Frequently Asked Questions (FAQs)

NEXPLANON is indicated for use by women to prevent pregnancy.

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 healthcare professional immediately if, at any time, they are unable to palpate the implant.
• NEXPLANON does not protect against HIV or other STDs.

Users of progestin-only contraceptives are likely to have changes in bleeding patterns. Based on data from clinical trials of the non-radiopaque etonogestrel implant (IMPLANON^®)¹:

• Patients who use NEXPLANON are likely to have changes in their menstrual bleeding patterns. These may include changes in bleeding frequency, intensity, or duration, or amenorrhea
• For many patients, the bleeding pattern experienced during the first 3 months of using NEXPLANON is broadly predictive of the future bleeding pattern

Percentages of 90-day intervals with these bleeding patterns during the first 2 years of use in clinical trials of IMPLANON^®a:

• Infrequent: <3 episodes (33.6%)
• Amenorrhea: No episodes (22.2%)
• Prolonged: Any episode lasting >14 days (17.7%)
• Frequent: >5 episodes (6.7%)

^aBased on 3315 recording periods in 780 women, excluding the first 90 days after implant insertion. Bleeding/spotting episode = 1 or more consecutive days during which bleeding or spotting occurred.

NEXPLANON consists of a single, radiopaque, rod-shaped implant that contains 68 mg etonogestrel, pre-loaded in the needle of a disposable applicator. NEXPLANON is inserted subdermally, just under the skin at the inner side of the non-dominant upper arm.

NEXPLANON must be inserted by the expiration date printed on the packaging. NEXPLANON 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.

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NEXPLANON provides pregnancy protection for up to 3 years.

NEXPLANON must be removed by the end of the third year and may be replaced by another NEXPLANON at the time of removal, if continued contraceptive protection is desired.

Yes, click here for the list of possible billing codes.

Due to the Affordable Care Act, NEXPLANON may be available to many women for $0 out-of-pocket expense.^2–4,b

^bThe cost of NEXPLANON depends on a patient’s insurance plan. Some patients may have coverage for NEXPLANON with out-of-pocket expenses, including a deductible, co-payment, or other charges. Patients may pay additional charges in connection with the insertion and/or removal of NEXPLANON (eg, office visit co-pay). You should confirm each patient’s coverage and cost-sharing obligations with the relevant payer.

In an analysis of representative commercial claims data, 98% of patient claims for NEXPLANON had $0 in out-of-pocket costs.⁴

This is based on data from over 49,000 patient claims for NEXPLANON in the Truven MarketScan^® Commercial Claims dataset, January 2019 through December 2019.⁴

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

How coverage status affects ordering and billing:

If NEXPLANON is covered as a medical benefit

• NEXPLANON is available through 2 specialty distributors as a medical benefit. Through the Buy-and-Bill process, HCPs who have completed the Clinical Training Program can order NEXPLANON from a specialty distributor. The CSCN can conduct a benefits investigation, and if NEXPLANON is covered as a medical benefit, then the HCP can bill the insurance carrier for NEXPLANON and the insertion procedure accordingly.

If NEXPLANON is covered as a pharmacy benefit

• NEXPLANON is available through 6 specialty pharmacies as a pharmacy benefit. Through the assignment of benefit (AOB) process, NEXPLANON is paid for by the insurance plan. The specialty pharmacy will ship NEXPLANON to the HCP’s office for the procedure, and there is no out-of-pocket cost to the HCP. The CSCN can conduct a benefits investigation, and if NEXPLANON is provided as a pharmacy benefit, the CSCN will forward your pharmacy prescription to the specialty pharmacy required by the insurance plan or to a specialty pharmacy of your choice. For a full list of participating specialty pharmacies, please reference the CSCN Enrollment Form, found at organon-cscn.com.

If NEXPLANON is not covered

• The patient can contact their human resources manager or health plan representative to determine if a medical exception can be authorized. Your patient has the option to pay for NEXPLANON with cash or a credit card.

Click here for more information on ordering NEXPLANON.

CSCN = Customer Support Center for NEXPLANON; HCP = healthcare professional.

Click here for additional resources, including instructions for insertion and removal, training, patient counseling, and patient education.

In a clinical trial, mean insertion time was <1 minute (27.9±29.3 seconds). Insertion time was measured from the removal of the protective cap of the applicator until the retraction of the needle from the arm.

In a clinical study evaluating the insertion characteristics of the applicator for NEXPLANON⁵:

Out of 301 insertions of the NEXPLANON implant, the mean insertion time (from the removal of the protective cap of the applicator until retraction of the needle from the arm) was 27.9±29.3 seconds.

HCP = healthcare professional.

If you are seeking a copy of your original training certificate, you can contact the Organon Information Center for NEXPLANON at 1-877-467-5266.

If you are seeking a copy of the training certificate that was issued after completing the Mandatory Training Module following the October 2018 label update, you can access the certificate at nexplanontraining.com.

• If you already have an account at nexplanontraining.com: To obtain a copy of the Mandatory Training Certificate, log into nexplanontraining.com using the username (email) and password you have already set up.
• If you have not created an account: You will need your NPI number to set up an account with a username and password. Your username should be your email address.

Once you log in, you will be able to access your certificate by clicking on the Training Certificates tab on the left-hand navigation. You will see an attachment for Training Certificate.

NPI = National Provider Identifier.

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

There is no cost for this training.

Click here to be redirected to nexplanontraining.com, where you can request training.

The approximately 2-hour session, which is sponsored by Organon, is not accredited for continuing medical education credit. The training is open only to MD/DO, NP, PA or CNMs, and residents authorized to perform the procedures entailed in the insertion and removal of NEXPLANON in the jurisdiction where they practice. Additionally, NPs, PAs, and CNMs must attest that they have met all specific state conditions and requirements, including but not limited to signing a collaborative agreement with an MD/DO. Residents must understand that they can only administer NEXPLANON under the supervision of an attending physician who has also been trained on the procedures to insert and remove NEXPLANON.

CNM = certified nurse midwife; DO = doctor of osteopathic medicine; HCP = healthcare professional; MD = medical doctor; NP = nurse practitioner; PA = physician assistant.

The Organon Information Center for NEXPLANON can be reached at 1-877-467-5266.