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 , and sections).
The following table shows pregnancy rates in the first year of use for other contraceptive methods.
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).
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.
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.
68 mg For Subdermal Use Only
Read this leaflet carefully and have your healthcare provider answer all of your questions before you decide to use 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.
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.
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.
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 to get pregnant.
Do not use Implanon () if you
Tell your healthcare provider if you have ever had any of the conditions just listed. Your healthcare provider can suggest another method of birth control.
In addition, talk to your healthcare provider about using Implanon () if you have or had
If you have any of these conditions, your healthcare provider can explain what to do.
Your healthcare provider will insert (or remove) Implanon () in a minor surgical procedure in his or her office. Implanon () is inserted just under the skin on the inner side of your upper arm.
The timing of insertion is important. Depending on your history, your healthcare provider may ask you to
You will be asked to review and sign a consent form prior to inserting Implanon () . You will also get a USER CARD to keep at home with your health records. Your healthcare provider will fill out the insertion and removal dates. Keep track of the removal date and schedule an appointment for removal with your healthcare provider on or before the removal date.
The insertion site is covered with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage dry, clean, and in place for 3 to 5 days.
Be sure to have checkups as advised by your healthcare provider.
Talk with your healthcare provider if
Besides irregular bleeding, the most frequent side effects that caused women to stop using Implanon () in studies were
The most common side effects reported by women using Implanon () in clinical trials were
Rare side effects that have been reported include: extra hair on your face and body, trouble using contact lenses, and spotty darkening of the skin, especially on the face. This is not a complete list of possible side effects. Talk to your healthcare provider if you have any side effects that concern you.
You should see your healthcare provider right away. It is important to remove Implanon () and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with birth control pills, Implanon () is not likely to cause birth defects.
Based on a small study, you may start Implanon () if you are breastfeeding and if you delivered your baby more than 4 weeks ago. A small amount of the active substance of Implanon () passes into the breast milk. The health of breastfed children whose mothers were using Implanon () has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use Implanon () , talk with your healthcare provider.
Your healthcare provider can remove Implanon () at any time with a minor surgical procedure in the office. The information on your USER CARD may help your healthcare provider find Implanon () .
After removal, keep the removal site clean, dry, and bandaged for 3 to 5 days to lessen the chance of infection.
If you want to become pregnant, your ability to get pregnant usually returns quickly. Some women have become pregnant within days after removal of Implanon () .
This leaflet contains important information about Implanon () . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about Implanon () that is written for healthcare providers. You may also call 1-877-Implanon () (1-877-467-5266) or visit .
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
I understand the Patient Labeling for Implanon () . I have discussed Implanon () with my healthcare provider who answered all my questions. I understand that there are benefits as well as risks from using Implanon () . I understand that there are other birth control methods and that each has its own benefits and risks.
I also understand that this Patient Consent Form is important. I understand that I need to sign this form to show that I am making an informed and careful decision to use Implanon () , and that I have read and understand the following points.
After learning about Implanon () , I choose to use Implanon () .
WITNESSED BY:
The patient above has signed this consent in my presence after I counseled her and answered her questions.
I have provided an accurate translation of this information to the patient whose signature appears above. She has stated that she understands the information and has had an opportunity to have her questions answered.
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
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