etonogestrel (implant)

What is the most important information I should know about etonogestrel?

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

What is etonogestrel implant?

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.

What should I discuss with my healthcare provider before receiving the etonogestrel implant?

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 this medicine.

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

• 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.

How is the etonogestrel implant used?

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).

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking 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.

What are the possible side effects of etonogestrel implant?

• 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 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.

What other drugs will affect etonogestrel implant?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about etonogestrel implant.