Sucroferric Oxyhydroxide Chewable Tablets

Dosage Forms And Strengths

Velphoro (sucroferric oxyhydroxide) chewable tablet 500 mg.

Each chewable tablet contains 500 mg iron (equivalent to 2,500 mg sucroferric oxyhydroxide).

Storage And Handling

Velphoro are chewable tablets supplied as brown, circular, bi-planar tablets, embossed with “PA 500” on 1 side. Each tablet of Velphoro contains 500 mg iron as sucroferric oxyhydroxide. Velphoro tablets are packaged as follows:

NDC 49230-645-51      Bottle of 90 chewable tablets

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).

Distributed by:Fresenius Medical Care North America 920 Winter Street Waltham, MA 02451. Revised: Aug 2017

There are no reports of overdosage with Velphoro in patients. Since the absorption of iron from Velphoro is low [see CLINICAL PHARMACOLOGY], the risk of systemic iron toxicity is low. Hypophosphatemia should be treated by standard clinical practice.

Velphoro has been studied in doses up to 3,000 mg per day.

Inform patients that Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed [see DOSAGE AND ADMINISTRATION].

Velphoro should be taken with meals.

Instruct patients on concomitant medications that should be dosed apart from Velphoro [see DRUG INTERACTIONS.]

Inform patients that Velphoro can stain teeth.

Inform patients to report any rash to their health care professional.

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%).

Postmarketing Experience

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

Read the entire FDA prescribing information for Velphoro (Sucroferric Oxyhydroxide Chewable Tablets)