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Basic Drug Info
Drug Name:Implanon
Manufacturer:Organon USA, Inc.
Other Info:



Clinical Trials:


Indications and Usage

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

IMPLANON™ is a long-acting (up to 3 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 1,854 women-years of IMPLANON™ use, the total exposure in 28-day cycles by year wasYear 1: 10,867 cyclesYear 2: 8,595 cyclesYear 3: 3,492 cyclesThe clinical trials excluded women whoWeighed more than 130% of their ideal body weightWere chronically taking medications that induce liver enzymesAmong 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.

See CLINICAL PHARMACOLOGY, Special Populations, Overweight Women, and PRECAUTIONS, Drug Interactions.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. % of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method(1)Typical UseAmong 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)Perfect UseAmong 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)(4) Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.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). Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.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. Adapted from Hatcher et al., Contraceptive Technology, 17th Revised Edition.

New York, NY: Irvington Publishers, 1998. ChanceThe 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.8585 SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640 Periodic abstinence2563    Calendar9    Ovulation Method3    Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulation phases.2    Post-Ovulation1 CapWith spermicidal cream or jelly.    Parous Women402642    Nulliparous Women20956 Sponge    Parous Women402042    Nulliparous Women20956 Diaphragm20656 Withdrawal194 CondomWithout spermicides.    Female (Reality)21556    Male14361 Pill571    Progestin Only0.5    Combined0.1 IUD    Progesterone T2.01.581    Copper T 380A0.80.678    LNg 200.10.181 Depo-Provera0.30.370 Norplant and Norplant-20.050.0588 Female sterilization0.50.5100 Male sterilization0.150.10100
Overweight -- A status with BODY WEIGHT that is above certain standard of acceptable or desirable weight. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal "over fat".

Contraindications
IMPLANON™ (etonogestrel implant) should not be used in women who haveKnown or suspected pregnancyCurrent or past history of thrombosis or thromboembolic disordersHepatic tumors (benign or malignant), active liver diseaseUndiagnosed abnormal genital bleedingKnown or suspected carcinoma of the breast or personal history of breast cancerHypersensitivity to any of the components of IMPLANON™.
Thrombosis -- Formation and development of a thrombus or blood clot in the blood vessel.

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Warnings

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.

See INSTRUCTIONS FOR INSERTION AND REMOVAL.In clinical trials, 1.0% of patients had complications at implant insertion and 1.7% had complications at implant removal.

Complications expected of a minor surgical procedure, such as pain, paresthesias, bleeding, hematoma, scarring or infection, have been reported.

Occasionally in post-marketing use, implant insertions have failed because the implant fell out of the needle or remained in the needle during insertion.

Implant removals may be difficult because the implant is deep, not palpable, encased in fibrous tissue, or has migrated.

Implants have broken during difficult removals.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 post-marketing use there have been cases of failure to localize and remove the implant, probably due to deep insertion.

There has been one case of an intravascular insertion reported post-marketing which led to inability to remove the implant.If infection develops at the insertion site, start suitable treatment.

If infection persists, remove IMPLANON™.

Incomplete insertions or infections may lead to expulsion.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.