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NELARABINE


DIR Classification


Classification:Less-DIR concern
Severity Score:1

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

  • ADVERSE REACTIONS
  • Postmarketing Experience
  • The following adverse reactions have been identified during post-approval use of ARRANON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Infections and Infestations: Fatal opportunistic infections.
  • Metabolism and Nutrition Disorders: Tumor lysis syndrome.
  • Nervous System Disorders: Demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
  • Musculoskeletal and Connective Disorders: Rhabdomyolysis, blood creatine phosphokinase increased.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
21
42891
Other ADRs
475
14116804

Odds Ratio = 14.552

Drug Property Information



ATC Code(s):
  • L01BB07 - nelarabine
    • L01BB - Purine analogues
    • L01B - ANTIMETABOLITES
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:nelarabine
Active Ingredient UNII:60158CV180
Drugbank ID:DB01280
PubChem Compound:3011155
CAS Number:121032-29-9
Dosage Form(s):injection
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:
COC1=NC(=NC2=C1N=CN2[C@H]3[C@H]([C@@H]([C@H](O3)CO)O)O)N

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Nelarabine associated myotoxicity and rhabdomyolysis.

[Haider Mahnur,Rizvi Syed Ahsan,Kasi Pashtoon Murtaza]
Case Rep Hematol.2015;2015:825670. doi: 10.1155/2015/825670. Epub 2015 Mar 18. PMID: 25866685

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