VELPHORO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VELPHORO (VELPHORO).
Iron-based phosphate binder that forms non-absorbable complexes with dietary phosphate in the gastrointestinal tract, reducing serum phosphate levels.
| Metabolism | Not metabolized; acts locally in the GI tract; minimal systemic absorption. |
| Excretion | Primarily fecal as unabsorbed drug; negligible renal excretion (<0.1%). |
| Half-life | Not applicable (non-absorbed drug acting locally in GI tract; no systemic half-life). |
| Protein binding | Not applicable (minimal systemic absorption; binding to serum proteins negligible). |
| Volume of Distribution | Not applicable (minimal systemic absorption; Vd not defined). |
| Bioavailability | Not applicable (not intended for absorption; systemic bioavailability <0.1% based on limited data). |
| Onset of Action | Rapid (within 1 hour) binding to dietary phosphate in the GI tract. |
| Duration of Action | Duration of phosphate binding is limited to GI transit time (approximately 3–5 hours per meal), requiring administration with each meal. |
1-2 tablets (500-1000 mg iron) orally three times daily with meals; titrate to achieve serum phosphorus target.
| Dosage form | TABLET, CHEWABLE |
| Renal impairment | Not applicable; drug is indicated for dialysis-dependent chronic kidney disease. No GFR-based dose reduction needed. |
| Liver impairment | No specific Child-Pugh dose adjustments provided in labeling; use with caution in severe hepatic impairment due to potential iron overload. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no weight-based guidelines available. |
| Geriatric use | No specific dose adjustment in elderly; monitor iron parameters and serum phosphorus as in younger adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VELPHORO (VELPHORO).
| Breastfeeding | Because sucroferric oxyhydroxide is not absorbed systemically, excretion into breast milk is negligible. Breastfeeding is considered safe. No M/P ratio is applicable. |
| Teratogenic Risk | Velphoro (sucroferric oxyhydroxide) is not absorbed systemically; therefore, no fetal exposure is expected. No teratogenicity or fetal harm is anticipated in any trimester. Animal studies with high doses showed no evidence of fetal harm. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to sucroferric oxyhydroxide or any component of the formulation","Patients with hemochromatosis or other iron accumulation disorders"]
| Precautions | ["Risk of iron overload, especially in patients with iron overload disorders or repeated blood transfusions; monitor iron status periodically.","Potential for gastrointestinal adverse reactions such as discolored stools (harmless), constipation, nausea, and diarrhea."] |
Loading safety data…
| Monitor serum phosphate levels to ensure efficacy; monitor serum iron, ferritin, and iron saturation if prolonged use to assess iron accumulation. No specific fetal monitoring required. |
| Fertility Effects | No evidence of impaired fertility in animal studies. No human data available; systemic absorption is minimal, so effects on fertility are unlikely. |