TEVA-ERLOTINIB 25 MG — DIN 02377691

What is TEVA-ERLOTINIB?

TEVA-ERLOTINIB 25 MG contains ERLOTINIB (ERLOTINIB HYDROCHLORIDE) : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02377691, held by TEVA CANADA LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Dec-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TEVA-ERLOTINIB used for?

TEVA-ERLOTINIB (erlotinib) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. TEVA-ERLOTINIB is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations after 4 cycles of standard platinum-based first-line chemotherapy. TEVA-ERLOTINIB is also indicated as monotherapy for the first-line treatment of patients with locally advanced (stage III b, not amenable to curative therapy) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with EGFR activating mutations.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

EGFR mutation testing should be performed and EGFR mutation-positive status must be confirmed prior to initiation of TEVA-ERLOTINIB as first-line, second line or maintenance therapy in patients with locally advanced or metastatic NSCLC. The recommended daily dose of TEVA-ERLOTINIB is 150 mg taken orally with a glass of plain water, at least one hour before or two hours after the ingestion of food. When dose reduction is necessary, it is recommended to reduce in 50 mg steps. Diarrhea can mostly be managed by loperamide. Patients with severe diarrhea that are unresponsive to loperamide or associated with dehydration may require a dose reduction or temporary interruption of therapy. Patients with severe skin reactions may also require a dose reduction or temporary interruption of therapy (see WARNINGS AND PRECAUTIONS). In patients who develop acute onset of new and/or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever, TEVA-ERLOTINIB therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, TEVA-ERLOTINIB should be discontinued and appropriate treatment initiated as necessary (see WARNINGS AND PRECAUTIONS). In patients being concomitantly treated with a potent CYP3A4 inhibitor such as, but not limited to, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, troleandomycin, or atanazavir, a dose reduction should be considered in the presence of severe adverse events (see DRUG INTERACTIONS). Hepatic impairment: Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure following a single 150 mg was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, ten of the fifteen patients with hepatic impairment died during treatment or within 30 days of the last dose of erlotinib. A reduced dose should be considered for patients with moderate hepatic impairment. Hepatic function should be closely monitored in patients with pre-existing liver disease, hepatic impairment and/or taking concomitant hepatotoxic medications. TEVA-ERLOTINIB dosing should be interrupted or discontinued if significant changes in liver function tests are observed. The use of TEVA-ERLOTINIB in patients with severe hepatic dysfunction including total bilirubin of > 3 x ULN and/or transaminases of > 5 x ULN is not recommended (see WARNINGS AND PRECAUTIONS - Special Populations and Conditions - Patients with Hepatic Impairment).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

TEVA-ERLOTINIB (erlotinib) is contraindicated in patients with severe hypersensitivity to erlotinib or to any component of TEVA-ERLOTINIB. For a complete listing, see the DOSAGE FORMS, COMPOSITION and PACKAGING.

Warnings and precautions

TEVA-ERLOTINIB should be administered under the supervision of a qualified health professional who is experienced in the treatment and management of patients with cancer. EGFR mutation-positive status must be confirmed prior to starting first-line TEVA-ERLOTINIB monotherapy (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests; CLINICAL TRIALS). Erlotinib has not been studied in patients with severe hepatic impairment. Erlotinib has not been studied in patients with severe renal impairment. TEVA-ERLOTINIB therapy may result in severe or fatal adverse reactions, including: Hepatotoxicity (see WARNINGS AND PRECAUTIONS/Hepatotoxicity) and Gastrointestinal Perforation (see WARNINGS AND PRECAUTIONS, Gastrointestinal).