Besilesomab

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Scintimun; Czech Republic: Scintimun; Estonia: Scintimun; France: Scintimun; Germany: Scintimun; Greece: Scintimun; Ireland: Scintimun; Latvia: Scintimun; Lithuania: Scintimun; Malta: Scintimun; Netherlands: Scintimun; Portugal: Scintimun; Sweden: Scintimun.

Drug combinations

Chemistry

Besilesomab: Mw: 150. Immunoglobulin G~1~, anti-human CEA ((carcinoembryonic antigen)-related antigen)(mouse monoclonal BW 250/183 heavy chain), disulfide with mouse monoclonal BW 250/183 κ-chain, dimer. CAS-537694-98-7.

Pharmacologic Category

Diagnostic Agents; Imaging Agents; Anti-Granulocyte Monoclonal Antibody. (ATC-Code: V09HA03).

Mechanism of action

Besilesomab is a monoclonal antibody, designed to attach to an antigen called NCA-95, found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection. When radiolabeled, the radioactive compound technetium (^99m^Tc) becomes attached to besilesomab. When the radiolabeled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes. As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans. The images will show where besilesomab has accumulated, allowing the physician to locate the areas of infection or inflammation.

Therapeutic use

For diagnostic use only. Used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods. Should not be used to diagnose diabetic foot infection.

Pregnancy and lactiation implications

Contraindicated in pregnancy. Not recommended in women of childbearing potential. Avoid use during lactation (if administration is considered necessary, breast-feeding should be interrupted for three days and the expressed milk discarded).

Unlabeled use

Contraindications

Hypersensitivity to the active substance, to other murine antibodies or to any of the excipients. Positive screening test for human anti-mouse antibody (HAMA). Pregnancy.

Warnings and precautions

There are currently no criteria to distinguish infection and inflammation by means of besilesomab imaging (images should be interpreted in the context of other appropriate anatomical and/or functional imaging examinations). Anaphylactic or anaphylactoid reactions may occur after administration of the medicinal product. Should only be used in hospitals with a nuclear medicine department and should only be handled by authorized staff. As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose. Should only be used once in a patient’s lifetime.

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