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

Cinryze is a man-made form of a protein that occurs naturally in the blood stream and helps control swelling in the body. People with a condition called hereditary angioedema do not have enough of this protein. Hereditary angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Cinryze is used to prevent attacks of angioedema.

The Berinert brand of complement C1 esterase inhibitor is used to treat attacks of angioedema.

Warnings

You should not use Cinryze if have ever had a life-threatening allergic reaction to complement C1 esterase inhibitor.

Before you receive Cinryze, tell your doctor if you have a history of stroke or blood clot.

Do not give this medication to a child without medical advice.

You may be shown how to use Cinryze in an IV at home. Cinryze comes with patient instructions for safe and effective use. Follow all directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not self-inject Cinryze if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine. Be sure you understand how to properly mix and store the medication. Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Cinryze is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Before taking this medicine

You should not use Cinryze if have ever had a life-threatening allergic reaction to complement C1 esterase inhibitor.

Tell your doctor if you have ever had:

• a stroke or blood clot;
• heart problems; or
• an “in-dwelling” catheter.

Tell your doctor if you are pregnant or breast-feeding.

Cinryze is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How should I use Cinryze?

Use Cinryze exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Cinryze is injected into a vein through an IV.

You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Cinryze is usually given every 3 or 4 days to prevent angioedema attacks.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Cinryze is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using this medicine at home, you will need to use two vials to make up a single dose. Follow all directions carefully. Be sure you understand how to properly mix and store the medicine.

Gently swirl but do not shake the mixed medicine or you may ruin it. Prepare your dose only when you are ready to give yourself an injection.

The powder and diluent mixture should be clear and colorless. Mixed Cinryze should be clear or slightly blue in color. Do not use the mixed medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of Cinryze is for one use only. Throw it away after one use, even if there is still medicine left inside.

Cinryze contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away.

Store the unmixed dry powder in a refrigerator or at cool room temperature. Protect from light and do not freeze. Throw away any unused vial after the expiration date on the label has passed.

After mixing Cinryze with the diluent, use the injection right away or store the mixture at room temperature and use it within 3 hours.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Dosing information

Usual Adult Dose for Hereditary Angioedema:

For routine prophylaxis against angioedema attacks in HAE patients.
1,000 Units by intravenous infusion at a rate of 1 mL per minute (1,000 units/ 10 mL) every 3 or 4 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

Keep this medicine on hand at all times to prevent angioedema, especially while traveling.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid after using Cinryze?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Cinryze side effects

Get emergency medical help if you have signs of an allergic reaction to Cinryze: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden numbness or weakness on one side of the body;
• pain, swelling, warmth, or redness in an arm or leg;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• chest pain while taking deep breaths; or
• fast heart rate.

Common Cinryze side effects may include:

• unusual or unpleasant taste in your mouth;
• headache, dizziness;
• nausea, vomiting;
• pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
• stuffy nose, sore throat;
• rash; or
• fever.

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

What other drugs will affect Cinryze?

Tell your doctor about all your other medicines, especially:

• testosterone; or
• birth control pills.

This list is not complete. Other drugs may interact with complement C1 esterase inhibitor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Cinryze 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 Cinryze.Cinryze (C1 Esterase Inhibitor (Human)) – Takeda Pharmaceuticals U.S.A., Inc.

Cimzia injection is used to treat Crohn’s disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-radiographic axial spondyloarthritis in certain patients. Cimzia works to reduce inflammation and improve symptoms by blocking a protein called TNFα (tumor necrosis factor alpha).  Cimzia (certolizumab  pegol) belongs to the drug class TNF alfa inhibitors.

In autoimmune conditions, like Crohn’s disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis inflammation can be caused or worsened when TNF is released in the body. By Cimzia blocking TNFα there is less inflammation so symptoms of the condition improve.

Cimzia first received FDA approval on April 22, 2008, for moderate to severe active Crohn’s disease in adults who have an inadequate response to conventional therapy to reduce signs and symptoms of the disease and to maintain clinical response. Since then, it has also been approved for specific adult patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

Cimzia Indications

Cimzia FDA-approved indications for adults are 

• Crohn’s disease for reducing signs and symptoms and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• active rheumatoid arthritis  that is moderate to severe
• active psoriatic arthritis
• active ankylosing spondylitis 
• active non-radiographic axial spondyloarthritis with objective signs of inflammation
• plaque psoriasis that is moderate to severe in patients who are candidates for systemic therapy or phototherapy.

Cimzia FDA-approved indication for patients 2 years of age and older is 

• active polyarticular juvenile idiopathic arthritis (pJIA)

Cimzia side effects

Common Cimzia side effects may include rash, pain or burning when you urinate, and cold symptoms such as stuffy nose, sneezing, and a sore throat.

Serious Cimzia side effects

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

Serious and sometimes fatal infections may occur during treatment with Cimzia. Tell your doctor if you have signs of infection, such as fever, chills, cough, sweating, muscle pain, open sores or skin wounds, unusual tiredness, feeling short of breath, painful urination, diarrhea, or weight loss.

Call your doctor right away if you have any of these symptoms of lymphoma:

• chest pain, cough, feeling short of breath;
• swelling in your neck, underarm, or groin (this swelling may come and go);
• fever, night sweats, itching, weight loss, feeling tired;
• feeling full after eating only a small amount; or
• pain in your upper stomach that may spread to your back or shoulder.

Stop using Cimzia and call your doctor at once if you have Cimzia side effect symptoms of:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• pale skin, easy bruising or bleeding;
• a new growth on your skin (may be red or purple), or any change in the size or color of a mole, freckle, or bump on your skin;
• nerve problems – vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
• liver problems – loss of appetite, right-sided stomach pain, tiredness, jaundice (yellowing of the skin or eyes); or
• new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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

Warnings

Cimzia affects your immune system. Serious and sometimes fatal infections may occur.

Your risk of infection may be higher if you have diabetes, HIV, a weak immune system, hepatitis B, chronic infections, if you use certain medications, or if you live in or travel to certain areas.

Call your doctor at once if you have symptoms such as fever, chills, cough, diarrhea, night sweats, flu symptoms, or skin sores.

Using Cimzia may also increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal.

Do not receive a “live” vaccine while you are being treated with Cimzia.

Do NOT use this medicine if you have had a serious hypersensitivity reaction to certolizumab pegol or to any of the inactive ingredients. 

Before taking this medicine

You should not use Cimzia if you are allergic to certolizumab. You may not be able to use Cimzia if you have symptoms of an infection such as fever, chills, cough, skin sores, shortness of breath, weight loss, diarrhea, or painful urination.

Tell your doctor if you have ever had tuberculosis, or 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.

Cimzia may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Tell your doctor if you have ever had:

• a chronic infection;
• hepatitis B (or if you are a carrier of the virus);
• lymphoma or other types of cancer;
• a blood cell disorder;
• congestive heart failure;
• a seizure;
• an allergy to latex;
• numbness or tingling, or a nervous system disorder such as multiple sclerosis; or
• if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

It is not known whether Cimzia will harm an unborn baby. Tell your doctor if you are pregnant. Your name may be listed on a pregnancy registry to track the effects of Cimzia on the baby.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Cimzia is not approved for use by anyone younger than 18 years old.

How is Cimzia given?

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

Cimzia is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor’s dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Cimzia if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your 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.

Cimzia can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

Store Cimzia in its original carton in the refrigerator. Protect from light and do not freeze.

Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.

Unopened prefilled syringes may also be stored at room temperature for up to 7 days, away from heat and light. Throw away any prefilled syringe not used within 7 days. Do not put it back in the refrigerator.

Each prefilled syringe is for one use only. Throw 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.

If you’ve ever had hepatitis B, using Cimzia can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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

Dosing information

Usual Adult Cimzia Dose for Rheumatoid Arthritis

Initial Cimzia dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Maintenance Cimzia dose: 400 mg subcutaneously every 4 weeks can be considered
Use: For the treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Usual Adult Cimzia Dose for Psoriatic Arthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active ankylosing spondylitis

Usual Adult Cimzia Dose for Crohn’s Disease

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4
Maintenance dose: 400 mg subcutaneously every 4 weeks
Use: For reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Plaque Psoriasis

Initial dose: 400 mg subcutaneously (given as 2 subcutaneous injections or 200 mg) every other week
For certain patients with body weight <=90 kg: 400 mg (given as 2 subcutaneous injections or 200 mg) at weeks 0, 2, and 4 followed by 200 mg every other week can be considered
Use: For the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Usual dose for Polyarticular Juvenile Idiopathic Arthritis  patients 2 years of age and older)

Dose is weight dependant, every other week:

10 kg (22 lbs) to less than 20 kg (44 lbs): dose 100 mg initially and at week 2 and 4, followed by maintenance dose of 50 mg every other week
20 kg (44 lbs) to less than 40 kg (88 lbs): dose 200 mg initially and at week 2 and 4, followed by a maintenance dose of 100 mg every other week
Greater than or equal to 40 kg (88 lbs): dose 400 mg initially and at week 2 and 4, followed by  a maintenance dose of 200 mg every other week 

General Cimzia Dosing Information

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Cimzia is available as 200 mg lyophilized powder in a single-dose vial and 200 mg/mL solution in a single-dose prefilled syringe

Withdrawal from Cimzia

Your healthcare profession will guide you on how long you will use Cimzia.
Withdrawal from Cimzia may be required if you have severe allergic reactions.  Clinical trials have also studied reducing the dose of Cimza and stopping Cimza after sustained low disease activity in treating rheumatoid arthritis. However, the NCT01521923 clinical study failed to meet its primary endpoint.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Cimzia?

Avoid injecting Cimzia into scars or stretch marks, or into skin that is red, bruised, swollen, hard, or tender.

Ask your doctor before receiving any vaccine while you are being treated with Cimzia.

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.