Indications and use
IMPLANON® (etonogestrel implant) 68 mg is indicated for women for the prevention of pregnancy.
IMPLANON® is a long-acting (up to three years), reversible, contraceptive method. 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.
In clinical trials involving 923 subjects and 1854 women-years of IMPLANON® use, the total exposure in 28-day cycles by year was:
- Year 1: 10,867 cycles
- Year 2: 8595 cycles
- Year 3: 3492 cycles
The clinical trials excluded women who:
- Weighed more than 130% of their ideal body weight
- Were chronically taking medications that induce liver enzymes
Among women aged 18-35 years of age at entry, six pregnancies during 20,648 cycles of use were reported. Two pregnancies occurred in each of Years 1, 2 and 3. Each conception was likely to have occurred shortly before or within two weeks after IMPLANON® removal. With these six pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.
The efficacy of IMPLANON® does not depend on patient self-administration. IMPLANON® may be less effective in women who are overweight or who are taking medications that induce liver enzymes.
For more information about CLINICAL PHARMACOLOGY, Special Populations, overweight women, PRECAUTIONS and drug interactions, see the full Prescribing Information.
The following Table shows pregnancy rates in the first year of use for other contraceptive methods.
PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL AND PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES.
 Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.(9)
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.(10)
Adapted from Hatcher et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998.
1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3. Among couples attempting to avoid pregnancy, the percentage who continues to use a method for one year.
4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
6. Cervical mucus (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the post-ovulation phases.
7. With spermicidal cream or jelly.
8. Without spermicides.
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (one dose is two white pills), Alesse (one dose is five pink pills), Nordette or Levlen (one dose is four yellow pills).
10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breast feeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
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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.
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