Implanon (Etonogestrel Subcutaneous) - Indications and Dosage

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 was

• Year 1: 10,867 cycles
• Year 2: 8,595 cycles
• Year 3: 3,492 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. 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.	85	85
SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation Method		3
Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulation phases.		2
Post-Ovulation		1
CapWith spermicidal cream or jelly.
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
Diaphragm	20	6	56
Withdrawal	19	4
CondomWithout spermicides.
Female (Reality)	21	5	56
Male	14	3	61
Pill	5		71
Progestin Only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T 380A	0.8	0.6	78
LNg 20	0.1	0.1	81
Depo-Provera	0.3	0.3	70
Norplant and Norplant-2	0.05	0.05	88
Female sterilization	0.5	0.5	100
Male sterilization	0.15	0.10	100

DOSAGE AND ADMINISTRATION

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™. Insert IMPLANON™ subdermally in the inner side of the upper arm (non-dominant arm) about 6-8 cm (2½-3 inches) above the elbow crease overlying the groove between the biceps and the triceps. See INSTRUCTIONS FOR INSERTION AND REMOVAL. IMPLANON™ must be inserted by the expiration date stated on the packaging. Remove IMPLANON™ no later than three years after the date of insertion.

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.

HOW SUPPLIED

One IMPLANON™ (etonogestrel implant) package consists of a single rod implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter. IMPLANON™ is pre-loaded in the needle of a disposable applicator. The applicator consists of acrylonitrile-butadiene-styrene body with a stainless steel needle and a polypropylene shield. The sterile applicator containing IMPLANON™ is packed in a blister pack.

NDC 0052-0272-01

Storage

Store IMPLANON™ (etonogestrel implant) at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. Avoid storing IMPLANON™ in direct sunlight or at temperatures above 30°C (86°F).

Rx only