Fixed-dose combination
Drospirenone and Estetrol is a fixed-dose combination medicine indicated by females of reproductive potential to prevent pregnancy. It is available as kits. MedsAcross supplies Drospirenone and Estetrol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. 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/m 2. In females with BMI ≥ 30 kg/m 2, decreasing effectiveness may be associated with increasing BMI.
Source: US FDA prescribing information
CHCs prevent pregnancy primarily by suppressing ovulation.
Source: US FDA prescribing information
Take one tablet by mouth at the same time every day. Take tablets in the order directed on the blister pack. 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. Table 1 NEXTSTELLIS Administration Instructions Starting NEXTSTELLIS in females with no current use of hormonal contraception Important: In females with irregular menstrual cycles, pregnancy testing may be necessary prior to initiation of this product.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. 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.
Source: US FDA prescribing information
The following clinically significant adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events including venous and arterial thromboembolism Hyperkalemia Liver disease Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
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).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Drospirenone and Estetrol, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Nextstellis kit | Drospirenone and Estetrol | Mayne Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Drospirenone and Estetrol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Drospirenone and Estetrol, including Nextstellis.
Yes. The US FDA first approved Drospirenone and Estetrol on 15 April 2021, according to Drugs@FDA.
Yes. Drospirenone and Estetrol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Drospirenone and Estetrol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Drospirenone and Estetrol is classified under ATC code G03 (Sex hormones and fertility medicines).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.