The package insert of Agamree provides comprehensive information on the use of the medication, including its indications, administration methods, and precautions. This article will conduct an in-depth interpretation of each section of the package insert to help patients understand the medication's functions and usage rules, ensuring the maximum efficacy and reliability of drug use.
Agamree(vamorolone): Clinical Uses, Recommended Dosage, Potential Side Effects
(I) Indications
AGAMREE is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients aged 2 years and older.
(II) Dosage and Administration
1. Assessment Before Initial Medication
Before initiating AGAMREE treatment, all necessary immunizations should be completed in accordance with immunization guidelines.
For live vaccines or live-attenuated vaccines, they should be administered at least 4 to 6 weeks before starting AGAMREE.
2. Administration Information
The recommended usual dose is 6 mg/kg orally once daily, preferably with meals. For patients weighing more than 50 kg, the maximum daily dose is 300 mg.
Some patients may respond to a dose of 2 mg/kg per day, and the dose can be reduced to 2 mg/kg per day based on individual tolerance.
3. Recommended Dose for Patients with Hepatic Impairment
For patients with mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment, the recommended dose is 2 mg/kg orally once daily, preferably with meals. For patients weighing more than 50 kg, the maximum daily dose is 100 mg.
The dose can be appropriately adjusted downward based on individual tolerance.
4. Important Preparation and Administration Procedures
Shake the AGAMREE oral suspension well for approximately 30 seconds before use.
Use only the oral syringe provided with the product: draw the appropriate dose into the syringe and administer the liquid directly into the mouth.
Any remaining liquid in the opened bottle that has not been used within 3 months should be discarded.
5. Switching from Other Corticosteroids to AGAMREE
Patients can switch from oral corticosteroids (such as prednisone or prednisolone) to AGAMREE without interruption, and there is no need to first reduce the dose of the corticosteroid, which reduces the risk of adrenal insufficiency.
For patients who have been receiving oral corticosteroids for a long time, the switch can start at a dose of 6 mg/kg per day.
6. Dose Adjustment When Used Concomitantly with Strong CYP3A4 Inhibitors
When used concomitantly with strong CYP3A4 inhibitors (such as itraconazole), the recommended dose of AGAMREE should be adjusted to 4 mg/kg orally once daily, preferably with meals. For patients weighing more than 50 kg, the maximum daily dose is 200 mg.
The dose can be appropriately adjusted downward based on individual tolerance.
7. Dose Tapering When Discontinuing the Medication
If AGAMREE has been used continuously for more than one week, the dose must be gradually reduced to lower the risk of adrenal insufficiency caused by sudden discontinuation.
(III) Target Population
This medication is suitable for patients with clinically confirmed Duchenne Muscular Dystrophy, and the applicable age is 2 years and older.
(IV) Contraindications
AGAMREE is contraindicated in the following patients: those who are allergic to vamorolone or any inactive ingredients (excipients) in this preparation (including patients who have experienced allergic reactions or anaphylactic shock).
(V) Side Effects
Adverse reactions mainly include (some data are extracted from clinical trial experience):
Cushingoid-like changes: including manifestations such as moon face, hirsutism, and fragile skin;
Psychiatric and behavioral disorders: including mood swings, insomnia, agitation, and even depression or psychotic symptoms;
Gastrointestinal reactions: such as vomiting, diarrhea, etc.;
Weight gain and vitamin D deficiency;
Others: Some patients may experience cough, headache, increased appetite, runny nose, etc.
Long-term use may also lead to endocrine disorders (such as adrenal cortical function suppression, Cushing's syndrome, elevated blood glucose), decreased bone mineral density, ocular complications, and an increased risk of infections caused by immunosuppression.
(VI) Precautions
1. Abnormal Endocrine Function
Long-term use of corticosteroids may cause hypothalamic-pituitary-adrenal axis suppression, leading to Cushing's syndrome, diabetes mellitus, and adrenal insufficiency. The dose should be gradually reduced when discontinuing the medication.
2. Immunosuppression and Infection Risk
AGAMREE can cause a decrease in systemic immune function, increasing the risk of new infections, reactivation of latent infections, and exacerbation of existing infections. When infection symptoms occur, patients should seek medical attention promptly, and consideration should be given to adjusting the dose or discontinuing the medication.
3. Monitoring of Cardiovascular and Renal Function
Monitor blood pressure and electrolyte (sodium, potassium) levels. Caution should be exercised when using the medication in patients at risk of heart failure, hypertension, or renal insufficiency.
4. Gastrointestinal Risk
For patients with active or potential gastric ulcers and a risk of intestinal perforation, a thorough assessment should be conducted before use; this is because corticosteroids can mask the symptoms of gastrointestinal perforation.
5. Behavioral and Mood Changes
Abnormal mood or behavior may occur in the early stage of medication use. Family members and patients need to closely observe. If symptoms such as depression or suicidal tendencies appear, medical attention should be sought promptly.
6. Impact on Bone Metabolism
Long-term medication use may lead to decreased bone mineral density and an increased risk of fractures. Bone status should be evaluated regularly, and bone protection therapy should be administered if necessary.
7. Ocular Effects
Long-term treatment may cause cataracts, glaucoma, or other ocular infections. It is recommended that patients who use the medication continuously for more than 6 weeks undergo regular monitoring of intraocular pressure and visual acuity.
8. Immunization
Before starting treatment, necessary vaccinations should be completed in accordance with immunization guidelines; live vaccines should be administered 4 to 6 weeks before the start of treatment.
(VII) Therapeutic Effects
Evaluated through multicenter, randomized, double-blind, placebo-controlled trials, AGAMREE has shown significant clinical efficacy in improving patients' muscle function (such as the speed of standing up, walking distance, and 10-meter walking speed). Its therapeutic effects were superior to those of the placebo group in clinical trials. The overall conclusion is that AGAMREE, as a new type of corticosteroid, can play a positive role in improving the motor function of patients with Duchenne Muscular Dystrophy.
(VIII) Drug Interactions
1. Strong CYP3A4 Inhibitors
Concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole) may increase the systemic exposure of vamorolone. It is recommended that when used concomitantly, the dose of AGAMREE be adjusted to 4 mg/kg per day, with a maximum daily dose not exceeding 200 mg for patients weighing more than 50 kg.
2. Moderate or Weak CYP3A4 Inhibitors
No special dose adjustment is required when AGAMREE is used concomitantly with moderate or weak CYP3A4 inhibitors.
In vitro studies have shown that vamorolone has the effect of inducing CYP3A4, which may reduce the blood concentration of other drugs that are substrates of CYP3A4, but this phenomenon has not been confirmed in clinical studies.
(IX) Storage Conditions
Unopened products: Should be stored upright in the original packaging at room temperature ranging from 20°C to 25°C (68°F to 77°F), with an allowable temperature fluctuation range of 15°C to 30°C (59°F to 86°F).
After opening: The bottle should be stored upright in a refrigerator at 2°C to 8°C (36°F to 46°F); do not freeze.
Any AGAMREE oral suspension that has not been used within 3 months after opening should be discarded.
Kind Reminder: The package inserts of some products are updated frequently. Please refer to the actual product for the most accurate information.
