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PEMIGATINIB


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • ADVERSE REACTIONS
  • Clinical Trials Experience
  • Dosage interruptions due to an adverse reaction occurred in 43% of patients who received PEMAZYRE. Adverse reactions requiring dosage interruption in 1% of patients included stomatitis, palmar-plantar erythrodysesthesia syndrome, arthralgia, fatigue, abdominal pain, AST increased, asthenia, pyrexia, ALT increased, cholangitis, small intestinal obstruction, alkaline phosphatase increased, diarrhea, hyperbilirubinemia, electrocardiogram QT prolonged, decreased appetite, dehydration, hypercalcemia, hyperphosphatemia, hypophosphatemia, back pain, pain in extremity, syncope, acute kidney injury, onychomadesis, and hypotension.
  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • At a dose 1.5 times the maximum recommended dose, PEMAZYRE does not result in a large mean increase (i.e. >20 ms) of the QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587

Odds Ratio = N/A

Drug Property Information



ATC Code(s):
  • L01EX20 - pemigatinib
    • L01EX2 -
    • L01EX -
    • L01E -
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:PEMIGATINIB
Active Ingredient UNII:Y6BX7BL23K
Drugbank ID:DB15102
PubChem Compound:N/ADIR Classification
CTD ID:C000705477
PharmGKB:
CAS Number:1513857-77-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure:
SMILE Code:
CCN1C(=O)N(CC2=CN=C3NC(CN4CCOCC4)=CC3=C12)C1=C(F)C(OC)=CC(OC)=C1F

Reference

N/A

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