Indications and Important Safety Information

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Venofer® Iron Sucrose Injection, USP

INDICATION
Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).

IMPORTANT SAFETY INFORMATION
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to rate of administration and/or total dose delivered.

Venofer is contraindicated in patients with known hypersensitivity to Venofer. Do not administer to patients with evidence of iron overload.

In multi-dose efficacy studies in hemodialysis dependent (HDD)-CKD patients (N=231), the most frequent adverse events (>2%) whether or not related to Venofer administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%), hypertension (6.5%), chest pain (6.1%), pain in extremity (5.6%), and diarrhea (5.2%).

In the study of peritoneal dialysis dependent (PDD)-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer, reported by ≥2% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract infections, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer treated patients (27/47) receiving 0.5 mg/kg Venofer experienced a treatment-emergent adverse reaction, 11% of which were serious. The most common treatment-emergent adverse reactions (>2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

Please see full Prescribing Information.

This website is intended for use by U.S. Healthcare Professionals only. For Patient Site, click here.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Customer Service at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Velphoro® Sucroferric Oxyhydroxide Chewable Tablet

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

IMPORTANT SAFETY INFORMATION
Velphoro chewable tablets must be administered with meals. Velphoro should be chewed or crushed. Do not swallow whole.

Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) 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.

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%).

Velphoro can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin. For oral medications where a reduction of bioavailability would be clinically significant consider separating of the timing of administration. Consider monitoring clinical responses or blood levels of the concomitant medications.

For additional important safety information, please see the full Prescribing Information.

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

This information is intended for use by US healthcare professionals only.

 

 

Phoslyra® Calcium Acetate Oral Solution

INDICATION
Phoslyra® (calcium acetate oral solution, 667 mg per 5 mL) is a phosphate binder (PB) indicated for the reduction of serum phosphorus in patients with end stage renal disease (ESRD). Phoslyra is administered orally with food.

IMPORTANT SAFETY INFORMATION
Phoslyra is contraindicated in patients with hypercalcemia. 

Patients should have serum calcium levels closely monitored and their dose of Phoslyra adjusted or terminated to bring levels to normal. No other calcium supplements should be given concurrently with Phoslyra.

Phoslyra may decrease the bioavailability of tetracyclines or fluoroquinolones.

There are no empirical data on avoiding drug interactions between calcium acetate or Phoslyra and most concomitant drugs. When administering an oral medication with Phoslyra where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug 1 hour before or 3 hours after Phoslyra or calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range.

The most common (>10%) adverse reactions experienced with Phoslyra are hypercalcemia, nausea, and diarrhea. Of the observed drug-related adverse reactions, diarrhea (5/38, 13.2%) was more common with Phoslyra than with a solid formulation calcium acetate.

Phoslyra may cause diarrhea with nutritional supplements that contain maltitol.

For additional important safety information, please see the full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or call Fresenius Medical Care at 1-800-323-5188.

This information is intended for use by U.S. Healthcare Professionals only. Patients and Families click here.

 

 

© 2015, 2017, 2019, Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, Fresenius Renal Pharmaceuticals, the triangle logo, PhosLo, and Phoslyra are trademarks of Fresenius Medical Care Holdings, Inc and/or its affiliated companies. All other trademarks are the property of their respective owners. Phoslyra is manufactured for Fresenius Medical Care North America. PhosLo is manufactured for Fresenius Medical Care North America. Venofer is manufactured under license from Vifor (International) Inc., Switzerland and American Regent, Inc. Shirley, NY. Velphoro is made in Switzerland and distributed by Fresenius Medical Care North America. P/N 102763-02 Rev C 06/2019