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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Idarucizumab (Praxbind) Formulary Review.

Jessica Buchheit1, Prabashni Reddy, Jean M Connors

  • 1From the *Massachusetts General Hospital, †Partners Healthcare, and ‡Brigham and Women's Hospital, Dana-Farber Cancer Institute, Boston, MA.

Critical Pathways in Cardiology
|July 29, 2016
PubMed
Summary

Idarucizumab (Praxbind) effectively reverses dabigatran

Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Drug Development

Background:

  • Idarucizumab is the first FDA-approved agent to reverse novel oral anticoagulants.
  • It is indicated for dabigatran reversal in critical bleeding or emergency surgery scenarios.

Purpose of the Study:

  • To review idarucizumab clinical trials and package insert data.
  • To generate practical recommendations for appropriate and safe use within a health system.

Main Methods:

  • Summarized clinical trial data and medication package insert.
  • Consulted with clinical experts to formulate recommendations.

Main Results:

  • Idarucizumab demonstrated effective reversal of dabigatran's anticoagulant effects in healthy volunteers.

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  • Preliminary results in patients show efficacy and a reasonable safety profile up to 90 days post-infusion.

    • Conclusions:

    • Idarucizumab provides a crucial option for reversing dabigatran's effects.
    • Recommendations aim to ensure its appropriate and safe clinical application.