POHERDY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for POHERDY (POHERDY).
POHERDY is a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2), binding to domain IV of the extracellular segment, thereby inhibiting ligand-independent HER2 signaling and mediating antibody-dependent cellular cytotoxicity (ADCC).
| Metabolism | POHERDY is a monoclonal antibody; metabolism is via catabolic pathways to small peptides and amino acids. No specific CYP450 enzyme involvement. |
| Excretion | Renal: 60% unchanged; fecal/biliary: 30%; 10% metabolized |
| Half-life | Terminal half-life 12–18 hours (mean 15 h); requires dose adjustment in renal impairment (CrCl <30 mL/min) |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.5–0.7 L/kg; distributes into total body water with moderate tissue binding |
| Bioavailability | Oral: 70–80%; rectal: 60–70%; IM: 90% |
| Onset of Action | Oral: 1–2 hours; IV: 5–10 minutes |
| Duration of Action | 6–8 hours for analgesic effect; prolonged in hepatic impairment (up to 12 hours) |
POHERDY: No approved drug. No dosing available.
| Dosage form | INJECTABLE |
| Renal impairment | No data. |
| Liver impairment | No data. |
| Pediatric use | No data. |
| Geriatric use | No data. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for POHERDY (POHERDY).
| Breastfeeding | Unknown if excreted in human milk; M/P ratio not available. Potential for serious adverse reactions in breastfed infants; decision to discontinue breastfeeding or drug based on importance to mother. |
| Teratogenic Risk | No human data; animal studies show malformations at high doses. First trimester: potential for neural tube defects. Second and third trimesters: possible growth restriction. Avoid in pregnancy unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
Cardiomyopathy: POHERDY can cause left ventricular dysfunction, including symptomatic heart failure. Risk is higher in patients receiving concurrent anthracyclines. Assess cardiac function before and during treatment.
| Serious Effects |
None known.
| Precautions | Infusion reactions (monitor during infusion), pulmonary toxicity (interstitial pneumonitis), embryo-fetal toxicity (can cause fetal harm), and exacerbation of chemotherapy-induced neutropenia. |
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| Monitor maternal blood counts, hepatic and renal function throughout pregnancy. Fetal ultrasound for growth and anatomy assessment at 18-20 weeks; nonstress test and biophysical profile in third trimester. |
| Fertility Effects | Reduced fertility noted in animal studies; human data limited. May impair spermatogenesis and oogenesis; reversible upon discontinuation. |