Why is this medication prescribed?

Agamree, which is a generic form of vamorolone, is prescribed primarily for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone is a type of drug called a dissociative steroid, which is designed to reduce inflammation and muscle damage while aiming to have fewer side effects compared to traditional corticosteroids. It helps manage the symptoms and progression of DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.

How should this medicine be used?

Here are general guidelines for its use:

• Dosage: Follow your healthcare provider’s prescribed dosage exactly. The dosage may vary based on the patient’s condition and response to the medication.
• Administration: It’s typically taken orally, in the form of tablets or capsules. Ensure you swallow them whole without crushing or chewing.
• Timing: Take it with or without food as directed. Consistency in timing can help maintain stable levels of the medication in your body.
• Monitoring: Regular follow-ups with your healthcare provider are important to monitor effectiveness and any potential side effects.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it’s almost time for your next dose. Do not double up on doses to make up for a missed dose.
• Side Effects: Be aware of potential side effects such as weight gain, mood changes, or increased blood sugar. Report any severe or unusual symptoms to your healthcare provider.

Always consult your healthcare provider for personalized advice and before making any changes to how you take your medication.

Other uses for this medicine

While Agamree (vamorolone) is primarily used for Duchenne muscular dystrophy (DMD), its effects and potential benefits are being studied for other conditions. Currently, there are no widely accepted uses beyond DMD, but research may explore its potential for other inflammatory or muscular disorders.

What special precautions should I follow?

Special Precautions:

• Allergies: Inform your healthcare provider if you have any allergies, especially to corticosteroids or similar medications.
• Medical History: Share your full medical history, including any history of infections, liver problems, or gastrointestinal issues, as vamorolone can impact these areas.
• Drug Interactions: Discuss all other medications, including over-the-counter drugs and supplements, with your healthcare provider. Some interactions can affect how vamorolone works or increase the risk of side effects.
• Infections: Vamorolone may suppress the immune system, increasing the risk of infections. Avoid close contact with people who have infections and notify your doctor if you develop signs of an infection.
• Bone Health: Long-term use of corticosteroids can impact bone health. Your healthcare provider may monitor your bone density and recommend preventive measures if needed.
• Blood Sugar Levels: Monitor blood sugar levels, especially if you have diabetes or are at risk of diabetes, as corticosteroids can affect glucose metabolism.
• Growth Monitoring: In children, regular monitoring of growth and development is important, as corticosteroids can impact growth.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, consult your healthcare provider about the risks and benefits of using Agamree.
• Withdrawal: Do not stop taking Agamree abruptly without consulting your healthcare provider. Sudden discontinuation can lead to withdrawal symptoms or a worsening of your condition.

Always follow your healthcare provider’s advice and guidelines for managing your treatment with Agamree.

What special dietary instructions should I follow?

• Balanced Diet: Maintain a balanced diet rich in fruits, vegetables, and whole grains to support overall health.
• Limit Salt Intake: Corticosteroids can increase the risk of fluid retention and high blood pressure, so reducing salt intake can be beneficial.
• Monitor Weight: Keep an eye on your weight, as corticosteroids can lead to weight gain. Report any significant changes to your healthcare provider.

What should I do if I forget a dose?

• Timing: If you remember within a few hours of your missed dose, take it as soon as possible.
• Next Dose: If it’s almost time for your next dose, skip the missed dose. Do not take two doses at once to make up for a missed dose.
• Consult: Contact your healthcare provider or pharmacist if you’re unsure about what to do or if you miss doses frequently.

What side effects can this medication cause?

Agamree (vamorolone) can cause a range of side effects, though not everyone will experience them. The side effects are often related to its role as a corticosteroid-like medication. Here are some potential side effects:

Common Side Effects:

• Weight Gain: Increased appetite or fluid retention can lead to weight gain.
• Mood Changes: You might experience mood swings, anxiety, or depression.
• Gastrointestinal Issues: Nausea, vomiting, or stomach upset can occur.
• Increased Blood Sugar: Elevated blood sugar levels, which can be a concern for individuals with diabetes or prediabetes.

Less Common but Serious Side Effects:

• Infections: Due to immune system suppression, there may be an increased risk of infections.
• Bone Health Issues: Long-term use can lead to bone thinning (osteoporosis) and an increased risk of fractures.
• Hypertension: Increased blood pressure may occur, so regular monitoring is essential.
• Eye Problems: Potential issues such as cataracts or glaucoma, especially with long-term use.
• Growth Delays: In children, long-term use might affect growth and development.
• Adrenal Insufficiency: The body’s natural production of steroid hormones might be affected, leading to potential symptoms like fatigue or weakness.
• Severe Allergic Reactions: Symptoms may include rash, itching, or swelling.
• Psychiatric Effects: Rarely, severe mood changes or behavior changes can occur.

Immediately report any severe or persistent side effects to your healthcare provider. Keep up with regular check-ups to monitor for potential side effects. Adhere to your healthcare provider’s guidance to minimize the risk of side effects. Your healthcare provider can provide more detailed information about potential side effects and how to manage them based on your specific health needs.

What should I know about storage and disposal of this medication?

Storage and Disposal of Agamree:

Storage:

• Temperature: Store Agamree at room temperature, away from excess heat and moisture. Typically, this means keeping it in a cool, dry place.
• Container: Keep the medication in its original container with the lid tightly closed to protect it from moisture and contamination.
• Children and Pets: Store out of reach of children and pets to prevent accidental ingestion.

Disposal:

• Medication Take-Back Programs: If you need to dispose of Agamree, use a medication take-back program if available. Many communities offer drug take-back days or have designated drop-off locations.
• Disposal Instructions: If no take-back program is available, follow the specific disposal instructions provided by your pharmacist or on the medication label.
• Household Trash: If instructed to dispose of it in household trash, mix the medication with an undesirable substance (like used coffee grounds or kitty litter), place it in a sealed plastic bag, and then throw it away. This helps prevent accidental ingestion.

In case of emergency/overdose

• Contact Emergency Services: If you suspect an overdose or experience severe symptoms, seek emergency medical attention immediately. Call emergency services or go to the nearest emergency room.
• Call Poison Control: You can also call your local poison control center for guidance on what to do in case of an overdose. They can provide specific instructions based on the situation.
• Symptoms of Overdose: Watch for symptoms like severe headache, dizziness, nausea, vomiting, or other unusual effects.

What other information should I know?

• Adherence: Take Agamree exactly as prescribed by your healthcare provider. Do not adjust the dosage without consulting them.
• Regular Monitoring: Attend all follow-up appointments and screenings as directed to monitor for side effects and assess the effectiveness of the treatment.
• Communication: Keep open communication with your healthcare provider about any new or worsening symptoms or side effects.
• Interactions: Inform your healthcare provider about all other medications and supplements you are taking to avoid potential interactions.
• Pregnancy and Breastfeeding: Discuss with your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding to understand the risks and benefits.

Always follow your healthcare provider’s instructions and guidelines for the safe use, storage, and disposal of Agamree.