Etonogestrel (8 brand names, 2 dosage forms, 2 routes)
Available dosage forms: RING, IMPLANT.
Routes of administration: VAGINAL, IMPLANTATION.
Brand Names
- ELURYNG
- ENILLORING
- ETHINYL ESTRADIOL; ETONOGESTREL
- HALOETTE
- IMPLANON
- NEXPLANON
- NUVARING
- VERARING
Boxed Warning
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)].
Indications and Usage
NEXPLANON® is indicated for prevention of pregnancy in women of reproductive potential for up to 5 years.
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 removal of NEXPLANON. A single NEXPLANON implant is inserted subdermally just under the skin at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus (see Figures 2a, 2b and 2c). Inserting an implant more deeply than subdermally (a deep insertion) may preclude palpation and localization, making removal difficult or impossible [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. NEXPLANON must be inserted by the expiration date stated 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.
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)]
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 progestin) oral contraceptives.
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 (5.3)] Ectopic Pregnancies [see Warnings and Precautions (5.4)] Thrombotic and Other Vascular Events [see Warnings and Precautions (5.5)] Liver Disease [see Warnings and Precautions (5.8)]
Drug Interactions
Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
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.
Overdosage
Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.