Implanon® (etonogestrel implant) 68 mg

IMPLANON (etonogestrel implant) is indicated for women for the prevention of pregnancy.

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.

SELECTED SAFETY INFORMATION

• Women should be informed that this product does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.
• Serious consequences may be associated with the insertion and removal of IMPLANON. IMPLANON should be inserted subdermally so that it is palpable after insertion. Failure to insert IMPLANON properly may go unnoticed unless the implant is palpated immediately after insertion. Deep insertions may lead to difficult or impossible removals. Failure to remove IMPLANON may result in infertility, ectopic pregnancy, or inability to stop a drug-related adverse event. Undetected failure to insert IMPLANON may lead to an unintended pregnancy.
• In clinical trials, 1.0% of patients had complications at implant insertion and 1.7% had complications at implant removal. Deep insertions may result in the need for a surgical procedure in an operating room in order to remove IMPLANON. When IMPLANON is inserted too deeply, this may cause neural or vascular damage. Too deep insertions have been associated with paraesthesia and migration of the implant and, in rare cases, with intravascular insertion. In postmarketing use, there have been cases of failure to localize and remove the implant, probably due to deep insertion. All healthcare providers performing insertions and/or removals of IMPLANON must receive instruction and training and, where appropriate, supervision prior to inserting or removing IMPLANON.
• IMPLANON should not be used in women who have the following conditions: known or suspected pregnancy, current or past history of thrombosis or thromboembolic disorders, hepatic tumors (benign or malignant), active liver disease, undiagnosed abnormal genital bleeding, known or suspected carcinoma of the breast (or a personal history of breast cancer), or hypersensitivity to any of the components of IMPLANON.
• Pregnancy must be excluded before inserting 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 cardiovascular conditions including myocardial infarction, stroke, venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism. There have been postmarketing reports of serious thromboembolic events, including cases of pulmonary emboli (some fatal) and strokes, in patients using IMPLANON. IMPLANON should be removed in the event of a thrombosis. Consider removal of IMPLANON in case of long-term immobilization due to surgery or illness. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.
• Cigarette smoking increases the risk of serious cardiovascular side effects from the use of hormonal contraceptives. This risk increases with age (women over 35 years of age) and with heavy smoking. Women who use hormonal contraceptives should be advised not to smoke.
• In clinical trials including 942 patients, bleeding irregularities (11%) were the most common adverse event causing discontinuation of IMPLANON. Adverse events reported in >5% of subjects include headache, vaginitis, weight increase, acne, breast pain, upper respiratory tract infection, abdominal pain, pharyngitis, leukorrhea, influenza-like symptoms, dizziness, dysmenorrhea, back pain, emotional lability, nausea, pain, nervousness, sinusitis, depression, and insertion site pain.
• The most common side effect is changes in bleeding pattern ranging from amenorrhea to spotting and/or irregular or prolonged bleeding. In clinical trials, on average, up to 36% of patients experienced >21 days of spotting or bleeding over a 90-day period. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy.

Please see Prescribing Information.