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TENECTEPLASE


DIR Classification


Classification:Most-DIR concern
Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • WARNINGS
  • Cholesterol Embolization
  • Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown. This serious condition, which can be lethal, is also associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy. Clinical features of cholesterol embolism may include livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
1
42911
Other ADRs
1071
14116208

Odds Ratio = 0.308

Drug Property Information



ATC Code(s):
  • B01AD11 - tenecteplase
    • B01AD - Enzymes
    • B01A - ANTITHROMBOTIC AGENTS
    • B01 - ANTITHROMBOTIC AGENTS
    • B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:tenecteplase
Active Ingredient UNII:WGD229O42W
Drugbank ID:DB00031
PubChem Compound:N/A
CAS Number:191588-94-0
Dosage Form(s):kit
Route(s) Of Administrator:-
Daily Dose:
  • 40.0 mg/day B01AD11
Chemical Structure:
SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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