IMPLANON (etonogestrel implant) | IMPLANON

00:02 EDT 1st October 2014 | BioPortfolio
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68 mg

For Subdermal Use Only

Women should be informed that this product does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.

IMPLANON (etonogestrel implant) is an off-white, nonbiodegradable, etonogestrel-containing single sterile rod implant for subdermal use. The implant is 4 cm in length with a diameter of 2 mm (see Figure 1 ). Each IMPLANON rod consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel (ENG), surrounded by an EVA copolymer skin. The release rate is 60 to 70 mcg/day in Week 5 to 6 and decreases to approximately 35 to 45 mcg/day at the end of the first year, to approximately 30 to 40 mcg/day at the end of the second year, and then to approximately 25 to 30 mcg/day at the end of the third year. IMPLANON is a progestin-only contraceptive and does not contain estrogen. IMPLANON does not contain latex and is not radio-opaque.

ENG [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula:

IMAGE implanon-02.jpg
FIGURE 1 (Not to scale)

The contraceptive effect of IMPLANON (etonogestrel implant) is achieved by several mechanisms that include suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

After subdermal insertion of IMPLANON, ENG is released into the circulation and is approximately 100% bioavailable.

The mean peak serum concentrations in 3 pharmacokinetic studies ranged between 781 and 894 pg/mL and were reached within the first few weeks after insertion. The mean serum ENG concentration decreases gradually over time declining to 192 to 261 pg/mL at 12 months (n=41), 154 to 194 pg/mL at 24 months (n=35), and 156 to 177 pg/mL at 36 months (n=17). The pharmacokinetic profile of IMPLANON from 1 of 3 pharmacokinetic studies is shown in Figure 2.

FIGURE 2: Mean Serum Concentration-time Profile of ENG During 2 Years of IMPLANON Use and After Removal in 20 Healthy Women

The apparent volume of distribution averages about 201 L. ENG is approximately 32% bound to sex hormone binding globulin (SHBG) and 66% bound to albumin in blood.

In vitro data shows that ENG is metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. The biological activity of ENG metabolites is unknown.

The elimination half-life of ENG is approximately 25 hours. Excretion of ENG and its metabolites, either as free steroid or as conjugates, is mainly in urine and to a lesser extent in feces. After removal of IMPLANON, ENG concentrations decreased below sensitivity of the assay by 1 week.

The effectiveness of IMPLANON in overweight women has not been defined because women who weighed more than 130% of their ideal body weight were not studied. However, serum concentrations of ENG are inversely related to body weight and decrease with time after insertion. It is therefore possible that, with time, IMPLANON may be less effective in overweight women, especially in the presence of other factors that decrease etonogestrel concentrations such as concomitant use of hepatic enzyme inducers.

No formal studies were conducted to evaluate the effect of race on the pharmacokinetics of IMPLANON.

No formal studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics of IMPLANON. However, ENG is metabolized by the liver, and therefore, use in patients with active liver disease is contraindicated.

No formal studies were conducted to evaluate the effect of renal disease on the pharmacokinetics of IMPLANON.

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 1854 women-years of IMPLANON use, the total exposure in 28-day cycles by year was

The clinical trials excluded women who

Among women aged 18 to 35 years of age at entry, 6 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 2 weeks after IMPLANON removal. With these 6 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 sections).

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 1 YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 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 1 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 (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 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 6 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 1 year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within 1 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 & Norplant-2 0.05 0.05 88
Female sterilization 0.5 0.5 100
Male sterilization 0.15 0.10 100

IMPLANON (etonogestrel implant) should not be used in women who have

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 postmarketing 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. When IMPLANON is inserted too deeply (intramuscular or in the fascia), this may cause neural or vascular damage. Too deep insertions have been associated with paraesthesia (due to neural damage), migration of the implant (due to intramuscular or fascial insertion), 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. There has been 1 case of an intravascular insertion reported postmarketing 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.

Be alert to the possibility of an ectopic pregnancy among patients using IMPLANON who become pregnant or complain of lower abdominal pain. Although ectopic pregnancies should be uncommon among patients using IMPLANON, a pregnancy that occurs in a patient using IMPLANON may be more likely to be ectopic than a pregnancy occurring in a patient using no contraception.

Patients who use IMPLANON are likely to have changes in their vaginal bleeding patterns, which are often unpredictable. These may include changes in bleeding frequency or duration, or amenorrhea. Patients should be counseled regarding unpredictable bleeding irregularities so that they know what to expect. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy.

In clinical trials, bleeding changes were the single most common reason for stopping treatment with IMPLANON (11.1%, or 105 of 942 patients using IMPLANON). Most patients stopped treatment with IMPLANON because of irregular bleeding (10.8%), but some stopped because of amenorrhea (0.3%). In these studies, patients using IMPLANON had an average of 17.7 days of bleeding or spotting every 90 days (based on 3315 intervals of 90 days recorded by 780 patients). The percentages of patients having 0, 1 to 7, 8 to 21, or >21 days of spotting or bleeding over a 90-day interval while using IMPLANON is shown in the following table.

Bleeding patterns observed with use of IMPLANON for up to 2 years, and the proportion of 90-day intervals with these bleeding patterns, are summarized in the following table.

Percentages of Patients with 0, 1 to 7, 8 to 21, or >21 Days of Spotting or Bleeding Over a 90-Day Interval While Using IMPLANON
Total Days of Spotting or Bleeding Percentage of Patients
Treatment Days
91–180
(N=566)
Treatment Days
270–360
(N=554)
Treatment Days
640–730
(N=547)
0 days 19% 24% 17%
1–7 days 15% 13% 12%
8–21 days 30% 30% 37%
>21 days 36% 33% 35%
Bleeding Patterns Using IMPLANON During the First 2 Years of Use
Bleeding Patterns Definitions %
% = Percentage of 90-day intervals with this pattern.
Based on 3315 recording periods of 90 day's duration in 780 women, excluding the first 90 days after implant insertion.
Infrequent Less than 3 bleeding and/or spotting episodes in 90 days (excluding amenorrhea) 33.6
Amenorrhea No bleeding and/or spotting in 90 days 22.2
Prolonged Any bleeding and/or spotting episode lasting more than 14 days in 90 days 17.7
Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7

IMPLANON is not recommended for women who chronically take drugs that are potent hepatic enzyme inducers because etonogestrel levels may be substantially reduced in these women (see also PRECAUTIONS, Drug Interactions section).

If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, they can require surgery.

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 (see also WARNINGS, WARNINGS BASED ON EXPERIENCE WITH COMBINATION (PROGESTIN PLUS ESTROGEN) ORAL CONTRACEPTIVES section).

Thromboembolism: Epidemiological investigations have associated the use of combination hormonal contraceptives with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism).

The use of combination hormonal contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, and stroke, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes.

Cigarette smoking increases the risk of serious cardiovascular side effects from the use of combination hormonal contraceptives. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years old who smoke. While this is believed to be an estrogen-related effect, it is not known whether a similar risk exists with progestin-only methods. However, patients should be advised not to smoke.

An increase in blood pressure has been reported in women taking combination hormonal contraceptives, and this increase is more likely with continued use and with those users who are older. Studies have shown that the incidence of hypertension increases with increasing concentrations of progestins.

Women with a history of hypertension-related diseases or renal disease should be discouraged from using hormonal contraceptives. If women with hypertension elect to use hormonal contraceptives, they should be monitored closely. If sustained hypertension develops during the use of hormonal contraceptives, or if a significant increase in blood pressure does not respond adequately to antihypertensive therapy, hormonal contraceptives should be discontinued.

For most women, elevated blood pressure will return to normal after stopping hormonal contraceptives, and there is no difference in the occurrence of hypertension between ever- and never-users.

Women with breast cancer should not use hormonal contraceptives because breast cancer may be hormonally sensitive.

The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives. However, after combination oral contraceptive discontinuation, this excess risk appears to decrease over time, and within 10 years after cessation the increased risk disappears. Some studies report an increased risk with duration of use while other studies do not, and no consistent relationships have been found with dose or type of steroid. Some studies have found a small increase in risk for women who first used combination oral contraceptives before age 20. Most studies show a similar pattern of risk with combination oral contraceptive use regardless of a woman's reproductive history or her family breast cancer history.

In addition, breast cancers diagnosed in current or ever oral contraceptive users may be less clinically advanced than in never-users.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

In spite of many studies on the relationship between combination oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.

Benign hepatic adenomas have been associated with the use of combination oral contraceptives, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after 4 or more years of use. Rupture of benign hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the US and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than 1 per million users.

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of combination oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among combination oral contraceptive users may be minimal. The recent findings of minimal risk may be related to the use of combination oral contraceptive formulations containing lower doses of estrogens and progestins.

Women should be informed that this product does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.

IMPORTANT: Pregnancy must be excluded before inserting IMPLANON (etonogestrel implant).

A complete medical evaluation, including history and physical examination and relevant laboratory tests, should be performed prior to IMPLANON insertion or reinsertion. It is good medical practice for patients using IMPLANON to have regular physical examinations. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a family history of breast cancer or who have breast nodules should be monitored with particular care.

Provide your patient with a copy of the Patient Labeling and ensure that she understands the information in the Patient Labeling before insertion and removal. A USER CARD and consent form are included in the packaging. Have the patient complete a consent form and retain it in your records. The USER CARD should be filled out and given to the patient after IMPLANON insertion so that she will have a record of the location of IMPLANON and when IMPLANON should be removed.

In clinical studies, mean weight gain in US IMPLANON users was 2.8 pounds after 1 year and 3.7 pounds after 2 years. How much of the weight gain was related to IMPLANON is unknown. In studies, 2.3% of IMPLANON users reported weight gain as the reason for having IMPLANON removed.

IMPLANON may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance. Women with diabetes or impaired glucose tolerance should be carefully observed while using IMPLANON.

Women who are being treated for hyperlipidemias should be followed closely if they elect to use hormonal contraceptives. Some progestins may elevate LDL levels and may render the control of hyperlipidemias more difficult.

If jaundice develops in any patient using IMPLANON, remove IMPLANON. The hormone in IMPLANON may be poorly metabolized in patients with impaired liver function.

Women with a history of depression should be carefully observed. Consideration should be given to removing IMPLANON in patients who become significantly depressed.

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

IMPLANON is not recommended for women who require chronic use of drugs that are potent inducers of hepatic enzymes because IMPLANON is likely to be less effective for these women.

Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with some antibiotics, antifungals, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in an unintended pregnancy or breakthrough bleeding. Examples include: barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and modafinil. Patients should use an additional nonhormonal contraceptive method when taking medications that may decrease the efficacy of hormonal contraceptives.

Several of the anti-HIV protease inhibitors have been studied with coadministration of combination oral contraceptives; significant changes (increase and decrease) in the mean area under the curve (AUC) of the estrogen and progestin have been noted in some cases. The efficacy and safety of combination oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors; it is unknown whether this applies to IMPLANON. Healthcare providers should refer to the labeling of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

Herbal products containing St. John's wort (Hypericum perforatum) may induce hepatic enzymes and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

Inhibitors of hepatic enzymes such as itraconazole or ketoconazole may increase plasma hormone levels.

Certain endocrine tests may be affected by IMPLANON use

In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel (ENG) per day (equal to approximately 1.8–3.6 times the systemic steady state exposure of women using IMPLANON), no drug-related carcinogenic potential was observed. ENG was not genotoxic in the in vitro Ames/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the in vivo mouse micronucleus test. Fertility returned after withdrawal from treatment.

IMPLANON is not indicated for use during pregnancy (see CONTRAINDICATIONS ).

Teratology studies have been performed in rats and rabbits, respectively, using oral administration up to 390 and 790 times the human IMPLANON dose (based upon body surface) and revealed no evidence of fetal harm due to ENG exposure.

Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy. There is no evidence that the risk associated with IMPLANON is different from that of combination oral contraceptives.

IMPLANON should be removed if maintaining a pregnancy.

Based on limited data, IMPLANON may be used during lactation after the fourth postpartum week. Use of IMPLANON before the fourth postpartum week has not been studied.

Small amounts of ENG are excreted in breast milk. During the first months after IMPLANON insertion, when maternal blood levels of ENG are highest, about 100 ng of ENG may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant ENG dose 1 month after insertion of IMPLANON is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. The health of breastfed infants whose mothers began using IMPLANON during the fourth to eighth week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a nonhormonal IUD (n=33). They were breastfed for a mean duration of 14 months and followed up to 36 months of age. No significant effects and no differences between the groups were observed on the physical and psychomotor development of these infants. No differences between groups in the production or quality of breast milk were detected.

Healthcare providers should discuss both hormonal and nonhormonal contraceptive options, as steroids may not be the initial choice for these patients.

In clinical trials, pregnancies occurred as early as during the first week after removal of IMPLANON. Therefore, a patient should restart contraception immediately after removal of IMPLANON if she still needs to prevent pregnancy.

Steroid contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if IMPLANON causes fluid retention.

Safety and efficacy of IMPLANON have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents. However, no clinical studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.

This product has not been studied in women over 65 years of age and is not indicated in this population.

See WARNINGS and PRECAUTIONS for additional important adverse events.

In clinical trials including 942 subjects, bleeding irregularities were the most common adverse event causing discontinuation of IMPLANON (etonogestrel implant) (see following table).

Adverse events that were reported by more than 5% of subjects in clinical trials appear in the following table.

Other "Less Common Adverse Events" Reported in Less Than 5% of Subjects in Clinical Trials Include: Allergic Reaction, Alopecia, Anorexia, Anxiety, Appetite Increased, Arthralgia, Asthenia, Asthma, Breast Discharge, Breast Enlargement, Breast Fibroadenosis, Cervical Smear Test Positive, Constipation, Coughing, Crying Abnormal, Diarrhea, Dyspepsia, Dysuria, Edema, Edema Generalized, Fatigue, Fever, Flatulence, Gastritis, Hot Flushes, Hypertension, Hypoesthesia, Injection Site Reaction, Insomnia, Lactation Nonpuerperal, Libido Decreased, Migraine, Myalgia, Otitis Media, Ovarian Cyst, Pelvic Cramping, Premenstrual Tension, Pruritus, Pruritus Genital, Rash, Rhinitis, Sexual Function Abnormal, Skeletal Pain, Somnolence, Vaginal Discomfort, Vein Varicose, Vision Abnormal, Vomiting, and Weight Decrease.

Hypertrichosis has also been reported with use of progestin-only contraceptives.

Implant site complications were reported by 3.6% of subjects during any of the assessments in clinical trials. Pain was the most frequent implant site complication, reported during and/or after insertion, occurring in 2.9% of subjects. Additionally, hematoma, redness, and swelling were reported by 0.1%, 0.3%, and 0.3% of patients, respectively (see also WARNINGS, WARNINGS BASED ON EXPERIENCE WITH IMPLANON AND OTHER PROGESTIN-ONLY CONTRACEPTIVES, Complications of Insertion and Removal section).

Adverse Events Leading to Discontinuation of Treatment in 1% or More of Subjects in Clinical Trials
Adverse Event All Studies
N=942
Bleeding IrregularitiesIncludes "frequent", "heavy", "prolonged", "spotting", and other patterns of bleeding irregularity. 11.0%
Emotional LabilityAmong US subjects, 6.1% experienced emotional lability that led to discontinuation. 2.3%
Weight Increase 2.3%
Headache 1.6%
Acne 1.3%
DepressionAmong US subjects, 2.4% experienced depression that led to discontinuation. 1.0%
Adverse Events Reported in More than 5% of Subjects in Clinical TrialsList may include adverse events associated with, but unrelated to, IMPLANON use.
Adverse Event All Studies
N=942
Headache 24.9%
Vaginitis 14.5%
Weight Increase 13.7%
Acne 13.5%
Breast Pain 12.8%
Upper Respiratory Tract Infection 12.6%
Abdominal Pain 10.9%
Pharyngitis 10.5%
Leukorrhea 9.6%
Influenza-Like Symptoms 7.6%
Dizziness 7.2%
Dysmenorrhea 7.2%
Back Pain 6.8%
Emotional Lability 6.5%
Nausea 6.4%
Pain 5.6%
Nervousness 5.6%
Sinusitis 5.6%
Depression 5.5%
Insertion Site Pain 5.2%

Insertion of multiple rods has been reported. Overdosage may result if more than 1 IMPLANON (etonogestrel implant) rod is in place. In case of suspected overdose, IMPLANON should be removed. It is important to remove the IMPLANON rod or other contraceptive implant(s) before inserting a new IMPLANON rod.

All healthcare providers performing insertions and/or removals of IMPLANON (etonogestrel implant) must receive instruction and training and where appropriate, supervision prior to inserting or removing IMPLANON. To minimize the risk of neural or vascular damage, IMPLANON should be inserted at the inner side of the nondominant upper arm about 8 to 10 cm (3–4 inches) above the medial epicondyle of the humerus. IMPLANON should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissues in the sulcus between the triceps and biceps muscles (see INSTRUCTIONS FOR INSERTION AND REMOVAL ). IMPLANON must be inserted by the expiration date stated on the packaging. Remove IMPLANON no later than 3 years after the date of insertion.

IMPORTANT: Rule out pregnancy before inserting IMPLANON.

Timing of insertion depends on the patient's recent history, as follows

If inserted as recommended above, backup contraception is not necessary. If deviating from the recommended timing of insertion, rule out pregnancy and use backup nonhormonal contraception for 7 days after IMPLANON insertion.

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 preloaded 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

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

REFERENCES FURNISHED UPON REQUEST

The basis for successful use and subsequent removal of IMPLANON (etonogestrel implant) is a correct and carefully performed subdermal insertion of the single rod implant in accordance with the instructions. If the implant is placed improperly leading to deep location or migration, it will be more difficult to remove than a correctly placed subdermal implant. All healthcare providers performing insertions and removals of IMPLANON must receive instruction and training, and where appropriate, supervision prior to inserting or removing IMPLANON.

Information concerning the insertion and removal of IMPLANON will be sent upon request free of charge [Telephone: 1-877-IMPLANON (1-877-467-5266)].

Prior to inserting IMPLANON (etonogestrel implant) carefully read the instructions for insertion and removal as well as the full prescribing information.

Place IMPLANON subdermally. Both you and your patient should be able to feel IMPLANON under her skin after placement.

Follow instructions carefully. All healthcare providers must receive training before inserting or removing IMPLANON. Proper IMPLANON insertion will facilitate removal. Correct timing of insertion is important (see DOSAGE AND ADMINISTRATION, When to Insert IMPLANON section). Perform a history and physical examination, including a gynecologic examination, before IMPLANON insertion. Ensure that the patient understands the risks and benefits of IMPLANON before insertion. Provide the patient with a copy of the Patient labeling included in packaging. Have the patient review and complete a consent form and maintain it with the patient's chart.

Exclude pregnancy before insertion.

Insert IMPLANON under aseptic conditions.

The following equipment is needed for IMPLANON insertion

An applicator and its parts are shown below (see Figures 3a and 3b).

The procedure used for IMPLANON insertion is opposite from that of an injection. The obturator keeps IMPLANON in place while the cannula is retracted. The obturator must remain fixed in place while the cannula with needle is retracted from the arm. Do not push the obturator.

FIGURE 3a: (Not to scale)
FIGURE 3b
Grooved tip of obturator (enlarged)

Before initiating the removal procedure, the healthcare provider may consult the USER CARD that is kept by the patient and/or the Patient Chart Label. The arm in which IMPLANON (etonogestrel implant) is located should be indicated on the USER CARD and the Patient Chart Label. IMPLANON should have been inserted in the medial aspect of the upper nondominant arm. Prior to removing IMPLANON, carefully read the instructions for removal. Find IMPLANON by palpation. If IMPLANON cannot be palpated, use either ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging to localize the implant. Consider conducting difficult removals with ultrasound guidance. Only remove a nonpalpable implant once the location of IMPLANON has been established. If these imaging methods fail, call 1-877-IMPLANON (1-877-467-5266) for further instructions.

There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position. This may complicate localization of the implant by palpation, ultrasound, or magnetic resonance imaging, and removal may require a larger incision and more time.

Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged. Removal of deeply inserted implants should be conducted with caution, in order to prevent damage to deeper neural or vascular structures in the arm, and be performed by healthcare providers familiar with the anatomy of the arm.

The patient's position for removal is similar to the position for insertion. Use aseptic technique.

The following equipment is needed for removal

Manufactured by N.V. Organon, Oss, The Netherlands. Distributed by Schering Corporation, a subsidiary of Schering-Plough Corporation, Kenilworth, NJ 07033 USA.

© 2006, 2009, Schering Corporation. All rights reserved.Rev. 3/09

33293704T

IMAGE implanon-25.jpg

IMPLANON (etonogestrel implant)

68 mg For Subdermal Use Only

Rx only

IMPLANON does not protect against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases.

Read this leaflet carefully and have your healthcare provider answer all of your questions before you decide to use IMPLANON.

What is the most important information I should know about IMPLANON?

After you receive IMPLANON, check that it is in place by pressing your fingertips over the skin in your arm where IMPLANON was placed. You should be able to feel the IMPLANON rod. If IMPLANON is not placed properly, it may not prevent pregnancy or it may be difficult or impossible to remove.

The most common side effect of IMPLANON is a change in your menstrual periods. Expect your menstrual period to be irregular and unpredictable throughout the time you are using IMPLANON. You may have more bleeding, less bleeding, or no bleeding. The time between periods may vary, and in between periods you may have spotting.

What if I change my mind about birth control?

Your healthcare provider can remove IMPLANON at any time. If you want to become pregnant after IMPLANON removal, your ability to get pregnant may return quickly. If you don't want to get pregnant, you should start another birth control method right away.

How does IMPLANON work?

IMPLANON prevents pregnancy in several ways. The most important way is by stopping release of an egg from your ovary. IMPLANON also changes the mucus in your cervix and this change may keep sperm from reaching the egg. Also, IMPLANON changes the lining of your uterus.

How well does IMPLANON work?

If IMPLANON is inserted correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use IMPLANON for 1 year). It is not known if IMPLANON is as effective in very overweight women because studies did not include many overweight women.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying t

Manufacturer

Organon Pharmaceuticals USA

Active Ingredients

Source

Drugs and Medications [1 Associated Drugs and Medications listed on BioPortfolio]

Nexplanon [Organon Pharmaceuticals USA]

These highlights do not include all the information needed to use NEXPLANON safely and effectively. See full prescribing information for NEXPLANON. NEXPLANON® (etonogestrel implant)RadiopaqueSubderma...

Clinical Trials [5 Associated Clinical Trials listed on BioPortfolio]

A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720)

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Pharmacokinetics of Implanon in Obese Women

Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who excee...

Acceptability of Long-term Progestin-only Contraception in Europe

The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and ...

A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(Study E-1729)(COMPLETED)

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various...

Safety of the Etonogestrel-Releasing Implant During the Puerperium of Healthy Women

The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.

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