DEPO-SUBQ PROVERA 104
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DEPO-SUBQ PROVERA 104 (DEPO-SUBQ PROVERA 104).
Medroxyprogesterone acetate is a progestin that inhibits gonadotropin secretion, thereby inhibiting ovulation and causing endometrial thinning.
| Metabolism | Hepatic metabolism via CYP3A4; metabolites are conjugated and excreted in urine and feces. |
| Excretion | Primarily metabolized in the liver; metabolites are excreted in urine (70-80%) and feces (20-30%). Less than 1% unchanged in urine. |
| Half-life | Terminal elimination half-life is approximately 40 hours (range 20-80 hours) with chronic administration due to slow absorption from the depot; clinically, this allows for once-weekly dosing. |
| Protein binding | Protein binding: 86-99% bound primarily to albumin; also binds to sex hormone-binding globulin (SHBG) with lower affinity. |
| Volume of Distribution | Volume of distribution: 20-40 L/kg, indicating extensive distribution into tissues and adipose tissue; high Vd consistent with lipophilic steroid. |
| Bioavailability | Subcutaneous injection: 100% bioavailability (complete absorption from depot). Not administered orally for contraception due to first-pass metabolism. |
| Onset of Action | Subcutaneous injection: Clinically significant contraceptive effect achieved within 24 hours if administered during the first 5 days of menses; maximal suppression of ovulation by 72 hours. |
| Duration of Action | Contraceptive efficacy extends for at least 14 weeks after a single injection; ovarian activity returns to pretreatment levels within 5-10 months after last dose. |
104 mg subcutaneously every 3 months (13 weeks). Administer into the anterior thigh or abdomen by a healthcare professional.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment recommended. Use with caution in severe renal impairment (CrCl <30 mL/min) due to limited data. |
| Liver impairment | Contraindicated in severe hepatic disease (Child-Pugh class C). For mild to moderate impairment (Child-Pugh A or B), use with caution; no specific dose adjustment recommended, but monitor for adverse effects. |
| Pediatric use | Not indicated for use in pediatric patients. Safety and efficacy have not been established. |
| Geriatric use | No specific dose adjustment recommended. Consider the greater frequency of renal, hepatic, or cardiac dysfunction in elderly patients. Monitor for thromboembolic events and bone mineral density loss. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DEPO-SUBQ PROVERA 104 (DEPO-SUBQ PROVERA 104).
| Breastfeeding | Medroxyprogesterone acetate is excreted in breast milk in small amounts (estimated infant dose <1% of maternal dose). M/P ratio not established. No reported adverse effects in breastfed infants. Consider benefits of breastfeeding and potential effects on milk production (may decrease). |
| Teratogenic Risk | FDA Pregnancy Category X. First trimester: Association with congenital anomalies (e.g., neural tube defects, cardiac defects) based on post-marketing data. Second and third trimesters: Risk of genital abnormalities in female fetuses (e.g., hypospadias, clitoral enlargement) and potential metabolic effects. Use contraindicated during pregnancy. |
■ FDA Black Box Warning
Loss of bone mineral density (BMD) occurs with long-term use; BMD loss is greater with increasing duration of use and may not be completely reversible. Use beyond 2 years is not recommended unless other contraceptive methods are inadequate.
| Serious Effects |
["Known or suspected pregnancy","Active thromboembolic disorders or history of these disorders","Known or suspected breast cancer","Undiagnosed abnormal uterine bleeding","Liver disease or impaired liver function","Known hypersensitivity to medroxyprogesterone acetate or any component"]
| Precautions | ["Bone mineral density loss","Thromboembolic disorders","Breast cancer risk","Ectopic pregnancy","Depression","Fluid retention","Glucose intolerance","Weight gain"] |
Loading safety data…
| Fetal Monitoring | Pregnancy test prior to initiation and every 3 months. If pregnancy occurs, discontinue and monitor fetus via ultrasound for anomalies. No specific fetal monitoring required if drug is avoided during pregnancy. |
| Fertility Effects | Delayed return to fertility after discontinuation (average 9-10 months, up to 18 months). Reversible. May cause anovulation due to suppression of gonadotropins. |