Imcivree

Imcivree is used to reduce excess body weight and maintain the weight loss in adults and children:

• 4 years and older with acquired hypothalamic obesity (HO)
• 2 years of age and older with Bardet-Biedl syndrome (BBS)
• 2 years of age and older with pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

It is not known if this medicine is safe and effective in children under 2 years of age.

• See the detailed Instructions for Use that comes with your prescription to learn how to prepare and inject Imcivree.
• Imcivree is given as an injection under your skin (subcutaneous) by you or a caregiver.
• A healthcare provider should show you or your caregiver how to prepare and inject your dose of Imcivree before injecting for the first time. Do not try to inject Imcivree unless you have been trained by a healthcare provider.
• Use Imcivree exactly as prescribed by your healthcare provider.
• Your healthcare provider may tell you to stop using Imcivree if you have not lost a certain amount of weight after 12 to 16 weeks of treatment.
• If you have BBS, your healthcare provider may tell you to stop using Imcivree if you have not lost a certain amount of weight after 1 year of treatment.
• Imcivree should be injected 1 time each day when you first wake up. Imcivree can be given with or without food.
• If you miss a dose, inject your next dose at the regularly scheduled time the next day.

Do not use Imcivree if you have had a serious allergic reaction to setmelanotide or any of the ingredients in Imcivree. Serious allergic reactions, including a severe allergic reaction called anaphylaxis, can happen when you use Imcivree.

Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:

• have or have had areas of darkened skin, including skin discoloration (hyperpigmentation)
• have or have had depression, or suicidal thoughts or behavior
• have kidney problems
• have had a prior allergic reaction to setmelanotide or any of the ingredients in Imcivree
• have adrenal insufficiency
• have diabetes insipidus
• are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment
• are breastfeeding or plan to breastfeed. It is not known if Imcivree passes into your breastmilk. You should not breastfeed during treatment.

Serious side effects and warnings

Imcivree may cause serious side effects, including:

• Male and female sexual function problems. Imcivree can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right away.
• Depression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression.
• Serious allergic reactions. Stop taking Imcivree and get medical help right away if you have any symptoms of a serious allergic reaction including: swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or rapid heartbeat.
• Increased skin pigmentation and darkening of skin lesions (moles or nevi) you already have. These changes happen because of how Imcivree works in the body and will go away when you stop using Imcivree. You should have a full body skin exam before starting and during treatment to check for skin changes.
• Benzyl alcohol toxicity. Benzyl alcohol is a preservative in Imcivree. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth-weight infants who have received medicines that contain benzyl alcohol. Imcivree should not be used in premature and low-birth-weight infants.
• Adrenal insufficiency. If you have acquired HO and adrenal insufficiency, your healthcare provider should evaluate your adrenal function before starting Imcivree. You or your caregiver should call your healthcare provider if you have changes in feeling tired or exhausted (fatigue), lack of energy (lethargy), mental status, or dizziness, fever, or signs of infection during treatment. Your healthcare provider should monitor and adjust any medicines that may be affected during treatment.
• Low sodium levels in the blood. If you have acquired HO and diabetes insipidus, you or your caregiver should watch for signs of dehydration. You or your caregiver should contact your healthcare provider if you have changes in fluid intake or urine output, confusion, lethargy, or nausea and vomiting during treatment with Imcivree. Your healthcare provider should closely monitor sodium levels in your blood and adjust your other medicines if needed.

Common side effects

The most common side effects of Imcivree are:

• injection site reactions
• darkening of the skin
• nausea
• vomiting
• headache
• erection that happens without any sexual activity in males
• diarrhea
• stomach pain.
• depression

These are not all the possible side effects of Imcivree.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or Rhythm Pharmaceuticals at 1-833-789-6337.

Recommended starting dosage of Imcivree injected subcutaneously:

• Adults and pediatrics ≥ 4 years with acquired HO: 0.5 mg (0.05 mL) once daily for 2 weeks
• Adults and pediatrics ≥ 12 years with BBS or POMC, PCSK1, or LEPR deficiency: 2 mg (0.2 mL) once daily for 2 weeks
• Pediatrics aged 6 to < 12 years with BBS or POMC, PCSK1, or LEPR deficiency: 1 mg (0.1 mL) once daily for 2 weeks
• Pediatrics aged 2 to < 6 years with BBS or POMC, PCSK1, or LEPR deficiency: 0.5 mg (0.05 mL) once daily for 2 weeks.

Recommended maintenance dosage:

• Adults and pediatrics ≥ 6 years for all indications: 3 mg (0.3 mL) injected subcutaneously once daily.
• Pediatrics with acquired HO aged 4 years to < 6 years, and pediatric patients with BBS or POMC, PCSK1, or LEPR deficiency aged 2 to < 6 years: determined by body weight.

For recommended dosage in patients with renal impairment, and for titration and administration recommendations, see the Full Prescribing Information.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Imcivree has low potential for drug interactions.

Active ingredient: setmelanotide

Inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, edetate disodium dihydrate, N-(carbonylmethoxypolyethylene glycol 2000)-1, 2-distearoyl- glycero-3-phosphoethanolamine sodium salt, mannitol, phenol, hydrochloric acid, sodium hydroxide, and water for injection.