COMPOSITION: Each radiopaque implant contains 68 mg of etonogestrel. THERAPEUTIC INDICATIONS: Contraception. DOSAGE AND ADMINISTRATION: Pregnancy should be excluded before insertion of lmplanon NXT^®. Healthcare professionals (HCPs) are strongly recommended to participate in a training session to become familiar with the use of the lmplanon NXT^® applicator and the techniques for insertion and removal of the lmplanon NXT^® implant and where appropriate, request supervision prior to inserting or removing the implant Subdermal insertion. No preceding hormonal contraceptive use in the past mth: Insert on day 1 & 5 of the menstrual cycle. Changing from combined oral contraceptive (COG), vaginal ring or transdermal patch: Insert preferably on the day after last active COC tab, but at the latest on the day following the usual tab-free interval or last placebo COG tab. Changing from progestagen-only method [pill, injectable, implant or intrauterine system (IUS)] Injectable contraceptives: Insert when the next injection would be due. Pill: Insert within 24 hr any day after last pill. Implant or IUS: Insert on the same day of removal. Post 1^st-trimester abortion Insert within 5 days following 1^st trimester abortion or miscarriage. Post 2^nd-trimester abortion Insert between day 21-28 following 2^nd trimester abortion or miscarriage. Postpartum with breastfeeding: Insert after 4^th postpartum week. Postpartum without breastfeeding: Insert between 21-28 days postpartum. CONTRAINDICATIONS: Progestagen-only contraceptives should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during the use of lmplanon NXT^®, the product should be stopped immediately. • Known or suspected pregnancy. • Active venous thromboembolic disorder. • Known or suspected sex steroid sensitive malignancies • Presence or history of liver tumours (benign or malignant). • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. • Undiagnosed vaginal bleeding. • Hypersensitivity to the active substance or to any of the excipients of lmplanon NXT^® SPECIAL WARNINGS & PRECAUTIONS: If any of the conditions/risk factors mentioned below is present, the benefits of progestagen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with lmplanon NXT®. • Carcinoma of the Breast • Liver Disease • Thrombotic and Other Vascular Events • Elevated Blood Pressure • Carbohydrate and Lipid Metabolic Effects • Chloasma • Body Weight • Complications of Insertion • Ovarian Cysts • Ectopic Pregnancies • Other Conditions The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestagens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss and (hereditary) angioedema. ADVERSE REACTIONS: During the use of lmplanon NXT, women are likely to have changes in their menstrual bleeding pattern. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration. Possibly related undesirable effects reported in clinical trials: Vaginal infection; headache; acne; breast pain & tenderness, irregular menstruation; increased weight. Increased appetite; affect !ability, depression, nervousness, decreased libido; dizziness; hot flush; abdominal pain, nausea, flatulence; alopecia; dysmenorrhea, ovarian cyst; implant site pain & reaction, fatigue, flu-like illness, pain; decreased weight.
Before initiating therapy, please consult the full Prescribing Information.