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
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)
DOSAGE FORMS AND STRENGTHS
Velphoro (sucroferric oxyhydroxide) chewable tablet 500 mg (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
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 have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients. (5.1)
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.
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 doxycycline at least 1 hour before Velphoro. (7)
Velphoro should not be prescribed with oral levothyroxine. (7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Monitoring in Patients with Gastrointestinal Disorders or Iron Accumulation Disorders
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicity and/or Pharmacology
14 CLINICAL STUDIES
14.1 Fixed-dose Study
14.2 Dose Titration Study
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
Velphoro (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chroni