Drug Guide

Generic Name

Bremelanotide Acetate

Brand Names Vyleesi

Classification

Therapeutic: Sexual Dysfunction Agent

Pharmacological: Melanocortin Receptor Agonist

FDA Approved Indications

  • Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

Mechanism of Action

Bremelanotide is a melanocortin receptor agonist that modulates neural pathways involved in sexual desire, leading to increased libido in women with HSDD.

Dosage and Administration

Adult: 30 mg injected subcutaneously once, at least 45 minutes before sexual activity, no more than once in 24 hours.

Pediatric: Not approved for pediatric use.

Geriatric: Limited data; use with caution, starting at lower doses.

Renal Impairment: No specific adjustments recommended; monitor for efficacy and tolerability.

Hepatic Impairment: Use with caution; no specific dose adjustments established.

Pharmacokinetics

Absorption: Rapid absorption following subcutaneous injection.

Distribution: Widely distributed, crosses the blood-brain barrier.

Metabolism: Primarily metabolized by proteolytic enzymes.

Excretion: Excreted mainly in urine; minimal unchanged drug recovered.

Half Life: Approximately 2 hours.

Contraindications

  • History of hypersensitivity to Bremelanotide or any components.
  • Use with caution in patients prone to cardiovascular disease or with uncontrolled hypertension.

Precautions

  • Monitor blood pressure; avoid in patients with known hormone-sensitive cancers or during pregnancy and breastfeeding.
  • Not recommended for use with other potent vasoconstrictive agents or medications affecting blood pressure.

Adverse Reactions - Common

  • Nausea (Very common)
  • Vomiting (Common)
  • Injection site reactions (pain, redness, irritation) (Common)
  • Flushing (Common)

Adverse Reactions - Serious

  • Transient increases in blood pressure (Uncommon)
  • Anaphylaxis (Rare)
  • Darkening of the skin in treated areas (Rare)

Drug-Drug Interactions

  • Other vasoconstrictors, agents affecting blood pressure, or serotonergic drugs.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor blood pressure before and after administration; assess for hypersensitivity reactions.

Diagnoses:

  • Risk for hypertension
  • Ineffective coping related to side effects

Implementation: Administer as prescribed via autoinjector; educate patient on injection technique.

Evaluation: Evaluate effectiveness in increasing sexual desire and monitor for adverse effects.

Patient/Family Teaching

  • Instruct on proper use of the autoinjector.
  • Report any adverse reactions, especially rapid changes in blood pressure or allergic reactions.
  • Do not use more than once in 24 hours.

Special Considerations

Black Box Warnings:

  • Potential for severe hypoperfusion and ischemia in some patients, especially those with cardiovascular risks.

Genetic Factors: No specific genetic factors impacting use.

Lab Test Interference: No significant interference reported.

Overdose Management

Signs/Symptoms: Excessive vasoconstriction, hypertensive crisis, or allergic reactions.

Treatment: Discontinue drug; provide supportive care, antihypertensive treatment if necessary; seek emergency care.

Storage and Handling

Storage: Store at controlled room temperature, away from moisture and light.

Stability: Stable until the expiration date on the packaging.

This guide is for educational purposes only and is not intended for clinical use.