Oral budesonide is used to treat the following conditions with inflammation as a symptom:

• Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [budesonide oral suspension 2 mg/10 mL])
• Active, mild to moderate Crohn’s disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [budesonide extended-release capsules 3 mg, 6 mg, 9 mg])
• Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [budesonide extended-release tablets 9 mg])
• Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [budesonide delayed release capsules 4 mg])

Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids.

Budesonide is a potent anti-inflammatory corticosteroid, 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism).

Budesonide oral FDA approvals are as follows:

• Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic.
• Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available.
• Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]).  
• Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available.
• Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic. 

Budesonide side effects

The most common side effects of budesonide oral suspension (Eohilia) are:

• respiratory tract infection
• sore throat
• fungal infections of the mouth, throat, and esophagus (thrush)
• adrenal suppression
• headache
• acid-related damage to the lining of the esophagus (erosive esophagitis)
• infection of the stomach and intestine (gastroenteritis).

The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion 
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain.

The most common side effects of budesonide delayed-release capsules (Tarpeyo) are:

• swelling of the lower legs, ankles, and feet
• high blood pressure
• muscle spasms
• acne
• headache
• upper respiratory tract infection
• swelling of the face
• weight increase
• indigestion
• irritation or inflammation of the skin
• joint pain
•  increased white blood cell count

The most common side effects of budesonide extended release tablets (Uceris, generic) are:

• headache
• nausea
• decreased blood cortisol levels
• stomach-area pain
• tiredness
• stomach or intestinal gas
• bloating
• acne
• urinary tract infection
• joint pain
• constipation.

Serious side effects and warnings

Budesonide (oral) may cause the following serious side effects:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
  • acne
  • thicker body hair and facial hair
  • bruise easily
  • a fatty pad or hump between your shoulders (buffalo hump)
  • rounding of your face
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
  • ankle swelling.
• Adrenal suppression. Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
  • tiredness
  • nausea and vomiting
  • weakness
  • low blood pressure.
• Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also:
  • make current infections worse
  • increase the risk of infections spreading (disseminated)
  • increase the risk of making infections active again or making infections worse that have not been active (latent)
  • hide (mask) some signs of infection

These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as:

• • fever
  • cough
  • chills
  • pain
  • stomach area (abdominal) pain
  • feeling tired
  • aches 
  • nausea and vomiting
  • diarrhea.
• Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide.
• Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
• Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide.
• Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms.
• Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include
  • white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or
  • swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur.
• Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as:
  • heartburn
  • chest pain
  • trouble swallowing.
• Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide.
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide.
• Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

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

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

Before taking this medicine

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products.

Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you:

• have liver problems
• are planning to have surgery
• have chicken pox or measles, or have recently been near anyone with chicken pox or measles
• have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections
• parasitic infections, including threadworm (Strongyloides) infections
• herpes simplex infection of the eye (ocular herpes simplex)
• have or had tuberculosis
• have malaria of the brain (cerebral malaria)
• have an infection of the mouth, throat, or esophagus
• have diabetes or glaucoma, or have a family history of diabetes or glaucoma
• have cataracts
• have high blood pressure (hypertension)
• have low bone mineral density or osteoporosis
• have stomach ulcers
• have a weak immune system
• have unexplained diarrhea
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Pregnancy

Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.

Breastfeeding

It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.

The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

How you take budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension

Eohilia stick packs

See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.

• Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
• Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
• Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
• After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.

Do not mix Eohilia with food or liquid.

Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.

Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.

Budesonide extended-release capsules

Entocort EC extended-release capsules and generic

Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.

• Take Entocort EC 1 time each day in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:

1. Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2. Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
3. Carefully empty all of the granules inside the capsule on the applesauce.
4. Stir the granules with the applesauce.
5. Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
6. Do not save the applesauce and granules for later use.

Ortikos extended-release capsules

Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.

• Take Ortikos 1 time each day, in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

Budesonide extended-release tablets

Uceris extended-release tablets and generic

Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.

• Take Uceris 1 time each day in the morning with or without food.
• Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.

Budesonide delayed-release capsules

Tarpeyo delayed-release capsules

Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.

• Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
• Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.

Dosing information

The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension 2 mg/10 mL

Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.

• 2mg is contained in one Eohilia stick pack.

Budesonide extended-release capsules

Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 9 mg once daily for up to 8 weeks
• Repeat 8-week courses with recurring episodes of active disease
• Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.

Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 6 mg once daily for up to 3 months.
• Taper to complete cessation after 3 months.
• Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.

Budesonide delayed-release tablets 

Dosage for ulcerative colitis (Uceris, generic)

• 9 mg once daily in the morning with or without food for up to 8 weeks.

Budesonide delayed-release capsules

Dosage for the treatment of IgAN in adults (Tarpeyo)

• 16 mg once daily
• Take in the morning at least 1 hour before food.
• The recommended duration of therapy is 9 months.
• When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I take too much budesonide?

If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking budesonide?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid receiving a “live” vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What other drugs will affect budesonide?

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

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.

Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.

Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Keep all medicines out of the reach of children.

Ingredients

Eohilia ingredients

Active ingredient: budesonide

Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Entocort EC ingredients

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Ortikos ingredients

Active ingredient: budesonide

Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.

Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.

The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.

Uceris ingredients

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Tarpeyo ingredients

Active ingredient: budesonide

Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.

The capsules contain: hypromellose and titanium oxide (E171).

The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).

The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who makes budesonide?

Budesonide is made by various manufacturers.

Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.

Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.

• A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.

Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.

Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.

• A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.

Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.

What is Kenalog-40?

Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions, including severe allergic reactions, skin disorders (including those caused by autoimmune disorders), severe colitis, inflammation of the joints or tendons, blood cell disorders, inflammatory eye disorders, lung disorders, and problems caused by low adrenal gland hormones. Kenalog-40 contains triamcinolone acetonide 40mg/mL.

Kenalog-40 was FDA-approved on February 1, 1965.

Warnings

• Rarely, anaphylactic reactions have occurred in patients receiving corticosteroids, including triamcinolone acetonide injections.
• Because Kenalog-40 is a suspension, it must not be administered intravenously.
• You may not be able to receive Kenalog-40 if you have a fungal infection, or a condition called idiopathic thrombocytopenic purpura (ITP).
• Kenalog-40 injection contains benzyl alcohol and exposure to excessive amounts has been associated with toxicity (such as hypotension and metabolic acidosis), particularly in neonates, and an increased risk of kernicterus (a type of brain damage caused by high levels of bilirubin in a baby’s blood). The amount of benzyl alcohol that causes toxicity is unknown but the combined daily amount of benzyl alcohol from all sources must be considered.
• If given intramuscularly, Kenalog-40 should be injected deeply into a large muscle, such as a gluteal muscle, rather than a deltoid muscle, because of the increased risk of local atrophy (shrinkage of tissue).
• Kenalog-40 is long-acting and not useful in acute stress situations. Supportive corticosteroid treatments may be necessary in times of stress, such as trauma, surgery, or severe illness during treatment with Kenalog-40 and for a year afterward.
• High dosages should not be used for the treatment of traumatic brain injury.

Before taking this medicine

You should not be treated with Kenalog-40 if you are allergic to it.

You may not be able to receive Kenalog-40 if you have an infection or a condition called idiopathic thrombocytopenic purpura (ITP).

Corticosteroids such as Kenalog-40 can affect your body’s response to vaccines. Administration of live or live attenuated vaccines is contraindicated.

Tell your doctor if you have ever had:

• an active or chronic infection, including tuberculosis
• idiopathic thrombocytopenic purpura (ITP)
• high blood pressure, heart problems, a recent heart attack
• cataracts, glaucoma, or herpes infection of the eyes
• a colostomy or ileostomy, or stomach surgery
• a head injury
• a nerve-muscle disorder, such as myasthenia gravis
• a parasite infection that causes diarrhea (such as threadworms)
• a previously unstable or infected joint or one you suspect is currently infected
• a problem with your thyroid or adrenal gland
• a peptic ulcer, diverticulitis, ulcerative colitis
• kidney of liver disease
• low bone mineral density.

Children are more susceptible to the effects of corticosteroids and the use of Kenalog-40 can lead to bone growth inhibition in pediatric patients and growth suppression

Tell your doctor if you are pregnant or breastfeeding.

Corticosteroids such as Kenalog-40 are teratogenic in many species when given in doses equivalent to the human dose and animal studies have shown a higher incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Administer only if the potential benefit justifies the risk.

Systemically administered corticosteroids such as Kenalog-40 appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Be cautious when administering to a breastfeeding woman.

How is Kenalog-40 given?

Kenalog-40 is given through a needle and can be injected into different areas of the body: into a muscle, into the space around a joint or tendon, or a lesion on the skin. A healthcare provider will give you this injection.

Systemic (intramuscular)

The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending on the condition being treated and the person being treated.

• The suggested initial intramuscular dose is 60mg, injected deep into the gluteal muscle then dosage is usually adjusted within the range of 40mg to 80mg. Some patients may be controlled on dosages as low as 20mg or less.
• The dose should be individualized and the lowest dose used to control the condition.
• Single seasonal injections of 40mg to 100mg may be effective for patients with hay fever or pollen asthma not responding to conventional therapy.
• For children, an initial dosage range of 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m²bsa/day) is suggested.

Intra-articular

Single local injections are usually sufficient but several injections may be needed.

Initial dose: 2.5mg – 5 mg (up to 10mg) for smaller joints and from 5mg – 15mg (up to 40mg) for larger joints.

Other information

Kenalog-40 can weaken (suppress) your immune system, and you may get an infection more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, weakness, cold or flu symptoms, skin sores, diarrhea, frequent or recurring illness). Viral infections, such as chickenpox or measles may have a more serious or even fatal course in children and adults.

Long-term use of steroids can cause harmful effects on the eyes. If you receive Kenalog-40 for longer than 6 weeks, your doctor may want you to have regular eye exams.

Your doctor may instruct you to limit your salt intake while you are receiving Kenalog-40. You may also need to take potassium supplements. Follow all instructions.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Kenalog-40.

You should not stop using Kenalog-40 suddenly after long-term repeated use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for a scheduled Kenalog-40.

When Kenalog-40 is used as a single dose, you will not be on a regular dosing schedule.

What happens if I overdose?

Since Kenalog-40 is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Using too much Kenalog-40 is not likely to cause serious problems. However, long-term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while receiving Kenalog-40?

After injection of triamcinolone into a joint, avoid overusing that joint through strenuous activity or high-impact sports. You could cause damage to the joint.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Kenalog-40.

Do not receive a “live” vaccine or a toxoid vaccine while using Kenalog-40, 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. Toxoid vaccines include diphtheria-tetanus toxoid (DT or Td).

What are the side effects of Kenalog-40?

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

Kenalog-40 may cause serious side effects. Call your doctor at once if you have:

• (after injection into a joint space) increased pain or swelling, joint stiffness, fever, and general ill feeling
• blurred vision, tunnel vision, eye pain, or seeing halos around lights
• unusual changes in mood or behavior
• swelling, rapid weight gain, feeling short of breath
• stomach cramps, vomiting, diarrhea, bloody or tarry stools, rectal irritation
• sudden numbness or weakness (especially on one side of the body)
• a seizure (convulsions)
• severe headache, blurred vision, pounding in your neck or ears
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes
• signs of low adrenal gland hormones–flu-like symptoms, headache, depression, weakness, tiredness, diarrhea, vomiting, stomach pain, craving salty foods, and feeling light-headed.

Certain side effects may be more likely with long-term use or repeated doses of Kenalog-40, such as osteoporosis.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Kenalog-40.

Common side effects of Kenalog-40 may include:

• skin changes (acne, dryness, redness, bruising, discoloration)
• increased hair growth, or thinning hair
• nausea, bloating, appetite changes
• stomach or side pain
• cough, runny or stuffy nose
• fluid retention
• headache, sleep problems (insomnia)
• a wound that is slow to heal
• sweating more than usual
• changes in your menstrual periods.

What is Medrol?

Medrol is a steroid that prevents the release of substances in the body that cause inflammation.

Medrol is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

Medrol may also be used for purposes not listed in this medication guide.

Medrol side effects

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

Medrol may cause serious side effects. Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• bruising, thinning skin, or any wound that will not heal;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe depression, changes in personality, unusual thoughts or behavior;
• new or unusual pain in an arm or leg or in your back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• seizure (convulsions); or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Medrol.

Common side effects of Medrol may include:

• fluid retention (swelling in your hands or ankles);
• dizziness, spinning sensation;
• changes in your menstrual periods;
• headache;
• mild muscle pain or weakness; or
• stomach discomfort, bloating.

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

You should not use this medicine if you have a fungal infection anywhere in your body.

Before taking this medicine

You should not use Medrol if you are allergic to it, or if you have:

• a fungal infection anywhere in your body.

Medrol can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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

• a thyroid disorder;
• herpes infection of the eyes;
• stomach ulcers, ulcerative colitis, or diverticulitis;
• depression, mental illness, or psychosis;
• liver disease (especially cirrhosis);
• high blood pressure;
• osteoporosis;
• a muscle disorder such as myasthenia gravis; or
• multiple sclerosis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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

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

How should I take Medrol?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Medrol is sometimes taken every other day. Follow your doctor’s dosing instructions very carefully.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Medrol.

You should not stop using Medrol suddenly. Follow your doctor’s instructions about tapering your dose.

Wear a medical alert tag or carry an ID card stating that you take Medrol. Any medical care provider who treats you should know that you take steroid medication.

If you need surgery, tell the surgeon ahead of time that you are using Medrol. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of methylprednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Medrol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while using Medrol. The vaccine may not work as well during this time, 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.

What is methylprednisolone?

Methylprednisolone is a corticosteroid medicine that prevents the release of substances in the body that cause inflammation.

Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

Methylprednisolone may also be used for purposes not listed in this medication guide.

Warnings

You should not use this medicine if you have a fungal infection anywhere in your body.

Before taking methylprednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. Do not receive a “live” vaccine while using this medicine. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using methylprednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Any doctor, dentist, or emergency medical professional who treats you should know that you take steroid medication.

Before taking this medicine

You should not use methylprednisolone if you are allergic to it, or if you have:

• a fungal infection anywhere in your body.

Methylprednisolone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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

• a thyroid disorder;
• herpes infection of the eyes;
• stomach ulcers, ulcerative colitis, or diverticulitis;
• depression, mental illness, or psychosis;
• liver disease (especially cirrhosis);
• high blood pressure;
• osteoporosis;
• a muscle disorder such as myasthenia gravis; or
• multiple sclerosis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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

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

How should I take methylprednisolone?

Take methylprednisolone exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Methylprednisolone is sometimes taken every other day. Follow your doctor’s dosing instructions very carefully.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using methylprednisolone.

You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.

Wear a medical alert tag or carry an ID card stating that you take methylprednisolone. Any medical care provider who treats you should know that you take steroid medication.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

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 .

An overdose of methylprednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What to avoid

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while using methylprednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, oral typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

Methylprednisolone side effects

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

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• bruising, thinning skin, or any wound that will not heal;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe depression, changes in personality, unusual thoughts or behavior;
• new or unusual pain in an arm or leg or in your back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• seizure (convulsions); or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common methylprednisolone side effects may include:

• fluid retention (swelling in your hands or ankles);
• dizziness, spinning sensation;
• changes in your menstrual periods;
• headache;
• mild muscle pain or weakness; or
• stomach discomfort, bloating.

What is prednisolone?

Prednisolone is a corticosteroid that may be used to reduce inflammation and calm down an overactive immune system. It works by mimicking the effects of cortisol, a hormone released by the adrenal glands (located on top of the kidneys) that regulates metabolism and stress. Prednisolone prevents the release of substances in the body that cause inflammation.

Prednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

Prednisolone has predominantly glucocorticoid activity, which means it mainly affects our immune response and reduces inflammation, rather than affecting the body’s balance of electrolytes and water (this is called mineralocorticoid activity).

Prednisolone was FDA approved in 1955.

Warnings

You should not use prednisolone if you have a fungal infection anywhere in your body.

Before taking this medicine

You should not use prednisolone if you are allergic to it, or if you have:

• a fungal infection anywhere in your body.

Prednisolone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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

• active tuberculosis;
• a thyroid disorder;
• herpes infection of the eyes;
• stomach ulcers, ulcerative colitis, or diverticulitis;
• depression, mental illness, or psychosis;
• liver disease (especially cirrhosis);
• high blood pressure;
• osteoporosis;
• a muscle disorder such as myasthenia gravis; or
• multiple sclerosis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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

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

How should I take prednisolone?

Take prednisolone exactly as prescribed by your doctor. Your doctor may occasionally change your dose. Do not use prednisolone in larger or smaller amounts or for longer than recommended.

Prednisolone is sometimes taken every other day. Follow your doctor’s dosing instructions very carefully.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

You may need to shake the oral suspension (liquid) well just before you measure a dose. Follow the directions on your medicine label.

Keep prednisolone disintegrating tablets in their blister pack until you are ready to take the medicine. Open the package using dry hands, and peel back the foil from the tablet blister (do not push the tablet through the foil). Remove the tablet and place it in your mouth. Allow the disintegrating tablet to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Prednisolone can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisolone.

You should not stop using prednisolone suddenly. Follow your doctor’s instructions about tapering your dose.

Wear a medical alert tag or carry an ID card stating that you take prednisolone. Any medical care provider who treats you should know that you take steroid medication.

If you need surgery, tell the surgeon ahead of time that you are using prednisolone. You may need to stop using the medicine for a short time.

Store prednisolone at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of prednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking prednisolone?

Do not receive a “live” vaccine while using prednisolone. The vaccine may not work as well during this time, 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.

Do not receive a smallpox vaccine or you could develop serious complications.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Prednisolone side effects

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

Prednisolone may cause serious side effects. Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• bruising, thinning skin, or any wound that will not heal;
• severe depression, changes in personality, unusual thoughts or behavior;
• new or unusual pain in an arm or leg or in your back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• severe pain in your upper stomach spreading to your back, nausea and vomiting;
• a seizure (convulsions); or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using prednisolone.

Common side effects of prednisolone may include:

• fluid retention (swelling in your hands or ankles);
• dizziness, spinning sensation;
• changes in your menstrual periods;
• headache;
• muscle pain or weakness; or
• stomach discomfort, bloating.

What is Agamree?

Agamree (vamorolone) is a novel corticosteroid used to treat Duchenne muscular dystrophy (DMD) to help improve motor function. Agamree works to reduce inflammation by blocking the production of proteins (cytokines) that cause inflammation. As well as improving motor function Agamree also has potentially less side effects on bone health, growth rate, and behavior. 

Agamree is an oral suspension that is given once a day. 

Agamree mechanism of action is through the glucocorticoid receptor where it has anti-inflammatory and immunosuppressive effects, although its precise mechanism of action is still unknown.

Agamree FDA approval

Agamree FDA approval is for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Agamree FDA approval was granted Santhera Pharmaceuticals (USA), Inc., on October 26, 2023. FDA approval was based on positive results from Vamorolone clinical trial VISION-DMD (NCT03439670), which showed it was a safe and effective treatment for boys with DMD. 

What is Duchenne Muscular Dystrophy?

Duchenne Muscular Dystrophy is a rare and life-threatening neuromuscular disorder with progressive muscle weakness so it becomes too difficult to carry out daily activities and advances to respiratory failure and death.  DMD is a hereditary disorder that results in muscle fiber damage and weakness. 

Agamree Side effects 

The most common Agamree side effects are cushingoid features, psychiatric disorders, vomiting, weight gain, and vitamin D deficiency, these side effects affected more than 10% of patients and more than the placebo group.

Serious Agamree side effects include: 

• Immunosuppression and increased risk of infection – seek medical advice immediately if the patient develops a fever or other signs of infection. Patients and caregivers should be made aware that some infections can potentially be severe and fatal. Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to tell their healthcare provider immediately if they are exposed to these.
• Change in cardiovascular and kidney function – increase in blood pressure and water retention.
• Changes in behavior and mood disturbances – seek medical attention if psychiatric symptoms develop 
• Lower bone mineral density – the risk of osteoporosis 
• Eye effects – may cause cataracts or glaucoma
• Muscle weakness  when used with neuromuscular blocking agents (e.g., pancuronium) or patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) 
• Kaposi’s Sarcoma
• Blood clots (venous thromboembolism)

What to avoid

Avoid exposure to chickenpox or measles.

Important information

Vaccination: Immunizations should be up-to-date according to immunization guidelines before starting therapy with Agamree. Live-attenuated or live vaccines should be administered at least 4 to 6 weeks before starting Agamree. Inform patients and caregivers that they may receive concurrent vaccinations with the use of Agamree, except for live-attenuated or live vaccines.

Stopping treatment: Do not stop taking Agamree abruptly or without first checking with your healthcare providers, as there may be a need for gradual dose reductions to decrease the risk of adrenal insufficiency crisis. 

Hyperglycemia: Corticosteroids can increase blood glucose, worsen pre-existing diabetes, predispose those on long-term therapy to diabetes mellitus, and may reduce the effect of anti-diabetic drugs. 

Patients with Altered Thyroid Function: Clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in the thyroid status of the patient may require a dose change of corticosteroid.

Pheochromocytoma Crisis: In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids.

Immunosuppression and increased risk of infection: Agamree suppresses the immune system and increases the risk of viral, bacterial, fungal, protozoan, or helminthic infections.

Gastrointestinal Perforation: There is an increased risk of gastrointestinal perforation  when corticosteroids are used in patients with certain gastrointestinal disorders.

Growth and Development Long-term use of corticosteroids can have negative effects on growth and development in children.

Before taking this medicine

Do not take Agamree if you are allergic or have hypersensitivity to the active ingredient vamorolone or any of the inactive ingredients. 

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant.
There are no data on the use of Agamree during pregnancy.  Corticosteroids, in general, should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Agamree is indicated for use in the treatment of DMD, which is a disease of young male patients. 

Breastfeeding

Talk to your healthcare provider if you are breastfeeding or planning to breastfeed while taking Agamree. There are no data on the presence of vamorolone in human milk or the effects on milk production. However, by taking corticosteroids, it will appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant. Agamree is indicated for use in the treatment of DMD, which is a disease of young male patients. 

How should I take Agamree?

Advise the patients and caregivers to read the FDA-approved patient labeling (Instructions for Use).

Agamree instructions

• Agamree oral suspension should be taken once daily, preferably with a meal.
• The suspension must be shaken well for about 30 seconds prior to measuring out each dose with the enclosed oral syringe. 
• Discard any unused Agamree oral suspension after 3 months of first opening the bottle.

Do NOT stop taking Agamree suddenly or without first checking with your healthcare providers, there may be a need for gradual dose reductions to decrease the risk of adrenal insufficiency crisis.

Agamree Dosing information

The usual Agamree dosage is 6 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 300 mg for patients weighing more than 50 kg.

Comments

• In patients with mild to moderate hepatic impairment, the recommended dosage is 2 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 100 mg for patients weighing more than 50 kg. 
• The recommended dosage of Agamree when given with strong CYP3A4 inhibitors is 4 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 200 mg for patients weighing more than 50 kg
• Decrease dosage gradually when administered for more than one week.

Agamree is available as: 40 mg/mL Oral Suspension

What other drugs will affect Agamree?

Other drugs may affect Agamree, 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.

Tell your doctor if taking itraconazole, a strong CYP3A4 inhibitor, as the drug interaction will increase Agamree levels.

Not all possible interactions are listed here.

Does Agamree interact with my other drugs?

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

Agamree Prescribing Information

Review the Agamree Prescribing Information for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. 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 Prescribing Information (PI)  Agamree Package Insert or FDA label.

Storage

• Store at room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) in the original carton. 
• After opening, store in a refrigerator 2°C to 8°C (36°F to 46°F). 
• Always store the bottle upright.
• Do not freeze.
• Discard any unused oral suspension remaining after 3 months of first opening the bottle.

Ingredients

Active ingredient: vamorolone

Inactive ingredients: citric acid (monohydrate), disodium phosphate, glycerin, hydrochloric acid (for pH adjustment), orange flavor, sodium benzoate, sucralose, water, and xanthan gum.

What is Agamree?

Agamree (vamorolone) is a novel corticosteroid used to treat Duchenne muscular dystrophy (DMD) to help improve motor function. Agamree works to reduce inflammation by blocking the production of proteins (cytokines) that cause inflammation. As well as improving motor function Agamree also has potentially less side effects on bone health, growth rate, and behavior. 

Agamree is an oral suspension that is given once a day. 

Agamree mechanism of action is through the glucocorticoid receptor where it has anti-inflammatory and immunosuppressive effects, although its precise mechanism of action is still unknown.

Agamree FDA approval

Agamree FDA approval is for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Agamree FDA approval was granted Santhera Pharmaceuticals (USA), Inc., on October 26, 2023. FDA approval was based on positive results from Vamorolone clinical trial VISION-DMD (NCT03439670), which showed it was a safe and effective treatment for boys with DMD. 

What is Duchenne Muscular Dystrophy?

Duchenne Muscular Dystrophy is a rare and life-threatening neuromuscular disorder with progressive muscle weakness so it becomes too difficult to carry out daily activities and advances to respiratory failure and death.  DMD is a hereditary disorder that results in muscle fiber damage and weakness. 

Agamree Side effects 

The most common Agamree side effects are cushingoid features, psychiatric disorders, vomiting, weight gain, and vitamin D deficiency, these side effects affected more than 10% of patients and more than the placebo group.

Serious Agamree side effects include: 

• Immunosuppression and increased risk of infection – seek medical advice immediately if the patient develops a fever or other signs of infection. Patients and caregivers should be made aware that some infections can potentially be severe and fatal. Warn patients who are on corticosteroids to avoid exposure to chickenpox or measles and to tell their healthcare provider immediately if they are exposed to these.
• Change in cardiovascular and kidney function – increase in blood pressure and water retention.
• Changes in behavior and mood disturbances – seek medical attention if psychiatric symptoms develop 
• Lower bone mineral density – the risk of osteoporosis 
• Eye effects – may cause cataracts or glaucoma
• Muscle weakness  when used with neuromuscular blocking agents (e.g., pancuronium) or patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) 
• Kaposi’s Sarcoma
• Blood clots (venous thromboembolism)

Agamree side effects (more detail)

What to avoid

Avoid exposure to chickenpox or measles.

Important information

Vaccination: Immunizations should be up-to-date according to immunization guidelines before starting therapy with Agamree. Live-attenuated or live vaccines should be administered at least 4 to 6 weeks before starting Agamree. Inform patients and caregivers that they may receive concurrent vaccinations with the use of Agamree, except for live-attenuated or live vaccines.

Stopping treatment: Do not stop taking Agamree abruptly or without first checking with your healthcare providers, as there may be a need for gradual dose reductions to decrease the risk of adrenal insufficiency crisis. 

Hyperglycemia: Corticosteroids can increase blood glucose, worsen pre-existing diabetes, predispose those on long-term therapy to diabetes mellitus, and may reduce the effect of anti-diabetic drugs. 

Patients with Altered Thyroid Function: Clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in the thyroid status of the patient may require a dose change of corticosteroid.

Pheochromocytoma Crisis: In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids.

Immunosuppression and increased risk of infection: Agamree suppresses the immune system and increases the risk of viral, bacterial, fungal, protozoan, or helminthic infections.

Gastrointestinal Perforation: There is an increased risk of gastrointestinal perforation  when corticosteroids are used in patients with certain gastrointestinal disorders.

Growth and Development Long-term use of corticosteroids can have negative effects on growth and development in children.

Before taking this medicine

Do not take Agamree if you are allergic or have hypersensitivity to the active ingredient vamorolone or any of the inactive ingredients. 

Pregnancy

Talk to your healthcare provider if you are pregnant or plan to become pregnant.
There are no data on the use of Agamree during pregnancy.  Corticosteroids, in general, should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Agamree is indicated for use in the treatment of DMD, which is a disease of young male patients. 

Breastfeeding

Talk to your healthcare provider if you are breastfeeding or planning to breastfeed while taking Agamree. There are no data on the presence of vamorolone in human milk or the effects on milk production. However, by taking corticosteroids, it will appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant. Agamree is indicated for use in the treatment of DMD, which is a disease of young male patients. 

How should I take Agamree?

Advise the patients and caregivers to read the FDA-approved patient labeling (Instructions for Use).

Agamree instructions

• Agamree oral suspension should be taken once daily, preferably with a meal.
• The suspension must be shaken well for about 30 seconds prior to measuring out each dose with the enclosed oral syringe. 
• Discard any unused Agamree oral suspension after 3 months of first opening the bottle.

Do NOT stop taking Agamree suddenly or without first checking with your healthcare providers, there may be a need for gradual dose reductions to decrease the risk of adrenal insufficiency crisis.

Agamree Dosing information

The usual Agamree dosage is 6 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 300 mg for patients weighing more than 50 kg.

Comments

• In patients with mild to moderate hepatic impairment, the recommended dosage is 2 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 100 mg for patients weighing more than 50 kg. 
• The recommended dosage of Agamree when given with strong CYP3A4 inhibitors is 4 mg/kg taken orally once daily, preferably with a meal, up to a maximum daily dosage of 200 mg for patients weighing more than 50 kg
• Decrease dosage gradually when administered for more than one week.

Agamree is available as: 40 mg/mL Oral Suspension

What other drugs will affect Agamree?

Other drugs may affect Agamree, 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.

Tell your doctor if taking itraconazole, a strong CYP3A4 inhibitor, as the drug interaction will increase Agamree levels.