Drug Interaction:
Ketoconazole, itraconazole, voriconazole, nefazodone, ciprofloxacin
Atazanavir, macrolides, rifampicin, nibabutin, anticonvulsants
Coumarins, midazolam, proton pump inhibitors, indinavir, nelfinavir, ritonavir, saquinavir
H2 antagonists,antacids, warfzarin, ciclosporin, veraprmil
NSAIDs, steroids,
Smoking
St.Johns Wort
Indication:
Proprietary Name- TARCEVA*
Established Name- Erlotinib
Applicant- ASTELLA PHARMA INC.
Indication- For the first-line treament of Metastatic Non-small cell lung cancer
(NSCLC) patients whose tumors have epidermal growth factor
receptor EGFR) exon 19 deletions or exon 21 (L858R) substitution
mutations .
This indication for erlotinib is being approved with the cobas EGFR
mutation test, a companion diaganostic test for patient selection
with BRAF V600ZE mutation as detected by an FDA approved test
Approval Date- May 14,2013
Approved by US FDA (Ref- FDA approved list- 2013)
Metastatic small lung cancer
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Erlotinib Hcl 25/100mg tablet 03-07-2010
Addl.indication
As monotherapy for maintenance treatment in patients with locally
advanced metastatic non small with stable disease after 4 cycles
of standard Platinum based first line chemotherapy
2. Erlotininib Hcl Tablet 150mg 04-01-2011
Addl. indication
Monotherapy for the maintenance treatment of patients with locally
advanced metastatic non-small lung cancer whose disease has
not progressed after 4 cycles of Platinum based first line chemotherapy
Adverse Reaction:
Rash, dry skin, stomatitis, hyperpigmentation, alopecia, paronychia
fatigue, dyspnoea, cough, diarrheoa, infections, weight loss, rigors, fever,headache,
keratitis, anorexia, conjuntivitis
GI bleeding, epistaxis, depression
MI , ischemia, CVA, LFT, abnormalites
Hepatic or renal failure
Rarely, hemolytic anemia
Contra-Indications:
Severe hepatic or renal impairment
Pregnancy, lactation
Special precautions-
Evaluate patients who develop unexplained pulmonary symtoms
Discontinue if interstitial lung disease is diazgonised
Risk of severe diarrhoea, vomiting or exfoliiative skin disorders
zdiscontinue therapy, intensively rehydrate patients and monitor LFTs,
renal function, and serum electrolytes periodically
Peptic ulcer. History of diverticular disease
Galactose intolerance. Lapp lactase deficiency
Glucose/galactose malbsorption
Elderly
Dosages/ Overdosage Etc:
Indication-
Metastatic small lung cancer
Dosage-
Non small lung cancer-
150mg daily taken after 1 hour before or 2 hours after food.
when dose adjustment is necessary, reduce in 50mg steps
Metastatic pancreatic cancer-
100mg 1 hour before or 2 hours after food in combination with gemcitabine
When dose adjustment is necessary, reduce in 50mg steps
Patients under 18 years not recommended
Other Information:
Metastatic small lung cancer
Patient Information:
Erlotinib Hydrochloride-
1. Advice patients to seek medical help if signs or symptoms of - anorexia, nausea, severe
or persistent diarrhea, or vomiting occur.
2. Advice patients to inform their doctor if they notice any worsening of unexplained shortness
of breath, or cough, eye iritattion or worsening of skin rash
3. Advice women of child bearing potential to avoid becoming pregnant while on treatment.
Advice them to to use adequate contraceptive measures during therapy and for atleast 2 weeks after completion
4. Adviice smokers to stop smoking while taking the erlotinib because cigerette reduces
plasma concentration of erlotinib.
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation
Manufacturer Details