Etonogestrel implant is used as contraception to prevent pregnancy. The medicine is contained in a small plastic rod that is implanted into the skin of your upper arm. The medicine is released slowly into the body. The rod can remain in place and provide continuous contraception for up to 3 years.

Etonogestrel implant may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant or if you have recently had a baby.

You should not use an etonogestrel implant if you have: undiagnosed vaginal bleeding, liver disease or liver cancer, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Using an etonogestrel implant can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not smoke while using an etonogestrel implant.

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 major surgery or will be on long-term bed rest, or if you need medical tests your etonogestrel implant may need to be 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.

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.

Using an etonogestrel implant can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using etonogestrel.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke.

Do not use if you are pregnant. If you become pregnant, the etonogestrel implant should be removed if you plan to continue the pregnancy.

You may need to have a negative pregnancy test before receiving the implant.

You should not use hormonal birth control if you have:

• a history of heart attack, stroke, or blood clot;

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;

• unusual vaginal bleeding that has not been checked by a doctor; or

• liver disease or liver cancer.

Tell your doctor if you have ever had:

• diabetes;

• high cholesterol or triglycerides;

• high blood pressure;

• headaches;

• gallbladder disease;

• kidney disease;

• depression; or

• an allergy to numbing medicines.

An etonogestrel implant may not be as effective in women who are overweight.

The etonogestrel implant should not be used in girls younger than 18 years old.

Etonogestrel can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Since etonogestrel is given as an implant by a healthcare professional, you will not be on a frequent dosing schedule. Be sure to see your doctor for removal of the implant by the end of the third year.

If the implant is correctly inserted, an overdose of etonogestrel is highly unlikely.

You should not smoke while using an etonogestrel implant.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Etonogestrel may cause serious side effects. Call your doctor at once if you have:

• warmth, redness, swelling, or oozing where the implant was inserted;

• severe pain or cramping in your pelvic area (may be only on one side);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;

• swelling in your hands, ankles, or feet;

• jaundice (yellowing of the skin or eyes);

• a breast lump; or

• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects of etonogestrel may include:

• pain where the implant was inserted;

• changes in your menstrual periods;

• vaginal itching or discharge;

• acne, mood changes, weight gain;

• back pain, menstrual cramps;

• nausea, stomach pain;

• breast pain;

• headache, dizziness; or

• flu-like symptoms, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Certain other medicines or herbal products may make etonogestrel less effective, which could result in pregnancy. You may need to use a non-hormonal form of back-up birth control (such as condoms with spermicide) while you are taking certain medicine, and for up to 28 days after stopping the medicine.

Tell your doctor about all your other medicines, especially:

• aprepitant;

• bosentan;

• griseofulvin;

• rifampin;

• St. John's wort;

• topiramate;

• medicine to treat hepatitis C, HIV, or AIDS;

• a barbiturate--butabarbital, secobarbital, phenobarbital; or

• seizure medicine--carbamazepine, felbamate, oxcarbazepine, phenytoin.

This list is not complete. Other drugs may affect etonogestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.