Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 07 May 2018

Indication(s)

1 INDICATIONS AND USAGE Velphoro (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Velphoro is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. ( 1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None.
Adverse reactions
6 ADVERSE REACTIONS In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%). ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data derived from Velphoro clinical trials reflect exposure to Velphoro in 2 active-controlled clinical studies involving a total of 778 patients on hemodialysis and 57 patients on peritoneal dialysis exposed for up to 55 weeks. Dosage regimens ranged from 250 mg to 3,000 mg per day. As expected with oral preparations containing iron, discolored (dark colored) feces was a commonly occurring adverse drug reaction. In a parallel design, dose-finding study of Velphoro with a treatment duration of 6 weeks in hemodialysis patients, adverse reactions for Velphoro (N=128) were similar to those reported for the active-control group (sevelamer hydrochloride) (N=26), with the exception of discolored feces (12%) which did not occur in the active-control group and diarrhea (6%). In a 55-week, open-label, active-controlled, parallel design, safety and efficacy study involving 968 hemodialysis patients and 86 peritoneal dialysis patients treated with either Velphoro (N=707 including 57 peritoneal dialysis patients) or the active-control (sevelamer carbonate) (N=348 including 29 peritoneal dialysis patients), adverse reactions occurring in more than 5% in the Velphoro group were diarrhea (24%), discolored feces (16%), and nausea (10%). The majority of diarrhea events in the Velphoro group were mild and transient, occurring soon after initiation of treatment, and resolving with continued treatment. Similar adverse reactions occurred at similar rates in hemodialysis and peritoneal dialysis patients. The most common adverse reactions (>1%) leading to withdrawal were diarrhea (4%), product taste abnormal (2%), and nausea (2%). 6.2 Postmarketing Experiences The following adverse reactions have been identified during post-approval use of Velphoro that are not included in other sections of labeling. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: tooth discoloration Skin and Subcutaneous Tissue Disorder: rash

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed. Starting Dose The recommended starting dose of Velphoro is 3 tablets (1,500 mg) per day, administered as 1 tablet (500 mg) 3 times daily with meals. Titration and Maintenance Monitor serum phosphorus levels and titrate the dose of Velphoro in decrements or increments of 500 mg (1 tablet) per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. Based on clinical studies, on average patients required 3 to 4 tablets (1,500 mg to 2,000 mg) a day to control serum phosphorus levels. The highest daily dose studied in a Phase 3 clinical trial in ESRD patients was 6 tablets (3,000 mg) per day. Administration Velphoro must be administered with meals. To maximize the dietary phosphate binding, distribute the total daily dose among meals. No additional fluid above the amount usually taken by the patient is required. If one or more doses of Velphoro are missed, the medication should be resumed with the next meal. Do not attempt to replace a missed dose. Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, tablets may be crushed. ( 2) The recommended starting dose of Velphoro is 3 tablets (1,500 mg) per day, administered as 1 tablet (500 mg) 3 times daily with meals. ( 2) Adjust by 1 tablet per day as needed until an acceptable serum phosphorus level is reached, with regular monitoring afterwards. Titrate as often as weekly. ( 2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B: Reproduction studies have been performed in rats and rabbits at doses up to 16 and 4 times, respectively, the human maximum recommended clinical dose on a body weight basis, and have not revealed evidence of impaired fertility or harm to the fetus due to Velphoro [see Nonclinical Toxicology ( 13.2)] . However, Velphoro at a dose up to 16 times the maximum clinical dose was associated with an increase in post-implantation loss in pregnant rats. Animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. 8.2 Labor and Delivery No Velphoro treatment-related effects on labor and delivery were seen in animal studies with doses up to 16 times the maximum recommended clinical dose on a body weight basis. The effects of Velphoro on labor and delivery in humans are not known. 8.3 Nursing Mothers Since the absorption of iron from Velphoro is minimal [see Clinical Pharmacology ( 12.3)] , excretion of Velphoro in breast milk is unlikely. 8.4 Pediatric Use The safety and efficacy of Velphoro have not been established in pediatric patients. 8.5 Geriatric Use Of the total number of subjects in two active-controlled clinical studies of Velphoro (N=835), 29.7% (n=248) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Pregnancy and lactation
8.3 Nursing Mothers Since the absorption of iron from Velphoro is minimal [see Clinical Pharmacology ( 12.3)] , excretion of Velphoro in breast milk is unlikely.

Interactions

7 DRUG INTERACTIONS Table 1 Oral drugs that can be administered concomitantly with Velphoro Calcitriol Ciprofloxacin Digoxin Enalapril Furosemide HMG-CoA reductase inhibitors Hydrochlorothiazide Losartan Metoprolol Nifedipine Omeprazole Quinidine Warfarin Oral drugs that are to be separated from Velphoro and meals Dosing Recommendations Doxycycline Take at least 1 hour before Velphoro. Oral drugs that should not be prescribed with Velphoro Levothyroxine Oral medications not listed in Table 1 There are no empirical data on avoiding drug interactions between Velphoro and most concomitant oral drugs. For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separating the administration of the two drugs. The necessary separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Where possible, consider monitoring for clinical response and/or blood levels of concomitant medications that have a narrow therapeutic range. Velphoro can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG‑CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin. ( 7) Take doxycycline at least 1 hour before Velphoro. ( 7) Velphoro should not be prescribed with oral levothyroxine. ( 7)

More information

Category Value
Authorisation number NDA205109
Agency product number 87PZU03K0K
Orphan designation No
Product NDC 49230-645
Date Last Revised 12-09-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1484296
Storage and handling Storage Store in the original package and keep the bottle tightly closed in order to protect from moisture. Store at 25°C (77°F) with excursions permitted to 15 to 30°C (59 to 86°F).
Marketing authorisation holder Fresenius Medical Care North America