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) )
|
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
There is limited information regarding Drospirenone and estetrol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Drospirenone and estetrol How Supplied in the drug label.
Storage
There is limited information regarding Drospirenone and estetrol Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Drospirenone and estetrol Patient Counseling Information in the drug label.
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
There is limited information regarding Drospirenone and estetrol Brand Names in the drug label.
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.