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IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS^® (drospirenone and estetrol tablets 3 mg/14.2 mg)

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.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.

NEXTSTELLIS (drospirenone and estetrol tablets), for oral use
Initial U.S. Approval: 2021

INDICATIONS AND USAGE

NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

LIMITATIONS OF 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.

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

CONTRAINDICATIONS

• 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.

ADVERSE REACTIONS

Most common adverse reactions (≥2%): Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased

DRUG INTERACTIONS

• 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.