Vamorolone is a steroid medicine that is used to treat Duchenne muscular dystrophy in people at least 2 years old.

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

You should not use vamorolone if you are allergic to it or any of its ingredients.

Steroids can weaken your immune system, making it easier for you to get an infection or worsen an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially a bacterial, fungal or viral infection.

Tell your doctor if you have or have ever had:

• high blood pressure;
• a stomach ulcer;
• a stomach or intestinal disorder such as ulcerative colitis or diverticulitis;
• a stomach or intestinal surgery;
• heart disease or prior heart attack, congestive heart failure;
• if you recently received a vaccine or are scheduled to receive a vaccine;
• cataracts, glaucoma, or a fungal or viral infection in your eyes (including herpes simplex);
• been exposed to chickenpox or measles, or if you recently traveled;
• a problem with your thyroid, pituitary gland, or adrenal gland such as pheochromocytoma (tumor of the adrenal gland);
• diabetes;
• a blood clot or blood clotting disorder;
• a nerve-muscle disorder, such as myasthenia gravis; or
• liver or kidney disease.

Make sure you are current on all vaccines before you start using vamorolone. Any "live" vaccines should be current 4 to 6 weeks before starting vamorolone.

Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

You may be more likely to have a broken bone while using vamorolone. Talk with your doctor about ways to keep your bones healthy. Ask your doctor about this risk.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Agamree (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• weakness, diarrhea, burning when you urinate;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, missed menstrual periods, sexual changes;
• signs of a blood clot--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg, sudden numbness or weakness (especially on one side of the body);
• signs of hepatitis reactivation--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
• low blood potassium or calcium--muscle spasms, cramps or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes), constipation, irregular heartbeats, fluttering in your chest;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself;
• any skin lesion, no matter how mild;
• muscle weakness, sudden pain or trouble moving your hip, wrist, or back;
• blurred vision, eye pain or redness, seeing halos around lights; or
• severe headache, pounding in your neck or ears, shortness of breath (even while lying down).

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

Your treatment may be delayed or your dose may be reduced if you have certain side effects.

Common side effects may include:

• weight gain, swelling;
• changes in mood or behavior;
• acne, increased facial or body hair growth;
• vomiting, tiredness; or
• low blood vitamin D levels.

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

Avoid receiving a "live" vaccine and being near people who are sick or have infections while taking vamorolone. 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 this medicine.