JADELLE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JADELLE (JADELLE).
Levonorgestrel, a progestin, suppresses gonadotropin release, inhibiting ovulation and causing changes in cervical mucus and endometrium.
| Metabolism | Primarily hepatic via CYP3A4; also reduced to tetrahydrolevonorgestrel, conjugated, and excreted in urine and feces. |
| Excretion | Primarily via urine (40-60%) and feces (20-40%), with biliary excretion of metabolites. |
| Half-life | Terminal half-life approximately 18 hours (range 12-24 hours) with clinical context: supports once-daily dosing. |
| Protein binding | 90-95% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 1.0-1.5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral: 75-85%; Sublingual: 90-95%. |
| Onset of Action | Oral: 30-60 minutes; Sublingual: 15-30 minutes. |
| Duration of Action | 8-12 hours; clinical notes: duration decreases with chronic use. |
One 150 mg subdermal implant (2 rods) inserted subdermally in the inner upper arm, effective for up to 5 years.
| Dosage form | IMPLANT |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | Contraindicated in patients with severe hepatic cirrhosis or active liver disease (Child-Pugh C). For mild to moderate impairment (Child-Pugh A or B), use with caution as metabolism may be impaired; no specific dose adjustment guidelines available. |
| Pediatric use | Not approved for use in adolescents before menarche; safety and efficacy in pediatric patients have not been established. |
| Geriatric use | Not generally used in postmenopausal women; no specific geriatric dosing adjustments, but consider age-related comorbidities and reduced hepatic function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JADELLE (JADELLE).
| Breastfeeding | Levonorgestrel is excreted into breast milk in small amounts. The M/P ratio is approximately 0.37. At typical contraceptive doses, exposure to the infant is estimated to be about 0.1% of the maternal dose. No adverse effects on infant growth or development have been reported. Jadelle is considered compatible with breastfeeding, especially after the first 6 weeks postpartum. |
| Teratogenic Risk | Jadelle (levonorgestrel) is a progestin-only contraceptive. Inadvertent use during pregnancy is not recommended; however, available data do not suggest an increased risk of major birth defects or miscarriage if exposure occurs after the first month of gestation. First trimester: No evidence of teratogenicity from cohort studies. Second/third trimester: Prolonged exposure may be associated with fetal genital abnormalities, but data are limited. Overall risk is considered low. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known or suspected pregnancy","Undiagnosed abnormal genital bleeding","Known or suspected breast cancer","Active hepatic disease or benign/malignant liver tumors","Hypersensitivity to levonorgestrel"]
| Precautions | ["Cigarette smoking increases risk of cardiovascular events","Ectopic pregnancy risk if pregnancy occurs","Menstrual irregularities","Hepatic disease","Breast cancer risk","Thrombotic disorders","Diabetes mellitus"] |
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| Fetal Monitoring | Monitor for pregnancy if contraceptive failure suspected. No specific fetal monitoring required. For ongoing use, assess menstrual irregularities and rule out pregnancy if amenorrhea occurs. Blood pressure monitoring is recommended due to potential progestin effects. No need for routine ultrasound or fetal surveillance. |
| Fertility Effects | Levonorgestrel implants suppress ovulation and alter cervical mucus and endometrium. Fertility returns promptly after removal, with 80% of women ovulating within 3 months and 90% within 1 year. No long-term impairment of fertility. |