Dosage and administration

When to insert IMPLANON® IMPORTANT: Rule out pregnancy before inserting IMPLANON®. Timing of insertion depends on the patient’s recent history, as follows: 1. No preceding hormonal contraceptive use in the past month Counting the first day of menstruation as “Day 1”, IMPLANON® must be inserted between Days 1 through 5, even if the woman is still bleeding. 2. Switching from a combination hormonal contraceptive IMPLANON® may be inserted: Anytime within seven days after the last active (estrogen plus progestin) oral contraceptive tablet Anytime during the seven-day ring-free period of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) Anytime during the seven-day patch-free period of a transdermal contraceptive system 3. Switching from a progestin-only method There are several types of progestin-only methods. IMPLANON® insertion must be performed as follows: Any day of the month when switching from a progestin-only pill, do not skip any days between the last pill and insertion of IMPLANON® On the same day as contraceptive implant removal On the same day as removal of a progestin-containing IUD On the day when the next contraceptive injection would be due 4. Following first trimester abortion or miscarriage IMPLANON® may be inserted immediately following a complete first trimester abortion. If IMPLANON® is not inserted within five days following a first trimester abortion, follow the instructions under “No preceding hormonal contraceptive use in the past month.” 5. Following delivery or a second trimester abortion IMPLANON® may be inserted between 21 to 28 days postpartum if not exclusively breast feeding or between 21 to 28 days following second trimester abortion. If more than four weeks have elapsed, pregnancy should be excluded and the patient should use a non-hormonal method of birth control during the first seven days after the insertion. If the patient is exclusively breast feeding, insert IMPLANON® after the fourth postpartum week (see Nursing Mothers section under PRECAUTIONS in the full Prescribing Information). If inserted as recommended above, backup contraception is not necessary. If deviating from the recommended timing of insertion, rule out pregnancy and use backup non-hormonal contraception for seven days after IMPLANON® insertion.

NuvaRing® is indicated for the prevention of pregnancy in women.

IMPORTANT SAFETY INFORMATION

The use of combination oral contraceptives is associated with increased risks of several side effects, including stroke or heart attack. NuvaRing® is not for women with a history of these conditions. Combination oral contraceptives are also associated with increased risk of thromboembolic diseases. Some studies suggest that this risk is increased by combination oral contraceptives containing desogestrel; additional studies do not support this finding. It is unknown whether NuvaRing® has a different risk of venous thromboembolism (VTE) than second-generation oral contraceptives. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35; women who use combination hormonal contraceptives are strongly advised not to smoke. NuvaRing® is not for women with certain cancers or those who may be pregnant. NuvaRing® does not protect against HIV infection and other sexually transmitted diseases. In clinical trials, discontinuation due to adverse events ranged from 1% to 2.5%. The most common adverse events reported by 5% to 14% of women using NuvaRing® in clinical trials (n=2501) were vaginitis, headache, upper respiratory tract infection, vaginal secretion, sinusitis, weight gain, and nausea. Please click here for full prescribing information.

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.

Indication
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.


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^®. 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.

Please see full Prescribing Information.

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.