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Who is not appropriate for NEXPLANON

NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors 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; or allergy to any component of NEXPLANON.

WARNINGS and PRECAUTIONS

Complications of insertion and removal

Palpate immediately after insertion to ensure proper placement. Undetected failure to insert
the implant may lead to unintended pregnancy.

Insertion and removal-related complications
may include pain, paresthesias, bleeding, hematoma, scarring, or infection. 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. If at any time the implant cannot be palpated, it should be localized and removed.

There have been postmarketing reports of implants located within the vessels of the arm
and the pulmonary artery; in these cases, endovascular or surgical procedures may be needed for removal.

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.

NEXPLANON and pregnancy

Should pregnancy or lower abdominal pain
occur while using NEXPLANON, be alert to the possibility of an ectopic pregnancy.

Educate her about the risk of serious vascular events

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. Assess women with known risk factors. NEXPLANON should be removed if thrombosis occurs.

NEXPLANON should not be used prior to 21
days postpartum due to risk of
thromboembolism.

Women with a history of thromboembolic disorders should be made aware of the
possibility of a recurrence.

Counsel her about changes in bleeding patterns

Women are likely to have changes in their menstrual bleeding pattern with NEXPLANON, including changes in frequency, intensity, or duration. Evaluate abnormal bleeding as needed to exclude pathologic conditions or pregnancy.
In clinical studies of the non-radiopaque etonogestrel implant, the most common reason for discontinuation was changes in bleeding patterns (11.1%).

Be aware of other serious complications, adverse reactions, and drug interactions

Remove NEXPLANON if jaundice occurs or
blood pressure rises significantly and becomes uncontrolled.

Observe women with a history of depressed mood. Consider removing NEXPLANON in patients who become significantly depressed.

The most common adverse reactions (≥10%) reported in 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%).

Drugs or herbal products that induce enzymes, including CYP3A4, may decrease the effectiveness of NEXPLANON or increase breakthrough bleeding.

The efficacy of NEXPLANON in women
weighing more than 130% of their ideal body weight has not been studied. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. NEXPLANON may be
less effective in overweight women.

Before prescribing NEXPLANON, please read the accompanying Prescribing Information.
The Patient Information also is available.