Etonogestrel

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Not studied; contraindicated in active liver disease or liver tumors

Efficacy does not depend on daily/weekly/monthly administration; insert by package expiration date

Instructions

• Rule out pregnancy before insertion
• Insertion/removal only by trained, REMS-certified healthcare professionals
• Insert subdermally just under the skin, inner side of non-dominant upper arm overlying triceps (8-10 cm from medial epicondyle, 3-5 cm posterior to biceps/triceps sulcus); avoid deep insertion
• Confirm implant is palpable immediately after insertion; if not palpable, localize — removal recommended
• No prior hormonal contraceptive: insert Days 1-5 of menstrual cycle
• Switching: from CHC — day after last active tablet/ring or patch removal; from injectable — day next injection due; from minipill — within 24 h of last tablet; from implant/IUS — same day as removal
• After 1st-trimester abortion/miscarriage: insert within 5 days; after 2nd-trimester: 21-28 days after
• Postpartum, not breastfeeding: insert 21-28 days postpartum; breastfeeding: not until after 4th postpartum week
• If insertion timing deviates from recommended, use barrier back-up method for 7 days after insertion
• Remove implant in its entirety no later than end of 5th year

Contraindications

• Known or suspected pregnancy
• Current or past history of thrombosis or thromboembolic disorders
• Liver tumors (benign or malignant) or active liver disease
• Undiagnosed abnormal uterine bleeding
• Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer (now or in the past)

Cautions

• Insertion/removal complications: pain, paresthesia, bleeding, hematoma, scarring, infection; deep insertion may cause neural/vascular injury or implant migration (incl. to pulmonary artery — chest pain, dyspnea, cough, hemoptysis); surgery may be needed for removal
• Non-palpable, broken, or bent implants: localize and remove in entirety; failure to remove may compromise fertility or cause ectopic pregnancy
• Changes in menstrual bleeding pattern (frequency, intensity, duration) — most common reason for discontinuation
• Ectopic pregnancy: be alert in users who become pregnant or report lower abdominal pain
• Thrombotic/vascular events (PE, DVT, MI, stroke reported): remove implant if thrombosis occurs; do not use before 21 days postpartum; consider removal with prolonged immobilization
• Remove if jaundice develops; remove if sustained/uncontrolled hypertension develops
• Ovarian cysts (enlarged follicles, usually resolve spontaneously)
• Monitor women with breast nodules or family history of breast cancer
• May induce mild insulin resistance — monitor prediabetic/diabetic women; may complicate hyperlipidemia control
• Weight gain; depressed mood — monitor women with history of depression

Adverse reactions

• Change in menstrual bleeding pattern (most common; leading cause of discontinuation, 11.1%)
• Headache (24.9%)
• Vaginitis (14.5%)
• Weight increase (13.7%)
• Acne (13.5%)
• Breast pain (12.8%)
• Abdominal pain (10.9%)
• Pharyngitis (10.5%)
• Emotional lability, depression, nervousness
• Implant site reactions (8.6%): erythema, hematoma, bruising, pain, swelling
• Insertion/removal complications incl. deep insertion, migration, difficult removal (postmarketing)

Pregnancy Contraindicated in pregnancy (no need for contraception if already pregnant); remove implant if maintaining a pregnancy; no increased risk of birth defects shown with low-dose hormonal exposure

Lactation Small amounts in human milk; no adverse effects observed in breastfed infants, but can reduce milk production; do not insert until after 4th postpartum week if breastfeeding; weigh benefits vs risk