Nexplanon implant

Subdermal

Contraception

Adult: Each implant contains 68 mg of Nexplanon implant: 1 implant is inserted during the 1st 5 days of the menstrual cycle; remove within 3 yr of insertion.

Vaginal

Contraception

Adult: Each vaginal ring delivers 120 mcg of etonorgestrel and 15 mcg of ethinylestradiol daily. Insert one ring into the vagina on the 1st day of menstruation. Leave the ring in place continuously for 3 wk. Remove it after 3 wk for the 1 wk break during which breakthrough bleeding will occur. Insert a new ring 1 wk after removal of the previous ring.

How should I use Nexplanon implant?

Nexplanon implant is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. After the implant is inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry.

The timing of when you receive the Nexplanon implant implant depends on whether you were using birth control before, and what type it was.

You should be able to feel the implant under your skin. Tell your doctor if you cannot feel the implant at any time while it is in place.

The Nexplanon implant implant can remain in place for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor's instructions.

You may have irregular and unpredictable periods while using Nexplanon implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

If you need major surgery with long-term bed rest, or if you need medical tests, may need to have your Nexplanon implant implant removed for a short time. Any doctor or surgeon who treats you should know that you have a Nexplanon implant implant.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

The Nexplanon implant implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. After the implant is removed, your ability to get pregnant will return quickly. If the implant is not replaced with a new one, start using another form of birth control right away if you wish to prevent pregnancy.

Call your doctor at once if it feels like the Nexplanon implant implant may be bent or broken while it is in your arm.

Uses of Nexplanon implant in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use: Labeled Indications

Contraception: Prevention of pregnancy

Nexplanon implant description

Each radiopaque implant contains etonogestrel 68 mg. The release rate is approximately 60-70 mcg/day in week 5-6 and has decreased to approximately 35-45 mcg/day at the end of the 1st year to approximately 30-40 mcg/day at the end of the 2nd year and to approximately 25-30 mcg/day at the end of the 3rd year. The innovative applicator is designed to be operated with 1 hand and help facilitate correct subdermal insertion of implant. Nexplanon implant also contains the following excipients: Core: Ethylene vinylacetate copolymer (28% vinyl acetate, 43 mg), barium sulfate 15 mg. Skin: Ethylene vinylacetate, copolymer (14% vinyl acetate, 15 mg).

Impanon NXT is a progestagen-only, flexible implant preloaded in a sterile, ready-for-use, disposable applicator.

Nexplanon implant dosage

The efficacy of Nexplanon implant 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 Nexplanon implant.

​A single Nexplanon implant 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, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult or impossible. Nexplanon implant must be inserted by the expiration date stated on the packaging. Nexplanon implant 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 Nexplanon implant

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

  Nexplanon implant 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 Nexplanon implant

  Combination hormonal contraceptives:

  Nexplanon implant 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, Nexplanon implant 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. Nexplanon implant should be inserted as follows:

  • Injectable Contraceptives: Insert Nexplanon implant on the day the next injection is due.

  • Minipill: A woman may switch to Nexplanon implant on any day of the month. Nexplanon implant should be inserted within 24 hours after taking the last tablet.

  • Contraceptive implant or intrauterine system (IUS): Insert Nexplanon implant 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: Nexplanon implant should be inserted within 5 days following a first trimester abortion or miscarriage.

  • Second Trimester: Insert Nexplanon implant 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: Nexplanon implant 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: Nexplanon implant should be inserted after the fourth postpartum week. 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 Nexplanon implant

The basis for successful use and subsequent removal of Nexplanon implant 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 Nexplanon implant should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of Nexplanon implant will be sent upon request free of charge [1-877-Nexplanon implant (1-877-467-5266)].

Preparation

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

Before insertion of Nexplanon implant, the healthcare provider should confirm that:

• The woman is not pregnant nor has any other contraindication for the use of Nexplanon implant.
• The woman has had a medical history and physical examination, including a gynecologic examination, performed.
• The woman understands the benefits and risks of Nexplanon implant.
• 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 Nexplanon implant 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).

The procedure used for Nexplanon implant insertion is opposite from that of an injection. The obturator keeps Nexplanon implant 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

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​If the rod is not palpable:

​If you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply:

• Check 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.
• Use other methods to confirm the presence of the implant. Suitable methods to locate are: ultrasound (US) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). Please note that the Nexplanon implant rod is not radiopaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI fail, call 1-877-Nexplanon implant (1-877-467-5266) for information on the procedure for measuring Nexplanon implant blood levels.

Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.

​Once the non-palpable implant has been located, removal is recommended.

Removal of Nexplanon implant

Preparation

​Before initiating the removal procedure, the healthcare provider should carefully read the instructions for removal and consult the USER CARD and/or the PATIENT CHART LABEL for the location of the implant. The exact location of the implant in the arm should be verified by palpation.

​Procedure for Removal of an Implant that is Palpable

Before removal of the implant, the healthcare provider should confirm that:

• The woman does not have allergies to the antiseptic or anesthetic to be used.

Remove the implant under aseptic conditions.

The following equipment is needed for removal of the implant:

• 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 scalpel, forceps (straight and curved mosquito)
• Skin closure, sterile gauze, adhesive bandage and pressure bandages

Removal Procedure

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​Localization and Removal of a Non-Palpable Implant

​There have been reports of migration of the implant; usually this involves minor movement relative to the original position, but may lead to the implant not being palpable in the location in which it was placed. An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization.

​A non-palpable implant should always be located prior to attempting removal. Suitable methods for localization include ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging. Once the implant has been localized in the arm, the implant should be removed according to the instructions in Dosage and Administration (2.3), Procedure for Removal of an Implant that is Palpable, and the use of ultrasound guidance during the removal should be considered.

​If the implant cannot be found in the arm after comprehensive localization attempts, consult a radiologist familiar with applying advanced imaging techniques to the chest, as events of migration to the pulmonary vasculature have been reported. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; healthcare providers familiar with the anatomy of the chest should be consulted.

​If at any time these imaging methods fail to locate the implant, Nexplanon implant blood level determination can be used for verification of the presence of the implant. For details on Nexplanon implant blood level determination, call 1-877-Nexplanon implant (1-877-467-5266) for further instructions.

​If the implant migrates within the arm, removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating room. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.

​Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.

Replacing Nexplanon implant

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 Nexplanon implant.

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.

Nexplanon implant (Nexplanon implant) is a hormone implant that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Nexplanon implant is radiopaque implant used as contraception to prevent pregnancy. Nexplanon implant is contained in a small plastic rod that is implanted into the skin of your upper arm. The medicine is released slowly into the body.

The Nexplanon implant rod can remain in place and provide continuous contraception for up to 3 years.

Nexplanon implant implants contain a small amount of barium sulfate so that the implant can be seen by X-ray.

See also:
What is the most important information I should know about Nexplanon implant?

Hypersensitivity to Nexplanon implant or to any of the excipients of Nexplanon implant.

Progestagen-only contraceptives should not be used in the presence of active venous thromboembolic disorder, known or suspected sex steroid-sensitive malignancies, presence or history of severe hepatic disease as long as liver function values have not returned to normal, undiagnosed vaginal bleeding, and known or suspected pregnancy. Should any of the conditions appear for the 1st time during the use of Nexplanon implant immediately discontinue use.

Use in pregnancy & lactation: Nexplanon implant is not indicated during pregnancy. If pregnancy occurs during use of Nexplanon implant, the implant should be removed. Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female fetuses. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used oral contraceptives (OCs) prior to pregnancy nor of a teratogenic effect when OCs were inadvertently used during pregnancy. Although this probably applies to all OCs, it is not clear whether this is also the case for Nexplanon implant. Pharmacovigilance data with various Nexplanon implant- and desogestrel-containing products (Nexplanon implant is a metabolite of desogestrel) do not indicate an increased risk.

Clinical data indicate that Nexplanon implant does not influence the production or the quality (protein, lactose or fat concentrations) of breast milk. However, small amounts of Nexplanon implant are excreted in breast milk. Based on an average daily milk ingestion of 150 mL/kg, the mean daily infant Nexplanon implant-dose calculated after 1 month of Nexplanon implant release is approximately 27 ng/kg/day. This corresponds to approximately 2.2% of the weight-adjusted maternal daily dose and to approximately 0.2% of the estimated absolute maternal daily dose. Subsequently the milk Nexplanon implant concentration decreases with time during the lactation period.

Long-term data are available on 38 children, whose mothers had an implant inserted during the 4th-8th week postpartum. They were breastfed for a mean duration of 14 months and followed-up to 36 months of age. Evaluation of growth and physical, and psychomotor development did not indicate any differences in comparison to nursing infants whose mothers used an intrauterine device (n=33). Nevertheless, development and growth of the child should be carefully followed. Based on the available data, Nexplanon implant may be used during lactation and should be inserted after the 4th postpartum week.

See also:
What other drugs will affect Nexplanon implant?

Influence of Other Medicinal Products on Nexplanon implant: Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. No specific interaction studies have been performed with Nexplanon implant. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).

Hepatic Metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, specifically cytochrome P-450 enzymes, which can result in increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, rifabutin, topiramate, felbamate, ritonavir, nelfinavir, nevirapine, griseofulvin and the herbal remedy St. John's wort).

Also human immunodeficiency virus HIV protease (eg, ritonavir, nelfinavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine, efavirenz) and combinations of them have been reported to potentially affect hepatic metabolism.

Women on treatment with any of these drugs should temporarily use a barrier method in addition to Nexplanon implant. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.

In women on long-term treatment with hepatic enzyme-inducing drugs, it is recommended to remove Nexplanon implant and to prescribe a non-hormonal method.

Increase in plasma hormone levels associated with co-administered drugs: Drugs (eg, ketoconazole) that inhibit microsomal enzymes eg, CYP3A4 may increase plasma hormone levels.

Influence of Nexplanon implant on Other Medicinal Products: Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations either increase (eg, cyclosporine) or decrease (eg, lamotrigine).

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Laboratory Test: Data obtained with combined oral contraceptives have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of the liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins eg, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestagen-only contraceptives is not known.

See also:
What are the possible side effects of Nexplanon implant?

During the use of Nexplanon implant, women are likely to have changes in their vaginal bleeding patterns which are often unpredictable. These may inlcude changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration. Ammenorhoea was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding. Occasionally, heavy bleeding has been reported. In clinical trials, bleeding changes were the most common reason for stopping treatment with Nexplanon implant (about 11%). Dysmenorrhoea tends to improve while using Nexplanon implant. The bleeding pattern experienced during the first 3 months is broadly predictive of future bleeding patterns for many women.

Possibly related undesirable effects reported in clinical trials with Nexplanon implant have been listed in the following table. An association has been neither confirmed nor refuted.

In rare cases, a clinically relevant rise in blood pressure has been observed during the use of Nexplanon implant. Urticaria and (aggravation of) angioedema and/or aggravation of hereditary angioedema may occur. Insertion or removal of Nexplanon implant may cause some bruising, slight local irritation, pain or itching. Occasionally, fibrosis at the injection site may occur or a scar may be formed or an abscess may develop. In rare cases, paresthesia or paresthesia-like events may occur. Expulsion or migration of Nexplanon implant may be possible. Minor surgical intervention might be necessary when removing Nexplanon implant.

On rare occasions, ectopic pregnancies have been reported.

In women using (combined oral) contraceptives, a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hypertension, hormone-dependent tumours (eg, liver tumours, breast cancer) and chloasma.