Dosing & Uses
Dosage Forms & 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
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- levothyroxine
sucroferric oxyhydroxide decreases levels of levothyroxine by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. No interaction anticipated with parenteral levothyroxine.
Serious - Use Alternative (1)
- erdafitinib
sucroferric oxyhydroxide, erdafitinib. Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid coadministration during initial dosing adjustment period (ie, first 21 days). Increases in serum phosphate levels are a pharmacodynamic effect of FGFR inhibition. Serum phosphate binders may obscure decisions regarding initial dosage increase.
Monitor Closely (4)
- alendronate
sucroferric oxyhydroxide decreases levels of alendronate by drug binding in GI tract. Use Caution/Monitor. Do not administer at the same time; take alendronate at least 1 hr before sucroferric oxyhydroxide.
- doxycycline
sucroferric oxyhydroxide decreases levels of doxycycline by drug binding in GI tract. Use Caution/Monitor. Do not administer at the same time; take doxycycline at least 1 hr before sucroferric oxyhydroxide.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of sucroferric oxyhydroxide by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of sucroferric oxyhydroxide by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
Minor (0)
Adverse Effects
>10%
Diarrhea (6-24%)
Discolored feces (12-16%)
1-10%
Nausea (10%)
Postmarketing Reports
Tooth discoloration
Rash
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; clinical studies not performed in these groups of patients
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 & Lactation
Pregnancy
The drug is not systemically absorbed following oral administration; maternal use is not expected to result in fetal exposure to the drug
Animal data
- In pregnant rats given up to 800 mg/kg/day by oral gavage from days 6 to 17 post-mating (16 times maximum recommended clinical dose), no embryo-fetal development toxicity observed.
- In pregnant rabbits given 50, 100, or 200 mg/kg/day (corresponding to 4 times the recommended maximum clinical dose) by oral gavage, from days 6 to 19 post-mating, the number of fetuses with incomplete/unossified epiphyses and metacarpals/phalanges was increased at highest dose; litter parameters were not adversely affected
- In pregnant rats given Velphoro at 100, 280, or 800 mg/kg/day (16 times the maximum recommended clinical dose) by oral gavage from day 6 post-mating to lactation day 20, offspring body weight gain was lower at age 5-13 weeks and neuromuscular function was delayed at dose of 800 mg/kg/day
Lactation
This drug is not absorbed systemically following oral administration and breastfeeding is not expected to result in exposure of the child to the drug
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
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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Velphoro oral - | 500 mg chewable tablet |  |
Copyright © 2010 First DataBank, Inc.
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