Label: NEXPLANON- etonogestrel implant

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use NEXPLANON safely and effectively. See full prescribing information for NEXPLANON. NEXPLANON® (etonogestrel implant) Radiopaque ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    NEXPLANON® is indicated for use by women to prevent pregnancy.
  • 2 DOSAGE AND ADMINISTRATION
    The efficacy of NEXPLANON does not depend on daily, weekly, or monthly administration. All healthcare professionals should receive instruction and training prior to performing insertion and/or ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Single, white/off-white, soft, radiopaque, flexible, ethylene vinyl acetate (EVA) copolymer implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel, 15 mg of barium sulfate, and ...
  • 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    The following information is based on experience with the etonogestrel implants (IMPLANON and/or NEXPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling: Changes in Menstrual Bleeding Patterns [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.1 Effects of Other Drugs ...
  • 8 USE IN SPECIFIC POPULATIONS
    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)] ...
  • 10 OVERDOSAGE
    Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.
  • 11 DESCRIPTION
    NEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The contraceptive effect of NEXPLANON is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium. 12.2 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel per day (equal to ...
  • 14 CLINICAL STUDIES
    14.1 Pregnancy - In clinical trials of up to 3 years duration that involved 923 subjects, 18-40 years of age at entry, and 1756 women-years of use with the non-radiopaque etonogestrel implant ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - NEXPLANON is supplied as follows: NDC 78206-145-01 - One NEXPLANON package consists of a single implant containing 68 mg etonogestrel, 15 mg of barium sulfate and 0.1 mg of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Counsel women about the insertion and removal procedure of the NEXPLANON implant. Provide the woman with a copy ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Organon USA LLC, a subsidiary of - ORGANON & Co., Jersey City, NJ 07302, USA - Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ ...
  • PATIENT PACKAGE INSERT
    FDA-Approved Patient Labeling - NEXPLANON® (etonogestrel implant) Radiopaque - Subdermal Use Only - NEXPLANON® does not protect against HIV infection (the virus that causes AIDS) or other sexually ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Organon USA LLC, a subsidiary of - ORGANON & Co., Jersey City, NJ 07302, USA - Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ ...
  • PRINCIPAL DISPLAY PANEL - 68 mg Implant Blister Pack Carton
    NDC 78206-145-01 - 1 applicator containing 1 subdermal implant - Nexplanon® (etonogestrel implant) 68 mg - Radiopaque - Subdermal Use Only - This product is intended to prevent pregnancy. It does not ...
  • INGREDIENTS AND APPEARANCE
    Product Information