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XYNTHA® Lyophilized Powder (antihemophilic factor [Recombinant])
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XYNTHA® Lyophilized Powder Quick Finder
1 INDICATIONS AND USAGE
XYNTHA, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:
- On-demand treatment and control of...
2 DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
2.1 Dose
- Dosage and duration of treatment depend on...
3 DOSAGE FORMS AND STRENGTHS
XYNTHA is available as a white to off-white lyophilized powder in the following nominal dosages:
- 250 International Units
- 500 International Units
- 1000...
4 CONTRAINDICATIONS
XYNTHA is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins.
...5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients...
6 ADVERSE REACTIONS
The most common adverse reactions (≥10%) with XYNTHA in adult and pediatric previously treated patients (PTPs) were headache, arthralgia, pyrexia, and cough.
...8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
It is not known whether...
11 DESCRIPTION
The active ingredient in XYNTHA, Antihemophilic Factor (Recombinant), is a recombinant antihemophilic factor (rAHF), also called coagulation factor VIII, which is produced by recombinant DNA technology. It is...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted with XYNTHA to assess its mutagenic or carcinogenic...
14 CLINICAL STUDIES
Three completed multicenter, open-label studies support the analysis of safety and efficacy of XYNTHA in on-demand treatment and control of bleeding episodes and perioperative management, and routine...
15 REFERENCES
- Nilsson IM, Berntorp EE and Freiburghaus C. Treatment of patients with factor VIII and IX inhibitors. Thromb Haemost. 1993;70(1):56–59.
- Hoyer LW. Hemophilia A....
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Each XYNTHA Vial Kit contains: one prefilled diluent syringe containing 4 mL 0.9...
17 PATIENT COUNSELING INFORMATION
Advise patients to:
- read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- report any adverse reactions or problems that concern them when...
Instructions for Use
XYNTHA® /ZIN-tha/
[Antihemophilic Factor (Recombinant)]
XYNTHA is supplied as a...
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