Gemita

In combination w/ cisplatin for the treatment of locally advanced or metastatic bladder cancer. Treatment of locally advanced or metastatic adenocarcinoma of the pancreas. In combination w/ cisplatin as 1st-line treatment of locally advanced or metastatic NSCLC (monotherapy can be considered in older patients or those w/ performance status 2). In combination w/ carboplatin for the treatment of locally advanced or metastatic epithelial ovarian carcinoma in patients w/ relapsed disease following a recurrence-free interval of at least 6 mth after platinum-based 1st-line therapy. In combination w/ paclitaxel for the treatment of unresectable, locally recurrent or metastatic breast cancer in patients who have relapsed following adjuvant/neoadjuvant chemotherapy (prior chemotherapy should have included an anthracycline unless clinically contraindicated).

Bladder cancer Administer 1,000 mg/m² gemcitabine as 30-min infusion on days 1, 8 & 15 of each 28-day cycle. Administer 70 mg/m² cisplatin on day 1 following gemcitabine or day 2 of each 28-day cycle. Repeat this 4-wk cycle. Pancreatic cancer Administer 1,000 mg/m² gemcitabine as 30-min IV infusion, repeated once wkly for up to 7 wk followed by 1-wk rest period. Subsequent cycles should consist of inj once wkly for 3 consecutive wk out of every 4 wk. NSCLC Monotherapy: Administer 1,000 mg/m² gemcitabine as 30-min IV infusion, repeated once wkly for 3 wk followed by 1-wk rest period. Repeat this 4-wk cycle. Combination: Administer 1,250 mg/m² gemcitabine as 30-min IV infusion on day 1 & 8 of the 21-day cycle. Administer 75-100 mg/m² cisplatin once every 3 wk. Breast cancer Administer 175 mg/m² paclitaxel on day 1 over approx 3 hr as IV infusion, followed by 1,250 mg/m² gemcitabine as 30-min IV infusion on days 1 & 8 of each 21-day cycle. Patients should have absolute granulocyte count of at least 1,500 x 10⁶/L prior to initiation of gemcitabine + paclitaxel combination. Ovarian cancer Administer 1,000 mg/m² gemcitabine as 30-min IV infusion on days 1 & 8 of each 21-day cycle. Administer carboplatin after gemcitabine on day 1 consistent w/ target AUC of 4 mg/mL·min.

Hypersensitivity. Lactation.

Increased toxicity w/ prolonged infusion time & increased dosing frequency. Reports of severe cutaneous adverse reactions including SJS, TEN, & acute generalized exanthematous pustulosis; posterior reversible encephalopathy syndrome; capillary leak syndrome; pulmonary effects eg, pulmonary oedema, interstitial pneumonitis or adult resp distress syndrome; haemolytic uraemic syndrome. Risk of haematological toxicity; cardiac &/or vascular disorders. Caution in patients w/ impaired bone marrow function; history of CV events. Monitor platelet, leucocyte & granulocyte counts prior to each dose. Consider suspension or modification of therapy when drug-induced bone marrow depression is detected. Consider risk of cumulative bone marrow suppression when gemcitabine treatment is given together w/ other chemotherapy. Administration in patients w/ concurrent liver metastases or pre-existing medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of underlying hepatic insufficiency. Periodically perform lab evaluation of renal & hepatic function (including virological tests). Reports of toxicity w/ concomitant RT. Not recommended w/ yellow fever vaccine & other live attenuated vaccines. Patients on a controlled Na diet should consider 17.5 mg Na per vial. May impair ability to drive or operate machinery. Risk of mild to moderate somnolence, especially in combination w/ alcohol consumption. Caution in patients w/ hepatic or renal impairment. Should not be used during pregnancy unless clearly necessary. Women should not become pregnant during treatment. Discontinue breast-feeding during therapy. Men should not father a child during & up to 6 mth after treatment. Possibility of male infertility. Not recommended for use in childn <18 yr.

Leucopaenia, thrombocytopaenia, anaemia; dyspnoea; vomiting, nausea; elevated AST, ALT & alkaline phosphatase; allergic skin rash (frequently associated w/ pruritus), alopecia; haematuria, mild proteinuria; flu-like symptoms, oedema/peripheral oedema including facial oedema. Infections; febrile neutropaenia; anorexia; headache, insomnia, somnolence; cough, rhinitis; diarrhoea, stomatitis, mouth ulceration, constipation; increased bilirubin; itching, sweating; back pain, myalgia; fever, asthenia, chills.

Significant toxicity w/ concurrent RT (given together or ≤7 days apart). Reports of radiation injury on targeted tissues (eg, oesophagitis, colitis, & pneumonitis) in association w/ concurrent & non-concurrent use of gemcitabine. Risk of systemic, possibly fatal, disease (particularly in immunosuppressed patients) w/ yellow fever & other live attenuated vaccines.

Cytotoxic Chemotherapy

L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

P₁S₁S₃