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XYNTHA® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe (antihemophilic factor [Recombinant])

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

XYNTHA® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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...
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2 DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

2.1 Dose

  • Dosage and duration of treatment...
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3 DOSAGE FORMS AND STRENGTHS

XYNTHA SOLOFUSE is available as a white to off-white lyophilized powder in the following nominal dosages:

  • 250 International Units
  • 500 International Units
  • ...
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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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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with XYNTHA. Inform patients...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

It is not known whether...

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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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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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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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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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15 REFERENCES

  1. Nilsson IM, Berntorp EE and Freiburghaus C. Treatment of patients with factor VIII and IX inhibitors. Thromb Haemost. 1993;70(1):56–59.
  2. Hoyer LW. Hemophilia A....
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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Each XYNTHA SOLOFUSE Kit contains: one plunger rod for assembly, one sterile...

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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...
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Instructions for Use

XYNTHA® SOLOFUSE® /ZIN-tha/
[Antihemophilic Factor (...

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