YORVIPATH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YORVIPATH (YORVIPATH).
Somatostatin receptor subtype 2 (SSTR2) agonist; suppresses growth hormone secretion from pituitary adenomas and inhibits tumor growth via SSTR2-mediated signaling.
| Metabolism | Hepatic metabolism via CYP3A4 and CYP2C19; excreted primarily in feces (80%) and urine (20%). |
| Excretion | Renal excretion of intact drug and metabolites accounts for approximately 80% of the administered dose, with fecal elimination accounting for the remaining 20%. |
| Half-life | Terminal elimination half-life is approximately 4 hours in healthy subjects, but may be prolonged (up to 6-8 hours) in patients with moderate to severe renal impairment, requiring dose adjustment. |
| Protein binding | Approximately 50-60% bound to plasma proteins, primarily to albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.4 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Subcutaneous administration: absolute bioavailability is approximately 60% compared to intravenous administration. |
| Onset of Action | Subcutaneous administration: time to maximal calcium elevation is approximately 4-6 hours; clinical effect on serum calcium is detectable within 2-4 hours. |
| Duration of Action | Duration of serum calcium elevation is approximately 12-24 hours, supporting once-daily or every-other-day dosing; duration is dose-dependent and may be shorter in patients with impaired renal function. |
YORVIPATH (palopegteriparatide) is administered subcutaneously once daily. The recommended dose is 0.7 mL (18 mcg) injected into the abdomen or thigh, with the needle inserted perpendicularly. Dose adjustments are based on serum calcium and albumin levels.
| Dosage form | SOLUTION |
| Renal impairment | No specific dose adjustment is recommended for renal impairment. However, caution is advised in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) as safety data are limited. |
| Liver impairment | No dose adjustment is recommended for hepatic impairment. Safety and efficacy have not been studied in patients with Child-Pugh Class B or C. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no approved dosing guidelines are available. |
| Geriatric use | No specific dose adjustment is recommended for elderly patients. Clinical studies included patients aged 65 years and older, but no overall differences in safety or efficacy were observed compared to younger adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for YORVIPATH (YORVIPATH).
| Breastfeeding | No data on presence in human milk. Abaloparatide is a peptide and likely degraded in infant GI tract. M/P ratio unknown. Caution advised; consider benefit of breastfeeding vs potential for infant harm. |
| Teratogenic Risk | YORVIPATH (abaloparatide) is a PTHrP analog. In animal studies, skeletal abnormalities and reduced fetal weight were observed at doses 20-40 times the human dose. No adequate human studies exist. Risk cannot be ruled out; contraindicated in pregnancy except for life-threatening conditions. |
■ FDA Black Box Warning
No FDA-issued black box warning.
| Serious Effects |
["Hypersensitivity to YORVIPATH or any of its excipients.","Severe liver impairment (Child-Pugh class C)."]
| Precautions | ["Risk of bradycardia and heart block; monitor heart rate and ECG.","Cholelithiasis; monitor gallbladder function.","Hypoglycemia or hyperglycemia; monitor blood glucose levels.","Pituitary tumor enlargement may cause visual field defects; monitor visual fields.","Immune-mediated hepatitis; monitor liver function tests."] |
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| Fetal Monitoring |
| Monitor serum calcium levels periodically. Fetal monitoring includes ultrasound for skeletal development if exposure occurs. Assess maternal bone mineral density before and during therapy. Evaluate for orthostatic hypotension and hypercalcemia. |
| Fertility Effects | In animal studies, abaloparatide did not impair fertility at doses up to 20 times the human dose. No human fertility data available. Theoretical risk due to calcium homeostasis disruption, but unlikely at therapeutic doses. |