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Metreleptin

Also known as: Myalept

Leptin Analog

Route: Subcutaneous

4 interactions on record⛔ Black Box Warning

Metreleptin has 4 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Cyclosporine, Oral Contraceptives, Theophylline. Patients taking Metreleptin should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Moderate: 4

Moderate (4)

Metreleptin + Cyclosporine— Metreleptin may alter CYP450 metabolism of cyclosporine. Drug concentration monitoring and dose adjustment recommended u…
Metreleptin + Oral Contraceptives— Metreleptin may alter CYP450 enzyme formation, potentially affecting oral contraceptive metabolism. Therapeutic monitori…
Metreleptin + Theophylline— Metreleptin may alter CYP450 metabolism of theophylline. Drug concentration monitoring and dose adjustment recommended u…
Metreleptin + Warfarin— Metreleptin may alter CYP450 metabolism of warfarin. Therapeutic monitoring of effect recommended upon initiation or dis…

Metreleptin + Cyclosporine🟡Moderate

Metreleptin may alter CYP450 metabolism of cyclosporine. Drug concentration monitoring and dose adjustment recommended upon initiation or discontinuation.

Metreleptin + Oral Contraceptives🟡Moderate

Metreleptin may alter CYP450 enzyme formation, potentially affecting oral contraceptive metabolism. Therapeutic monitoring recommended upon initiation or discontinuation.

Metreleptin + Theophylline🟡Moderate

Metreleptin may alter CYP450 metabolism of theophylline. Drug concentration monitoring and dose adjustment recommended upon initiation or discontinuation.

Metreleptin + Warfarin🟡Moderate

Metreleptin may alter CYP450 metabolism of warfarin. Therapeutic monitoring of effect recommended upon initiation or discontinuation of metreleptin.

⛔ FDA Black Box Warning

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 [see Contraindications (4.1) and Warnings and Precautions (5.1) ]. 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 [see Warnings and Precautions (5.2) ]. 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 [see Warnings and Precautions (5.3) ]. WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA See full prescribing information for complete boxed warning. 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 activit

Contraindications

4 CONTRAINDICATIONS General obesity not associated with congenital leptin deficiency. ( 4.1 ) Hypersensitivity to metreleptin. ( 4.2 ) 4.1 General Obesity MYALEPT is contraindicated in patients with general obesity not associated with congenital leptin deficiency. MYALEPT has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodies with neutralizing activity has been reported in obese patients treated with MYALEPT [see Warnings and Precautions (5.1) ]. 4.2 Hypersensitivity MYALEPT is contraindicated in patients with prior severe hypersensitivity reactions to metreleptin or to any of the product components. Known hypersensitivity reactions have included anaphylaxis, urticaria and generalized rash [see Warnings and Precautions (5.6) ].

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a program that monitors outcomes in women exposed to MYALEPT during pregnancy. Women who become pregnant during MYALEPT treatment are encouraged to enroll. Patients or their physicians should call 1-855-669-2537 to enroll. Risk Summary Available pharmacovigilance reports with the use of MYALEPT in pregnant women are insufficient to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. These reports describe similar adverse pregnancy outcomes as those documented in women with lipodystrophy (see Clinical Considerations ) . In an animal reproduction study, no adverse developmental effects were observed with subcutaneous administration of metreleptin to pregnant mice during organogenesis at doses 7- and 15-fold the maximum recommended clinical dose, based on body surface area of a 20- and 60-kg patient, respectively. In a pre- and postnatal development study in mice, subcutaneous administration of metreleptin caused prolonged gestation and dystocia resulting in maternal death during parturition and lower survival of offspring in the immediate postnatal period at doses starting approximately at the maximum recommended clinical dose (see Data ) . MYALEPT contains benzyl alcohol when reconstituted with BWFI. MYALEPT contains no preservative when reconstituted with WFI. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ]. Therefore, if therapy with MYALEPT is needed during pregnancy, consider using preservative-free WFI when reconstituting [see Dosage and Administration (2.2) ]. The estimated background risk of major birth defects and miscarriage for the indicated

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.