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NEXPLANON<sup>®</sup> NEXPLANON<sup>®</sup>

Administration

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All HCPs performing insertions and/or removals of NEXPLANON should receive instructions and training prior to inserting or removing the implant.

If you require certification to administer NEXPLANON, you’ll find all the resources you need here to register and request training. If you are already registered and trained, you can access your certification document and review training materials.

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NEXPLANON is a soft, flexible implant that is inserted into your patient’s arma

aPlaced subdermally just under the skin in the inner, non-dominant upper arm.

Learn more about the insertion of NEXPLANON

The video below is for informational purposes only and is not intended to serve as a substitute for training on the insertion and removal procedures for NEXPLANON.

Download instructions for inserting and removing NEXPLANON

Insertion instructions
Removal instructions

Palpation is an important technique for locating NEXPLANON after insertion and before removal.

Palpate immediately after insertion

  • NEXPLANON should be inserted subdermally in the inner side of the upper nondominant arm
  • Always verify the presence of the implant in the patient’s arm immediately after insertion by palpation
    • The patient should be able to palpate the implant
  • If the implant is not palpable or there is doubt about its presence, check the applicator and use 1 of the 4 available methods (listed below) to confirm its presence
  • Until the presence of the implant has been verified, the patient should be advised to use a nonhormonal contraceptive method, such as condoms

Palpate before removal

  • The exact location of the implant in the arm should be verified by palpation before removal procedure
  • A nonpalpable implant should always be located prior to removal using 1 of the 4 available localization methods
  • Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged

Methods for confirming presence if implant is not palpable

The NEXPLANON implant is radiopaque, providing 4 methods for confirming presence after insertion and localizing before removal, in the event that the implant is not palpable.

  • CT scan
  • 2-Dimensional X-ray
  • Ultrasound
  • MRI

If Unable to Palpate Implant, Use a 2-D X-Ray to Confirm Implant Presence and an Ultrasound to Guide Removal

CT = computed tomography; MRI = magnetic resonance imaging.

In a clinical trial, mean insertion timeb was under 1 minute1

  • The basis for successful use and subsequent removal of NEXPLANON is a correct and carefully performed subdermal insertion in accordance with the instructions
  • Both the HCP and the patient should be able to feel the implant under the skin after placement

Study Design1

In a clinical trial evaluating the insertion characteristics of the applicator for NEXPLANON:

Out of 301 insertions of the NEXPLANON implant, the mean insertion timeb was (±SD) 27.9±29.3 seconds.

bFrom the removal of the protective cap of the applicator until retraction of the needle from the arm.

SD = standard deviation.

IMPORTANT: Rule out pregnancy before inserting the implant

If inserted as recommended, backup 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.

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

No hormonal contraceptive use in the past month

  • Recommended timing: NEXPLANON should be inserted between Day 1 and Day 5 of the menstrual cycle, even if the woman is still bleeding

Switching contraceptive method to NEXPLANON

If switching from combination hormonal contraception:

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

If switching from progestin-only contraception:

  • Injectable contraception: Insert NEXPLANON on the day the next injection is due
  • Minipill: Insert NEXPLANON on any day of the month within 24 hours after taking the last tablet
  • Contraceptive implant or IUS: Insert NEXPLANON on the same day the previous contraceptive implant or IUS is removed

Following abortion or miscarriage

  • First trimester: Insert NEXPLANON within 5 days following a first trimester abortion or miscarriage
  • Second trimester: Insert NEXPLANON between 21 and 28 days following second trimester abortion or miscarriage

Postpartum

  • Not breastfeeding: Insert NEXPLANON between 21 and 28 days postpartum

Breastfeeding: NEXPLANON should not be inserted until 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.

IUS = intrauterine system.

HCP = healthcare professional.

About NEXPLANON Bleeding Changes

Indication and Selected Safety Information

Indication

NEXPLANON is indicated for use by women to prevent pregnancy.

Selected Safety Information

CONTRAINDICATIONS

  • NEXPLANON 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; and/or allergic reaction to any of the components of NEXPLANON.

WARNINGS AND PRECAUTIONS

Complications of Insertion and Removal

  • NEXPLANON 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 NEXPLANON 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 may occur, e.g., pain, paresthesia, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted deeply (intramuscular or intrafascial), neural or vascular injury may occur.
  • Postmarketing reports of implants located within the vessels of the arm and the pulmonary artery may have been related to deep insertions or intravascular insertions. Endovascular or surgical procedures may be needed for removal.
  • 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. If at any time the implant cannot be palpated, it should be localized and removal is recommended. When an implant is removed, it is important to remove it in its entirety. 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.

Broken or Bent Implants

  • Cases of breakage or bending of implants while inserted within a patient’s arm have been reported. Cases of migration of a broken implant fragment within the arm have also occurred. These cases may be related to external forces, e.g., manipulation of the implant or contact sports. The release rate of etonogestrel may be slightly increased in a broken or bent implant, based on in vitro data.

Changes in Menstrual Bleeding Patterns

  • After starting NEXPLANON, 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 the non-radiopaque etonogestrel implant, 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.

Ectopic Pregnancies

  • Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.

Thrombotic and Other Vascular Events

  • 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 thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON 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 NEXPLANON implant in case of long-term immobilization due to surgery or illness.

Ovarian Cysts

  • 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.

Carcinoma of the Breast and Reproductive Organs

  • 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.

Liver Disease

  • NEXPLANON should be removed if jaundice occurs.

Elevated Blood Pressure

  • The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled.

Gallbladder Disease

  • 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 NEXPLANON.

Carbohydrate and Lipid Metabolic Effects

  • Prediabetic and diabetic women using NEXPLANON should be carefully monitored.

Depressed Mood

  • Women with a history of depressed mood should be carefully observed. Consideration should be given to removing NEXPLANON in patients who become significantly depressed.

Return to Ovulation

  • In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), 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.

Fluid Retention

  • 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 NEXPLANON causes fluid retention.

Contact Lenses

  • Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

ADVERSE REACTIONS

Clinical Trial Experience

  • The most common adverse reaction causing discontinuation of use of the implant in clinical trials was change in menstrual bleeding patterns (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%).

DRUG INTERACTIONS

Effects of Other Drugs on Hormonal Contraceptives
Substances decreasing the plasma concentrations of hormonal contraceptives and potentially diminishing the efficacy of hormonal contraceptives:

  • Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of hormonal contraceptives and potentially diminish the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Women should use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with hormonal contraceptives, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of hormonal contraceptives:

  • Co-administration of certain hormonal contraceptives and strong or moderate CYP3A4 inhibitors may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

  • Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors, HCV protease inhibitors, or with non-nucleoside reverse transcriptase inhibitors. These changes may be clinically relevant.

Effects of Hormonal Contraceptives on Other Drugs

  • Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine).

USE IN SPECIFIC POPULATIONS
Pregnancy

  • Rule out pregnancy before inserting NEXPLANON.

Lactation

  • Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants.
  • Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

Pediatric Use

  • Safety and efficacy of NEXPLANON 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.

Overweight Women

  • The efficacy of NEXPLANON 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, NEXPLANON may be less effective in overweight women.

PATIENT COUNSELING INFORMATION

  • Counsel women to contact their health care professional immediately if, at any time, they are unable to palpate the implant.
  • NEXPLANON does not protect against HIV or other STDs.

Before prescribing NEXPLANON, please read the accompanying Prescribing Information. The Patient Information also is available.

1. Mansour D, Mommers E, Teede H, et al. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception. 2010;82(3):243–249.

Indication

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Indication:

NEXPLANON is indicated for use by women to prevent pregnancy.

Selected Safety Information +

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Selected Safety Information:

NEXPLANON 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; and/or allergic reaction to any of the components of NEXPLANON.

NEXPLANON should be inserted subdermally so that it will be palpable after insertion…