ADDYI INDICATIONS

Indications

Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or adverse effect of a medication or other drug substance.

Limitations of Use

Not for HSDD in postmenopausal women or in men. Not for sexual performance enhancement.

ADDYI DOSAGE AND ADMINISTRATION

Adult

100mg daily at bedtime. Discontinue if no improvement after 8 weeks.

Children

Not recommended.

ADDYI CONTRAINDICATIONS

Contraindications

Concomitant moderate or strong CYP3A4 inhibitors (eg, azole antifungals, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan, amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fosamprenavir, verapamil, grapefruit juice). Hepatic impairment.

Hypotension and syncope in certain settings.

ADDYI WARNINGS/PRECAUTIONS

Warnings/Precautions

Increased risk of severe hypotension and syncope with concomitant alcohol; see Interactions. Increased risk of CNS depression if taken during waking hours. Conditions that predispose to hypotension. CYP2C19 poor metabolizers; monitor. Elderly: not established. Pregnancy. Nursing mothers: not recommended.

REMS

YES

ADDYI PHARMACOKINETICS

See Literature

ADDYI INTERACTIONS

Interactions

See Contraindications. Increased risk of severe hypotension and syncope with concomitant moderate or strong CYP3A4 inhibitors, if use necessary, discontinue Addyi at least 2 days before starting the CYP3A4 inhibitor; discontinue the CYP3A4 inhibitor for 2 weeks before restarting Addyi. Increased risk of severe hypotension, syncope, and CNS depression with concomitant alcohol (avoid until following day after taking Addyi; advise to wait ≥2hrs before taking Addyi if 1 or 2 standard alcoholic drinks are consumed; skip dose if ≥3 alcoholic drinks are consumed) or concomitant strong CYP2C19 inhibitors (eg, PPIs, SSRIs, antifungals). Increased risk of CNS depression with other CNS depressants (eg, diphenhydramine, opioids, hypnotics, benzodiazepines). Potentiated by weak CYP3A4 inhibitors (eg, oral contraceptives, cimetidine, fluoxetine, ginkgo, resveratrol, ranitidine). Antagonized by CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. Johns wort): not recommended. Potentiates digoxin, sirolimus, other P-gp substrates: monitor levels.

ADDYI ADVERSE REACTIONS

Adverse Reactions

Dizziness, somnolence, nausea, fatigue, insomnia, dry mouth; hypotension, syncope, hypersensitivity reactions (immediately discontinue if occurs).

ADDYI CLINICAL TRIALS

See Literature

ADDYI NOTE

Not Applicable

ADDYI PATIENT COUNSELING

See Literature