Selected Safety Information
- 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 allergic reaction to any of the components of NEXPLANON.
Get the facts
Introduction to the facts of NEXPLANON (etonogestrel implant)
NEXPLANON is a radiopaque, progestin-only, soft and flexible implant preloaded in a sterile, disposable applicator for subdermal use
In a 3-year clinical trial, NEXPLANON and the non-radiopaque etonogestrel implant (IMPLANON) yielded comparable systemic exposure to etonogestrel - with less than 1 pregnancy per 100 women who used NEXPLANON for 1 year
The NEXPLANON applicator differs from the IMPLANON applicator, which requires a different insertion procedure
All health care providers should receive instruction and training prior to performing insertion and/or removal of NEXPLANON
Palpation is an important step in insertion and removal of NEXPLANON
Always verify the presence of the implant in the woman's arm immediately after insertion by palpation
Until the presence of the implant has been verified, the woman should be advised to use a nonhormonal contraceptive method, such as condoms
If the implant cannot be located by palpation after insertion or before removal:
The NEXPLANON implant is radiopaque, providing 4 methods for confirming presence after insertion and localizing before removal:
Computed tomography (CT) scan
2-Dimensional x-ray
Ultrasound
Magnetic Resonance Imaging (MRI)
Why consider NEXPLANON (etonogestrel implant) for her pregnancy prevention?
It’s more than 99% effective with just 1 insertion - with less than 1 pregnancy per 100 women who used NEXPLANON for 1 year
Efficacy is achieved through the implant’s continuous release of etonogestrel over 3 years
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
Selected Safety Information
About NEXPLANON (etonogestrel implant) 68 mg (continued)
- 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, such as pain, paresthesias, bleeding, hematoma, scarring, or infection, may occur. If NEXPLANON is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur. 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. Deep insertions may lead to difficult localization of the implant and may also result in the need for a surgical procedure in an operating room in order to remove the implant.
- 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.
