DOSAGE AND ADMINISTRATION
- Take one tablet by mouth at the same time every day.
- Take tablets in the order directed on the blister pack.
DOSAGE FORMS AND STRENGTHS
NEXTSTELLIS consists of 28 tablets in the following order:
- 24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg
- 4 white inert tablets
- 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.
Most common adverse reactions (≥2%): 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.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Discontinue if pregnancy occurs.
- Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.
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