Rx Item-VYLEESI bremelanotide 1.7MG/.3ML SQ INJ BY AMAG PHARMA

VYLEESI (bremelanotide) is supplied as:

1.75 mg bremelanotide in 0.3 mL solution in a single-dose, disposable prefilled autoinjector (NDC 64011-701-01) provided in a carton of 4 autoinjectors (NDC 64011-701-04). These highlights do not include all the information needed to use VYLEESI� safely and effectively. See full prescribing information for VYLEESI�.

VYLEESI (bremelanotide injection), for subcutaneous use
Initial U.S. Approval: 2019

INDICATIONS AND USAGE

VYLEESI is a melanocortin receptor agonist 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 with the relationship, or
The effects of a medication or drug substance (1)

Limitations of Use (1):

Not indicated for treatment of HSDD in postmenopausal women or in men.
Not indicated to enhance sexual performance.

DOSAGE AND ADMINISTRATION

Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. (2.1)
Do not administer more than one dose within 24 hours. (2.1)
More than 8 doses per month is not recommended. (2.1)

DOSAGE FORMS AND STRENGTHS

Subcutaneous injection: 1.75 mg/0.3 mL solution. (3)

CONTRAINDICATIONS

Uncontrolled hypertension or known cardiovascular disease. (4)

WARNINGS AND PRECAUTIONS

Transient increase in blood pressure and decrease in heart rate: Occurs after each dose and usually resolves within 12 hours. Consider the patient�s cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. VYLEESI is not recommended in patients at high risk for cardiovascular disease. (5.1)
Focal hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Higher risk in patients with darker skin and with daily dosing. Resolution was not confirmed in some patients. Consider discontinuing VYLEESI if hyperpigmentation develops. (5.2)
Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Improved for most patients with the second dose. Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea. (5.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AMAG Pharmaceuticals at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. (7.1)
VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction. (7.2)

USE IN SPECIFIC POPULATIONS

Pregnancy: Advise patients to discontinue VYLEESI if pregnancy is suspected. (8.1)
Females of Reproductive Potential: Advise patients to use effective contraception while taking VYLEESI. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2019

Storage

Store at or below 25�C (77�F). Do not freeze. Protect from light.

Rx Item-VYLEESI bremelanotide 1.7MG/.3ML
RX64011-0701-01

Rx Item-VYLEESI bremelanotide 1.7MG/.3ML
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop