Desirudin description

Desirudin
IPRIVASK® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Description

Iprivask® (desirudin for injection) is a specific inhibitor of human thrombin. It has a protein structure that is similar to that of hirudin, the naturally occurring anticoagulant present in the peripharyngeal glands in the medicinal leech, Hirudo medicinalis. Hirudin is a single polypeptide chain of 65 amino acids residues and contains three disulfide bridges. Desirudin has a chemical formula of C287H440N80O110S6 with a molecular weight of 6963.52. Desirudin, which is expressed in yeast (Saccharomyces cerevisiae,strain TR 1456) by recombinant DNA technology differs from the natural hirudin by lack of a sulfate group on Tyr-63. The biological activity of desirudin is determined through a chromogenic assay which measures the ability of desirudin to inhibit the hydrolysis of a chromogenic peptidic substrate by thrombin in comparison to a desirudin standard. One vial of desirudin contains 15.75 mg desirudin corresponding to approximately 315,000 antithrombin units (ATU) or 20,000 ATU per milligram of desirudin with reference to the WHO International Standard (prepared 1991) for alphathrombin.

Iprivask 15 mg is supplied as a sterile, white, freeze dried powder for injection. Each vial contains 15.75 mg desirudin and the following inactive ingredients: 1.31 mg anhydrous magnesium chloride USP, sodium hydroxide for injection USP. Each prefilled syringe of diluent for Iprivask contains 0.6 mL sterile Mannitol USP (3%) in Water for Injection and is preservative free. See DOSAGE AND ADMINISTRATION section for reconstitution instructions. Iprivask 15 mg is administered by subcutaneous (SC) injection, preferably at an abdominal or thigh site.

To prepare the reconstituted aqueous solution, 0.5 mL of the mannitol diluent is added under aseptic conditions to the vial containing the sterile powder. Shaking gently rapidly disperses the drug. The reconstituted solution has a pH of 7.4.