--------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Discontinuation of VYLEESI
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Transient Increase in Blood Pressure andReduction in Heart Rate
5.2 Focal Hyperpigmentation
5.3 Nausea
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Effect of VYLEESI on Other Drugs
7.2 Naltrexone
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED / STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribinginformation are not listed
--------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexualdesire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonaldifficulty and is NOT due to:
• A co-existing medical or psychiatric condition,
• Problems with the relationship, or
• The effects of a medication or 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
• VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
• VYLEESI is not indicated to enhance sexual performance.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage of VYLEESI is 1.75 mg administered subcutaneously in the abdomen or thigh, asneeded, at least 45 minutes before anticipated sexual activity.
The duration of efficacy after each dose isunknown and the optimal window for VYLEESI administration has not been fully characterized. Patients maydecide the optimal time for VYLEESI administration based on how they experience the duration of effect ondesire and any adverse reactions such as nausea [see Warnings and Precautions (5.3)].
Patients should not administer more than one dose within 24 hours. The efficacy of consecutive doses within 24hours has not been established and administering doses close together may increase the risk of additive effectson blood pressure [see Warnings and Precautions (5.1)].
Administering more than 8 doses per month is not recommended. Few patients in the phase 3 program receivedmore than 8 doses per month. Also, more frequent dosing increases the risk for focal hyperpigmentation and thelength of time per month when blood pressure is increased [see Warnings and Precautions (5.1, 5.2)].
VYLEESI is self-administered via a prefilled autoinjector pen. Visually inspect the drug product for particulatematter and discoloration prior to administration, whenever solution and container permit. Discard if the solutionis cloudy, discolored, or visible particles are obse |
