NEXPLANON is a progestin indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.

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 uterine 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

Risk of Complications Due to Improper Insertion and Removal

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, is 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.

NEXPLANON is available only through a restricted program under a REMS.

NEXPLANON REMS

• NEXPLANON is only available through a restricted program under a REMS called NEXPLANON REMS because of the risk of complications due to improper insertion and removal.

Notable requirements of the NEXPLANON REMS include the following:

• Healthcare providers must be certified with the program by enrolling and completing training on the proper insertion and removal of NEXPLANON prior to first use.
• Pharmacies must be certified with the program and must only dispense NEXPLANON to certified healthcare providers who dispense NEXPLANON for insertion.
• Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

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 3-year clinical trials was change in menstrual bleeding patterns (11.1%).The most common adverse reactions (≥5%) reported in these 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%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. The most frequently reported adverse reaction >5% was intermenstrual bleeding (5.4%). Changes in menstrual bleeding patterns were the most frequently reported adverse reaction leading to discontinuation occurring in 4.0% of participants.

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 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 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

• The safety and effectiveness of NEXPLANON have been established in women of reproductive potential. Safety and effectiveness of NEXPLANON are expected to be the same in postpubertal adolescents as in adult women. NEXPLANON is not indicated before menarche.

PATIENT COUNSELING INFORMATION

• Advise 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.

Before prescribing NEXPLANON, please read the Prescribing Information, including Boxed Warning. The Patient Information also is available.

NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the NEXPLANON REMS program, to ensure HCPs are trained on the proper insertion and removal of NEXPLANON prior to first use.

Further information is available at www.NEXPLANONREMS.com and 1-833-697-7367.

To enroll and become certified in the NEXPLANON REMS, please visit www.NEXPLANONREMS.com.

If you previously completed the CTP, you still need to enroll in the NEXPLANON REMS and may have to complete additional training depending on your individual circumstances. To enroll and become certified, please visit www.NEXPLANONREMS.com.

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 5 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the fifth year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

Click here to explore hypothetical patient profiles.

NEXPLANON provides pregnancy protection for up to 5 years.

NEXPLANON must be removed by the end of the fifth 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.^2,3,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 Commercial, Medicare, and Medicaid claim reporting, ~98.8% of NEXPLANON claims were covered with $0 out-of-pocket costs to patients.⁴

This is based on IQVIA LAAD Mx and Remit Datasets from May 2024–April 2025.⁴

All HCPs performing insertions of NEXPLANON are required to be certified in the NEXPLANON REMS. To enroll and become certified, visit www.NEXPLANONREMS.com.

How coverage status affects ordering and billing:

If NEXPLANON is covered as a medical benefit

• NEXPLANON is available through 3 specialty distributors as a medical benefit. Through the Buy-and-Bill process, HCPs who are REMS certified 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 2 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.

The user card and consent form have been removed from the label and packaging for NEXPLANON. This removal came at the request of the FDA as part of a September 2023 label update for NEXPLANON. As a result, these items are no longer being included in NEXPLANON packaging.

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.

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