Dosing and uses of Velphoro (sucroferric oxyhydroxide)
Adult dosage forms and strengths
chewable tablet
- 500mg (amount of iron)
Hyperphosphatemia
Indicated for control of serum phosphorus levels in patients with chronic kidney disease on hemodialysis
Initial: 500 mg PO TID with each meaL
Titration and maintenance
- Monitor serum phosphorus levels and titrate the dose in decrements or increments of 500 mg (ie, 1 tablet) per day as needed until an acceptable serum phosphorus level (≤5.5 mg/dL) is reached, with regular monitoring afterwards
- Titration can be started as early as 1 week after treatment initiation and adjusted at weekly intervals thereafter if necessary
- Based on clinical studies, on average patients required 3-4 tablets (1,500-2,000 mg/day)
- The highest daily dose studied in a Phase 3 clinical trial in patients with ESRD was 6 tablets (3,000 mg/day)
Administration
Must be administered with meals (adsorbs dietary phosphate in the gut)
To maximize the dietary phosphate binding, the total daily dose should be divided across the meals of the day
Tablets must be chewed and not swallowed whole; to aid with chewing and swallowing, the tablets may be crushed
If 1 or more doses are missed, the medication should be resumed with the next meal; do not attempt to replace a missed dose
Pediatric dosage forms and strengths
Safety and efficacy not established
Velphoro (sucroferric oxyhydroxide) adverse (side) effects
>10%
Diarrhea (6-24%)
Discolored feces (12-16%)
1-10%
Nausea (10%)
Warnings
Contraindications
None
Cautions
Monitor effect and iron homeostasis with patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal surgery, or with a history of hemochromatosis or other diseases with iron accumulation
Do not prescribe with oral levothyroxine
Do not administer alendronate or doxycycline at the same time; alendronate or doxycycline must be given at least 1 hr before sucroferric oxyhydroxide
Pregnancy and lactation
Pregnancy category: B
Lactation: Absorption of iron is minimal, and therefore excretion into to breast milk is unlikely
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Velphoro (sucroferric oxyhydroxide)
Mechanism of action
Iron-based, calcium-free phosphate binder (stabilized polynuclear iron [III]-oxyhydroxide); when taken with meals, adsorbs dietary phosphate in the GI tract and prevents its uptake into the blood
Phosphate binding takes place by ligand exchange between hydroxyl groups and/or water in sucroferric oxyhydroxide and the phosphate in the diet; bound phosphate is eliminated with feces
Pharmacokinetics
Active moiety (polynuclear iron[III]-oxyhydroxide) is practically insoluble and therefore not absorbed and not metabolized
The sucrose and starch components can be digested to glucose and fructose, and maltose and glucose, respectively; these compounds can be absorbed in the blood (1 tablet = 1.4 g of carbohydrates)
Median iron update in patients with chronic kidney disease is 0.04% on Day 21 (based on 2,000 mg/day of sucroferric oxyhydroxide/day)
