TRIFERIC AVNU Solution for injection (2020)
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Rockwell Medical Inc.
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1. Indications and Usage
Triferic AVNU 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). <u>Limitations ...
2. Dosage and Administration
2.1 Recommended Dosage The recommended dosage of Triferic AVNU is 6.75 mg iron (III) undiluted as a slow continuous intravenous infusion over 3 to 4 hours via the pre-dialyzer infusion line, post-dialyzer ...
3. Dosage Forms and Strengths
Injection: 6.75 mg iron (III) per 4.5 mL solution (1.5 mg iron (III) per mL) in single-dose luer lock ampule.
4. Contraindications
None.
5. Warnings and Precautions
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after hemodialysis and until clinically stable. 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, ...
6. Adverse Reactions
The following clinically significant adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions <em>[see Warnings and Precautions (5.1)]</em>
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. The safety of ferric ...
8.1. Pregnancy
Risk Summary There are no available data on Triferic AVNU use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction ...
8.2. Lactation
Risk Summary There are no data on the presence of ferric pyrophosphate citrate in human milk, the effects on the breastfed child, or the effect on milk production. The developmental and health benefits ...
8.4. Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
8.5. Geriatric Use
In controlled clinical trials, 99 (29%) patients ≥65 years of age were treated with ferric pyrophosphate citrate. No overall differences in safety and efficacy were observed between older and younger patients ...
11. Description
Triferic AVNU (ferric pyrophosphate citrate), an iron replacement product, is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. It has a molecular formula of Fe<sub> ...
12.1. Mechanism of Action
Triferic AVNU contains iron in the form of ferric pyrophosphate citrate. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
12.2. Pharmacodynamics
Ferric pyrophosphate citrate exposure-response relationships and the time course of pharmacodynamics response are unknown. Drug interaction Studies In vitro studies showed that ferric pyrophosphate citrate ...
12.3. Pharmacokinetics
Following administration of ferric pyrophosphate citrate 6.75 mg via a 3-hour intravenous infusion at a rate of 1.5 mg/hr (6.5 mg delivered), the total plasma iron and transferrin bound iron exposure values ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies examining the carcinogenic potential of ferric pyrophosphate citrate have not been conducted. Ferric pyrophosphate citrate was clastogenic in the <em>in vitro</em> chromosomal aberration assay ...
14. Clinical Studies
The efficacy of Triferic AVNU has been established based on adequate and well-controlled adult studies of ferric pyrophosphate citrate in iron replacement in patients with hemodialysis-dependent chronic ...
16.1. How Supplied
Triferic AVNU injection is a clear to slightly yellow-green solution available in single-dose luer lock ampules in the following package sizes: NDC Code Package Description Amount/Total Volume (per ampule) ...
16.2. Storage and Handling
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°-30°C (59° to 86°F) [See USP Controlled Room Temperature]. ...
17. Patient Counseling Information
Prior to the administration of Triferic AVNU: Question patients regarding any prior history of reactions to parenteral iron products. Advise patients of the risk of hypersensitivity reactions associated ...