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

Important 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™. Any of the possible complications of surgery may occur. 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 insertion 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 heaving 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.

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