VELPHORO- sucroferric oxyhydroxide tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) (FERRIC OXYHYDROXIDE - UNII:87PZU03K0K)

Available from:

Fresenius Medical Care North America

INN (International Name):

FERRIC OXYHYDROXIDE

Composition:

IRON 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Velphoro is indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. None. Velphoro is not systemically absorbed following oral administration and maternal use is not expected to result in fetal exposure to the drug. Data Animal Data In pregnant rats given up to 800 mg/kg/day Velphoro by oral gavage from Days 6 to 17 post-mating, no embryo-fetal development toxicity was observed. This dose corresponds to 16 times the maximum recommended clinical dose. In pregnant rabbits given 50, 100 or 200 mg/kg/day Velphoro by oral gavage, from Days 6 to 19 post-mating, the number of fetuses with incomplete/unossified epiphyses and metacarpals/phalanges was increased at the highest dose (corresponding to 4 times the recommended maximum clinical dose). Litter parameters were not adversely affected. In pregnant rats given Velphoro at 100, 280, or 800 mg/kg/day by oral gavage from Day 6 post-mating to lactation Day 20, offspring body weight gain was lower at age 5-13 weeks and

Product summary:

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 tablets Storage 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).

Authorization status:

New Drug Application

Summary of Product characteristics

VELPHORO- SUCROFERRIC OXYHYDROXIDE TABLET, CHEWABLE
FRESENIUS MEDICAL CARE NORTH AMERICA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VELPHORO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VELPHORO
.
VELPHORO (SUCROFERRIC OXYHYDROXIDE) CHEWABLE TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Velphoro is a phosphate binder indicated for the control of serum
phosphorus levels in patients with
chronic kidney disease on dialysis. ( 1)
DOSAGE AND ADMINISTRATION
Chew or crush Velphoro tablets, do not swallow whole. ( 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)
DOSAGE FORMS AND STRENGTHS
Velphoro chewable tablet 500 mg ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Patients with peritonitis during peritoneal dialysis, significant
gastric or hepatic disorders, history of
recent major gastrointestinal surgery, or with a history of
hemochromatosis or other diseases with iron
accumulation have not been included in clinical studies with Velphoro.
Monitor effect and iron
homeostasis in such patients. ( 5.1)
ADVERSE REACTIONS
The most common adverse drug reactions to Velphoro chewable tablets in
clinical trials were 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_.
DRUG INTERACTIONS
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 acetylsalicylic acid, cephalexin and doxycycline at least 1 hour
before Velphoro. (