Indications and clinical use:

NEXPLANON® (etonogestrel extended-release subdermal implant) is indicated for the prevention of pregnancy for up to 3 years.

NEXPLANON® may become less effective in overweight women over time, especially in the presence of other factors that decrease etonogestrel concentrations, such as concomitant use of hepatic enzyme inducers.

Health Canada has not authorized an indication for pediatric or geriatric use, as no clinical studies have been conducted in women less than 18 years of age or over 65 years of age. NEXPLANON® is not indicated for use before menarche or in postmenopausal women.

Contraindications:

• Known or suspected pregnancy
• Current or past history of thrombosis or thromboembolic disorders
• Liver tumours, 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

Most serious warnings and precautions:

Insertion and/or removal by a healthcare professional (HCP) only: All HCPs should receive instruction and training prior to performing insertion and/or removal of NEXPLANON® and, where appropriate, request supervision prior to inserting or removing the implant.

Immediate action if not palpable: If at any time the implant is not palpable by the HCP or the patient, NEXPLANON® should be localized as soon as possible and removed as soon as medically appropriate to manage the risks of migration. There have been post-marketing reports of implants located within the vessels of the arm and the pulmonary artery which may be related to deep insertions or intravascular insertion.

Protection against sexually transmitted infections (STIs): Women should be counselled that NEXPLANON® DOES NOT PROTECT against STIs including human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH NEXPLANON®.

Other relevant warnings and precautions:

• Complications of insertion and removal
• Changes in the menstrual bleeding pattern
• In situ broken or bent implant. The broken implant may move from the insertion site
• Need for medical examination/consultation prior to the initiation or reinstitution of NEXPLANON®
• Reduced efficacy with concomitant medications
• Risk of carcinoma of the breast and reproductive organs
• Risk of elevated blood pressure
• Risk of thrombotic and other vascular events
• Carbohydrate and lipid metabolic effects
• Weight gain
• Fluid retention
• Risk of ectopic pregnancy
• Risk of ovarian cysts
• Liver disease
• Risk of gallbladder disease
• Effect on laboratory parameters
• Ophthalmologic considerations in contact lens wearers
• Peri-operative considerations
• Depressed mood
• Return to ovulation
• Chloasma
• Use in special populations (i.e. breastfeeding women)
• Other conditions reported during pregnancy and during sex steroid use not otherwise described

For more information:

Consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece. The Product Monograph is also available by calling 1‑844‑820‑5468.