Vamorolone (va-MOR-oh-lone)

Treats Duchenne muscular dystrophy. This medicine is a corticosteroid.

Brand Name(s):

Agamree

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine with food. Do not mix it with any type of liquid before taking or giving this medicine.
• Oral liquid:
  • Shake the bottle well for at least 30 seconds.
  • Place the open bottle on a flat surface. Insert the bottle adapter into the bottle by pushing it tightly into the top of the bottle. Do not remove the bottle adapter after it is inserted into the bottle.
  • Measure the oral liquid medicine with the provided oral dosing syringe.
  • Push the plunger completely down toward the tip of the syringe. Use one hand to hold the bottle upright. Insert the oral syringe tip firmly into the opening of the bottle adapter.
  • Hold the syringe in place and carefully turn the bottle upside down. Pull the plunger down slowly until you reach the prescribed dose. Do not pull the plunger out of the oral dispenser.
  • If there are large bubbles in the syringe or if you draw up the wrong dose, push the plunger all the way down so that the medicine flows back into the bottle. Pull the plunger down slowly until you reach the prescribed dose.
  • Leave the tip of the syringe in the bottle and turn the bottle to an upright position. Slowly remove the syringe tip from the bottle by pulling the syringe straight up. Do not hold the plunger because it may come out.
  • Place the tip of the oral syringe tip in the mouth towards the cheek and slowly push the plunger down. Do not forcefully push on the plunger. Do not give the medicine too fast into the back of the mouth or throat.
• If you are receiving steroid treatment (including prednisone, deflazacort), your doctor may switch you to this medicine anytime. Ask your doctor if you have questions.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may store the opened medicine in the refrigerator. Do not freeze.
• Throw away any unused liquid after 3 months of opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how vamorolone works. Tell your doctor if you are using itraconazole.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should receive live or live-attenuated vaccines at least 4 to 6 weeks before starting this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, adrenal or pituitary problems, blood clots, Cushing syndrome, diabetes, heart attack, heart failure, high blood sugar, high blood pressure, osteoporosis, pheochromocytoma, stomach or bowel problems, or thyroid problems.
• This medicine may cause the following problems:
  • Adrenal problems
  • High blood sugar levels
  • Increased risk of infection
  • Stomach or bowel perforation (tear or hole)
  • Changes in mood or behavior
  • Bone problems
  • Eye or vision problems, including cataracts and glaucoma
  • Slow growth in children
  • Muscle problem, including myopathy
  • Increased risk for cancer (including Kaposi's sarcoma)
  • Increased risk of blood clots
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools, diarrhea, stomach pain
• Blurred vision, eye pain, headache, tearing
• Bone pain
• Changes in behavior, trouble concentrating, trouble sleeping
• Changes in skin color, dark freckles, easy bruising, muscle weakness
• Chest pain, trouble breathing, coughing up blood
• Fever, chills, cough, sore throat, body aches
• Muscle pain, tenderness, wasting
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Slow growth in children
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088