etonogestrel
Dosage Form: implant
Implanon®
(etonogestrel implant)
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 Description
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.
| FIGURE 1 (Not to scale) |
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:
C22H28O2
Implanon - Clinical Pharmacology
Pharmacodynamics
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.
Pharmacokinetics
Absorption
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.
Metabolism
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.
Excretion
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.
Special Populations
Overweight Women
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.
Race
No formal studies were conducted to evaluate the effect of race on the pharmacokinetics of Implanon.
Hepatic Insufficiency
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.
Renal Insufficiency
No formal studies were conducted to evaluate the effect of renal disease on the pharmacokinetics of Implanon.
Indications and Usage for 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
- 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 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.
| % of Women Experiencing an Unintended Pregnancy within the First Year of Use | % of Women Continuing Use at 1 Year* | ||
|---|---|---|---|
| Method (1) | Typical Use† (2) | Perfect Use‡ (3) | (4) |
| Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§ | |||
| Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.¶ | |||
| Adapted from Hatcher et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998. | |||
| |||
| Chance# | 85 | 85 | |
| SpermicidesÞ | 26 | 6 | 40 |
| Periodic abstinence | 25 | 63 | |
| Calendar | 9 | ||
| Ovulation Method | 3 | ||
| Sympto-Thermalß | 2 | ||
| Post-Ovulation | 1 | ||
| Capà | |||
| Parous Women | 40 | 26 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Sponge | |||
| Parous Women | 40 | 20 | 42 |
| Nulliparous Women | 20 | 9 | 56 |
| Diaphragmà | 20 | 6 | 56 |
| Withdrawal | 19 | 4 | |
| Condomè | |||
| 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 |
Contraindications
Implanon® (etonogestrel implant) should not be used in women who have
- 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 personal history of breast cancer
- Hypersensitivity to any of the components of Implanon
Warnings
A. WARNINGS BASED ON EXPERIENCE WITH Implanon® (etonogestrel implant) AND OTHER PROGESTIN-ONLY CONTRACEPTIVES
1. Complications of Insertion and Removal
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.
2. Ectopic Pregnancies
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.
3. Bleeding Irregularities
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.
| 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 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.
| 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).
5. Ovarian Cysts
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.
6. Thrombosis
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).
B. WARNINGS BASED ON EXPERIENCE WITH COMBINATION (PROGESTIN PLUS ESTROGEN) ORAL CONTRACEPTIVES
1. Thromboembolic Disorders and Other Vascular Problems
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.
2. Cigarette Smoking
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.
3. Elevated Blood Pressure
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.
4. Carcinoma of the Breast and Reproductive Organs
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.
5. Hepatic Neoplasia
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.
6. Gallbladder Disease
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.
Precautions
1. General
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).
2. Physical Examination and Follow-up
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.
3. Information for the Patient
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.
4. Weight Gain
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.
5. Carbohydrate and Lipid Metabolic Effects
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.
6. Liver Function
If jaundice develops in any patient using Implanon, remove Implanon. The hormone in Implanon may be poorly metabolized in patients with impaired liver function.
7. Depression
Women with a history of depression should be carefully observed. Consideration should be given to removing Implanon in patients who become significantly depressed.
8. Contact Lenses
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
9. Drug Interactions
Changes in Contraceptive Effectiveness Associated with Coadministration of Other Drugs
a. Anti-Infective Agents and Anticonvulsants
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.
b. Anti-HIV Protease Inhibitors
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.
c. Herbal Products
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.
Increase in Plasma Hormone Levels Associated with Coadministered Drugs
Inhibitors of hepatic enzymes such as itraconazole or ketoconazole may increase plasma hormone levels.
10. Interactions with Laboratory Tests
Certain endocrine tests may be affected by Implanon use
- Sex hormone-binding globulin concentrations may be decreased for the first 6 months after Implanon insertion followed by a gradual recovery.
- Thyroxine concentrations may initially be slightly decreased followed by gradual recovery to baseline.
11. Carcinogenesis, Mutagenesis, Impairment of Fertility
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.
12. Pregnancy
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.
13. Nursing Mothers
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.
14. Return to Ovulation
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.
15. Fluid Retention
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.
16. Pediatric Use
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.
17. Geriatric Use
This product has not been studied in women over 65 years of age and is not indicated in this population.
Adverse Reactions
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 Event | All Studies N=942 |
|---|---|
| |
| Bleeding Irregularities* | 11.0% |
| Emotional Lability† | 2.3% |
| Weight Increase | 2.3% |
| Headache | 1.6% |
| Acne | 1.3% |
| Depression‡ | 1.0% |
Adverse events that were reported by more than 5% of subjects in clinical trials appear in the following table.
| 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% |
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).
Overdosage
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.
Implanon Dosage and Administration
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.
When to Insert Implanon
IMPORTANT: Rule out pregnancy before inserting Implanon.
Timing of insertion depends on the patient's recent history, as follows
- 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. - Switching from a combination hormonal contraceptive
Implanon may be inserted- Anytime within 7 days after the last active (estrogen plus progestin) oral contraceptive tablet
- Anytime during the 7-day ring-free period of NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring)
- Anytime during the 7-day patch-free period of a transdermal contraceptive system
- 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
- Following first trimester abortion or miscarriage
- Implanon may be inserted immediately following a complete first trimester abortion. If Im
No comments:
Post a Comment