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IMCIVREE is a brand name for Setmelanotide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IMCIVREE (setmelanotide solution for subcutaneous injection) is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to: • Bardet-Biedl syndrome (BBS) • Genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic aetiology. IMCIVREE (setmelanotide) Page 5 of 36 • IMCIVREE should be administered once daily, at the beginning of the day, without regard to meals.
• Select patients for treatment with IMCIVREE who have genetically determined deficiency of POMC, PCSK1, or LEPR or clinical diagnosis of BBS (see 14 CLINICAL TRIALS). • Assess response to IMCIVREE therapy regularly. • In patients with BBS, evaluate weight loss after 22 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.
• In patients with POMC, PCSK1, or LEPR deficiency, evaluate weight loss after 12 to 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.
• In pediatric patients, evaluate the impact of weight loss on growth and maturation. 1 mL) injected subcutaneously (SC) once daily (QD) for 2 weeks. • Monitor patients for gastrointestinal (GI) adverse reactions to adjust dosage. 0 mg daily.
• If the starting dose is not tolerated, IMCIVREE should be discontinued. 05 mL) injected subcutaneously (SC) once daily (QD) for 2 weeks. • Monitor patients for gastrointestinal (GI) adverse reactions to adjust dosage. 0 mg daily. • If the starting dose is not tolerated, IMCIVREE should be discontinued.
73 m2) renal impairment. 05 mL) injected subcutaneously QD for 2 weeks. Monitor patients for GI adverse reactions. 5 mg daily. • If the starting dose is not tolerated, IMCIVREE should be discontinued. The use of IMCIVREE in pediatric patients from 6 to 11 years of age with severe renal impairment is not recommended.
Hepatic impairment Data are not available in patients with any degree of hepatic impairment. IMCIVREE is not recommended in these patients. 4 Administration • Prior to initiation of IMCIVREE, train patients or their caregivers on proper injection technique.
). For management of a suspected drug overdose, contact your regional poison control centre. IMCIVREE (setmelanotide) Page 7 of 36 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Solution, 10 mg/mL setmelanotide (as setmelanotide acetate) in a 1 mL multiple-dose vial.
Benzyl alcohol (preservative), carboxymethylcellulose sodium, edetate disodium dihydrate (EDTA), mannitol, mPEG-2000- DSPE, nitrogen, phenol (preservative), water for injection. May contain hydrochloric acid and sodium hydroxide to adjust pH.
7 WARNINGS AND PRECAUTIONS General IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol- preserved drugs, including IMCIVREE.
The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (IMCIVREE contains 10 mg of benzyl alcohol per mL).
Psychiatric Depression and suicidal ideation IMCIVREE may cause depression or suicidal ideation. Depression and suicidal ideation occurred in adults and pediatric patients in IMCIVREE clinical studies (see 8 ADVERSE REACTIONS). Some cases of depression and suicidal ideation or behaviour that occurred in clinical studies were serious.
Patients with a history of depression or suicidal ideation may be at increased risk for recurrent episodes while taking IMCIVREE. Monitor patients for new onset or worsening of depression, suicidal thoughts or behaviour, or any unusual changes in mood or behaviour.
). 2 Geriatrics Geriatrics: Clinical studies of IMCIVREE did not include patients aged 65 and over. It is not known whether geriatric patients would respond differently than younger adult patients. 2 CONTRAINDICATIONS IMCIVREE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic aetiology. IMCIVREE (setmelanotide) Page 5 of 36 • IMCIVREE should be administered once daily, at the beginning of the day, without regard to meals.
• Select patients for treatment with IMCIVREE who have genetically determined deficiency of POMC, PCSK1, or LEPR or clinical diagnosis of BBS (see 14 CLINICAL TRIALS). • Assess response to IMCIVREE therapy regularly. • In patients with BBS, evaluate weight loss after 22 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.
• In patients with POMC, PCSK1, or LEPR deficiency, evaluate weight loss after 12 to 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.
• In pediatric patients, evaluate the impact of weight loss on growth and maturation. 1 mL) injected subcutaneously (SC) once daily (QD) for 2 weeks. • Monitor patients for gastrointestinal (GI) adverse reactions to adjust dosage. 0 mg daily.
IMCIVREE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg to 3 mg. • 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. • 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. • Administer IMCIVREE once daily, at the beginning of the day, without regard to meals. • Inject IMCIVREE subcutaneously in the abdomen each day.
Do not administer IMCIVREE intravenously or intramuscularly. • See detailed Instructions for Use at the end of the Patient Medication Information. 5 Missed Dose If a dose is missed, resume the once daily regimen as prescribed with the next scheduled dose.
Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviours or if clinically significant or persistent depression symptoms occur.
Reproductive Health:
Disturbance in sexual arousal Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE (see 8 ADVERSE REACTIONS).
Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. IMCIVREE (setmelanotide) Page 8 of 36 Skin Skin pigmentation and darkening of nevi Generalized increased skin pigmentation occurred in the majority of patients treated with IMCIVREE in clinical trials (see 8 ADVERSE REACTIONS).
IMCIVREE may also cause darkening of pre-existing nevi due to its pharmacologic effect. Melanocytic nevi were observed in all pivotal studies (30% of patients in Study 1 and Study 2 combined and 14% of patients in Study 3). This effect is generally reversible upon discontinuation of the drug.
Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions. IMCIVREE should not be used in patients with a personal medical history or a family history of melanoma or pre-melanoma skin lesions.
1 Pregnant Women There are no available data with IMCIVREE in pregnant women. It is not recommended to use IMCIVREE when pregnant or while trying to get pregnant, as it has not been studied in pregnant women. Weight loss during pregnancy may harm the baby.
Patients who are pregnant should also be advised of the potential risk from the preservative benzyl alcohol. Benzyl alcohol is rapidly metabolized by a pregnant woman, thus benzyl alcohol exposure in the fetus is unlikely. However, its metabolite benzoic acid might accumulate over time and cause metabolic acidosis.
Adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs (see 7 WARNINGS AND PRECAUTIONS). In animal reproductive studies, administration of setmelanotide to pregnant rabbits resulted in decreased maternal food consumption leading to embryo-fetal effects.
Setmelanotide was not teratogenic in two species (rats and rabbits) (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding Treatment with IMCIVREE is not recommended while breastfeeding. IMCIVREE from multiple-dose vials contains the preservative benzyl alcohol.
Because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs (see 7 WARNINGS AND PRECAUTIONS).
There is no information on the presence of setmelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. However, setmelanotide was present in the milk of female rats (see 16 NON-CLINICAL TOXICOLOGY).
It is therefore likely that the drug will be present in human milk. 1 Pediatrics). The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 6 years old. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants who received drugs containing benzyl alcohol as a preservative.
378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and […]
• If the starting dose is not tolerated, IMCIVREE should be discontinued. 05 mL) injected subcutaneously (SC) once daily (QD) for 2 weeks. • Monitor patients for gastrointestinal (GI) adverse reactions to adjust dosage. 0 mg daily. • If the starting dose is not tolerated, IMCIVREE should be discontinued.
73 m2) renal impairment. 05 mL) injected subcutaneously QD for 2 weeks. Monitor patients for GI adverse reactions. 5 mg daily. • If the starting dose is not tolerated, IMCIVREE should be discontinued. The use of IMCIVREE in pediatric patients from 6 to 11 years of age with severe renal impairment is not recommended.
Hepatic impairment Data are not available in patients with any degree of hepatic impairment. IMCIVREE is not recommended in these patients. 4 Administration • Prior to initiation of IMCIVREE, train patients or their caregivers on proper injection technique.
5 mg to 3 mg. • 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. • 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. • Administer IMCIVREE once daily, at the beginning of the day, without regard to meals. • Inject IMCIVREE subcutaneously in the abdomen each day.
Do not administer IMCIVREE intravenously or intramuscularly. • See detailed Instructions for Use at the end of the Patient Medication Information. 5 Missed Dose If a dose is missed, resume the once daily regimen as prescribed with the next scheduled dose.
, monitoring of heart rate and blood pressure) should be initiated according to the patient’s clinical signs and symptoms. While data on overdosage is limited, it is expected that symptoms of setmelanotide overdose would be consistent with adverse events observed in patients in the clinical trials (see