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Fludarabine phosphate
Fludara, Oforta (fludarabine phosphate) is a small molecule pharmaceutical. Fludarabine phosphate was first approved as Fludara on 1991-04-18. It is used to treat b-cell chronic lymphocytic leukemia and non-hodgkin lymphoma in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fludarabine phosphate
Tradename
Company
Number
Date
Products
FLUDARABINE PHOSPHATESandozN-022137 RX2007-09-21
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
fludarabine phosphateANDA2021-07-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell chronic lymphocytic leukemia—D015451C91.1
non-hodgkin lymphoma—D008228C85.9
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BB: Purine analogs, antimetabolites antineoplastic
— L01BB05: Fludarabine
HCPCS
Code
Description
J8562
Fludarabine phosphate, oral, 10 mg
J9185
Injection, fludarabine phosphate, 50 mg
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.0—368622
Ventricular premature complexesD018879I49.3—1—214
Ventricular tachycardiaD017180I47.2—112—4
Brugada syndromeD053840Orphanet_130I49.8———112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Supraventricular tachycardiaD013617HP_0004755I47.1——1—23
Cardiovascular diseasesD002318EFO_0000319I98—12——3
Heart diseasesD006331EFO_0003777I51.9—12——3
Cardiac arrhythmiasD001145EFO_0004269I49.9—11—13
Heart arrestD006323EFO_0009492I46——2——2
RecurrenceD012008—11——1
Atrial flutterD001282EFO_0003911——1——1
Myocardial infarctionD009203EFO_0000612I21——1——1
Coronary diseaseD003327——1——1
Myocardial ischemiaD017202EFO_1001375I20-I25——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Arrhythmogenic right ventricular dysplasiaD019571Orphanet_247I42.8—1——12
Blood pressureD001794EFO_0004325—1———1
PainD010146EFO_0003843R52—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUDARABINE PHOSPHATE
INNfludarabine
Description
Fludarabine phosphate is a purine arabinonucleoside monophosphate having 2-fluoroadenine as the nucleobase. A prodrug, it is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. Once incorporated into DNA, 2-fluoro-ara-ATP functions as a DNA chain terminator. It is used for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to, or whose disease has progressed during, treatment with at least one standard alkylating-agent containing regimenas. It has a role as an antimetabolite, an antineoplastic agent, an immunosuppressive agent, an antiviral agent, a prodrug and a DNA synthesis inhibitor. It is an organofluorine compound, a nucleoside analogue and a purine arabinonucleoside monophosphate. It is functionally related to a 2-fluoroadenine.
Classification
Small molecule
Drug classantineoplastics (arabinofuranosyl derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1nc(F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)O)[C@@H](O)[C@@H]1O
Identifiers
PDB—
CAS-ID75607-67-9
RxCUI25102
ChEMBL IDCHEMBL1096882
ChEBI ID63599
PubChem CID30751
DrugBankDB01073
UNII IDP2K93U8740 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 181 documents
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Safety
Black-box Warning
Black-box warning for: Fludarabine phosphate
Adverse Events
Top Adverse Reactions
Mock data
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4,027 adverse events reported
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