Etonogestrel

FDA label, Organon LLC, subcutaneous, effective 2026-05-28. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Boxed warning

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ] . Because of the risk of complications due to improper insertion and removal NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ] .

WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION and REMOVAL Improper insertion of NEXPLANON increases the risk of complications [see Warnings and Precautions (5.1) ] . Proper training prior to first use of NEXPLANON can minimize the risk of improper NEXPLANON insertion [see Warnings and Precautions (5.1) ] . NEXPLANON is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the NEXPLANON REMS [see Warnings and Precautions (5.2) ] .

Handling and access

REMS

Required
NEXPLANON REMS

Stated in the label quoted on this page.

  • Restricted distribution (ETASU)
  • Pharmacy certification
  • Prescriber education
Source: FDA prescribing information (openFDA), checked Nov 4, 2026Confirm on REMS@FDAAbout REMS

Progestin

Dosing in kidney impairment

In studies, 2.3% of the users reported weight gain as the reason for having the non-radiopaque etonogestrel implant removed. 5.10 Elevated Blood Pressure Women with a history of hypertension-related diseases or renal disease should be discouraged from using hormonal contraception. For women with well-controlled hypertension, use of NEXPLANON can be considered.

Dosing in liver impairment

Hepatic Impairment No studies were conducted to evaluate the effect of hepatic disease on the disposition of NEXPLANON. The use of NEXPLANON in women with active liver disease is contraindicated [see Contraindications ] .

Preparation and administration

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Basis

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Removal of NEXPLANON Preparation Removal of the implant should only be performed under aseptic conditions by a healthcare professional who is familiar with the removal technique. If you are unfamiliar with the removal technique, call 1-844-674-3200 for further information. Before initiating the removal procedure, the healthcare professional should assess the location of the implant and carefully read the instructions for removal.

The exact location of the implant in the arm should be verified by palpation. If the implant is not palpable, consult the medical record to verify the arm which contains the implant. If the implant cannot be palpated, it may be deeply located or have migrated. Consider that it may lie close to vessels and nerves. Removal of non-palpable implants should only be performed by a healthcare professional experienced in removing deeply placed implants and familiar with localizing the implant and the anatomy of the arm.

Call 1-844-674-3200 for further information. [See Localization and Removal of a Non-Palpable Implant , below.] Figure Procedure for Removal of an Implant that is Palpable Before removal of the implant, the healthcare professional should confirm that: The woman does not have allergies to the antiseptic or anesthetic to be used.

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, surgical marker Local anesthetic, needles, and syringe Sterile scalpel, forceps (straight and curved mosquito) Skin closure, sterile gauze, and pressure bandage Removal Procedure For illustrative purposes, Figures depict the left inner arm Step 1.

Have the woman lie on her back on the table. The arm should be positioned with the elbow flexed and the hand underneath the head (or as close as possible). (See Figure 1 .) Step 2. Locate the implant by palpation. Push down the end of the implant closest to the shoulder ( Figure 10 ) to stabilize it; a bulge should appear indicating the tip of the implant that is closest to the elbow.

If the tip does not pop up, removal of the implant may be more challenging and should be performed by professionals experienced with removing deeper implants. Call 1-844-674-3200 for further information. Mark the distal end (end closest to the elbow), for example, with a surgical marker. Figure 10 P – Proximal (toward the shoulder) D – Distal (toward the elbow) Step 3.

Clean the site with an antiseptic solution. Step 4. Anesthetize the site, for example, with 0.5 to 1 mL 1% lidocaine, where the incision will be made ( Figure 11 ). Be sure to inject the local anesthetic under the implant to keep the implant close to the skin surface. Injection of local anesthetic over the implant may make removal more difficult.

Figure 11 Step 5. Push down the end of the implant closest to the shoulder ( Figure 12 ) to stabilize it throughout the procedure. Starting over the tip of the implant closest to the elbow, make a longitudinal (parallel to the implant) incision of 2 mm towards the elbow. Take care not to cut the tip of the implant. Figure 12 Step 6.

The tip of the implant should pop out of the incision. If it does not, gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps and, if possible, remove the implant ( Figure 13 ). If needed, gently remove adherent tissue from the tip of the implant using blunt dissection. If the implant tip is not exposed following blunt dissection, make an incision into the tissue sheath and then remove the implant with the forceps ( Figures 14 and 15 ).

Figure 13 Figure 14 Figure 15 Step 7. If the tip of the implant does not become visible in the incision, insert forceps (preferably curved mosquito forceps, with the tips pointed up) superficially into the incision ( Figure 16 ). Gently grasp the implant and then flip the forceps over into your other hand ( Figure 17 ).

Figure 16 Figure 17 Step 8. With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant ( Figure 18 ). The implant can then be removed . If the implant cannot be grasped, stop the procedure and refer the woman to a healthcare professional experienced with complex removals or call 1-844-674-3200.

Figure 18 Step 9. Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. There have been reports of broken implants while in the patient's arm. In some cases, difficult removal of the broken implant has been reported. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3.

If the woman would like to continue using NEXPLANON, a new implant may be inserted immediately after the old implant is removed using the same incision as long as the site is in the correct location [see Dosage and Administration ] . Step 10. After removing the implant, close the incision with a sterile adhesive wound closure.

Step 11. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the sterile adhesive wound closure in 3 to 5 days. Figure Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure Figure 18 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 [see Warnings and Precautions ] , but may lead to the implant not being palpable at 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. Given the radiopaque nature of the implant, suitable methods for localization include two-dimensional X-ray and X-ray computer tomography (CT).

Ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI) may be used. Once the implant has been localized in the arm, the implant should be removed by a healthcare professional experienced in removing deeply placed implants and familiar with the anatomy of the arm.

The use of ultrasound guidance during the removal should be considered. If the implant cannot be found in the arm after comprehensive localization attempts, consider applying 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 professionals familiar with the anatomy of the chest should be consulted.

If at any time these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. For details on etonogestrel blood level determination, call 1-844-674-3200 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 to help prevent injury to deeper neural or vascular structures in the arm. Non-palpable and deeply-inserted implants should be removed by healthcare professionals familiar with the anatomy of the arm and removal of deeply-inserted implants. Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.

Drug interactions

Check etonogestrel against a medication list
Label text (5 paragraphs)

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin hormonal contraceptives or increase breakthrough bleeding. ( 7.1 )

7.1 Effects of Other Drugs on Hormonal Contraceptives Substances decreasing the plasma concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John's wort.

Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, 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 HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV) 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 (decrease [e.g., nelfinavir] or increase [e.g., indinavir, ritonavir and ritonavir-boosted protease inhibitors]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine, efavirenz] or increase [e.g., etravirine]). These changes may be clinically relevant in some cases. Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.

7.2 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). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Contraindications

4 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 Allergic reaction to any of the components of NEXPLANON [see Adverse Reactions (6) ] Known or suspected pregnancy. ( 4 ) Current or past history of thrombosis or thromboembolic disorders. ( 4 , 5.5 ) Liver tumors, benign or malignant, or active liver disease. ( 4 , 5.8 ) Undiagnosed abnormal uterine bleeding.

( 4 , 5.3 ) Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past. ( 4 , 5.7 ) Allergic reaction to any of the components of NEXPLANON. ( 4 , 6 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for etonogestrel. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary NEXPLANON is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant [see Contraindications (4) ] . Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse development outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses of 315 or 781 times the anticipated human dose (60 µg/day) (see Data ) .

NEXPLANON should be removed if maintaining a pregnancy. Data Animal Data Teratology studies have been performed in rats and rabbits using oral administration up to 315 and 781 times the human etonogestrel dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure.

Breastfeeding (LactMed)

Etonogestrel is available in the United States in a combination contraceptive vaginal ring (NuvaRing) that releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily, and subcutaneous implants (Implanon, Nexplanon) that release etonogestrel at a decreasing rate over a 3-year period. Based on the available evidence, expert opinion in the United States holds that postpartum women who are breastfeeding should not use combined hormonal contraceptives (e.g., NuvaRing) during the first 3 weeks after delivery because of concerns about increased risk for venous thromboembolism and generally should not use combined hormonal contraceptives during the fourth week postpartum because of concerns about potential effects on breastfeeding performance.

Alternatives LactMed suggests considering:
Source: LactMed: Etonogestrel (NICHD, public domain)Revised Jul 15, 2026

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