Applies to setmelanotide: subcutaneous solution.

Serious side effects of Setmelanotide

Along with its needed effects, setmelanotide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking setmelanotide:

More common

• Aggressive, angry
• darkening of the skin or skin lesions
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• prolonged erection of the penis
• reddish purple lines on the arms, face, legs, trunk, or groin
• thoughts of killing oneself changes in behavior
• tiredness
• trouble concentrating
• trouble sleeping

Other side effects of Setmelanotide

Some side effects of setmelanotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• chills
• cough
• diarrhea
• difficulty in breathing
• difficulty in moving
• dizziness
• dry mouth
• ear congestion
• fever
• hair loss, thinning of hair
• headache
• joint pain
• lack or loss of strength
• loss of voice
• muscle pain, stiffness, or spasm
• nausea
• pain in the arms or legs
• rash
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to setmelanotide: subcutaneous solution.

General

The most commonly reported adverse reactions have included injection site reactions, skin hyperpigmentation, nausea, headache, and diarrhea.^[Ref]

Cardiovascular

Common (1% to 10%): Hot flush^[Ref]

Dermatologic

Very common (10% or more): Skin hyperpigmentation (78%), dry skin (15%), alopecia (11%), rash (11%)

Common (1% to 10%): Pruritus, hyperhidrosis, skin discoloration, skin lesion

Uncommon (0.1% to 1%): Ephelides, erythema, skin striae, hair color changes, lentigo, macule, dermal cyst, dermatitis, nail disorder nail discoloration, papular rash, application site pruritus^[Ref]

Skin hyperpigmentation includes pigmentation disorders.^[Ref]

Endocrine

Very common (10% or more): Spontaneous penile erection (23%)

Common (1% to 10%): Disturbance in sexual arousal (female)^[Ref]

Gastrointestinal

Abdominal pain includes upper abdominal pain.^[Ref]

Very common (10% or more): Nausea (56%), diarrhea (37%), abdominal pain (33%), vomiting (30%), dry mouth (15%), constipation (11%)

Common (1% to 10%): Dyspepsia

Uncommon (0.1% to 1%): Gingival discoloration, abdominal distention, salivary hypersecretion, flatulence, gastroesophageal reflux disease^[Ref]

Genitourinary

Common (1% to 10%): Sexual adverse reactions, erection increased, increased libido

Uncommon (0.1% to 1%): Female sexual arousal disorder, genital discomfort, female genital disorder, genital hypoesthesia, ejaculation disorder, decreased libido

Frequency not reported: Hypersensitivity of the labia^[Ref]

Local

Very common (10% or more): Injection site reaction (96%)

Uncommon (0.1% to 1%): Chest pain^[Ref]

Injection site reaction includes injection site erythema, pruritus, edema, pain, induration, bruising, hypersensitivity, hematoma, nodule, and discoloration.^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (33%), arthralgia (19%), muscle spasm (11%), extremity pain (11%)

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Musculoskeletal chest pain^[Ref]

Ocular

Uncommon (0.1% to 1%): Scleral discoloration, ocular icterus^[Ref]

Nervous system

Very common (10% or more): Headache (41%), asthenia (19%), dizziness (15%)

Uncommon (0.1% to 1%): Somnolence, hyperesthesia, migraine, parosmia, dysgeusia, anxiety, altered mood^[Ref]

Oncologic

Common (1% to 10%): Melanocytic naevus

Uncommon (0.1% to 1%): Dysplastic naevus, eye nevis^[Ref]

Other

Very common (10% or more): Fatigue (30%), vertigo (15%), chills (11%), influenza-like illness (11%)

Uncommon (0.1% to 1%): Temperature intolerance, feeling cold, feeling hot^[Ref]

Psychiatric

Very common (10% or more): Depression (26%), insomnia (15%), suicidal ideation (11%)

Uncommon (0.1% to 1%): Depressed mood, sleep disorder, nightmare^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (26%)

Uncommon (0.1% to 1%): Yawning, cough, rhinorrhea^[Ref]