Patient Information

Indication

IMPLANON^® (etonogestrel implant) is for the prevention of pregnancy in women.

IMPORTANT SAFETY INFORMATION

IMPLANON^® does not protect against HIV (AIDS) or other sexually transmitted diseases.

IMPLANON^® must be removed by the end of the third year and may be replaced by a new IMPLANON^® at the time of removal, if continued contraceptive protection is desired. Failure to remove IMPLANON^® may result in infertility, ectopic pregnancy, or inability to stop a drug related adverse event.

After you receive IMPLANON^®, check that it is in place by pressing your fingertips over the skin in your arm where IMPLANON^® was placed. You should be able to feel the IMPLANON^® rod. If IMPLANON^® is not placed properly, it may not prevent pregnancy or it may be difficult or impossible to remove.

Serious consequences may be associated with the insertion and removal of IMPLANON^®. This may result in the need for a surgical procedure in an operating room in order to remove IMPLANON^®. Difficult removals may cause pain and scarring, and may result in damage to nerves and blood vessels. In clinical trials, 9 out of 942 (1.0%) patients had complications at implant insertion and 15 out of 942 (1.7%) had complications at implant removal.

You should not use IMPLANON^® if you are pregnant or think you may be pregnant, have or have had blood clots, have unexplained vaginal bleeding, have liver disease, have or have had breast cancer, or if you are allergic to anything in IMPLANON^®.

The use of IMPLANON^® and other progestin-only hormonal contraceptives have been associated with ectopic pregnancy, bleeding irregularities, and ovarian cysts. The use of hormonal contraceptives is associated with increased risks of several serious side effects including blood clots which may lead to stroke or heart attack. Blood clots are a side effect of birth control pills and pregnancy. It is unknown if the risk of blood clots with IMPLANON^® is different than with birth control pills. Some examples of blood clots are deep vein thrombosis (legs), pulmonary embolism (lungs), retinal thrombosis (eyes), stroke (head) and heart attack (heart). There have been reports of blood clots, including pulmonary emboli and strokes, in patients using IMPLANON^®. Tell your doctor at least 4 weeks before if you are going to have surgery or will need to be on bed rest because you have an increased chance of experiencing blood clots during surgery or bed rest.

Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. The risk increases with age (women >35), and with heavy smoking. Women who use hormonal contraceptives are strongly advised not to smoke.

The most common side effect of IMPLANON^® is a change in your menstrual periods. In studies, about 1 in 10 women stopped using IMPLANON^® because of bleeding problems. Expect your menstrual periods to be irregular and unpredictable throughout the time you are using IMPLANON^®. You may have more bleeding, less bleeding, or no bleeding. The time between periods may vary, and in between periods you may have spotting. Other common side effects reported in women using IMPLANON^® during clinical trials include: headache; vaginitis; weight gain; acne; breast pain; viral infections such as colds, sore throats, sinus infections, or flu-like symptoms; stomach pain; painful periods; mood swings; nervousness or depression; back pain; nausea; dizziness; pain; and pain at the site of insertion.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.