Vyleesi (bremelanotide acetate)

Dosage of bremelanotide acetate is expressed in terms of bremelanotide.

Bremelanotide acetate is administered by subcutaneous injection only. The drug is commercially available in single-dose prefilled auto-injectors (i.e., injection pens), which contain 1.75 mg of bremelanotide and are intended for patient self-administration.

Bremelanotide should be administered subcutaneously only into the abdomen or thigh; injections within 2 inches of the navel should be avoided. Injection into areas where the skin is irritated, tender, bruised, erythematous, indurated, or scarred also should be avoided. A different injection site should be selected for each injection. The manufacturer's labeling should be consulted for detailed instructions regarding subcutaneous administration of the drug using the prefilled auto-injectors.

Prior to administration, the injection solution should be inspected visually for particulate matter and discoloration; the prefilled auto-injector should not be used if the solution is cloudy or discolored or contains particles.

Prefilled auto-injectors of bremelanotide acetate should be stored at room temperature up to 25degreesC. The prefilled auto-injectors should not be frozen and should be protected from light.

Bremelanotide was administered intranasally+ in some initial clinical trials; however, intranasal use of the drug was associated with variable bioavailability that could result in increased adverse effects (e.g., hypertension) or decreased efficacy. Therefore, a subcutaneous formulation of bremelanotide was developed instead of an intranasal formulation.

No dosing information is available for this tab.

Bremelanotide undergoes minimal hepatic metabolism and does not inhibit nor induce hepatic microsomal enzymes at therapeutic dosages in vitro. Clinically important pharmacokinetic interactions are therefore unlikely with drugs affecting or metabolized by hepatic microsomal enzymes.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Bremelanotide is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease. (See Cardiovascular Effects under Cautions: Warnings/Precautions.)

There are no contraindication contraindications for this drug.

• Hypertension

There are no moderate contraindications for this drug.

Adverse effects reported in more than 4% of patients with acquired, generalized hypoactive sexual desire disorder (HSDD) in controlled clinical trials and more frequently than with placebo include nausea (see Nausea under Cautions: Warnings/Precautions), flushing, injection site reactions, headache, and vomiting.

Less Frequent

• Hypertension
• Increased creatine kinase level

Rare or Very Rare

• Hepatitis

More Frequent

• Flushing
• Headache disorder
• Injection site sequelae
• Nausea
• Skin pigmentation enhancement
• Vomiting

Less Frequent

• Arthralgia
• Cough
• Diarrhea
• Dizziness
• Fatigue
• Myalgia
• Nasal congestion
• Pain
• Paresthesia
• Restless leg syndrome
• Rhinorrhea
• Upper abdominal pain

Rare or Very Rare

• Flu-like symptoms

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Safety and efficacy of bremelanotide have not been established in pediatric patients.

The few pregnancies in women exposed to bremelanotide in clinical trials are insufficient to determine whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on animal studies, bremelanotide may cause fetal harm. Embryofetal toxicity and developmental delays were observed when the drug was administered subcutaneously on a daily basis to pregnant animals at exposures of 16 or more times the maximum recommended dosage based on area under the concentration-time curve (AUC). However, the lowest bremelanotide dosage associated with fetal harm in animals has not been identified.

Bremelanotide use during pregnancy is not recommended. Women of reproductive potential should use effective contraceptive methods during bremelanotide therapy and the drug should be discontinued if pregnancy is suspected. (See Drug Interactions: Oral Contraceptives.)

A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to bremelanotide during pregnancy; patients or clinicians may contact the Vyleesi Pregnancy Exposure Registry at 877-411-2510 to report any exposures to the drug that occur during pregnancy.

It is not known whether bremelanotide or its metabolites are distributed into human milk. The effects of the drug on the breast-fed infant or on milk production also are unknown. The manufacturer states that the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for bremelanotide and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Safety and efficacy of bremelanotide have not been established in geriatric patients. The manufacturer states that bremelanotide is not indicated for treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women+.