Agamree Vamorolone Application Scope

Agamree, with the active ingredient vamorolone, is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 2 years and older.

Agamree Vamorolone Characteristics

Ingredients: Vamorolone
Properties: Vamorolone is a first-in-class steroidal anti-inflammatory drug that binds to the same receptors as corticosteroids but modifies downstream activity, potentially reducing typical steroid-associated side effects.
Specification: Oral suspension
Packaging Specification: Available in bottles containing 105 mL of oral suspension
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
Expiry Date: Refer to the packaging for expiration date
Executive Standard: Complies with FDA-approved prescribing information
Approval Number: NDA 214769
Date of Revision: September 2023
Manufacturer: Catalyst Pharmaceuticals, Inc.

Guidelines For The Use Of Agamree Vamorolone

Dosage and Administration:
- The recommended starting dose is 2 mg/kg orally once daily.
- The dose may be increased to 6 mg/kg daily based on clinical response and tolerability.
- Administer the oral suspension using an oral dosing syringe.
- Shake the bottle well before each use.
Adverse Reactions:
- Common adverse reactions include facial puffiness (cushingoid features), psychiatric disorders, vomiting, weight gain, and vitamin D deficiency.
- Serious adverse reactions may include increased risk of infection, hypertension, gastrointestinal perforation, behavioral and mood changes, osteoporosis, cataracts, and glaucoma.
Contraindications:
- Patients with known hypersensitivity to vamorolone or any of its inactive ingredients.
Precautions:
- Do not abruptly discontinue Agamree; tapering may be necessary to reduce the risk of adrenal insufficiency.
- Monitor patients for signs of infection; advise avoiding exposure to chickenpox or measles.
- Regularly monitor blood pressure and for signs of fluid retention.
- Assess bone health periodically due to the risk of osteoporosis.
- Perform regular eye examinations to detect cataracts or glaucoma.
- Ensure immunizations are up to date before initiating therapy; avoid live vaccines during treatment.

Agamree Vamorolone Interactions

Drug Interactions:

Concomitant use of CYP3A4 inducers or inhibitors may affect vamorolone plasma concentrations.
Coadministration with other corticosteroids may increase the risk of adverse effects.
Monitor for potential interactions with anticoagulants, antidiabetic agents, and vaccines.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.