Generic Name and Formulations:
Etonogestrel 68mg, barium sulfate 15mg; radiopaque; implantable rod; latex-free; may also contain magnesium stearate.
Merck & Co., Inc.
Indications for NEXPLANON:
See full labeling. Insert 1 implant subdermally in the inner side of upper (non-dominant) arm. Remove no later than 3 years after insertion.
Premenarchal: not applicable.
Pregnancy. Thromboembolic disorders. Liver tumors. Active liver disease. Undiagnosed abnormal genital bleeding. Breast or other progestin-sensitive carcinoma.
Complete physical exam before insertion and at least annually. Exclude pregnancy (see full labeling for switching from other contraceptive methods); use back-up contraception if appropriate. Complications of insertion and removal (eg, pain, paresthesias, bleeding, scarring, infection); incomplete or incorrect insertions may lead to expulsion or migration. See full labeling for insertion and removal technique; perform only if properly qualified. Remove implant if jaundice or thrombotic event occurs, or if a pregnancy is maintained; consider removing in prolonged immobilization. Risk of thromboembolism with pregnancy and post delivery; avoid use prior to 21 days postpartum. History of breast cancer; monitor. History of hypertension; monitor closely; remove implant if BP is significantly elevated or uncontrolled. Renal disease. Depression. Monitor diabetes, hyperlipidemia. Conditions aggravated by fluid retention. Risk of in situ broken or bent implant. Overweight women (may be less effective). Nursing mothers: may use after 4th postpartum week.
May be potentiated by CYP3A4 inhibitors (eg, itraconazole, voriconazole, fluconazole, grapefruit juice, ketoconazole). May be antagonized by certain enzymes including CYP3A4 inducers (eg, efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, St. John's wort-containing products); use non-hormonal contraception or back-up method during and for 28 days after discontinuing the enzyme inducer. May be affected by HIV/HCV protease inhibitors or NNRTIs. May affect plasma levels of cyclosporine (increased) or lamotrigine (decreased). May affect measurement of sex hormone-binding globulin, thyroxine.
Headache, vaginitis, weight increase, acne, mastodynia, abdominal pain (exclude ectopic pregnancy), pharyngitis, leukorrhea, influenza-like symptoms, dizziness, dysmenorrhea, back pain, emotional lability, nausea, pain, nervousness, depression, insertion site pain; menstrual irregularities (eg, amenorrhea, changes in bleeding patterns), thrombotic events, others (see full labeling).
Provide adequate counseling. Obtain signed written consent (see full labeling).
Single rod implant (in pre-loaded disposable applicator)—1