IMPORTANT SAFETY INFORMATION FOR LYLEQ™ (NORETHINDRONE 0.35 MG TABLETS USP)
INDICATION
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
CONTRAINDICATIONS
include known or suspected pregnancy, known or suspected carcinoma of the breast, undiagnosed abnormal genital bleeding, benign or malignant liver tumors or active liver disease, and hypersensitivity to any components of the pills.
WARNINGS
Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes.
Women who use oral contraceptives are strongly advised not to smoke
OTHER WARNINGS
include ectopic pregnancy considerations, delayed follicular atresia/ovarian cysts, irregular genital bleeding, carcinoma of the breast and reproductive organs, and hepatic neoplasias.
PRECAUTIONS
include carbohydrate and lipid metabolism, drug interactions, interactions with laboratory tests, pregnancy, nursing mothers, pediatric use, fertility following discontinuation and headache.
ADVERSE REACTIONS
include menstrual irregularities, headache, breast tenderness, nausea, and dizziness. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reference:
Lyleq™ prescribing information. Charleston, SC: Afaxys Pharma, LLC; August 2020.
Please see Full Prescribing Information .
To report SUSPECTED ADVERSE REACTIONS, call
1-855-888-2467 or
report via the FDA MedWatch Program at www.fda.gov/medwatch
or 1-800-FDA-1088.