FLIBANSERIN

Other

Brand names: ADDYI

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of ADDYI in the treatment of women less than 65 years of age with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty (not due a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance) is not known.

Indications

1 INDICATIONS AND USAGE ADDYI is indicated for the treatment of women less than 65 years of age with acquired

• Problems within the relationship

or • The effects of a medication or other drug substance. Limitations of Use: • ADDYI is not indicated in men (1) • ADDYI is not indicated to enhance sexual performance. ( 1 )

Contraindications

• including anaphylaxis
• reactions consistent with angioedema (e.g.
• swelling of the face
• lips
• and mouth)

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hypotension and Syncope due to an Interaction with Alcohol : After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day
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
The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Dizziness

>10%

Nausea

1-10%

Drowsiness

1-10%

Insomnia

1-10%

Fatigue

1-10%

Headache

1-10%

General Unwellness

0.1-1%

Low Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral