Abingem

Abingem

gemcitabine

Manufacturer:

Naprod

Distributor:

Multicare
Concise Prescribing Info
Contents
Gemcitabine HCl
Indications/Uses
Locally advanced or metastatic bladder cancer in combination w/ cisplatin. Locally advanced or metastatic adenocarcinoma of the pancreas. 1st-line treatment of patients w/ locally advanced or metastatic NSCLC in combination w/ cisplatin. Locally advanced or metastatic epithelial ovarian carcinoma in combination w/ carboplatin in patients w/ relapse disease following recurrence-free interval or at least 6 mth after platinum-based 1st-line therapy. Unresectable, locally recurrent or metastatic breast cancer in combination w/ paclitaxel in patients experiencing relapse after adjuvant/neoadjuvant chemotherapy.
Dosage/Direction for Use
Adult Bladder cancer Combination therapy: 1,000 mg/m2 as 30 min infusion. Dose should be given in days 1, 8 & 15 of each 28 day cycle in combination w/ cisplatin. Cisplatin is given at 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28 day cycle. Pancreatic cancer 1,000 mg/m2 by 30 min IV infusion, repeated once wkly for up to 7 wk followed by 1 wk rest period. Subsequent cycles should consist of gemcitabine infusions once wkly for 3 consecutive wk out of every 4 wk. NSCLC Monotherapy: 1,000 mg/m2 by 30 min IV infusion, repeated once wkly for 3 wk followed by 1 wk rest period. Combination therapy: 1,250 mg/m2 by 30 min IV infusion on days 1 & 8 of each 21 day cycle. Cisplatin 75-100 mg/m2 once every 3 wk. Ovarian cancer Combination therapy w/ carboplatin: 1,000 mg/m2 by 30 min IV infusion on days 1 & 8 of each 21 day cycle. Breast cancer Combination therapy w/ paclitaxel: Paclitaxel 175 mg/m2 IV infused over 3 hr on day 1 followed by gemcitabine 1,250 mg/m2 IV infused for 30 min on days 1 & 8 of each 21 day treatment cycle.
Contraindications
Special Precautions
Possible increase toxicity w/ prolonged infusion time & increased dosing frequency. Haematological toxicity; patients w/ impaired bone marrow function. Concomitant RT (given together or ≤7 days apart). Not recommended to give yellow fever vaccine & other live attenuated vaccines. Patients presenting a history of CV events. Consider discontinuing therapy if pulmonary effects (eg, pulmonary oedema, interstitial pneumonitis or adult resp distress syndrome) develop. Discontinue use at 1st signs of microangiopathic haemolytic anaemia. Hepatic or renal impairment. Advise men not to father a child during & up to 6 mth after treatment; seek further advice on sperm cryoconservation prior to treatment. Pregnancy. Not recommended for childn <18 yr.
Adverse Reactions
Leucopenia, thrombocytopaenia, anaemia; dyspnoea; vomiting, nausea; elevated liver transaminases (AST & ALT) & alkaline phosphatase; allergic skin rash frequently associated w/ pruritus, alopecia; haematuria, mild proteinurea. Febrile neutropenia; anorexia; headache, insomnia, somnolence; cough, rhinitis; diarrhoea, stomatitis & mouth ulceration, constipation; increased bilirubin; itching, sweating; back pain, myalgia.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Abingem lyo powd for inj 1 g
Packing/Price
1's
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