Proper Use

Drug information provided by: Merative, Micromedex®

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is to be used only in the vagina. This combination medicine is contained in a vaginal system that is placed into your vagina. The vaginal system will slowly release small amounts of the medicine for your body to absorb.

This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is used in a 4 week cycle for 13 cycles (1 year). You may start using the vaginal system between the second and fifth day of your menstrual period, keeping it in place for 3 weeks.

Once the vaginal system is in place inside your vagina, you should not be able to feel it. If you feel uncomfortable, it may not be inserted far enough. Gently push the vaginal system farther into your vagina. If you feel pain, talk to your doctor.

The vaginal system may move down accidently. This can happen if you remove a tampon, during sex, or strain to have a bowel movement. Gently push it back into place. If the vaginal system comes all the way out, wash it with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and put it back inside. Call your doctor if the vaginal system comes out several times.

Remove the vaginal system after 3 weeks on the same day of the week and time it was inserted. During the 1-week break, you will usually have your menstrual period. Wash the vaginal system with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and keep it inside the case that comes with it. Reinsert it after a week.

While using this medicine, you may need to use an additional form of birth control method (eg, condom, spermicide) during the first 7 days to prevent pregnancy, especially if you have an irregular menstrual cycle or if you start using this vaginal system more than 5 days from your last menstrual bleeding.

If you need to remove the vaginal system, hook your finger through it and pull it out.

If you are switching from a combination hormonal method (eg, pills, patch) to Annovera™, start using this medicine on any day. Do not use this medicine after more than 7 hormone-free days.

If you are switching from a progestin-only method (eg, progestin-only implant, injection, intrauterine system, pill) to Annovera™, start using it on the day after you used your last progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use an additional barrier method of birth control (eg, male condom with spermicide) for the first 7 days.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not use this medicine together with oil-based vaginal creams, gels, lubricants, or suppositories. Ask your doctor before you use other products or medicines into your vagina.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For vaginal dosage form (vaginal system):
    • For contraception (to prevent pregnancy):
      • Adults—One vaginal system inserted into the vagina for 21 days (3 weeks), followed by a 1 week vaginal system-free interval. It is then reinserted 1 week after.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

If the vaginal system has slipped out and it has been out for 2 hours or less, wash it with mild soap and warm water, pat it dry with a clean cloth towel or paper towel, and reinsert it. You should still be protected from pregnancy. If the vaginal system has been out for more than 2 hours (including multiple removals), use an additional form of birth control (including condoms or spermicide) until the vaginal system has been in the vagina for 7 days in a row.

If you forget to reinsert the vaginal system after the vaginal system-free week, use an additional form of birth control (including condoms or spermicide) until the vaginal system has been in the vagina for 7 days in a row.

If you leave the vaginal system inside the vagina for more than 21 days, remove it for 7 days and then reinsert it for 21 days to go back to the regular schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not use the vaginal system for more than 13 cycles (1 year). Place the used vaginal system inside the case that comes with it. Throw it in the trash. Do not flush the vaginal system down the toilet.