imcivree
Imcivree (Setmelanotide Acetate) is a medication supplied as a solution.
Setmelanotide Acetate · by Rhythm
Key facts
- Active ingredient
- Setmelanotide Acetate
- Form
- Solution
- Strength
- Setmelanotide Acetate EQ 10MG BASE/ML (EQ 10MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Rhythm
- FDA application
- NDA213793
What is Imcivree?
From the FDA label:IMCIVREE contains setmelanotide acetate, a melanocortin 4 (MC4) receptor agonist. Setmelanotide is an 8 amino acid cyclic peptide analog of endogenous melanocortin peptide α‑MSH (alpha-melanocyte stimulating hormone). The chemical name for setmelanotide acetate is acetyl-L-arginyl-L-cysteinyl-D-alanyl-L-histidinyl-D-phenylalanyl-L-arginyl-L-tryptophanyl-L-cysteinamide cyclic (2→8)-disulfide acetate. Its molecular formula is C 49 H 68 N 18 O 9 S 2 (anhydrous, free-base), and molecular mass is 1117.3 Daltons (anhydrous, free-base). The chemical structure of setmelanotide acetate is: IMCIVREE (setmelanotide) injection is a sterile clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. Each 1 mL vial of IMCIVREE contains 10 mg of setmelanotide provided as setmelanotide acetate, which is a salt with 2 to 4 molar equivalents of acetate, and the following inactive ingredients: 10 mg benzyl alcohol, 8 mg carboxymethylcellulose sodium (average MWt 90,500), 1 mg edetate disodium dihydrate, 100 mg N-(carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl- glycero-3- phosphoethanolamine sodium salt, 11 mg mannitol, 5 mg phenol, hydrochloric acid, sodium hydroxide and Water for Injection. The pH of IMCIVREE is 5 to 6. CHEMICAL-STRUCTURES
How to use
Select patients for treatment who have a clinical diagnosis of acquired HO or BBS or who have genetically determined or suspected deficiency of POMC, PCSK1, or LEPR. ( 2.1 ) Recommended starting dosage injected subcutaneously for: Adults and pediatric patients aged 4 years and older with acquired HO is 0.5 mg (0.05 mL) once daily for 2 weeks. ( 2.2 ) Adults and pediatric patients aged 12 years and older with BBS or POMC, PCSK1, or LEPR deficiency is 2 mg (0.2 mL) once daily for 2 weeks. ( 2.3 ) Pediatric patients aged 6 to less than 12 years with BBS or POMC, PCSK1, or LEPR deficiency is 1 mg (0.1 mL) once daily for 2 weeks. ( 2.3 ) Pediatric patients aged 2 to less than 6 years with BBS or POMC, PCSK1, or LEPR deficiency is 0.5 mg (0.05 mL) once daily for 2 weeks. ( 2.4 ) Recommended maintenance dosage for adults and pediatric patients aged 6 years and older for all indications is 3 mg (0.3 mL) injected subcutaneously once daily. ( 2.2 , 2.3 ) Recommended maintenance dose for pediatric patients with acquired HO aged 4 years to less than 6 years and for pediatric patients with BBS or POMC, PCSK1, or LEPR deficiency aged 2 to less than 6 years is determined by body weight. ( 2.2 , 2.3 ) For recommended dosage in patients with renal impairment, see Full Prescribing Information. ( 2.4 ) For titration and administration recommendations, see Full Prescribing Information. ( 2.2 ,…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Disturbance in Sexual Arousal [see Warnings and Precautions (5.1)] Depression and Suicidal Ideation [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi [see Warnings and Precautions (5.4)] Acute Adrenal Insufficiency in Patients with Acquired HO [ see Warnings and Precautions (5.5) ] Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus [ see Warnings and Precautions (5.6) ] Most common adverse reactions (incidence ≥20% in at least 1 indication) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 1-833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Acquired HO (Adults and Pediatric Patients Aged 4 Years and Older) The safety of…
Warnings
Important safety information
Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. ( 5.1 ) Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur. ( 5.2 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE. ( 5.3 ). Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi: Generalized increased skin pigmentation, darkening of pre-existing nevi, and development of new nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmentary lesions. ( 5.4 ) Acute Adrenal Insufficiency in Patients with Acquired HO : Monitor patients for signs of acute adrenal insufficiency. ( 5.5 ) Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus : Monitor patients for signs and symptoms of hyponatremia and hypernatremia. (5.6) 5.1 Disturbance in Sexual Arousal Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections and increased frequency of penile erections in males occurred in clinical trials with IMCIVREE [see Adverse Reactions (6.1)]. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention. 5.2 Depression and Suicidal Ideation Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation [see Adverse Reactions (6.1) ]. 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 behavior, or any unusual changes in mood or behavior. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors or if clinically significant or persistent depression symptoms occur. 5.3 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with IMCIVREE. These reactions generally occurred within minutes to hours after injecting IMCIVREE [see Adverse Reactions ( 6.2 )]. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of IMCIVREE. IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE. 5.4 Skin Hyperpigmentation, Darkening of Pre-Existing Nevi, and Development of New Melanocytic Nevi Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients in clinical trials [ see Adverse Reactions (6.1) and Clinical Pharmacology (12.1) ]. This effect is reversible upon discontinuation of the drug. IMCIVREE may also cause the development of new melanocytic nevi or darkening of pre-existing nevi due to its pharmacologic effect. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmented lesions. 5.5 Acute Adrenal Insufficiency in Patients with Acquired HO In a clinical trial of adults and pediatric patients aged 4 years and older with acquired HO and secondary adrenal insufficiency, serious adverse reactions related to acute adrenal insufficiency were reported by 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency. 5.6 Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus In a clinical trial of adults and pediatric patients aged 4 years and older with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency, hyponatremia was reported in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients, and hypernatremia was reported in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. In patients with acquired HO and concomitant DI/AVP deficiency, monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.
Who should not take Imcivree
IMCIVREE is contraindicated in patients with a prior serious hypersensitivity reaction to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE ( 4 )
Overdose — what happens if you take too much
In the event of an overdose of IMCIVREE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations and initiate appropriate supportive treatment according to the patient’s clinical signs and symptoms.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Imcivree?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Imcivree. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Imcivree?
- Imcivree is marketed by Rhythm. You can see Rhythm's full profile, rating, and other products on pharmaranks.
- Is Imcivree a brand-name or generic drug?
- Imcivree is a brand-name product with the active ingredient Setmelanotide Acetate.
- Is Imcivree available over the counter?
- No. Imcivree is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Imcivree come in?
- Imcivree is currently marketed as solution, per the FDA's National Drug Code Directory.
- Is Imcivree FDA-registered?
- Imcivree is on record with the U.S. FDA under application number NDA213793. You can verify this on its official FDA label.
- Is Imcivree safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Imcivree. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Imcivree?
- Imcivree's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Disturbance in Sexual Arousal [see Warnings and Precautions (5.1)] Depression and Suicidal Ideation [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Ski… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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