16 HOW SUPPLIED / STORAGE AND HANDLING

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).

Storage

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

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Transient Increase in Blood Pressure and Decrease in Heart Rate

Advise patients that increases in blood pressure and decreases in heart rate may occur after taking each VYLEESI dose, and that these changes usually resolve within 12 hours post-dose [see Warnings and Precautions (5.1)].

Advise patients not to take VYLEESI within 24 hours of a prior dose and that more than 8 doses per month is not recommended. Advise patients that taking VYLEESI more frequently or too close together may lead to more pronounced increases in blood pressure [see Dosage and Administration (2.1)].

Focal Hyperpigmentation

Advise patients that focal hyperpigmentation, including on the face, gingiva and breasts, may occur when VYLEESI is used intermittently, particularly in patients with darker skin. The incidence may increase with daily VYLEESI use. Advise patients that the pigmentary changes may not resolve completely after stopping VYLEESI, and to contact their healthcare provider if they have any concerns about changes to their skin [see Warnings and Precautions (5.2)].

Nausea

Advise patients that nausea may occur, most commonly with the first injection of VYLEESI, but could occur intermittently with continued use. Advise patients that nausea most commonly lasts for two hours after taking a dose but could last longer in some patients, and that anti-emetic medications may be necessary. Advise patients to contact their healthcare provider for persistent or severe nausea [see Warnings Precautions (5.3)].

Females of Reproductive Potential

Advise patients to use effective contraception while taking VYLEESI and to discontinue VYLEESI if pregnancy is suspected. Advise pregnant patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy [see Use in Specific Populations (8.1, 8.3)].

Manufactured for:

AMAG Pharmaceuticals, Inc.

1100 Winter Street

Waltham, MA 02451

VYLEESI is a trademark of AMAG Pharmaceuticals, Inc.

© 2019 AMAG Pharmaceuticals, Inc. All rights reserved.

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