GEFTIB
Manufacturer Details
GLENMARK
Compositions:
Gefitinib 250mg Film coated tablets,
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Strength
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Rate
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Packing Style
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250mg f.c tabs
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0.00
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30s film coated tablets
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List of Related Indications:
- Metastatic Non-small cell lung carcinoma
List Of Drugs:
- Gefitinib - @ - Epidermal Growth Factor Receptor Inhibitors - Antineoplastic Agents- (Feb 2004)
Indication Type Description:
Drug Interaction:
Rifampicin
Other CYP3A4 Inducers eg phenytoin, carbamazepine, barbiturates,St Johns Wart, itraconazole,
Other CYPA4 inhibitors eg. ketoconazole, clotrimazole, ritonvir
Drugs that increase gastric pH eg, H2 blockers, proton pump inhibitors metoprolol,
Other drugs metabolised by CYP2D6
May exacerbate neutropenia with vinorelbine
Indication:
LIST OF DRUGS DURING 2004
Sr.No-189
Name of the Drug- Gefitinib
Pharmacological Classification- Anti-cancer
Date of Approval- 17-02-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Geftinib Anti-cancer 17-02-2004
2.Geftinib 25mg 18-12-2009
Additional Indn.
Indicated for the first line treatment of patients with locally advanced
or metastatic non small lung cancer (NSLC) who have activating
mutation of EGFRTK
Proprietary Name- IRESSA*
Established Name- Geftinib
Applicant-
Indication- For the treatment of Patients with metastatic Non-Small Cell
lung cancer (NSCLC) whose tumors have epidermal growth factor
receptor exon 19 deletions or exon 21 (L858R) substitution
mutation as detected by an FDA -approved test
This approval is being approved concurrently with a labelling
expansion of the Therascreen EGR RGQ PCR Kit, a companion
diagnostic test for patient selection
Approval Date- July 13,2015
Approved by U.S.FDA as on 13-7-2015 (Ref- FDA approved List- 2015)
Metastatic non-small cell lung cancer
Adverse Reaction:
Hepatic disturbances GI upset, Rash, dry skin, Acne, nail disorder Asthenia, alopecia Interstitial lung disease Peripheral oedema Increased incidence of tumor haemorrhage Dyspnoea Stomatitis
Contra-Indications:
Monitor LFT Pregnancy Lactation
No advantage over methotrexate in head and neck cancers
Suspend if symptoms of intestinal lung disease occur (eg. dyspnoea, cough, fever ), discontinue if confirmed and treat
Pulmonary fibrosis may increase interstital lung disease
Dosages/ Overdosage Etc:
Indication-
Metastatic non-small cell lung cancer
Dosage-
250mg once daily
Patient Information:
Geftinib-
1. Advice patients to seek medical advice promptly if they develop - severe or persistent
diarrhea, nausea, anorexia, or vomiting as these are sometines associated with dehydration
2. Advice patient to inform their doctor, if they notice any onset or worsening of pulmonary
symptoms eg shortness of breath, or cough , an eye irritation or any other symptoms
3. Advice women of child bearing potential to avoid becoming pregnant
Pregnancy and lactation:
Use contraindicated. Observe caution
