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Overview: Agamree is used to treat a muscle disorder called Duchenne muscular dystrophy. It is a type of medicine called a steroid, and it may help your muscles work better. Call your health care provider if you notice a rounded face, weight gain in your upper body, fat buildup in your upper back or base of the neck, thinning skin that bruises easily, or any unusual changes in your mood or behavior. Tell your health care provider right away if you get a fever or any other symptom of an infection.

Uses

What is Agamree used for?

Agamree (vamorolone) is commonly used to treat a certain muscle disorder called Duchenne muscular dystrophy (DMD).

Agamree may also be used for other conditions as determined by your health care provider.

How does Agamree work (mechanism of action)?

Agamree is a type of medicine called a corticosteroid. In DMD, Agamree may help your muscles work better, which may make it easier for you to move. 

How is Agamree supplied (dosage forms)?

Brands and other names

  • Agamree

Dosage forms and strengths

  • 40 mg/mL oral suspension

How should I store Agamree?

Agamree should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

After you open the bottle of Agamree, store it upright in a refrigerator, between 36 F and 46 F (2 C and 8 C). Do not put it in the freezer. If you have any medicine left three months after opening the bottle, throw the rest of it away.

Side Effects

What are the most common side effects of Agamree?

The most common side effects of Agamree are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Cushing’s syndrome (see below)
  • Mental health problems (see below)
  • Vomiting
  • Increased weight
  • Low levels of vitamin D

There may be other side effects of Agamree that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Agamree?

While less common, the most serious side effects of Agamree are described below, along with what to do if they happen.

Severe Allergic Reactions. Agamree may cause allergic reactions, which can be serious. Stop taking Agamree and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cushing’s Syndrome. Taking Agamree at high doses or for a long time may increase your risk for Cushing’s syndrome. Cushing’s syndrome is a condition that happens when your body is exposed to too much cortisol (the stress hormone). The risk may be higher in children. Call your health care provider if you have any of the following symptoms of Cushing’s syndrome.

  • A rounded face that may have a rosy color 
  • Weight gain, especially in the upper body
  • A fat buildup in the upper back or base of the neck
  • Thinning skin that bruises easily
  • Feeling very weak or tired
  • Depression or anxiety
  • High blood sugar
  • High blood pressure
  • Sleep problems

Reduced Adrenal Function. Agamree can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone) if it is stopped suddenly. This is known as adrenal insufficiency and can be life-threatening. Take Agamree as prescribed, and follow your health care provider’s instructions if they want you to stop taking Agamree. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Your health care provider may prescribe you a steroid to take if your body is under stress while you are taking Agamree. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Low blood pressure

High Blood Sugar. Agamree may increase your blood sugar levels. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments with your health care provider for blood tests. Call your health care provider if you have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Infections. Agamree can increase your risk of infections, including serious infections that can be life-threatening. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Increased Blood Pressure (Hypertension). Agamree may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Stomach or Intestinal Tears. Agamree can increase your risk of tears (perforation) in your gut. The risk is higher if you have a history of stomach ulcers, diverticulitis, or other gut problems. Get emergency help if you have any of the following symptoms.

  • Vomit blood
  • Black or tarry poop
  • Stomach pain that does not go away
  • Upset stomach
  • Feel faint

Mental Health Problems. Agamree commonly causes certain mental health problems that can lead to serious behavioral or mood changes (mood disorders). The risk is higher in the first few months of taking the medicine or when the dose is changed. Depression or other serious mental health conditions are the most important causes of suicidal thoughts or actions. If you or your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider or your child’s health care provider right away if any of the following symptoms occur.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior
  • Euphoria (feeling really happy)
  • Trouble sleeping
  • Irritability
  • Aggressive behavior

Bone Problems. Agamree may make it harder for bones to grow in children. Using Agamree for a long time may also cause your bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause your bones to break (fracture) more easily. Tell your health care provider if you break a bone, and get a bone mineral density test if one is ordered for you.

Eye Problems. Agamree may cause certain eye problems, including cataracts, glaucoma, and eye infections. Keep all appointments to have your eyes checked. Tell your health care provider right away if you have any of the following symptoms.

  • Trouble seeing faraway objects
  • Loss of vision or vision that’s cloudy, blurry, foggy, or filmy
  • Changes in the way you see color
  • Eye pain, redness, or itchiness
  • Swollen or itchy eyelids
  • Severe headache or vomiting
  • Seeing bright, colorful circles around lights (vision halos)

Blood Clots. Agamree may cause a blood clot in your veins, called venous thromboembolism (VTE). A blood clot that travels to your lungs is called a pulmonary embolism. A blood clot in your legs or arms is called a deep venous thrombosis. Stop using Agamree and get emergency help if you have any of the following signs of a blood clot.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Fast breathing or shortness of breath
  • Pain, swelling, or tenderness in your arm or leg
  • Red or warm skin in your arm or leg

Warnings & Precautions

Who should not use Agamree?

Allergies to Ingredients. People who are allergic to any of the following should not take Agamree.

  • Agamree
  • Vamorolone
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Agamree.

What should I know about Agamree before using it?

Do not take Agamree unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Agamree with other people, even if they have the same condition as you. It may harm them.

Keep Agamree out of the reach of children. Since this medicine should be kept in a refrigerator after it is opened, take special precautions to keep it away from children who also use the refrigerator.

If you have visited the tropics or have diarrhea, make sure to tell your health care provider before you take Agamree.

Shake the bottle of Agamree well for about 30 seconds before measuring out your dose. You should use a timer to make sure you shake the bottle for the full 30 seconds. Only use the oral syringe that comes with Agamree to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist if you have any questions on how to take Agamree.

Agamree should be taken with a meal.

Do not stop taking Agamree without talking to your health care provider. Stopping too quickly may cause serious side effects, such as reduced adrenal function. See the Side Effects section for more details.

Steroid medicines can slow growth and development in children, especially when taken for a long time. If you have a child taking Agamree, keep all of their appointments, including their regular checkups. This way, your child’s health care provider can keep track of your child’s height and weight.

If you take Agamree and are not immune to chickenpox (varicella) or measles, you could have serious problems from these diseases. You may not be immune if you have never had chickenpox or measles or never received vaccines for them. If you are not immune, stay away from anyone with chickenpox or measles. Tell your health care provider right away if you get symptoms of either measles or chickenpox.

What should I tell my health care provider before using Agamree?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Agamree is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • A condition in which your pituitary gland does not work properly, called hypopituitarism
  • Problems with your adrenal glands, including adrenal insufficiency or congenital adrenal hyperplasia
  • Problems with your thyroid, including hypothyroidism or hyperthyroidism
  • Pheochromocytoma
  • Diabetes
  • Past or current infections, including tuberculosis, chickenpox (varicella), measles, hepatitis B, fungal or parasitic infections, or malaria
  • Immune system problems or get infections a lot
  • Heart problems, such as heart failure or a recent heart attack
  • Kidney or liver problems
  • High blood pressure
  • Stomach or intestinal problems, such as ulcers or diarrhea
  • Low bone mineral density or osteoporosis
  • Blood clots
  • Fluid retention (edema)

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Agamree. Tell your health care provider about any vaccines you have recently received or have scheduled.

Muscle Problems or Upcoming Surgeries. Tell your health care provider if you have any conditions that cause your nerves and muscles to not work properly, such as myasthenia gravis, or any upcoming surgeries or procedures. The risk of muscle problems caused by Agamree may be increased if you are taking certain medicines used during surgeries or have any medical conditions that affect your muscles.

Other Medicines and Supplements. Agamree may interact with other medicines and supplements. Before taking Agamree, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. People who can become pregnant are not usually prescribed Agamree.

Breastfeeding. People who can breastfeed are not usually prescribed Agamree.

How can I get more information about Agamree?

For more information about Agamree, you can visit the drugmaker’s website at www.agamree.com or call them at 833-422-8259.

Interactions

Does Agamree interact with foods or drinks?

There are no known interactions between Agamree and foods or drinks.

It is unknown if drinking alcohol will affect Agamree.

Does Agamree interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are taking any of the following before taking Agamree.

  • Itraconazole (Sporanox, Tolsura), which is a medicine used for fungal infections
  • A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels

Some other medicines may alter the blood levels of Agamree, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Agamree. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Agamree?

If you or someone else has used too much Agamree, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Agamree?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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