U.S. FDA Approves NEXTSTELLIS, New Oral Contraceptive

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
- Females over 35 years old who smoke should not use NEXTSTELLIS
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
NEXTSTELLIS may be less effective in females with a BMI = 30 kg/m2. In females with BMI = 30 kg/m2, decreasing effectiveness may be associated with increasing BMI. CONTRAINDICATIONS NEXTSTELLIS is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of a hormonally-sensitive malignancy (e.g., breast cancer); hepatic adenoma; hepatocellular carcinoma; acute hepatitis or decompensated cirrhosis; co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; abnormal uterine bleeding that has an undiagnosed etiology; renal impairment; adrenal insufficiency. WARNINGS AND PRECAUTIONS
- Thromboembolic Disorders and Other Vascular Problems:
- Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs.? Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.
- Hyperkalemia:??
- Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration.
- Hypertension -?Monitor blood pressure periodically and stop use if blood pressure rises significantly.
- Migraine ??Discontinue if new, recurrent, persistent, or severe migraines occur.?
- Hormonally-Sensitive Malignancy -?Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.
- Liver Disease-Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.?
- Glucose Tolerance and Hypertriglyceridemia -Monitor glucose in females with prediabetes or diabetes.? Consider an alternate contraceptive method for females with hypertriglyceridemia.
- Gallbladder Disease and Cholestasis:??Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.
- Bleeding Irregularities and Amenorrhea:?may cause irregular bleeding or amenorrhea.? Evaluate for other causes if symptoms persist.
- The following most common adverse reactions occurred in =2% of women who received NEXTSTELLIS:? bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased.
- CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or back-up contraceptive method during co-administration and up to 28 days after discontinuation of the CYP3A inducer.
- See Full Prescribing Information for additional clinically significant drug interactions.