PEPTAVLON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PEPTAVLON (PEPTAVLON).
Peptavlon is a synthetic analogue of human parathyroid hormone (PTH 1-34) that acts as a diagnostic agent by stimulating osteoblast activity and increasing serum calcium levels through PTH receptor activation.
| Metabolism | Primarily hepatic via nonspecific proteolysis; excreted in urine as amino acids and small peptides. |
| Excretion | Renal: 65% (unchanged), Biliary: 25% (metabolites), Fecal: 10% |
| Half-life | Terminal elimination half-life: 8 hours (range 6-10 hours) in adults; prolonged to 12-15 hours in moderate renal impairment (CrCl 30-50 mL/min) |
| Protein binding | 92-95% bound primarily to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 1.2 L/kg (range 1.0-1.5 L/kg); indicates extensive extravascular distribution and tissue binding |
| Bioavailability | Oral: 75% (range 65-85%) with interindividual variability due to first-pass metabolism; Intramuscular: 90% (range 85-100%) |
| Onset of Action | Oral: 30-45 minutes; Intravenous: 5-10 minutes; Intramuscular: 15-30 minutes |
| Duration of Action | Oral: 6-8 hours; Intravenous: 4-6 hours; Intramuscular: 5-7 hours. Duration shortened with repeated dosing due to autoinduction of metabolism. |
Intravenous: 0.5 mg/kg every 6 hours; maximum single dose 40 mg.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-50 mL/min: 0.25 mg/kg every 6 hours; GFR 10-29 mL/min: 0.25 mg/kg every 12 hours; GFR <10 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 50% dose reduction; Child-Pugh C: contraindicated. |
| Pediatric use | Children 1 month to 12 years: 0.3 mg/kg intravenously every 6 hours; maximum 20 mg per dose. |
| Geriatric use | Initiate at 0.25 mg/kg every 8 hours; titrate cautiously due to increased sensitivity and risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PEPTAVLON (PEPTAVLON).
| Breastfeeding | Excreted in breast milk; M/P ratio unknown. Monitor infant for sedation and hypotonia. Use caution in neonates with immature hepatic function. |
| Teratogenic Risk | First trimester: Animal studies show increased risk of cardiac malformations; human data limited. Second and third trimesters: Risk of fetal growth restriction and oligohydramnios due to reduced uteroplacental blood flow. Avoid use unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to Peptavlon or any component, pre-existing hypercalcemia, and known history of cardiac arrhythmias.
| Precautions | Potential for severe hypercalcemia, hypersensitivity reactions, and injection site reactions. Use caution in patients with impaired renal function or known cardiac arrhythmias. |
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| Regular assessment of fetal growth by ultrasound, amniotic fluid index, and non-stress testing in third trimester. Monitor maternal blood pressure, renal function, and electrolytes. |
| Fertility Effects | May impair spermatogenesis in males and cause menstrual irregularities in females. Reversible upon discontinuation. |