Selected Safety Information
- Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain.
What it is
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 length with a diameter of 2 mm.
Each implant consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel and barium sulfate (radiopaque ingredient), surrounded by an EVA copolymer skin.
Once inserted subdermally, the release rate is 60–70 mcg/day in weeks 5–6, and decreases to approximately 35–45 mcg/day at the end of the first year, to approximately 30–40 mcg/day at the end of the second year, and then to approximately 25–30 mcg/day at the end of the third year.
NEXPLANON is a progestin-only contraceptive and does not contain estrogen. NEXPLANON does not contain latex.
Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18, 19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula:
![ENG [13-Ethyl-17-hydroxy-11-methylene-18, 19-dinor-17α-pregn-4-en-20-yn-3-one]](/en/Images/1%2E1_WhatItIsB_tcm1909-289434.jpg)
Selected Safety Information
About NEXPLANON (etonogestrel implant) 68 mg (continued)
- The use of combination hormonal contraceptives increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is recommended that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed. There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using the non-radiopaque etonogestrel implant. NEXPLANON should be removed in the event of a thrombosis. Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, NEXPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence. Consider removal of the NEXPLANON implant in case of long-term immobilization due to surgery or illness.
- If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. Rarely, surgery may be required.
- Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer, and increase the risk of cervical cancer or intraepithelial neoplasia. Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.
