Usual Adult Dose for Hypoactive Sexual Desire Disorder

1.75 mg subcutaneously as needed 45 minutes before anticipated sexual activity

• No more than 1 dose should be administered within 24-hour period
• Administering more than 8 doses/month is not recommended

Comments:

• Hypoactive sexual desire disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty.
• Acquired HSDD means the patient has previously had no problems with sexual desire.
• Generalized HSDD means the condition occurs regardless of the type of stimulation, situation, or partner.
• This drug is not for the treatment of HSDD in postmenopausal women or in men; it is not indicated to enhance sexual performance.
• This drug should be discontinued if there is no improvement in symptoms after 8 weeks.

Use: For the treatment of acquired, generalized HSDD in premenopausal women not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.

Renal Dose Adjustments

Mild renal impairment (eGFR 30 to 89 mL/min/1.73 m2): No adjustment recommended
Severe renal impairment (eGFR less than 30 mL/min/1.73 m2): Use with caution

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh A and B): No adjustment recommended
Severe hepatic impairment (Child-Pugh C): Use with caution

Precautions

CONTRAINDICATIONS:

• Uncontrolled hypertension
• Known cardiovascular disease

Safety and efficacy have not been established in patients younger than 18 years or in postmenopausal women.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Inject subcutaneously in the abdomen or thigh at least 45 minutes prior to sexual activity
• Do not administer more than 1 dose in 24-hour period
• Administering more than 8 doses in a 1-month period is not recommended

Storage requirements:

• Store below 25C (77F); do not freeze
• Protect from light

Preparation techniques:

• This drug is self-administered via a prefilled auto-injector pen; consult instructions for use for specific administration instructions with illustrations.

General:

• This drug should not be administered more than once in a 24-hour period to minimize the risk of more pronounced blood pressure effects.

This drug should not be administered more than 8 times per month as more frequent dosing increases the risk for focal hyperpigmentation and the length of time per month when blood pressure is increased.

• The duration of efficacy after each dose is unknown; the optimal time for drug administration has not been fully characterized and patient experience may guide their use.
• This drug should be discontinued after 8 weeks if there is no improvement in symptoms of hypoactive sexual desire disorder (HSDD).

Monitoring:

• Monitor for improvement in symptoms of HSDD
• Monitor for focal hyperpigmentation

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Patients should understand that transient blood pressure elevations may occur and generally resolve within 12 hours; taking this drug with less than 24 hours between doses may lead to more pronounced blood pressure elevations.
• Patients should be advised that pigmentary changes may occur, and they should contact their healthcare provided if they have changes to their skin.
• Patients should understand that nausea may occur, most commonly with first dose; if nausea is severe or persistent, they should contact their healthcare provider.
• Patients of reproductive potential should be instructed to use effective contraception and should discontinue use if they suspect they are pregnant.

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