Apo-Erlotinib

Apo-Erlotinib

erlotinib

Manufacturer:

Apotex

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Erlotinib
Indications/Uses
Advanced NSCLC where chemotherapy has not helped to stop disease progression; the disease has not worsened after 4 cycles of 1st line chemotherapy; or activating mutation of the Epidermal Growth Factor Receptor tyrosine kinase (EGFR-TK) is confirmed.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. If taken w/ medication that reduces stomach acid production: 2 hr before morning dose of medication & 10 hr after evening dose of medication. Swallow w/ a glass of plain water.
Special Precautions
Confirm activating mutation of EGFR-TK prior to starting therapy. Reports of liver failure & GI perforation. Patients w/ GI ulcers or diverticular disease; lung disease; liver or kidney problems; sugar intolerance; cataracts, previous cataract surgery, patients wearing contact lenses; patients who smoke tobacco. Women of childbearing potential must use adequate contraception during treatment & for at least 2 wk after taking the last tab. Avoid pregnancy while on treatment. Avoid breastfeeding while on treatment & for at least 2 wk after the final dose.
Adverse Reactions
Rash, diarrhea. Tiredness, loss of appetite, difficulty in breathing, cough, infection, nausea, vomiting, mouth irritation, stomach pain, itching, dry skin, eye irritation. Stomach or intestinal bleeding, abnormal blood tests for liver function; headache, dizziness; hair & nail changes; acne or other red or pink little bumps at hair follicles.
Drug Interactions
Potential interaction w/ antifungals (eg, ketoconazole, fluconazole); Ca channel blockers (eg, diltiazem, verapamil); macrolide antibiotics (eg, erythromycin, clarithromycin); fluoroquinolone antibiotics (eg, ciprofloxacin, norfloxacin); other antibiotics eg, rifampin; some antivirals (eg, ritonavir, indinavir); grapefruit juice; St. John's Wort; anticonvulsants eg, carbamazepine, phenytoin; blood thinners eg, warfarin; medications which reduce acid in the stomach eg, omeprazole, ranitidine; statins.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Apo-Erlotinib coated tab 100 mg
Packing/Price
3 × 10's
Form
Apo-Erlotinib coated tab 150 mg
Packing/Price
3 × 10's
Form
Apo-Erlotinib coated tab 25 mg
Packing/Price
3 × 10's
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