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XYNTHA® Lyophilized Powder (antihemophilic factor [Recombinant])
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XYNTHA® Lyophilized Powder Quick Finder
Highlights
Indications and Usage
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
2.1 Dose
- Dosage and duration of treatment depend on...
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Dosage Forms and Strengths
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...
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Contraindications
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.
...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients...
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Adverse Reactions
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.
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
It is not known whether...
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Description
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...
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Clinical Pharmacology
...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
XYNTHA temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis.
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted with XYNTHA to assess its mutagenic or carcinogenic...
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Clinical Studies
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...
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References
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....
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Each XYNTHA Vial Kit contains: one prefilled diluent syringe containing 4 mL 0.9...
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Medication Guide
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...
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Instructions For Use
Instructions for Use
XYNTHA® /ZIN-tha/
[Antihemophilic Factor (Recombinant)]
XYNTHA is supplied as a...
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