DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Implanon (Etonogestrel Subcutaneous) - Indications and Dosage

 
 



INDICATIONS AND USAGE

IMPLANON® is indicated for use by women to prevent pregnancy.

DOSAGE AND ADMINISTRATION

The efficacy of IMPLANON does not depend on daily, weekly or monthly administration.

All healthcare providers should receive instruction and training prior to performing insertion and/or removal of IMPLANON.

A single IMPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant 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. IMPLANON must be inserted by the expiration date stated on the packaging. IMPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

Initiating Contraception with IMPLANON

IMPORTANT: Rule out pregnancy before inserting the implant.

Timing of insertion depends on the woman's recent contraceptive history, as follows:

  • No preceding hormonal contraceptive use in the past month
     
       IMPLANON should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.
       
    •  If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
       
  • Switching contraceptive method to IMPLANON
        Combination hormonal contraceptives:

    IMPLANON should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of the removal of the vaginal ring or transdermal patch. At the latest, IMPLANON should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
     
  •   Progestin-only contraceptives:

    There are several types of progestin-only methods. IMPLANON should be inserted as follows:
     
      Injectable Contraceptives: Insert IMPLANON on the day the next injection is due.
       
    • Minipill: A woman may switch to IMPLANON on any day of the month. IMPLANON should be inserted within 24 hours after taking the last tablet.
       
    • Contraceptive implant or intrauterine system (IUS): Insert IMPLANON on the same day as the previous contraceptive implant or IUS is removed.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
  • Following abortion or miscarriage
     
      First Trimester: IMPLANON should be inserted within 5 days following a first trimester abortion or miscarriage.
       
    • Second Trimester: Insert IMPLANON between 21 to 28 days following second trimester abortion or miscarriage.

    If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
  • Postpartum
     
      Not Breastfeeding: IMPLANON should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
       
    • Breastfeeding: IMPLANON should be inserted after the fourth postpartum week [see Use in Specific Populations]. The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

    Insertion of IMPLANON

    The basis for successful use and subsequent removal of IMPLANON is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the healthcare provider and the woman should be able to feel the implant under the skin after placement.

    All healthcare providers performing insertions and/or removals of IMPLANON should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of IMPLANON will be sent upon request free of charge [1-877-IMPLANON (1-877-467-5266)].

    Preparation

    Prior to inserting IMPLANON carefully read the instructions for insertion as well as the full prescribing information.

    Before insertion of IMPLANON, the healthcare provider should confirm that:

    • The woman is not pregnant nor has any other contraindication for the use of IMPLANON [see Contraindications (4) ].
    • The woman has had a medical history and physical examination, including a gynecologic examination, performed.
    • The woman understands the benefits and risks of IMPLANON.
    • The woman has received a copy of the Patient Labeling included in packaging.
    • The woman has reviewed and completed a consent form to be maintained with the woman's chart.
    • The woman does not have allergies to the antiseptic and anesthetic to be used during insertion.

    Insert IMPLANON under aseptic conditions.

    The following equipment is needed for the implant insertion:

    • An examination table for the woman to lie on
    • Sterile surgical drapes, 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 below (Figures 1a and 1b).

    Figure 1a (Not to scale)
    Figure 1b
    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.

    Insertion Procedure

    •  Step 1.    Have the woman 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 2).
  • Figure 10
    In this figure, the right hand is holding the obturator in place while the left hand is retracting the cannula.
    •  Step 19.    Confirm that the implant has been inserted by checking the tip of the needle for the absence of the implant. After insertion of the implant, the grooved tip of the obturator will be visible inside the needle (Figure 11).
    Figure 17 Figure 18
    Figure 19 Figure 20
    Figure 21

    Figure 21

    Replacing IMPLANON

    Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of IMPLANON.

    The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it just under the skin along the 'insertion canal.'

    Follow the subsequent steps in the insertion instructions [see Dosage and Administration].

    DOSAGE FORMS AND STRENGTHS

    Single, off-white, soft, flexible, ethylene vinylacetate (EVA) implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel.

    HOW SUPPLIED/STORAGE AND HANDLING

    How Supplied

    One IMPLANON package consists of a single implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator. The sterile applicator containing the implant is packed in a blister pack.

    NDC 0052-0272-01

    Storage and Handling

    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).

    -- advertisement -- The American Red Cross
     
    Home | About Us | Contact Us | Site usage policy | Privacy policy

    All Rights reserved - Copyright DrugLib.com, 2006-2017