SOGROYA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOGROYA (SOGROYA).
Selective progesterone receptor modulator (SPRM) with antiproliferative and proapoptotic effects on endometrial tissue, and suppression of ovulation.
| Metabolism | Hepatic via CYP3A4 and CYP3A5. |
| Excretion | Primarily renal (hepatic metabolism and biliary excretion are minor). Approximately 70-80% of a dose is excreted unchanged in urine via glomerular filtration and tubular secretion. Fecal excretion accounts for <20%. |
| Half-life | Terminal elimination half-life is approximately 2.5-3 hours in healthy adults. In patients with renal impairment, half-life is prolonged (up to 10-15 hours in end-stage renal disease). |
| Protein binding | Approximately 80-85%, primarily to albumin and α1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.3 L/kg. This low Vd indicates predominantly extracellular distribution with minimal tissue penetration. |
| Bioavailability | Subcutaneous: 100% (complete absorption). Oral: 0% (not orally active due to GI degradation). |
| Onset of Action | Subcutaneous: 30-60 minutes. Intravenous: immediate (within minutes). Oral: not applicable (only available parenterally). |
| Duration of Action | Subcutaneous: 6-8 hours due to sustained release formulation. Intravenous: 2-4 hours for single dose; continuous infusion provides steady effect. |
Subcutaneous injection: 10 mg once daily for 6 days, followed by 30 mg once daily thereafter.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment is recommended for GFR >30 mL/min. For GFR 15-29 mL/min, reduce dose to 10 mg once daily. For GFR <15 mL/min or on dialysis, use is not recommended. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose to 10 mg once daily. Child-Pugh C: Not recommended. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dose adjustment is warranted based on age alone; monitor renal function as elderly patients are more likely to have decreased GFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOGROYA (SOGROYA).
| Breastfeeding | Contraindicated in breastfeeding. M/P ratio not established. Sogroya is excreted in human milk; potential for serious adverse reactions in nursing infants. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in pregnancy due to risk of fetal harm. In first trimester, associated with craniofacial defects, cardiovascular malformations, and neural tube defects. Second and third trimester exposure may cause central nervous system effects and growth retardation. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warnings.
| Serious Effects |
["Hypersensitivity to ulipristal acetate or any component","Pregnancy (may cause fetal harm)","Breastfeeding","Active liver disease or hepatic impairment"]
| Precautions | ["Endometrial changes (thickening, cystic dilation) due to unopposed estrogen effect; requires monitoring with ultrasound.","Increased risk of depression; monitor mood changes.","Potential for prolonged QT interval; use caution with other QT-prolonging drugs.","Hepatic enzyme elevation; monitor liver function.","Loss of bone mineral density with prolonged use; not recommended beyond 3 months."] |
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| Monitor maternal renal function, electrolytes, and blood pressure regularly. Ultrasound for fetal growth and anatomy if inadvertent exposure occurs. Assess fetal heart rate and amniotic fluid volume. |
| Fertility Effects | May impair fertility in females by disrupting menstrual cycle and ovulation. In males, may reduce sperm count and motility. Reversible upon discontinuation. |