Important Safety Information
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Tyblume (levonorgestrel and ethinyl estradiol) tablets, are contraindicated in women who are over 35 years of age and smoke.
Contraindications
Tyblume is contraindicated in females with a high risk of arterial and venous thrombotic diseases, current/history of breast cancer or other estrogen-progestin-sensitive cancers, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, and in women who use Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Warnings and Precautions
- Discontinue Tyblume if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery.
- Tyblume should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding.
- If jaundice occurs, treatment should be discontinued.
- Tyblume should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease.
- Women who are pre-diabetic or diabetic should be monitored while using Tyblume.
- Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia.
- Evaluate significant change in headaches and discontinue Tyblume if indicated.
- May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.
Adverse Reactions
- Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.
- For serious side effects, see the Boxed Warning, Contraindications, and Warnings and Precautions.
To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
Drug Interactions
Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of Tyblume or increase breakthrough bleeding. Counsel patients to use a back-up or alternative non-hormonal method of contraception when enzyme inducers are used with Tyblume and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer. Drugs or products that inhibit CYP3A4 may increase Tyblume systemic exposure.
Use in Specific populations
Pregnancy: Discontinue Tyblume during pregnancy.
Lactation: Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. CHCs can also reduce milk production in breast- feeding females. Advise the nursing female to use other methods of contraception until she discontinues breast-feeding.
Counsel patients that Tyblume does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
Before prescribing Tyblume and for complete safety and risk information, please read the full Prescribing Information, including BOXED WARNING and Patient Information at tyblume.com.
