Etonogestrel implant

NEXPLANON® is indicated for use by women to prevent pregnancy.

• Birth Control Options (Types and Side Effects)

The timing of when you will receive this implant depends on whether you were using birth control before, and what type it was.

Etonogestrel implant is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. After the implant is inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry.

You should be able to feel the implant under your skin. Tell your doctor if you cannot feel the implant at any time while it is in place.

Etonogestrel implant can remain in place for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor's instructions.

You may have irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

If you need surgery or medical tests or if you will be on bed rest, you may need to have your etonogestrel implant removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

The etonogestrel implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. After the implant is removed, your ability to get pregnant will return quickly. If the implant is not replaced with a new one, start using another form of birth control right away if you wish to prevent pregnancy.

Call your doctor at once if it feels like the implant may be bent or broken while it is in your arm.

Do not smoke while using etonogestrel implant, especially if you are older than 35 years of age.

Etonogestrel implant will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Usual Adult Dose for Contraception:

One 68 mg implant subdermally just under the skin at the inner side of the non-dominant upper arm
-Remove no later than the end of the third year

Comments:
-Implant may be replaced by a new implant at the time of removal.
-If no preceding hormonal contraceptive in the last month: insert between days 1 and 5 of the menstrual cycle, even if still bleeding.
-Switching from combined hormonal contraceptive: insert the day after the last active tablet of the oral contraceptive, or the day of removal of the vaginal ring or patch.
-Switching from progestin-only injectable contraceptive: implant the day the next injection is due.
-Switching from progestin-only minipill: switch any day of the month, within 24 hours after the last tablet.
-Switching from progestin-only implant or intrauterine device: insert the same day the previous contraception is removed.
-Following first trimester abortion or miscarriage: insert within 5 days of abortion/miscarriage.
-Following second trimester abortion or miscarriage: insert between 21 and 28 days of abortion/miscarriage.
-Postpartum, not breastfeeding: insert between 21 and 28 days postpartum.
-Postpartum, breastfeeding: insert after the fourth week postpartum, advise use of a barrier contraceptive method until 7 days after implantation.
-If inserted as recommended above, back up contraception is not necessary. If deviating from the above recommendations, a barrier contraceptive is recommended until 7 days after insertion.

Commonly reported side effects of etonogestrel include: irregular menses and weight gain. Other side effects include: depression and pain. See below for a comprehensive list of adverse effects.

Contraindicated

Animal studies have shown that high doses may cause masculinization of female fetuses; doses of this drug up to 2 mg/kg/day (approximately 1.6 to 3 times the human dose) showed no embryotoxic or fetotoxic effects. There are no controlled data in human pregnancy. Epidemiological studies have not shown increased birth defects or teratogenicity when combined oral contraceptives are used prior to or during pregnancy, but it is not clear if this applies for this medication also. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is contraindicated. (AU, US) Use is not indicated during pregnancy. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned Comments: - Remove implant if pregnancy occurs.

Use is considered acceptable after 4 weeks postpartum. Excreted into human milk: Yes Comments: -May be used during breastfeeding after the fourth postpartum week; use prior to this time has not been studied. -Plasma drug levels are highest the first month after insertion, and during that time may expose the breastfed infant to approximately 0.2% of the estimated maternal dose. -A small breastfeeding study comparing this drug (started 4 to 8 weeks postpartum) to non-hormonal IUD use found no physical or psychomotor development differences at 36 months of age, nor any differences in milk quality or production. -Carefully monitor the child's development.

ETONOGESTREL (et oh noe JES trel) is a contraceptive (birth control) device. It is used to prevent pregnancy. It can be used for up to 3 years.

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.