ADDYI

ADDYI- flibanserin tablet, film coated
Sprout Pharmaceuticals, Inc.

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 [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening.

Contraindicated with Strong or Moderate CYP3A4 Inhibitors

The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2)]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4)].

Contraindicated in Patients with Hepatic Impairment

The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5)]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4)].

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 difficulty and is NOT due to:

A co-existing medical or psychiatric condition,
Problems within the relationship, or
The effects of a medication or other drug substance.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.

Limitations of Use

ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
ADDYI is not indicated to enhance sexual performance.

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 hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation).

2.2 Missed Dose

If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.

2.3 Discontinuation of ADDYI

Discontinue ADDYI after 8 weeks if the patient does not report an improvement in her symptoms.

2.4 Initiation of ADDYI Following Moderate or Strong CYP3A4 Inhibitor Use

If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor.

If initiating a moderate or strong CYP3A4 inhibitor following ADDYI use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI [see Warnings and Precautions (5.2)].

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 in patients:

Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2)].
With hepatic impairment [see Boxed Warning and Warnings and Precautions (5.5)].
With known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth), pruritus, and urticaria have been reported [see Adverse Reactions (6.2)].

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 to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime [see Boxed Warning and Adverse Reactions (6.1)]. Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. One standard alcoholic drink contains 14 grams of pure alcohol and is equivalent to one 12-ounce regular beer (5% alcohol), 5-ounces wine (12% alcohol), or 1.5 ounces of distilled spirits/shot (40% alcohol).

After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.

5.2 Hypotension and Syncope with CYP3A4 Inhibitors

Moderate or Strong CYP3A4 Inhibitors

The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors significantly increases flibanserin concentrations, which can lead to hypotension and syncope [see Adverse Reactions (6.1)]. The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. If the patient requires a moderate or strong CYP3A4 inhibitor, discontinue ADDYI at least 2 days prior to starting the moderate or strong CYP3A4 inhibitor. In cases where the benefit of initiating a moderate or strong CYP3A4 inhibitor within 2 days of stopping ADDYI clearly outweighs the risk of flibanserin exposure related hypotension and syncope, monitor the patient for signs of hypotension and syncope. Discontinue the moderate or strong CYP3A4 inhibitor for 2 weeks before restarting ADDYI [see Drug Interactions (7)].

Multiple Concomitant Weak CYP3A4 Inhibitors
Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope [see Drug Interactions (7)].

5.3 Central Nervous System Depression

ADDYI can cause CNS depression (e.g., somnolence, sedation). In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, the incidence of somnolence, sedation or fatigue was 21% and 8% in patients treated with 100 mg ADDYI once daily at bedtime and placebo, respectively [see Adverse Reactions (6.1) and Clinical Studies (14.1)]. The risk of CNS depression is increased if ADDYI is taken during waking hours, or if ADDYI is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations, such as CYP3A4 inhibitors [see Contraindications (4),Warnings and Precautions (5.1,5.2), Adverse Reactions (6.1), and Drug Interactions (7)].

Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking ADDYI and until they know how ADDYI affects them [see Clinical Studies (14.2)].

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