IMPLANON™ (etonogestrel implant) is indicated for women for the prevention of pregnancy. IMPLANON™ is a long-acting (up to three 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 pro- tection 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 18-35 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 PER- CENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES.

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™. Insert IMPLANON™ subdermally in the inner side of the upper arm (non-dominant arm) about 6-8 cm (21/2-3 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

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 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

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 IMPLANON™ is not inserted within five days following a first trimester abortion, follow the instructions under “No preceding hormonal contraceptive use in the past month.”

Following delivery or a second trimester abortion

• IMPLANON™ may be inserted between 21 to 28 days postpartum if not exclusively breast feeding or between 21 to 28 days following second trimester abortion. If more than four weeks have elapsed, pregnancy should be excluded and the patient should use a non-hormonal method of birth control during the first seven days after the insertion. If the patient is exclusively breast feeding, insert IMPLANON™ after the fourth postpartum week (see Nursing Mothers section under PRECAUTIONS)

If inserted as recommended above, backup contraception is not necessary. If deviating from the recommended timing of insertion, rule out pregnancy and use backup non-hormonal contraception for seven 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 pre-loaded in the needle of a disposable applicator. The applicator consists of acrylonitrile-buta- diene-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 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Avoid storing IMPLANON™ in direct sunlight or at temperatures above 30ºC (86ºF).

REFERENCES FURNISHED UPON REQUEST

INSTRUCTIONS FOR INSERTION AND REMOVAL

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 [Organon USA Inc., telephone: 1-877-IMPLANON (1-877-467-5266)].

INSERTION PROCEDURE

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 When to Insert IMPLANON™ in the DOSAGE AND ADMINISTRATION 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 examination table for the patient to lie on
• Sterile surgical drapes, talc-free sterile gloves, antiseptic solution, sterile marker (optional)
• Local anesthetic, needles, and syringe
• Sterile gauze, adhesive bandage, pressure bandage

An applicator and its parts are shown in the following diagrams (Figures 3a and 3b).

Figure 3a (Not to scale)

Figure 3b Grooved tip of obturator (enlarged)

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.

1. Confirm that the patient does not have allergies to IMPLANON™, as well as the antiseptic and anesthetic to be used during insertion.

2. Have the patient lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 4).

3. Identify the insertion site, which is 6-8 cm (21/2 to 3 inches) above the elbow crease at the inner side of the upper arm overlying the groove between the biceps and the triceps of her nondominant arm.

4. Mark the insertion site with a sterile marker. Make two marks: first, mark the spot where the IMPLANON™ rod will be inserted, and second, mark a spot about 6-8 cm (21/2 to 3 inches) proximal to the first mark (Figure 5). This second mark will later serve as a direction guide during IMPLANON™ insertion.

5. Clean the insertion site with an antiseptic solution.

6. Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 cc of 1% lidocaine just under the skin along the planned insertion tunnel).

7. Carefully remove the IMPLANON™ applicator from its blister. Keep the shield on the needle and look for the IMPLANON™ rod, seen as a white cylinder inside the needle tip.

8. If you don't see the IMPLANON™ rod, tap the top of the needle shield against a firm surface to bring the implant into the needle tip.

9. Following visual confirmation, lower the IMPLANON™ rod back into the needle by tapping it back into the needle tip. Then remove the needle shield, while holding the applicator upright.

10. Note that IMPLANON™ can fall out of the needle. Therefore, after you remove the needle shield, keep the applicator in the upright position until the moment of insertion.

11. Keep the IMPLANON™ needle and rod sterile. If contamination occurs, use a new package of IMPLANON™ with a new sterile applicator.

12. Apply counter-traction to the skin around the proposed insertion (Figure 6).

13. At a slight angle (not greater than 20º), insert only the tip of the needle with the beveled side up into the insertion site (Figure 7).

14. Lower the applicator to a horizontal position. Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue (Figure 8).

15.While “tenting” (lifting) the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin dur- ing insertion (Figure 9).

16. If IMPLANON™ is placed too deeply, the removal process can be difficult or impossible. If the needle is not inserted to its full length, the implant may protrude from the insertion site and fall out.

17.  Break the seal of the applicator by pressing the obturator support (Figure 10).

18.  Turn the obturator 90º in either direction with respect to the needle (Figure 11).

19. While holding the obturator fixed in place on the arm, fully retract the cannula (Figure 12). Note: This procedure is opposite from an injection. Do not push the obturator. By holding the obturator fixed in place on the arm and fully retracting the cannula, IMPLANON™ will be left in its correct subdermal position. Do not simultaneously retract the obturator and cannula from the patient's arm.

20. Confirm that IMPLANON™ has been inserted by checking the tip of needle for the absence of IMPLANON™. After IMPLANON™ insertion, the grooved tip of the obturator will be visible inside the needle (Figure 13).

In this figure, the right hand is holding the obturator in place while the left hand is retracting the cannula.

21. Always verify the presence of IMPLANON™ in the patient's arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod.

22. Place a small adhesive bandage over the insertion site. Request that the patient palpate IMPLANON™.

23. If you cannot feel IMPLANON™ as a 4 cm long rod, confirm its presence using other methods. Suitable methods to locate IMPLANON™ are: ultrasound (US) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). Please note that the IMPLANON™ rod is not radio-opaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI fail, call 1-877-IMPLANON (1-877-467-5266) for information on the procedure for measuring ENG blood levels.

Until you confirm proper IMPLANON™ insertion, your patient must use a non-hormonal contraceptive method.

24. Apply a pressure bandage with sterile gauze to minimize bruising. The patient may remove the pressure bandage in 24 hours and the small bandage over the insertion site in three to five days.

25. Complete the USER CARD and give it to the patient to keep. Also, complete the Patient Chart Label and affix it to the patient's medical record.

26. The applicator is for single use only. Dispose of the applicator in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.

REMOVAL PROCEDURE

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 non-dominant 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 non-palpable 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.

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

The following equipment is needed for removal

• An examination table for the patient to lie on
• Sterile surgical drapes, talc-free sterile gloves, antiseptic solution, sterile marker (optional)
• Local anesthetic, needles, and syringe
• Sterile scalpel, forceps (straight and curved mosquito)
• Skin closure, sterile gauze, adhesive bandage and pressure bandages

1. IMPLANON™ must only be removed by a healthcare provider who has been instructed and trained in the IMPLANON™ removal technique.

2. The arm in which IMPLANON™ is located should be indicated on the USER CARD and the Patient Chart Label. IMPLANON™ should be in the medial aspect of the upper non-dominant arm.

3. After confirming that the patient does not have any allergies to the antiseptic, wash the patient's arm and apply an antiseptic. Locate IMPLANON™ by palpation and mark the end closest to the elbow, for example, with a sterile marker (Figure a).

4. After determining the absence of allergies to the anesthetic agent or related drugs, anesthetize the arm, for example, with 0.5 to 1 cc 1% lidocaine at the site where the incision will be made (near the tip of IMPLANON™ that is closest to the elbow) (Figure b). Be sure to inject the local anesthetic under IMPLANON™ to keep the implant close to the skin surface.

5. Make a 2-3 mm incision in the longitudinal direction of the arm at the tip of the implant closest to the elbow (Figure c).

6. Gently push IMPLANON™ toward the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and pull it out gently (Figure d).

7. If IMPLANON™ is encapsulated, make an incision into the tissue sheath and then remove IMPLANON™ with the forceps (Figures e and f).

8. If the tip of the implant is still not visible after gently pushing it towards the incision (as in step 6), gently insert a forceps into the incision and grasp the implant (Figures g and h). Turn the forceps around (Figure h).

9. With a second forceps carefully dissect the tissue around IMPLANON™ and then remove IMPLANON™ (Figure i). Be sure to remove the IMPLANON™ rod entirely. Confirm that the entire rod, which is 4 cm long, has been removed by mea- suring its length.

If the patient would like to continue using IMPLANON™, insert a new IMPLANON™ rod immediately after the old IMPLANON™ rod is removed. The new IMPLANON™ can be inserted in the same arm, and through the same incision, or a new IMPLANON™ can be inserted in the other arm. If the patient does not wish to continue using IMPLANON™ and does not want to become pregnant, recommend another contraceptive method.

10. After removing IMPLANON™, close the incision with a butterfly closure and apply an adhesive bandage.

11. Apply a pressure bandage with sterile gauze to minimize bruising.

Manufactured for Organon USA Inc. Roseland, NJ 07068 by N.V. Organon, Oss, The Netherlands. FDA Rev date: 1/18/2007

Bookmark this page: