Imcivree Dosage
Generic name: SETMELANOTIDE 10mg in 1mL
Medically reviewed by Drugs.com. Last updated on Dec 11, 2020.
Patient Selection
- Select patients for treatment with IMCIVREE who have genetically confirmed or suspected deficiency of POMC, PCSK1, or LEPR [see Clinical Studies (14)].
- Treat patients with variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) in the clinical context of the patient [see Clinical Studies (14)].
- Currently available tests for the detection of variants in the POMC, PCSK1, or LEPR genes have not been approved or cleared by the FDA.
Dosage in Adults and Pediatric Patients 12 Years of Age and Older
- The starting dose of IMCIVREE is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks. Monitor patients for gastrointestinal (GI) adverse reactions [see Adverse Reactions (6.1)].
- If the starting dose is not tolerated, reduce to 1 mg (0.1 mL) once daily. If the 1 mg once daily dose is tolerated and additional weight loss is desired, titrate to 2 mg (0.2 mL) once daily.
- If the 2 mg daily dose is tolerated and additional weight loss is desired, increase the dose to 3 mg (0.3 mL) once daily. If the 3 mg once daily dose is not tolerated, maintain administration of 2 mg (0.2 mL) once daily.
Dosage in Pediatric Patients 6 to less than 12 Years of Age
- For pediatric patients aged 6 to less than 12 years, the starting dose of IMCIVREE is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks. Monitor patients for GI adverse reactions [see Adverse Reactions (6.1)].
- If the starting dose is not tolerated, reduce to 0.5 mg (0.05 mL) once daily. If the 0.5 mg once daily dose is tolerated and additional weight loss is desired, the dose may be increased to 1 mg (0.1 mL) once daily.
- If the 1 mg dose is tolerated, increase the dose to 2 mg (0.2 mL) once daily.
- If the 2 mg once daily dose is not tolerated, reduce to 1 mg (0.1 mL) once daily. If the 2 mg once daily dose is tolerated and additional weight loss is desired, the dose may be increased to 3 mg (0.3 mL) once daily.
Monitoring
- Periodically assess response to IMCIVREE therapy. In pediatric patients, evaluate the impact of weight loss on growth and maturation.
- Evaluate weight loss after 12-16 weeks of treatment. If a patient has not lost at least 5% of baseline body weight or 5% of baseline BMI for patients with continued growth potential, discontinue IMCIVREE as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Administration Instructions
- Prior to initiation of IMCIVREE, train patients on proper injection technique. Instruct patients to use a 1-mL syringe with a 28- or 29-gauge needle appropriate for subcutaneous injection.
- Inspect IMCIVREE visually before use. It should appear clear to slightly opalescent, colorless to slightly yellow. Do not use if particulate matter or discoloration is seen.
- Remove IMCIVREE from the refrigerator approximately 15 minutes prior to administration. Alternatively, warm IMCIVREE prior to administration by rolling the vial gently between the palms of the hands for 60 seconds.
- Administer IMCIVREE once daily, at the beginning of the day, without regard to meals.
- Inject IMCIVREE subcutaneously in the abdomen, thigh, or arm, rotating to a different site each day. Do not administer IMCIVREE intravenously or intramuscularly.
- If a dose is missed, resume the once daily regimen as prescribed with the next scheduled dose.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
