What is the recommended treatment and administration protocol for Bremelanotide (Bremelanotide) in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD)?

Bremelanotide Treatment Protocol for Premenopausal Women with HSDD

Bremelanotide 1.75 mg should be administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity, with no more than one dose within 24 hours and no more than 8 doses per month. 1

Indication and Patient Selection

• Bremelanotide is FDA-approved specifically for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) 1
• HSDD must be characterized by:
  • Low sexual desire causing marked distress or interpersonal difficulty
  • NOT due to a co-existing medical/psychiatric condition
  • NOT due to relationship problems
  • NOT due to effects of medication or substance use 1

Administration Protocol

Dosing Regimen

• Dose: 1.75 mg per administration 1
• Route: Subcutaneous injection via prefilled autoinjector pen 1
• Administration site: Abdomen or thigh 1
• Timing: At least 45 minutes before anticipated sexual activity 1
• Frequency limitations:
  • No more than one dose within 24 hours
  • No more than 8 doses per month 1

Administration Instructions

• Self-administered via prefilled autoinjector pen
• Visually inspect solution before use (should be clear, not cloudy)
• Discard if solution is cloudy, discolored, or contains visible particles 1

Efficacy Assessment and Continuation

• Discontinue bremelanotide after 8 weeks if the patient does not report improvement in symptoms 1, 2
• In clinical trials, bremelanotide demonstrated:
  • Statistically significant increases in sexual desire
  • Statistically significant reductions in distress related to low sexual desire 3
  • Efficacy across various age groups, weight categories, and BMI subgroups 4

Safety Considerations

Contraindications

• Uncontrolled hypertension
• Known cardiovascular disease 1

Warnings and Precautions

1. Cardiovascular effects:

   • Transient increases in blood pressure (up to 6 mmHg systolic, 3 mmHg diastolic)
   • Reduction in heart rate (up to 5 beats per minute)
   • Effects peak between 2-4 hours post-dose
   • Return to baseline usually within 12 hours 1

2. Focal hyperpigmentation:

   • Reported in 1% of patients
   • Can involve face, gingiva, and breasts
   • Higher risk in patients with darker skin and with daily dosing
   • Consider discontinuation if hyperpigmentation develops 1

3. Nausea:

   • Reported by 40% of patients
   • May require anti-emetic therapy (13% of patients)
   • Led to discontinuation in 8% of patients
   • Often improves with second dose 1

Common Adverse Effects

• Nausea (39.9%)
• Facial flushing (20.4%)
• Headache (11%)
• Injection site reactions 1, 2

Drug Interactions

• May slow gastric emptying and impact absorption of oral medications
• May significantly decrease systemic exposure of orally-administered naltrexone
• Avoid use with oral naltrexone-containing products for alcohol or opioid addiction 1

Special Populations

• Not indicated for postmenopausal women or men 1
• Not indicated to enhance sexual performance 1
• Advise patients to discontinue if pregnancy is suspected 1
• Female patients of reproductive potential should use effective contraception while taking bremelanotide 1

Alternative Options for HSDD

If bremelanotide is not suitable or ineffective, other FDA-approved options include:

• Flibanserin for premenopausal women with HSDD 5
• Off-label options may include bupropion and buspirone, though these have limited safety and efficacy data 5

Clinical Pearls

• The optimal window for bremelanotide administration has not been fully characterized; patients may determine their optimal timing based on experienced duration of effect and adverse reactions 1
• PDE5 inhibitors are not recommended for sexual dysfunction in cisgender females due to limited effectiveness data 5
• Treatment should be discontinued if no improvement is seen after 8 weeks 1, 2