What is the dosage of ?

is available in 1 dosages, including mixed Pack

contains drospirenone / estetrol which is a Progestin

What is mechanism of action?

mechanism of action is Estrogen Receptor Agonists

Nextstellis

(drospirenone / estetrol)

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Dosage & Administration

* Take one tablet by mouth at the same time every day.
* Take tablets in the order directed on the blister pack.

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This AI tool offers medical information for informational purposes only and is not a substitute for professional medical judgment or advice. Physicians and healthcare professionals should exercise their expertise and discretion when interpreting and applying the provided information to specific clinical situations.

Nextstellis Prescribing Information

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. [See Contraindications (4) and Warnings and Precautions (5.1)]

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).

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. Day 1 Start: Take the first pink active tablet on the first day of menses. Take subsequent pink active tablets once daily at the same time each day for a total of 24 days. Take one white inert tablet daily for 4 days and at the same time of day that active tablets were taken. Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) If not starting on the first day of menses, use a non-hormonal contraceptive (e.g. condoms and/or spermicide) as back-up until one active tablet has been taken daily for 7 days in a row.
Switching to NEXTSTELLIS from another contraceptive method	Start NEXTSTELLIS on the day:
Combined Oral Contraceptive (COC)	When the new pack of the previous COC would have started.
Transdermal System	When the next application would have been scheduled.
Vaginal Insert	When the next insertion would have been scheduled.
Injection	When the next injection would have been scheduled.
Intrauterine System (IUS)	After removal.
Implant	After removal.
Progestin-only pill	After the last tablet was taken.
Starting NEXTSTELLIS after delivery (>20 weeks gestation)	Must not start earlier than 4 weeks after delivery (due to the increased risk of thromboembolism [see Contraindications (4) and Warnings and Precautions (5.1)] If menstrual cycles have returned, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception". If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy. If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use.
Starting NEXTSTELLIS after Abortion or Miscarriage ≤14 weeks gestation	Within the first 7 days of complete first trimester abortion or miscarriage, use additional nonhormonal contraception for the next 7 days. After the first 7 days, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception".
> 14 weeks but ≤ 20 weeks gestation	After 4 weeks following second trimester abortion or miscarriage. Consider duration of pregnancy and increased risk of thromboembolism [see Warnings and Precautions (5.1)] If menstrual cycles have returned, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception." If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy. If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use.

Missed Doses

Table 2 Instructions for Missed NEXTSTELLLIS Tablets in a Monthly Dosing Regimen
If one pink active tablet is missed	Take the missed tablet as soon as possible and take the next tablet at the scheduled time, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished.
If two or more pink active tablets are missed in Week 1 or Week 2	Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Continue taking one tablet a day until the pack is finished. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.
If two pink active tablets are missed in Week 3	Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Finish the active tablets and discard the inactive tablets in the pack. Start a new pack of tablets the next day. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.
If one or more white inert tablets are missed	Skip the missed pill days and continue taking one tablet a day until the pack is finished.

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 [see Dosage and Administration (2.3)].

Pregnancy

Risk Summary

Discontinue NEXTSTELLIS if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy [see Contraindications (4)]. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. Reproductive toxicity studies performed with E4 alone have shown expected pharmacologic effects in animals, which are considered consistent with estrogen exposure.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

Lactation

Risk Summary

Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. When possible, advise the nursing woman to use other methods of contraception until she discontinues breast-feeding [see also Dosage and Administration (2.1)]. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for NEXTSTELLIS and any potential adverse effects on the breast-fed child from NEXTSTELLIS or from the underlying maternal condition.

After oral administration of DRSP 3 mg/EE 30 µg, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum females within 24 hours. This results in a potential maximal daily dose of less than 1 µg DRSP in an infant.

Pediatric Use

Safety and efficacy of NEXTSTELLIS have been established in females of reproductive potential. The study population of C302 [see Clinical Studies (14)] was in females of reproduction age 16-50 years of age. Use of NEXTSTELLIS before menarche is not indicated.

Geriatric Use

NEXTSTELLIS has not been studied in postmenopausal females and is not indicated in this population.

Hepatic Impairment

NEXTSTELLIS is contraindicated in females with hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1, 5.3)]. The mean exposure to drospirenone (DRSP) in females with moderate liver impairment is approximately three times higher than the exposure in females with normal liver function. NEXTSTELLIS has not been studied in females with severe hepatic impairment [see Clinical Pharmacology (12.3)].

Renal Impairment

NEXTSTELLIS is contraindicated in females with renal impairment [see Contraindications (4), Warnings and Precautions (5.1)].

In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30–49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Race/Ethnicity

No clinically significant difference was observed between the pharmacokinetics of E4 or DRSP depending on race [see Clinical Pharmacology (12.3)].

Body Mass Index (BMI)/Body Weight

The safety and efficacy of NEXTSTELLIS in females with a BMI ≥ 35 kg/m2 have not been adequately evaluated.

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:
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Smoke, if 35 years of age and older [see Boxed Warning and Warnings and Precautions (5.1)]
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Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)]
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Have cerebrovascular disease [see Warnings and Precautions (5.1)]
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Have coronary artery disease [see Warnings and Precautions (5.1)]
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Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
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Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
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Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.1)]
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Have diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.9)]
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Have migraine headaches with aura [see Warnings and Precautions (5.4)]
Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.5)]
Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.6)]
Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.7)]
Abnormal uterine bleeding that has an undiagnosed etiology [see Warnings and Precautions (5.5)]
Renal Impairment [see Warnings and Precautions (5.2)]
Adrenal insufficiency [see Warnings and Precautions (5.2)]