Drotrecogin Alpha

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe (d)

Austria: Xigris; Belgium: Xigris; Bulgaria: Xigris; Cyprus: Xigris; Czech Republic: Xigris; Denmark: Xigris; Estonia: Xigris; Finland: Xigris; France: Xigris; Germany: Xigris; Greece: Xigris; Hungary: Xigris; Ireland: Xigris; Italy: Xigris; Latvia: Xigris; Lithuania: Xigris; Luxembourg: Xigris; Malta: Xigris; Netherlands: Xigris; Poland: Xigris; Portugal: Xigris; Romania: Xigris; Slovakia: Xigris; Slovenia: Xigris; Spain: Xigris; Sweden: Xigris; UK: Xigris.

North America (d)

Canada: Xigris; USA: Xigris.

Latin America (d)

Argentina: Xigris; Brazil: Xigris; Mexico: Xigris.

Drug combinations

Chemistry

Drotrecogin Alpha (activated): C~2000~H~3059~N~559~O~610~S~31~ (plus approximately 20% by weight Asn-linked carbohydrate). Mw: approx. 56000.01. (1) Recombinant human activated protein C (rh-APC); (2) Blood coagulation factor XIV (human). CAS-98530-76-8 (2000).

Pharmacologic Category

Other Miscellaneous Therapeutic Agents. Recombinant Human Activated Protein C. Blood Coagulation Factor XIV. (ATC-Code: B01AD10).

Mechanism of action

Drotrecogin alpha is a recombinant form of human activated protein C that has antithrombotic, anti-inflammatory, and profibrinolytic properties. It inhibits factors Va and VIIIa, limiting thrombotic effects. Although precise mechanisms by which drotrecogin alpha affects survival in severe sepsis is not known, the drug produces dose-dependent decreases in D-dimer (a breakdown product of cross-linked fibrin) and interleukin 6, which are markers of coagulopathy and inflammation, respectively.

Therapeutic use

Drotrecogin alpha is used for mortality reduction in adults with severe sepsis (associated with acute organ dysfunction) and a high risk of death.

Pregnancy and lactiation implications

Not known whether drotrecogin alpha is distributed into milk. Not recommended during lactation.

Unlabeled use

Purpura fulminans.

Contraindications

Hypersensitivity to drotrecogin alpha or any component of the formulation. Active internal bleeding. Recent hemorrhagic stroke. Severe head trauma. Recent intracranial or intraspinal surgery. Intracranial neoplasm or mass lesion. Cerebral herniation. Presence of an epidural catheter. Trauma with an increased risk of life-threatening bleeding.

Warnings and precautions

Use with caution in patients at risk of bleeding (bleeding is the most common adverse effect), with chronic renal failure requiring dialysis, with hypercoagulable conditions (i.e. hereditary deficiencies of protein C, protein S, or antithrombin III, suspected thromboembolism), or with resistance to activated protein C. May interfere with one-stage coagulation assays (e.g. factor VIII, IX, XI assays) based on the activated partial thromboplastin time.

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