TRIFERIC- ferric pyrophosphate solution TRIFERIC- ferric pyrophosphate citrate powder

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

FERRIC PYROPHOSPHATE CITRATE (UNII: UBY79OCO9G) (FERRIC CATION - UNII:91O4LML611)

Fáanlegur frá:

Rockwell Medical, Inc

Stjórnsýsluleið:

HEMODIALYSIS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Triferic is not intended for use in patients receiving peritoneal dialysis. Triferic has not been studied in patients receiving home hemodialysis. None Risk Summary There are no data on Triferic use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In pregnant rats and rabbits, ferric pyrophosphate citrate caused adverse developmental outcomes at maternally toxic dose levels that were higher than the maximum theoretical amount of iron transferred to patients from Triferic. Use Triferic during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background of birth defect, loss, or other adverse outcomes. In the US. general populati

Vörulýsing:

Triferic is available in ampules or packets in the following package sizes: Store ampules protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store packets at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Leyfisstaða:

New Drug Application

Vara einkenni

TRIFERIC- FERRIC PYROPHOSPHATE SOLUTION
TRIFERIC- FERRIC PYROPHOSPHATE CITRATE POWDER
ROCKWELL MEDICAL, INC
REFERENCE LABEL SET ID: BEF06C1F-EDA6-4CFA-A578-379F23964599
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIFERIC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRIFERIC.
TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) SOLUTION, FOR HEMODIALYSIS USE
TRIFERIC (FERRIC PYROPHOSPHATE CITRATE) FOR SOLUTION, FOR HEMODIALYSIS USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
TRIFERIC is an iron replacement product indicated for the replacement
of iron to maintain hemoglobin in adult patients
with hemodialysis-dependent chronic kidney disease (HDD-CKD). ( 1)
Limitation of Use
Triferic is not intended for use in patients receiving peritoneal
dialysis. ( 1)
Triferic has not been studied in patients receiving home hemodialysis.
( 1)
DOSAGE AND ADMINISTRATION
Add one 5 mL ampule of Triferic solution to each 2.5 gallons of
bicarbonate concentrate to achieve a concentration of
iron (III) in the final hemodialysate of 2 micromolar (110 mcg/L). (
2.1)
Add one packet of Triferic powder to each 25 gallons of bicarbonate
concentrate to achieve a concentration of iron (III)
in the final hemodialysate of 2 micromolar (110 mcg/L). ( 2.1)
DOSAGE FORMS AND STRENGTHS
27.2 mg of iron (III) per 5 mL ampule as Triferic solution (5.44 mg of
iron (III) per mL). ( 3)
272 mg of iron (III) per packet as Triferic powder. ( 3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Observe for signs and symptoms of
hypersensitivity during and after hemodialysis and until
clinically stable. ( 5.1)
ADVERSE REACTIONS
The most common adverse reactions (incidence >3%) are headache,
peripheral edema, asthenia, AV fistula thrombosis,
urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue,
procedural hypotension, muscle spasms, pain in
extremity, back pain, and dyspnea. (6)
(6)
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROC