ADDYI Film coated tablet (2019)

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Sprout Pharmaceuticals, Inc.

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BOXED WARNING SECTION

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope ...

1. Indications and Usage

ADDYI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal ...

2. Dosage and Administration

2.1 Recommended Dosage The recommended dosage of ADDYI is 100 mg administered orally once per day at bedtime. ADDYI is dosed at bedtime because administration during waking hours increases the risks of ...

3. Dosage Forms and Strengths

Tablets: 100 mg, oval, pink, debossed on one side with f100 and blank on the other side.

4. Contraindications

ADDYI is contraindicated: With concomitant use with moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2)]. In patients with hepatic impairment [see Boxed ...

5. Warnings and Precautions

5.1 Hypotension and Syncope due to an Interaction with Alcohol Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Hypotension and syncope [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5)] CNS depression ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of ...

7. Drug Interactions

Table 3 contains clinically significant drug interactions (DI) with ADDYI. Table 3. Clinically Significant Drug Interactions with ADDYI: Alcohol Clinical Implications The coadministration of ADDYI ...

8. Use in Specific Populations

8.7 CYP2C19 Poor Metabolizers CYP2C19 poor metabolizers had increased flibanserin exposures compared to CYP2C19 extensive metabolizers. Additionally, syncope occurred in a subject who was a CYP2C19 poor ...

8.1. Pregnancy

Risk Summary There are no studies of ADDYI in pregnant women to inform whether there is a drug-associated risk in humans. In animals, fetal toxicity only occurred in the presence of significant maternal ...

8.2. Lactation

Risk Summary Flibanserin is excreted in rat milk. It is unknown whether flibanserin is present in human milk, whether ADDYI has effects on the breastfed infant, or whether ADDYI affects milk production. ...

8.4. Pediatric Use

ADDYI is not indicated for use in pediatric patients.

8.5. Geriatric Use

ADDYI is not indicated for use in geriatric patients. Safety and effectiveness have not been established in geriatric patients.

8.6. Hepatic Impairment

ADDYI is contraindicated for use in patients with any degree of hepatic impairment. Flibanserin exposure increased 4.5-fold in patients with hepatic impairment, compared to those with normal hepatic function, ...

10. Overdosage

Overdosage of ADDYI may cause an increase in the incidence or severity of any of the reported adverse reactions [see Warnings and Precautions (5.3, 5.4) and Adverse Reactions (6.1)]. In the event ...

11. Description

ADDYI (flibanserin) is a tablet for oral administration. The chemical name of flibanserin is 2H-Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]. Its empirical formula ...

12.1. Mechanism of Action

The mechanism of action of ADDYI in the treatment of premenopausal women with hypoactive sexual desire disorder is not known.

12.2. Pharmacodynamics

Receptor Binding In vitro, flibanserin demonstrated high affinity for the following serotonin (5-hydroxytryptamine or 5-HT) receptors: agonist activity at 5-HT1A and antagonist activity at 5-HT ...

12.3. Pharmacokinetics

Flibanserin showed dose-proportional pharmacokinetics for Cmax after single oral doses of 100 mg to 250 mg (the recommended and 2.5 times the recommended dosage, respectively) in healthy female ...

12.5. Pharmacogenomics

Patients who are poor metabolizers of CYP2D6, CYP2C9 or CYP2C19 are deficient in CYP2D6, CYP2C9 or CYP2C19 enzyme activity, respectively. Extensive metabolizers have normal functioning CYP enzymes. CYP2C19 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis A two-year carcinogenicity study was conducted in CD-1 mice with dietary administration of 0, 10, 80, 200 and 1000/1200 mg/kg/day of flibanserin. Statistically significant increases in combined ...

14. Clinical Studies

14.1 Trials in Premenopausal HSDD Patients The efficacy of ADDYI for the treatment of HSDD in premenopausal women was established in three 24-week, randomized, double-blind, placebo-controlled trials (Studies ...

16.1. How Supplied

ADDYI is available as a 100 mg oval, pink, film-coated tablet debossed on one side with f100 and blank on the other side. Available in bottles of 30 tablets. (NDC 58604-214-30)

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature].

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Medication Guide). Hypotension and Syncope Inform patients that ADDYI can cause severe hypotension and syncope, particularly when taken close in time with alcoholic drinks ...