Tarlonib

Patients w/ locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. 1st-line treatment of patients w/ locally advanced, unresectable or metastatic pancreatic cancer in combination w/ gemcitabine.

NSCLC 150 mg daily taken at least 1 hr before or 2 hr after meals. Pancreatic cancer 100 mg daily taken at least 1 hr before or 2 hr after meals. Concomitant use of CYP3A4 substrates & modulators Reduce dose in 50 mg steps. Smokers Max tolerated dose: 300 mg.

Should be taken on an empty stomach.

Severe hypersensitivity.

Bullous, blistering & exfoliative skin conditions including SJS/TEN. Permanently discontinue treatment in patients who develop GI perforation. Discontinue treatment if ILD is diagnosed. Interrupt or discontinue treatment if patient develops severe bullous, blistering or exfoliating conditions; acute/worsening ocular disorders eg, eye pain. Interrupt treatment pending diagnostic evaluation in patients who develop acute onset of new &/or progressive unexplained pulmonary symptoms eg, dyspnea, cough & fever; in more severe or persistent diarrhea, or cases leading to dehydration, particularly in patients w/ aggravating risk factors (concomitant medications, symptoms or diseases or advanced age). Hepatic failure including fatalities. Increased risk of developing perforation in patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs &/or taxane-based chemotherapy, or those w/ history of peptic ulceration or diverticular disease. Corneal perforation or ulceration; abnormal eyelash growth, keratoconjunctivitis sicca or keratitis. Monitor renal function & serum electrolytes including K in patients at risk of dehydration. Consider periodic LFTs in patients w/ pre-existing liver disease or concomitant hepatotoxic medications. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic & renal impairment. Women of childbearing potential must avoid pregnancy while on treatment; use adequate contraceptive methods during & for at least 2 wk after therapy. Pregnancy & lactation. Childn <18 yr.

Anxiety, dizziness, fatigue, headache; skin rash; abdominal pain, anorexia, diarrhea, dyspepsia, nausea, stomatitis, vomiting, wt loss; hyperbilirubinemia, increased serum ALT; increased susceptibility to infection; ostealgia; renal failure; cough, dyspnea, ILD; fever; bullous & exfoliative dermatitis, dermatitis; hepatic failure. Monotherapy: Chest pain, peripheral edema; insomnia, neurotoxicity, pain, paresthesia, voice disorder; acne vulgaris, acneiform eruption, alopecia, erythema, erythematous rash, folliculitis, hypertrichosis, nail disease, palmar-plantar erythrodysesthesia, paronychia, pruritus, skin fissure, xeroderma; constipation, decreased appetite, mucositis, nausea, taste disorder, xerostomia; UTI; anemia, leukopenia, lymphocytopenia, thrombocytopenia; increased γ-glutamyl transferase; arthralgia, back pain, muscle spasm, musculoskeletal pain (including chest), weakness; conjunctivitis, keratoconjunctivitis sicca, ophth signs & symptoms; tinnitus; increased serum creatinine; epistaxis, nasopharyngitis, pneumonitis, pulmonary embolism & fibrosis, resp tract infection; fever. Erlotinib plus gemcitabine combination therapy: Cardiac arrhythmia, CVA (including cerebral hemorrhage), DVT, edema, MI, syncope, thrombosis; depression; alopecia; flatulence, intestinal obstruction, pancreatitis; hemolytic anemia, microangiopathic hemolytic anemia w/ thrombocytopenia; increased serum AST; myalgia, neuropathy, rigors; renal insufficiency. SJS, TEN.

Decreased metabolism & increased plasma conc w/ potent CYP3A4 inhibitors. Increased AUC & C_max w/ ketoconazole; ciprofloxacin. Decreased AUC & C_max w/ omeprazole. Increased INR & bleeding events w/ coumarin-derived anticoagulants including warfarin. Increased potential for statin-induced myopathy including rhabdomyolysis w/ statin. Increased exposure w/ smoking. Concomitant use w/ potent CYP3A4 or combined CYP3A4/CYP1A2 inhibitors; rifampicin.

Targeted Cancer Therapy

L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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