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Myalept
Metreleptin
$8165.00
11.3mg · 1 vial
BrandBranded medicine· By Chiesi
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FDA boxed warningRisk of anti-metreleptin antibodies with neutralizing activity and risk of lymphoma
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT 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 MYALEPT efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. 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 MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT 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 MYALEPT and the risk for lymphoma, MYALEPT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYALEPT REMS PROGRAM.
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences are not well characterized but could include inhibition of endogenous leptin action and loss of MYALEPT efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during MYALEPT treatment. Contact Chiesi Farmaceutici S.p.A. at 1-866-216-1526 for neutralizing antibody testing.,
MYALEPT is available only through a restricted program called the MYALEPT REMS PROGRAM.
About Myalept
Overview
Myalept (metreleptin) is a medicine that acts as a replacement for leptin, a hormone normally made by body fat. It is used alongside diet to treat complications of leptin deficiency in people with congenital or acquired generalized lipodystrophy, a condition involving loss of body fat. It works by activating leptin receptors, helping provide the signal that tells the brain about the body’s energy stores.
What it treats
- Complications of leptin deficiency in people with congenital or acquired generalized lipodystrophy, used as replacement therapy alongside diet.
Safety information
Side effects
Common side effects include headache, low blood sugar, weight loss and abdominal pain. Serious risks include antibodies that may block the action of the body’s own leptin or make Myalept less effective. Contact your doctor if you develop a severe infection or the treatment seems to stop working; testing for these antibodies is recommended. Other serious risks include T-cell lymphoma and worsening autoimmune disease. Your doctor should carefully weigh the benefits and risks if you have significant blood-related abnormalities, acquired generalized lipodystrophy or an autoimmune disease. Low blood sugar is a particular concern if you also use insulin or medicines that stimulate insulin release. Blood glucose needs close monitoring, and your prescriber may need to adjust those medicines. Allergic reactions, including anaphylaxis, hives and a widespread rash, have been reported. Seek medical advice promptly if you suspect an allergic reaction. The label also warns of benzyl alcohol toxicity in newborns and infants.
FDA boxed warning
Risk of anti-metreleptin antibodies with neutralizing activity and risk of lymphoma
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT 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 MYALEPT efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. 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 MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT 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 MYALEPT and the risk for lymphoma, MYALEPT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYALEPT REMS PROGRAM.
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences are not well characterized but could include inhibition of endogenous leptin action and loss of MYALEPT efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during MYALEPT treatment. Contact Chiesi Farmaceutici S.p.A. at 1-866-216-1526 for neutralizing antibody testing.,
MYALEPT is available only through a restricted program called the MYALEPT REMS PROGRAM.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Myalept if you are allergic to metreleptin or have general obesity that is not associated with congenital leptin deficiency. Careful assessment of benefits and risks is needed in people with significant blood abnormalities or acquired generalized lipodystrophy because of the warning about T-cell lymphoma. Caution is also needed in people with autoimmune disease, as worsening of autoimmune disorders has been observed during treatment. Myalept can lead to antibodies that block its effects or the action of the body’s own leptin. Testing for these antibodies is recommended if severe infections occur or treatment becomes less effective. People using insulin or medicines that stimulate insulin release need close blood glucose monitoring because of the risk of low blood sugar. The prescriber may need to adjust these medicines. Seek medical advice promptly if an allergic reaction is suspected, including anaphylaxis, hives or a widespread rash. For newborns and infants, the label recommends preservative-free sterile water for injection when preparing Myalept because of the risk of benzyl alcohol toxicity.
Interactions
No formal drug interaction studies have been performed with Myalept (metreleptin). It may affect liver enzymes that process some medicines, including oral contraceptives. Tell your doctor if you take warfarin, cyclosporine or theophylline. When you start or stop Myalept, your doctor should monitor how these medicines are working or check their levels in your blood, and adjust their doses if needed.
Using Myalept
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.] (DailyMed, retrieved 19 September 2026).
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