Agamree is mainly indicated for the treatment of Duchenne Muscular Dystrophy (DMD) patients aged 4 years and older, regardless of their underlying mutations and ambulatory status. Accurate mastery of its dosage and administration is crucial for therapeutic efficacy and patient safety. This article will elaborate on the dosage and administration of Agamree in detail. The recommended regular dose of Agamree is 6mg per kilogram of body weight, taken orally once daily, preferably with meals.

What is the Dosage and Administration of Agamree?

Before initiating Agamree treatment, patients must complete all necessary immunizations to avoid potential risks associated with vaccination in an immunosuppressed state.

Regular Dosage and Administration Route

The recommended regular dose of Agamree is 6mg/kg, administered orally once daily. It is preferably taken with meals to enhance the drug’s absorption rate. For patients with a body weight exceeding 50 kilograms, the maximum daily dose is set at 300mg.

Dose Tapering Upon Discontinuation

If a patient has been taking the drug continuously for more than one week, the dose must be gradually reduced when discontinuing the medication. This is to lower the risk of adrenal insufficiency caused by sudden discontinuation, a step that is vital for protecting the stability of the patient’s endocrine system.

Side Effects of Agamree

During Agamree treatment, patients must undergo comprehensive physical examinations regularly to detect and manage any potential issues in a timely manner.

Common Adverse Reactions

Agamree may cause a series of adverse reactions during treatment, including Cushingoid-like changes (e.g., moon face, hirsutism, fragile skin), psychiatric and behavioral disorders (e.g., mood swings, insomnia, agitation), gastrointestinal reactions (e.g., vomiting, diarrhea), as well as weight gain and vitamin D deficiency. Most of these reactions are mild to moderate and tolerable for the majority of patients.

Long-Term Use Risks

Long-term use of Agamree may also lead to endocrine disorders (e.g., adrenal cortical suppression, Cushing’s syndrome, elevated blood glucose), decreased bone mineral density, ocular complications (e.g., cataracts, glaucoma), and an increased risk of infections due to immunosuppression. Physicians must monitor the patient’s endocrine function, bone mineral density, and ocular health regularly, and adjust the treatment plan promptly if necessary.

Agamree Use in Special Populations

Special precautions should be observed when using Agamree in special populations.

Pregnant and Lactating Women

Currently, there is no safety data on Agamree use in pregnant women. Its use during pregnancy requires a careful weighing of the benefits and risks. For lactating women, there is no data on the secretion of vamorolone in breast milk. However, systemic glucocorticoids may be excreted in breast milk and potentially affect the infant’s growth and development. Lactating women using Agamree need to balance the benefits of breastfeeding against potential risks.

Patients with Hepatic or Renal Impairment

For patients with mild to moderate hepatic impairment, the recommended dose has been adjusted accordingly. For patients with severe hepatic impairment, there is currently no clinical experience with Agamree use, so specific dose recommendations cannot be provided. Recommendations for dose adjustments in patients with renal impairment have also not been specified in the package insert.

A more cautious medication strategy must be adopted for special populations.