Vamorolone Suspension

What is this medication?

VAMOROLONE (va MOR oh lone) treats Duchenne muscular dystrophy (DMD), an inherited condition that causes muscle weakness. It works by decreasing inflammation and slowing down an overactive immune system. This helps to maintain muscle strength. It belongs to a group of medications called steroids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AGAMREE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Glaucoma
• Heart failure
• High blood pressure
• History of blood clots
• Infection
• Kidney disease
• Myasthenia gravis
• Osteoporosis, weak bones
• Pheochromocytoma
• Recent heart attack
• Recent or upcoming vaccine
• Stomach ulcers, other stomach or intestine problems
• Thyroid disease
• An unusual or allergic reaction to vamorolone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take it with food. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Live virus vaccines

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

Talk to your care team about your vaccination history. To lower your risk of infection, you may need certain vaccines before you start this medication.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

This medication may cause cataracts or glaucoma, especially with long-term use. You should have regular eye exams while taking this medication. Tell your care team if you have changes in your eyesight.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Cushing syndrome—increased fat around the midsection, upper back, neck, or face, pink or purple stretch marks on the skin, thinning, fragile skin that easily bruises, unexpected hair growth
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stomach pain that is severe, does not go away, or gets worse
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Acne
• General discomfort and fatigue
• Headache
• Increase in appetite
• Nausea
• Trouble sleeping
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Before first use: Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container.

After first use: Store in the refrigerator. Do not freeze. Keep this medication in the original container. Get rid of any unused medication after it expires or 3 months after opening, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.