Note: This document contains side effect information about bremelanotide. Some dosage forms listed on this page may not apply to the brand name Vyleesi.

Applies to bremelanotide: subcutaneous solution.

Serious side effects of Vyleesi

Along with its needed effects, bremelanotide (the active ingredient contained in Vyleesi) 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 bremelanotide:

More common

• Nausea

Less common

• Vomiting

Rare

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Incidence not known

• Dark urine
• general tiredness and weakness
• light-colored stools
• upper right abdominal pain
• yellow eyes and skin

Other side effects of Vyleesi

Some side effects of bremelanotide 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

• Bleeding, blistering, burning, coldness, discoloration of the 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
• feeling of warmth
• redness of the face, neck, arms, and occasionally the upper chest

Less common

• Aching or discomfort in the lower legs or sensation of crawling in the legs
• arm or leg pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cough
• darkening of the face, gums, or breasts
• diarrhea
• difficulty in moving
• joint pain or swelling
• muscle pains, cramps, or stiffness
• runny or stuffy nose
• stomach pain

Rare

• Chills
• fever
• general feeling of discomfort or illness
• loss of appetite
• shivering
• sore throat
• sweating
• trouble sleeping

For Healthcare Professionals

Applies to bremelanotide: subcutaneous solution.

General

The more commonly reported adverse reactions have included nausea, flushing, injection site reactions, headache, and vomiting.^[Ref]

Cardiovascular

Results of ambulatory blood pressure (BP) monitoring (n=127) showed a mean increase of 1.9 mmHg in daytime systolic BP and 1.7 mmHg in daytime diastolic BP after 8 days of dosing. Increases were transient with a mean peak increase of 2.8 mmHg in systolic BP occurring between 4- and 8-hours post-dose and a mean peak increase in diastolic blood pressure of 2.7 mmHg occurring at 0 to 4 hours post-dose. A mean transient decrease in heart rate of 0.5 beats per minute accompanied these transient increases in BP. At 12 to 24 hours post-dose, BP values were similar to pre-dose values.

Very common (10% or more): Flushing (20.3%)

Common (1% to 10%): Hot flush

Frequency not reported: Transient blood pressure increases, decreased heart rate

Gastrointestinal

In clinical trials, nausea was reported in 40% of patients (vs 1% placebo); median onset 1 hour and duration 2 hours. The incidence was highest with the first dose and declined with subsequent doses. Upper abdominal pain and diarrhea were reported in less than 2% of patients.

Very common (10% or more): Nausea (40%)

Common (1% to 10%): Vomiting

Frequency not reported: Upper abdominal pain, diarrhea

Dermatologic

Focal hyperpigmentation involving face, gingiva and breasts was reported in 1% of patients who received up to 8 doses per month (placebo 0%). In another clinical study, 38% of patients developed focal hyperpigmentation after receiving this drug daily for 8 days; an additional 14% developed new focal pigmentary changes upon continuing this drug for 8 more consecutive days.

Frequency not reported: Focal skin hyperpigmentation

Local

Injection site reactions include injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia and hypoesthesia.

Very common (10% or more): Injection site reactions (13.2%)

Musculoskeletal

Frequency not reported: Myalgia, arthralgia, extremity pain, restless leg syndrome, increased creatine phosphokinase

Myalgia, arthralgia, restless leg syndrome, increased creatine phosphokinase, and pain in extremity were reported in less than 2% of patients.

Hepatic

Frequency not reported: Acute hepatitis

One case of acute hepatitis has been reported in a patient receiving 10 doses of this drug over a 1-year period; serum transaminases exceeded 40 times the upper limit of normal (ULN), total bilirubin 6 x ULN, and alkaline phosphatase less than 2 x ULN. Upon discontinuation, liver tests returned to normal after 4 months.

Respiratory

Rhinorrhea was reported in less than 2% of patients.

Common (1% to 10%): Cough, nasal congestion

Frequency not reported: Rhinorrhea

Other

Common (1% to 10%): Fatigue

Nervous system

Very common (10% or more): Headache (11.3%)

Common (1% to 10%): Paraesthesia, dizziness