Metreleptin (Subcutaneous)
Medically reviewed by Drugs.com. Last updated on May 20, 2022.
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of metreleptin efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of metreleptin efficacy during treatment. Contact Amryt Pharmaceuticals DAC at 1-866-216-1526 for neutralizing antibody testing of clinical samples .T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with metreleptin. Carefully consider the benefits and risks of treatment with metreleptin in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy .Because of these risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or metreleptin and the risk for lymphoma, metreleptin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Myalept(TM) REMS Program .
Commonly used brand name(s)
In the U.S.
- Myalept
Available Dosage Forms:
- Powder for Solution
Uses for metreleptin
Metreleptin injection is used together with a proper diet as replacement therapy to treat problems caused by leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
Metreleptin is only available under a restricted distribution program called Myalept® REMS program.
Before using metreleptin
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For metreleptin, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to metreleptin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metreleptin injection in children.
Geriatric
Although appropriate studies on the relationship of age to the effects of metreleptin injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving metreleptin injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other case..