Implanon ® (etonogestrel implant) 68 mg

Insertion instructions

The basis for successful use and subsequent removal of IMPLANON 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 be trained prior to inserting or removing IMPLANON.

Information concerning the insertion and removal of IMPLANON will be sent upon request free of charge. Contact Merck at 1.877.IMPLANON (1-877-467-5266).

Prior to insertion

Prior to inserting IMPLANON, carefully read the instructions for insertion and removal as well as the full Prescribing Information .

  • Follow instructions carefully. Proper IMPLANON insertion will facilitate removal.
  • Correct timing of insertion is important. Find out 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 .

Equipment needed

Insert IMPLANON (etonogestrel implant) 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.

 

An applicator and its parts

Insertion procedure

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

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.

 

Patient positioned 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.

 

Insertion site marked 3. Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8–10 cm (3–4 inches) above the medial epicondyle of the humerus. IMPLANON (etonogestrel implant) should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissue of the sulcus between the biceps and triceps muscles.

 

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 a few centimeters proximal to the first mark (see above image). 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 (etonogestrel implant) 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.

 

Applying counter-traction to skin 12. Apply counter-traction to the skin around the proposed insertion.

 

Inserting tip of needle at a slight angle 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.

 

Applicator lowered to horizontal position 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.

 

Needle inserted to full length 15. While "tenting" (lifting) the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin during insertion.

 

16. If IMPLANON (etonogestrel implant) 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.

 

Breaking seal of applicator 17. Break the seal of the applicator by pressing the obturator support.

 

Rotating the obturator 90º 18. Turn the obturator 90º in either direction with respect to the needle.

 

Cannula being fully retracted. The right hand is holding the obturator in place while the left hand is retracting the cannula 19. While holding the obturator fixed in place on the arm, fully retract the cannula. 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.

 

Confirming that IMPLANON has been inserted correctly 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.

 

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 40 mm 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 40 mm 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.

IMPLANON (etonogestrel implant) is indicated for use by women to prevent pregnancy.

SELECTED SAFETY INFORMATION

  • IMPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors, benign or malignant, or active liver disease; undiagnosed abnormal genital bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past; or allergic reaction to any of the components of IMPLANON (etonogestrel implant).
  • IMPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert IMPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.
  • Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring, or infection, may occur. Occasionally in post-marketing use, implant insertions have failed because the implant fell out of the needle or remained in the needle during insertion. If IMPLANON is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur. Implant removal may be difficult or impossible if the implant is not inserted correctly, inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. Deep insertions may lead to difficult localization of the implant and may also result in the need for a surgical procedure in an operating room in order to remove the implant.
  • After starting IMPLANON, women are likely to have changes in their menstrual bleeding pattern. These may include changes in frequency, intensity, or duration. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy. In clinical studies of IMPLANON, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Women should be counseled regarding bleeding pattern changes that they may experience.
  • Be alert to the possibility of an ectopic pregnancy in women using IMPLANON who become pregnant or complain of lower abdominal pain.
  • The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and stroke, in women using IMPLANON. IMPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, IMPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the IMPLANON implant in case of long-term immobilization due to surgery or illness.
  • 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, surgery may be required.
  • Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer, and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.
  • IMPLANON (etonogestrel implant) should be removed if jaundice occurs.
  • The IMPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.
  • Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like IMPLANON.
  • Prediabetic and diabetic women using IMPLANON should be carefully monitored.
  • Women with a history of depressed mood should be carefully observed. Consideration should be given to removing IMPLANON in patients who become significantly depressed.
  • In clinical trials, the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.
  • Hormonal 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.
  • Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
  • The most common adverse reaction causing discontinuation of use of the implant in clinical trials was change in menstrual bleeding patterns, specifically irregular menses (11.1%).The most common adverse reactions (=10%) reported in clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%).
  • Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins and may decrease the effectiveness of IMPLANON. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug. Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of coadministration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.
  • CYP3A4 inhibitors, such as itraconzaole or ketoconazole, may increase plasma concentrations of etonogestrel.
  • Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine).
  • Rule out pregnancy before inserting IMPLANON.
  • Based on limited clinical data, IMPLANON may be used during breast-feeding after the fourth postpartum week. Use of IMPLANON before the fourth postpartum week has not been studied. Small amounts of etonogestrel are excreted in breast milk. The health of breast-fed 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 non-hormonal IUD (n=33). They were breast-fed 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.
  • Safety and efficacy of IMPLANON have been established in women of reproductive age and are expected to be the same for postpubertal adolescents. However, no studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.
  • The efficacy of IMPLANON in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. Therefore, IMPLANON may be less effective in overweight women.
  • IMPLANON does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Before prescribing IMPLANON, please read the Prescribing Information.