Contraceptives
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Nextstellis Dosage

Drug Detail:Nextstellis (Drospirenone and estetrol)

Generic Name: drospirenone 3mg, estetrol monohydrate 14.2mg;

Dosage Form: tablets

Drug Class: Contraceptives

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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)].

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