prescribed, call your healthcare provider right away.

Interactions

Other drugs may interact with guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

CYP450 substrates. When starting guselkumab in patients who are currently on CYP450 substrates, particularly those with a narrow therapeutic index, your healthcare provider will monitor the therapeutic effect or drug concentration and consider dosage adjustment as needed.

This list is not all-inclusive and other medications may interact with guselkumab. You should refer to the prescribing information for Tremfya for a complete list of interactions or use the interactions checker below.

Guselkumab Package Insert 

HCPs and patients often use the Guselkumab Package Insert (Tremfya) for more detailed information about this medicine. The Tremfya Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Prescribing Information (PI) or FDA label.

Guselkumab J code

Guselkumab J code is J1628.

J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need guselkumab J code when filling out forms for your treatment.

Storage

• Store guselkumab in refrigerator at 36° to 46°F (2° to 8°C).
• Do not freeze guselkumab prefilled syringes or One-Press injector.
• Do not shake your guselkumab prefilled syringe or One-Press injector.
• Keep guselkumab prefilled syringe or One-Press injector in the original carton to protect from light and physical damage.

Keep guselkumab prefilled syringe or One-Press injector and all medicines out of reach of children.

How should I dispose of the used prefilled syringe or One-Press injector?

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal

What are the ingredients in guselkumab?

Active ingredient: guselkumab

Inactive ingredients: 

• Single-dose prefilled syringe, single-dose One-Press patient-controlled injector, single-dose prefilled pen for subcutaneous use (TREMFYA PEN): L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection.
• Single-dose vial for intravenous infusion: EDTA disodium dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection.

Not made with natural rubber latex.

Company

Guselkumab is manufactured under the brand name Tremfya by Janssen Biotech, Inc., Horsham, PA 19044, U.S.

Guselkumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for guselkumab.Tremfya (guselkumab) – Janssen Biotech, Inc.

What is Ilumya? 

Ilumya injection is used for moderate-to-severe plaque psoriasis to help reduce plaques, scales, and redness, making the skin clearer and less itchy. Ilumya works to balance the overactive immune system by blocking the IL-23 protein involved in inflammatory and immune responses. Ilumya active ingredient is tildrakizumab asmn.

Ilumya mechanism of action is it selectively binds to the p19 subunit of interleukin-23  (IL-23) and blocks its interaction with the IL-23 receptor. This decreases the release of proteins  (cytokines and chemokine) that cause inflammation, which improves plaque psoriasis symptoms. Ilumya injection is a humanized IgG1/k monoclonal antibody.

Ilumya is given as an injection under the skin (subcutaneous) monthly and then every 12 weeks as a maintenance dose.

Who can use Ilumya?

Ilumya FDA approval is for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya FDA approval was granted on March 21, 2018, after positive results from clinical trials reSURFACE 1 study.  In the study, 74 percent (229 patients) using Ilumya (tildrakizumab-asmn) achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100 mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo.

Ilumya side effects

Common Ilumya side effects

Common Ilumya side effects may include:

• including pain, itching, rash, redness, swelling, bruising, or bleeding where the medicine was injected injections site reactions)
• diarrhea; or
• cold symptoms including stuffy nose, sneezing, sore throat (upper respiratory infections).

 Serious Ilumya side effects

Get emergency medical help if you have signs of an allergic reaction to Ilumya: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection, such as:

• fever, chills, sweating;
• skin sores;
• muscle pain;
• increased urination, pain or burning when you urinate;
• stomach pain, diarrhea, weight loss; or
• cough, shortness of breath, coughing up pink or red mucus.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Warnings

Infections Ilumya affects your immune system, and you may get infections more easily. Call your doctor if you have signs or symptoms of clinically important chronic or acute infection, including fever, chills, aches, cough, shortness of breath, skin sores, diarrhea, weight loss, or burning when you urinate. If a serious infection develops, your doctor may consider discontinuing Ilumya until the infection has cleared.

Tuberculosis (TB). Before starting Ilumya treatment, your healthcare provider will test you for tuberculosis (TB). If you have active TB or a history of it, you will receive treatment for TB first. You will also be monitored for any signs and symptoms of TB. 

Serious allergic reactions: Get emergency medical help right away if you get any symptoms of serious allergic reactions, including feeling faint, skin rash, swelling of your face, eyelids, lips, trouble breathing or throat tightness, mouth, tongue or throat, chest tightness.

 Immunizations: Avoid the use of live vaccines.

Before receiving this medicine

You should not be treated with Ilumya if you are allergic to the active ingredient tildrakizumab or any inactive ingredients. There is a full list of ingredients at the bottom of this page.

Tell your doctor if you have a chronic infection or are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis.

It is not known whether Ilumya will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How is Ilumya given?

Ilumya is given as an injection under your skin (subcutaneous injection) in areas of your body such as your thighs, stomach area (abdomen), or upper arm.

A healthcare provider will administer your Ilumya injection.

Before you start treatment with Ilumya, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Ilumya Dosing information

Usual Adult Ilumya Dose for Plaque Psoriasis:

• 100 mg subcutaneously at Weeks 0 and 4 and every 12 weeks after that.

General dosing information

Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.

• Ilumya should only be administered by a healthcare provider.
• Before injection, remove the carton from the refrigerator and let the prefilled syringe (in the carton with the lid closed) sit at room temperature for 30 minutes.
• Follow the instructions on the carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.
• Inspect the syringe visually for particulate matter and discoloration before administration. The product is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.
• Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Do not inject into scars, stretch marks, or blood vessels.
• While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  Inject the full amount (1 mL), which provides 100 mg of drug per syringe.
• Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
• Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safely lock will draw the needle inside the needle guard.
• If a dose is missed, administer the dose as soon as possible; thereafter, resume dosing at the regularly scheduled interval.

Ilumya J code

Ilumya J code is J3245 (1 mg, injection)
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important, accurate, and consistent coding for billing and reimbursement purposes.

Your physician will need an Ilumya J-code when filling out forms for your treatment.

Ilumya Support and savings

Ilumya Support is a program to help patients with personalized email and text message support when treated with Ilumya for moderate-to-severe plaque psoriasis. Ilumya Support will also help with financial support if you are eligible.

Ilumya Enrolment form and Ilumya copay card

To access the support program, you will need to fill out the Ilumya enrolment form which is available on the Ilumya prices and coupon page.

With the Ilumya Copay card, you may pay as little as $0 for Ilumya if you have commercial insurance that provides coverage for this medicine and are a resident of the United States, Puerto Rico, Guam, or the Virgin Islands. This coverage is for out-of-pocket costs, which may include Copay, co-insurance, or deductible. 

You are not eligible for the copay program is you are enrolled in any state or federally-funded insurance program, including, but not limited to, Medicare, Medicaid, TRICARE, Veterans Affairs Health Care, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other state or federal assistance program. Check the terms and conditions for the copay program at Ilumya Support.

What happens if I miss a dose?

If you miss a follow-up appointment and do not receive your dose, schedule another appointment as soon as possible.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Ilumya?

Do not receive a “live” vaccine while using Ilumya. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Ilumya?

Other drugs may interact with tildrakizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Does Ilumya interact with my other drugs?

Enter medications to view a detailed interaction report using  Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Ilumya Package Insert 

Review the Ilumya Package Insert  (Ilumya PI) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called  Ilumya Prescribing Information or  Ilumya FDA label.

Storage 

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. 
• It can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard ILUMYA. Do not store ILUMYA above 25°C (77°F).
• Do not freeze. 
• Do not shake.

Ingredients

Active ingredient: tildrakizumab-asmn

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Company

Ilumya Sun Pharmaceutical Industries Limited

Manufactured by Sun Pharmaceutical Industries Limited Mumbai, Maharashtra India 400 063

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Tildrakizumab-asmn (active ingredient) is a Product of South Korea.

What is Kevzara?

Kevzara (sarilumab) is used to treat rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) in certain adults, and also active polyarticular juvenile idiopathic arthritis (pJIA) to help reduce pain, stiffness, swelling, and other symptoms.

Kevzara works by blocking the effects of a protein called interleukin-6 (IL-6), which is involved in causing inflammation, by blocking IL-6 reduces the inflammatory process and improves symptoms. Kevzara belongs to the class of medicines known as interleukin-6 receptor antagonists (also called IL-6 inhibitors) and is a type of biologic.

Kevzara is often given after other medications have been tried without successful treatment of symptoms, depending on the condition being treated. It is sometimes given together with other arthritis medicines.

Who can use Kevzara?

Kevzara FDA approval was received on May 22, 2017. It is now FDA approved to treat:

• active rheumatoid arthritis (moderate to severe) in adults who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
• polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
• active polyarticular juvenile idiopathic arthritis in patients who weigh 63 kg or greater.

Kevzara side effects

Common Kevzara side effects

Common Kevzara side effects may include runny or stuffy nose, sinus pain, sore throat, abnormal liver function tests, painful urination, or skin redness where an injection was given.

Serious Kevzara side effects

Get emergency medical help if you have signs of an allergic reaction to Kevzara: hives; chest pain, difficult breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Kevzara. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, body aches;
• cough with bloody mucus;
• feeling short of breath;
• diarrhea, stomach pain, weight loss;
• sores on your skin;
• pain or burning when you urinate; or
• feeling very tired.

Also call your doctor at once if you have signs of perforation (a hole or tear) in your stomach or intestines:

• fever;
• ongoing stomach pain; or
• a change in bowel habits.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Kevzara affects your immune system. You may get infections more easily, even serious or fatal infections. Tell your doctor if you have a fever, chills, tiredness, cough, diarrhea, stomach pain, weight loss, skin sores, or painful urination.

Kevzara may cause you to have a tear in your stomach or intestines. This is more likely if you have diverticulitis or a stomach ulcer, or if you also take steroids, methotrexate, or an NSAID (nonsteroidal anti-inflammatory drug). Call your doctor right away if you have a fever and ongoing stomach pain.

Before and during your treatment with Kevzara, you will need frequent blood tests. Your treatment may be delayed or stopped based on the results of these tests.

This medicine may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

Before taking this medicine

You should not use Kevzara if you are allergic to sarilumab.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Kevzara is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;
• diabetes;
• HIV or AIDS;
• a weak immune system;
• hepatitis or other liver problems;
• stomach pain, diverticulitis, or stomach or intestinal ulcers;
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using Kevzara may increase your risk of developing certain types of cancers. Ask your doctor about this risk.

It is not known whether sarilumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sarilumab on the baby.

You should not breast-feed while using Kevzara.

How should I take Kevzara?

Kevzara is injected under the skin, usually given once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

Kevzara affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store this medicine in its original container in a refrigerator. Protect from light. Do not shake or freeze the medicine. Keep Kevzara cold even while traveling.

Before injecting your dose, take the medicine out of the refrigerator and let it reach room temperature (for 30 minutes if using the prefilled syringe, or for 60 minutes if using the injection pen). Once at room temperature, the medicine must be used within 14 days.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

• Place used needles, syringes, or injection pens in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Adult Kevzara Dose for Rheumatoid Arthritis:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.
• Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.
• Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.
• Avoid use in patients with active infections.

Adult Kevzara Dose for Polymyalgia Rheumatica:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug is recommended to be used in combination with a tapering course of corticosteroids. It can be used as monotherapy following discontinuation of corticosteroids.

Kevzara Dose active polyarticular juvenile idiopathic arthritis

Usual recommended dose: 200 mg given subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater using the 200 mg/1.14 mL pre-filled syringe.

Comments:

• Can be used as monotherapy or in combination with conventional DMARDs.

Dose Modification

Dosage Modifications are required for cytopenias, abnormal liver enzymes, and infections. Click on the link below for more detailed dosage information.

Kevzara Dosage Forms

Single-dose pre-filled syringe injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

Single-dose pre-filled pen injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Kevzara, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Kevzara?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with sarilumab, especially:

• any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or tofacitinib.

This list is not complete and many other drugs may affect Kevzara. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

• Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light.
• If needed, patients/caregivers may store this medicine at room temperature up to 77°F (25°C) up to 14 days in the outer carton. Do not store above 77°F (25°C). After removal from the refrigerator, use KEVZARA within 14 days or discard.
• Do not freeze.
• Do not shake.

Ingredients

Active Ingredient: sarilumab

Inactive Ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.

Company

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY U.S. License # 1752.

Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

Registered trademark: Sanofi Biotechnology ©2024 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC

Kevzara Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kevzara.Kevzara (sarilumab) – Sanofi-Aventis U.S. LLC

What is Kineret?

Kineret is a FDA approved medicine used to treat moderate to severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children.
Kineret also has emergency use authorization (EUA) for the treatment of COVID-19 in specific hospitalized patients.

Kineret works to reduce the body’s immune response and inflammation by blocking the IL-1 receptor as it is an interleukin-1 (IL-1) receptor antagonist. 

Kineret is given as a subcutaneous injection daily or sometimes twice daily.

Kineret (anakinra) is used to control symptoms in: 

• Active rheumatoid arthritis that is moderate to severe, in adult patients who have tried disease modifying antirheumatic drugs (DMARDs) and they have not worked.
• Neonatal-onset multisystem inflammatory disease (NOMID) in new born babies. NOMID is a rare genetic condition that is a form of cryopyrin-associated periodic syndromes (CAPS). NOMID causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.
• Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children. DIRA is a very rare genetic condition that causes a severe inflammatory reaction during the first days of life and can lead to organ failure throughout the body.
• The US Food and Drug Administration (FDA) has authorized emergency use of anakinra for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

Warnings

The US Food and Drug Administration (FDA) has authorized emergency use of Kineret for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

You should not use Kineret if you are allergic to medicines that contain E. coli bacteria proteins, or if you have an active infection.

Before using Kineret, tell your doctor if you have asthma, kidney disease, a latex allergy, a weak immune system, an active or chronic infection, or signs of infection such as fever, chills, or open sores on your skin.

Kineret can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, mouth sores, weight loss, or feeling tired or short of breath.

You may have a higher risk of infection if you are also using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), adalimumab (Humira), cancer medicines, steroids, or medicines to prevent organ transplant rejection.

Do not give Kineret to anyone under 18 years old without medical advic

Before taking this medicine

You should not use Kineret if you are allergic to anakinra or if you have:

• an active infection; or
• an allergy to any medicine that contains E. coli bacteria proteins.

To make sure Kineret is safe for you, tell your doctor if you have:

• kidney disease;
• an active or chronic infection;
• fever, chills, or open sores on your skin;
• a weak immune system (caused by disease or by using certain medicines):
• asthma;
• tuberculosis; or
• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or plan to become pregnant. Having rheumatoid arthritis or CAPS during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating rheumatoid arthritis or CAPS may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice. Kineret is not approved to treat rheumatoid arthritis in anyone younger than 18 years old.

How should I use Kineret?

Use Kineret exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Kineret is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Kineret is given either once per day or once every other day. Follow your doctor’s dosing instructions very carefully. Inject your dose at the same time of day when you use the medicine.

Your healthcare provider will show you where on your body to inject Kineret. Use a different place each time you give an injection. Each injection should be given at least 1 inch away from where you last injected the medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Do not shake the prefilled syringe or you may ruin the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Call your doctor if your arthritis symptoms do not improve, or if they get worse while using Kineret.

Anakinra affects your immune system. You may get infections more easily. You will need frequent medical tests before and while using Kineret and for several months after you stop using it.

Store in the refrigerator, do not freeze. Protect from light. Throw away any unused medicine after the expiration date on the label has passed.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult Dose of Kineret for Rheumatoid Arthritis:

100 mg subcutaneously once daily at approximately the same time each day

Comments:
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: To reduce symptoms and slow the progression of structural damage in moderately to severely active rheumatoid arthritis (RA) in patients who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Usual Adult Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Usual Pediatric Dose of Kineret for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily
NOTE: Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Comments:
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Usual Pediatric Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

1 month and older:
Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in children 1 month and older

Usual dose of Kineret for adults with COVID-19:

Recommended dosage of Kineret is 100 mg administered daily by subcutaneous injection for 10 days.

Dose for patients with severe renal insufficiency or end stage renal disease  (creatinine clearance < 30 mL/min, estimated from serum creatinine levels) consider a dose of 100 mg of Kineret administered every other day for 5 total doses over 10 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Kineret?

Do not receive a “live” vaccine while using Kineret, or you could develop an infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Kineret side effects

Get emergency medical help if you have signs of an allergic reaction to Kineret: hives, sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness, fainting; swelling of your face, lips, tongue, or throat.

If you are using Kineret for DIRA, you may have an increased risk of allergic reactions, especially in the first weeks of treatment.

Call your doctor at once if you have:

• fever or chills;
• low white blood cell counts – mouth sores, skin sores, sore throat; or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Kineret side effects may include:

• abnormal liver function tests;
• rash;
• worsening arthritis symptoms;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• joint pain;
• flu symptoms;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• redness, bruising, itching, stinging, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Kineret?

You may have a higher risk of infection from Kineret if you are also using:

• certolizumab;
• etanercept;
• golimumab;
• infliximab;
• adalimumab; or
• cancer medicines, steroids, or medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with anakinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Kineret Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kineret.Kineret (anakinra) – Swedish Orphan Biovitrum AB (publ)

What is Nucala?

Nucala is used to treat severe eosinophilic asthma, eosinophilic COPD, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is self-administered by injection subcutaneously (under the skin) every 4 weeks, or a healthcare provider or caregiver can give it.

Nucala autoinjector is approved for adults and children 12 years and older, while the prefilled syringe can be used for children as young as 6.

Nucala (mepolizumab) gained FDA approval on November 4, 2015. There is no generic or biosimilar.

FDA approvals and indications

Nucala is approved for: 

• Severe asthma with an eosinophilic phenotype in adults and children aged 6 years and older as an add-on maintenance treatment. It is not a rescue medicine for acute bronchospasm or status asthmaticus 
• Inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype in adults as an add-on maintenance treatment
•  Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults aged 18 years and older whose disease is not controlled with nasal corticosteroids, as an add-on maintenance treatment. Nucala helps reduce symptoms (such as nasal congestion, nasal discharge, mucus in the throat, and loss of smell) and may help prevent surgery for nasal polyps
• Eosinophilic granulomatosis with polyangiitis (EGPA) in adults
• Hypereosinophilic syndrome [HES] in adults and children 12 years and older that has been present for 6 months or longer without an identifiable non-hematologic secondary cause.

Mechanism

Nucala works by reducing levels of eosinophils in the blood. Eosinophils are a type of white blood cell that are involved in inflammation. The mechanism of action of Nucala involves targeting and preventing the immune system protein interleukin-5 (IL-5) from interacting with its receptor on eosinophils, reducing eosinophil levels and inflammation.

Nucala belongs to the drug class interleukin inhibitors. It may also be called a monoclonal antibody or a biologic.

Side effects

The most common side effects of Nucala are:

• headache
• feeling tired
• mouth or throat pain
• back pain, joint pain
• pain, swelling, redness, burning, or itching where the medicine was injected.

Serious side effects and warnings

Nucala can cause the following serious side effects:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen hours or days after you get your Nucala injection. Get emergency medical help if you have signs of an allergic reaction such as hives, a rash, wheezing, chest tightness, difficulty breathing, feeling like you might pass out, or swelling of your face, lips, tongue, or throat.
• Herpes zoster infections. Herpes zoster infections, which can cause shingles, have happened in
  people who received Nucala. Call your doctor if you have symptoms of herpes zoster, such as skin sores or blisters, itching, tingling, burning pain, or a rash on your face or torso. 

If you also use an oral or inhaled steroid medication, do not stop using it suddenly. Talk to your healthcare provider about this.

Nucala injection is not approved for use in:

• HES in a child younger than 12
• Asthma in a child younger than 6
• COPD, EPGA, or CRSwNP in adolescents and children younger than 18.

This is not a complete list of side effects, and others may occur. See the Nucala Prescribing Information for a full list, or call your doctor for more information.

Before using

Do not use Nucala if you are allergic to mepolizumab, Nucala, or any inactive ingredients in the injection.

Before receiving Nucla, tell your healthcare provider about all your medical conditions, including if you have ever:

• used an oral or inhaled steroid medicine
• had herpes zoster (also called shingles)
• had an infection caused by helminths (worm-like parasites).

Tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

You may be given a zoster (shingles) vaccine before starting your Nucala injection.

Pregnancy

It is not known if Nucala may harm your unborn baby. Tell your doctor if you become pregnant while using this medicine. Your name may be added to a pregnancy registry to track the effects of Nucala on the baby.

Breastfeeding

You and your healthcare provider should decide if you will use Nucala and breastfeed. You should not do both without talking with your healthcare provider first.

How is Nucala administered?

Nucala is injected under the skin, usually once every 4 weeks.

• It can be given under the skin of your thigh or stomach (abdomen) or a caregiver can administer it under the skin of the back of your upper arm.
• A healthcare provider can teach you how to use the medication before you give it to yourself. Or your healthcare provider can give it to you every 4 weeks.
• The single-dose prefilled autoinjector is for use by people 12 years and older, and the single-dose prefilled syringe is for children 6 years and older, to be administered by a caregiver.
• Each Nucala prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.

Read the Instructions for Use in the Nucala Package Insert that comes with Nucala or contact the MyNucala Patient Support Program for more details about self-administration.

Nucala is not a rescue medicine for asthma attacks. Use only a fast-acting bronchodilator such as albuterol for an asthma attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Dosing information

Dose of Nucala for severe eosinophilic asthma

• Adults and children 12 years and older: 100 mg SC 1 time every 4 weeks.
• Children aged 6 to 11 years: 40 mg SC 1 time every 4 weeks.

Dose of Nucala for chronic obstructive pulmonary disease (COPD) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of Nucala for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults

• 100 mg SC 1 time every 4 weeks.

Dose of Nucala for eosinophilic granulomatosis with polyangiitis (EGPA) in adults

• 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

Dose of Nucala for hypereosinophilic syndrome (HES)

• Adults and children aged 12 and older: 300 mg (as 3 separate 100mg injections) SC every 4 weeks.

What happens if I miss a dose?

If you miss a dose, inject a dose as soon as possible. Then continue (resume) your injection on your regular dosing schedule.

If you do not notice that you have missed a dose until it is time for your next scheduled dose, then inject the next scheduled dose as planned. Do not use two doses at one time.

If you are not sure when to inject Nucala, call your healthcare provider.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Nucala?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• oral or inhaled steroid medicines.

Other drugs may interact with Nucala, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using. Formal drug interaction trials have not been performed with Nucala.

Storage

Store the Nucala prefilled syringe or Nucala autoinjector in the original carton in a refrigerator. Do not freeze or shake the medicine.

• After removing the medicine from the carton, you must use it within 8 hours.

You may store the prefilled syringe or autoinjector in the unopened carton at room temperature for up to 7 days.

• Throw away a syringe or autoinjector left out of the refrigerator for longer than 7 days.

Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

Ingredients

Active Ingredient: mepolizumab.

Inactive Ingredients (vials): polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Inactive Ingredients (prefilled autoinjectors and prefilled syringes): citric acid monohydrate, EDTA, disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.

Nucala for injection is available as:

• 100 mg of lyophilized powder in a single-dose vial for reconstitution
• 100 mg/mL single-dose prefilled autoinjector/syringe
• 40 mg/0.4 mL single-dose prefilled syringe. 

Who makes Nucala?

Nucala (mepolizumab) is a prescription medication manufactured by GlaxoSmithKline (GSK), a multinational pharmaceutical company. GSK’s global headquarters are located in Brentford, London, United Kingdom. The company was formed through the merger of Glaxo Wellcome and SmithKline Beecham in 2000.

Nucala Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Nucala.Nucala (mepolizumab) – GlaxoSmithKline LLC

What is Actemra?

Actemra (tocilizumab) is a FDA approved biological medicine that is given by intravenous infusion or injection under the skin to treat specific patients with COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome.

Actrema was FDA approved to treat COVID-19 on December 21, 2022, for specific adult patients. Pediatric patients (aged 2 years to 18 years) with COVID-19 still have access to Actrema under emergency use authorization (EUA).

Actrema is a monoclonal antibody that blocks a protein in your body called interleukin-6 (IL-6).  If this protein is activated, it causes your immune system to be overactive which results in inflammation and the signs and symptoms of autoimmune disease. As Actrema blocks the interleukin-6 receptor, this is how it is thought to reduce the immune system from being overactive, so there is less inflammation and a reduction in the signs and symptoms of autoimmune diseases.

At a more technical level the mode of action (MOA) of Actrema is that it binds to IL-6 receptors (sIL-6R and mIL-6R) which have been shown to inhibit IL-6-mediated signaling through these receptors. Interleukin-6 is a pro-inflammatory cytokine that is made by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts.

Actemra can be used with other medications as part your complete treatment.

What is Actemra used for?

Actemra is indicated for the treatment of:

• Rheumatoid Arthritis (RA) Adult patients who have moderately to severely active rheumatoid arthritis and have tried one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs) but have had an inadequate response to them.
• Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. 
• Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Adult patients with systemic sclerosis-associated interstitial lung disease to slow the rate of decline in pulmonary function.
• Polyarticular Juvenile Idiopathic Arthritis (PJIA)  Patients 2 years of age and older who have active polyarticular juvenile idiopathic arthritis. 
• Systemic Juvenile Idiopathic Arthritis (SJIA)  Patients 2 years of age and older  who have active systemic juvenile idiopathic arthritis.
• Cytokine Release Syndrome (CRS) Adults and pediatric patients 2 years of age and older who have chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. 
• COVID-19: FDA approved for adult patients that are hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
• COVID-19: Emergency Use Authorisation for pediatric patients (2 years old to less than 18 years of age) with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Warnings

Actemra affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

Actemra may also cause a perforation (a hole or tear) in your stomach or intestines. Tell your doctor if you have a fever and stomach pain with a change in your bowel habits.

Actemra may also cause liver problems. Tell your doctor right away if you have right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Before you start treatment with Actemra, your doctor may perform tests to make sure you do not have tuberculosis or other infections. While using Actemra, you may need frequent medical tests.

Before taking this medicine

You should not use Actemra if you are allergic to Actemra.

Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Actemra is safe for you, tell your doctor if you have:

• an active or chronic infection;
• liver disease;
• diverticulitis, ulcers in your stomach or intestines;
• a nerve-muscle disease such as multiple sclerosis;
• diabetes;
• HIV, or a weak immune system;
• hepatitis B (or if you are a carrier of the virus);
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using Actemra may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant: Tell your baby’s doctor if you used Actemra during pregnancy. It could affect your baby’s vaccination schedule during the first months of life. Your name may be listed on a pregnancy registry to track the effects of tocilizumab on the baby.

How is Actemra given?

Use Actemra exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Before you use Actemra, your doctor may test you for tuberculosis or other infections.

Actemra is injected under the skin or into a vein. This medicine is usually given every 1 to 4 weeks for most conditions. For CRS, only one dose is usually given.

When injected into a vein, this medicine is given slowly for about 1 hour.

Read and carefully follow any Instructions for Use provided with the medicine. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject Actemra. Do not inject into the same place two times in a row.

Do not reuse a needle, syringe, or autoinjector. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you’ve had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

Tell your doctor if you have a planned surgery.

Use all your medications as directed. Do not change your dose or stop using a medicine without your doctor’s advice.

Store Actemra injection in the original carton in a refrigerator. Protect from moisture and light. Do not freeze. Throw away any prefilled syringes not used before the expiration date on the medicine label.

After removed from the refrigerator, the prefilled syringe and autoinjector can be stored up to 2 weeks at or below 86 F (30 C). Throw away the prefilled syringe or autoinjector after one use, even if there is still medicine left inside.

Actemra can have long-lasting effects on your body. You may need certain medical tests every 6 months after you stop using this medication.

Dosing information

Usual Adult Dose of Actemra for Rheumatoid Arthritis:

IV: 4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60-minute single drip infusion based on clinical response, doses exceeding 800 mg per infusion are not recommended
SUBCUTANEOUS:
-Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response
-Patients 100 kg or greater: 162 mg subcutaneously every week

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs.
-When transitioning from IV to subcutaneous, give the first subcutaneous dose instead of the next IV dose.

Use: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Usual Adult Dose of Actemra for Giant Cell Arteritis:

SUBCUTANEOUS:
-In combination with a tapering course of glucocorticoids, 162 mg subcutaneously once a week
-Based on clinical considerations, 162 mg subcutaneously once every other week in combination with a tapering course of glucocorticoids may be prescribed

Comments:
-This drug may be used alone following discontinuation of glucocorticoids.

Use: For the treatment of giant cell arteritis (GCA) in adult patients

Usual Adult Dose for Cytokine-Associated Toxicity:

IV:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

Comments:
-Doses exceeding 800 mg per infusion are not recommended.
-If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered.
-The interval between consecutive doses should be at least 8 hours.
-This drug may be used alone or in combination with corticosteroids.
-Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
-Subcutaneous route not approved for CRS.

Use: For the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

Polyarticular Juvenile Idiopathic Arthritis (PJIA):
IV formulation: 2 years or older
-Weight less than 30 kg: 10 mg/kg IV over 60 minutes every 4 weeks
-Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 4 weeks
SUBCUTANEOUS formulation:
-Weight less than 30 kg: 162 mg once every 3 weeks
-Weight 30 kg or more: 162 mg once every 2 weeks

Systemic Juvenile Idiopathic Arthritis (SJIA):
IV formulation: 2 years or older:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes every 2 weeks
-Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 2 weeks
SUBCUTANEOUS formulation:
-Weight less than 30 kg: 162 mg subcutaneously once every 2 weeks
-Weight 30 kg or more: 162 mg subcutaneously once a week

Comments:
-This drug may be used as monotherapy or concomitantly with methotrexate.
-Weight may fluctuate; therefore, dose adjustments should not be based on a single weight measurement.
-When transitioning from IV to subcutaneous, administer the first subcutaneous dose instead of the next IV dose.

Uses:
-For the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older
-For the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older

Usual Pediatric Dose for Cytokine-Associated Toxicity:

IV:
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes
-Weight 30 kg or above: 8 mg/kg IV over 60 minutes

Comments:
-Doses exceeding 800 mg per infusion are not recommended.
-If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered.
-The interval between consecutive doses should be at least 8 hours.
-This drug may be used alone or in combination with corticosteroids.
-Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
-Subcutaneous route not approved for CRS.

Use: For the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older

For dosage information on Systemic Sclerosis-Associated Interstitial Lung Disease and
Polyarticular Juvenile Idiopathic Arthritis click on the dosage link below.

For more detailed dosage information other conditions click on the link below.

Detailed Actemra dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What should I avoid while receiving Actemra?

While using Actemra: Do not receive a “live” vaccine or you could develop a serious infection. The vaccine may not work as well and may not fully protect you from disease.

• Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster ( shingles), and nasal flu (influenza) vaccine.
• You may still be able to receive a yearly flu shot, or an “inactivated” or other vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough.
• Ask your doctor before getting any vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Actemra side effects

Get emergency medical help if you have signs of an allergic reaction to Actemra: hives; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach cramps, bloating, diarrhea or constipation;
• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – loss of appetite, right-sided stomach pain, vomiting, confusion, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of infection – fever, chills, aches, skin sores, diarrhea, burning when you urinate;
• signs of tuberculosis: cough, shortness of breath, night sweats, loss of appetite, weight loss, and feeling very tired; or
• signs of perforation (a hole or tear) in your stomach or intestines – fever, ongoing stomach pain, change in bowel habits.

Common Actemra side effects may include:

• runny or stuffy nose, sinus pain, sore throat;
• headache;
• increased blood pressure;
• abnormal liver function tests; or
• pain, swelling, burning, or irritation where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Actemra side effects (more detail)

What other drugs will affect Actemra?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially other medicines to treat rheumatoid arthritis, such as:

• abatacept, etanercept;
• anakinra; or
• adalimumab, certolizumab, golimumab, infliximab, or rituximab.