Drospirenone and estetrol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Black Box Warning
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CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
Condition Name: (Females over 35 years old who smoke should not use NEXTSTELLIS (4)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) )
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Overview
Drospirenone and estetrol is a combination of drospirenone, a progestin, and estetrol, an estrogen, that is FDA approved for the treatment of reproductive potential to prevent pregnancy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased ..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Recommended Dosage and Administration
Start NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.
Additional Administration Information
To achieve maximum contraceptive effectiveness, take one tablet every day at about the same time each day. The recommended dosage of NEXTSTELLIS is one tablet daily for 28 consecutive days: one pink active tablet daily during the first 24 days followed by one white inactive tablet daily during the 4 following days (see TABLE 1).
Missed Doses
Administration Recommendations after Vomiting or Acute Diarrhea
- If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. Take the new tablet within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, follow the advice concerning missed tablets, including using backup non-hormonal contraception. For additional recommendations, refer to the table above.
3 DOSAGE FORMS AND STRENGTHS
- NEXTSTELLIS (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order:
- 24 pink active tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side.
- 4 white inert tablets embossed with a drop-shaped logo on one side.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Drospirenone and estetrol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and estetrol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Drospirenone and estetrol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Drospirenone and estetrol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and estetrol in pediatric patients.
Contraindications
- NEXTSTELLIS is contraindicated in females who are known to have or develop the following conditions:
- A history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. Examples include females who are known to:
- Smoke, if 35 years of age and older. - Have current or history of deep vein thrombosis or pulmonary embolism. - Have cerebrovascular disease.
- Have coronary artery disease.
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation).
- Have inherited or acquired hypercoagulopathies .
- Have uncontrolled hypertension or hypertension with vascular disease .
- Have diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of > 20 years duration.
- Have migraine headaches with aura.
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive .
• Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis.
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations .
• Abnormal uterine bleeding that has an undiagnosed etiology.
• Renal Impairment.
• Adrenal insufficiency.
Warnings
|
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
Condition Name: (Females over 35 years old who smoke should not use NEXTSTELLIS (4)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) )
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There is limited information regarding Drospirenone and estetrol Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Drospirenone and estetrol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Drospirenone and estetrol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Drospirenone and estetrol Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Drospirenone and estetrol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Drospirenone and estetrol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Drospirenone and estetrol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Drospirenone and estetrol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Drospirenone and estetrol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Drospirenone and estetrol in geriatric settings.
Gender
There is no FDA guidance on the use of Drospirenone and estetrol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Drospirenone and estetrol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Drospirenone and estetrol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Drospirenone and estetrol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Drospirenone and estetrol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Drospirenone and estetrol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Drospirenone and estetrol Administration in the drug label.
Monitoring
There is limited information regarding Drospirenone and estetrol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Drospirenone and estetrol and IV administrations.
Overdosage
There is limited information regarding Drospirenone and estetrol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Drospirenone and estetrol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Drospirenone and estetrol Mechanism of Action in the drug label.
Structure
There is limited information regarding Drospirenone and estetrol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Drospirenone and estetrol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Drospirenone and estetrol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Drospirenone and estetrol Nonclinical Toxicology in the drug label.
Clinical Studies
Pregnancy Prevention
- The efficacy of NEXTSTELLIS was evaluated in a prospective, multicenter, open-label, single-arm study in North America (NCT02817841; C302) of one-year duration that enrolled 1,674 females 16 to 35 years of age. The mean age was 25.8 years and mean BMI was 25.8 kg/m2. Females with a BMI between 30 and 35 kg/m2 accounted for 22.3% of the study population. Females with a BMI greater than 35 kg/m2 were not enrolled in the study. The racial distribution was 70.1% Caucasian, 19.5% Black or African American, 4.8% Asian, 0.9% American Indian or Alaska native, 0.4% Native Hawaiian or other Pacific Islander and 4.2% other.
- A total of 26 on-treatment pregnancies occurred in 1,524 females contributing 12,763 at-risk cycles. The overall Pearl Index was 2.65 (95% CI: 1.73-3.88) per 100 woman-years of use. Table 9 lists the Pearl Index by BMI subgroup. A trend of decreasing effectiveness with increasing BMI was observed in the study.
How Supplied
- NEXTSTELLIS® (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order:
- 24 pink active film-coated tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side.
- 4 white inert film-coated tablets embossed with a drop-shaped logo on one side.
NEXTSTELLIS® is supplied in cartons containing 1 blister card of 28 tablets: NDC 51862-258-01.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- Advise the patient to read the FDA-Approved patient labeling (Patient Information and Instructions of Use).
Sexually Transmitted Infections
- Advise females that NEXTSTELLIS does not protect against HIV infection or other sexually transmitted infections.
Important Administration Instructions and Instructions for Missed Doses
Instruct females to take one tablet daily by mouth at the same time every day. Advise patients about what to do in the event that pills are missed. • Advise females starting NEXTSTELLIS to use additional nonhormonal contraception for 7 days after the first dose unless NEXTSTELLIS is started on the first day (Day 1) of menses.
• Advise females who miss more than two consecutive days of NEXTSTELLIS or experience vomiting or diarrhea for > 48 hours consecutively to use additional nonhormonal contraception for 7 days.
Thromboembolic Disorders and Other Vascular Problems
• Advise females that there is an increased risk of arterial and/or venous thrombotic/thromboembolic events with NEXTSTELLIS and the risk of arterial and/or venous thrombotic/thromboembolism is greater in smokers and females with preexisting medical conditions including hypertension, dyslipidemia, diabetes, and obesity.
• Advise patients of the pertinent factors that further increase their risk and ways to diminish the risk, e.g., to stop smoking (if applicable).
• Advise patients to contact their healthcare professional for any signs or symptoms of arterial and/or VTE.
• Advise patients to contact their healthcare professional if they will be immobilized for a prolonged period of time.
Hyperkalemia
- Advise females to contact their healthcare professional if signs or symptoms of hyperkalemia develop.
Hypertension
- Advise females that NEXTSTELLIS can cause an increase in blood pressure over time. Instruct patients to contact their healthcare professional if blood pressure increases.
Liver Disease
- Advise females that use of NEXTSTELLIS can cause elevated liver enzymes and can increase the risk of liver tumors. Instruct females to contact their healthcare professional for any signs or symptoms of liver disease.
Glucose Tolerance
- Advise females that NEXTSTELLIS may decrease glucose tolerance. Instruct females with diabetes and prediabetes to contact their healthcare professional for any signs or symptoms of hyperglycemia.
Gallbladder Disease and Cholestasis
- Advise females that use of NEXTSTELLIS is associated with an increased risk of developing and/or worsening gallbladder disease. Instruct patients to contact their healthcare professional for any signs or symptoms of gallbladder disease.
Bleeding Irregularities, Amenorrhea, and Pregnancy
- Advise females that NEXTSTELLIS can cause unscheduled bleeding and spotting, as well as amenorrhea and oligomenorrhea. Advise females to contact their health care professional if amenorrhea occurs in two or more consecutive cycles or symptoms of pregnancy occur, e.g., morning sickness or unusual breast tenderness. Instruct females to stop NEXTSTELLIS if pregnancy is confirmed during use.
Chloasma
- Advise females that NEXTSTELLIS can cause chloasma and the risk is highest in females with a history of chloasma, especially chloasma gravidarum. Instruct females to take precautions to limit UVA and UVB exposure while using NEXTSTELLIS.
Lactation
Advise postpartum females that NEXTSTELLIS may reduce breast milk production. Advise females that this reduction is less likely to occur if breast-feeding is well established.
Drug Interactions
- NEXTSTELLIS may interact with many drugs, foods, and dietary supplements. Therefore, advise females to report to their healthcare professional the use of any other prescription or nonprescription drugs or dietary supplements.
Precautions with Alcohol
Alcohol-Drospirenone and estetrol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
NEXTSTELLIS
Look-Alike Drug Names
There is limited information regarding Drospirenone and estetrol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.