Generic Name

Gemcitabine

Precaution

Children, hepatic and renal impairment. May impair ability to drive or operate machinery. Discontinue on 1st sign of microangiopathic haemolytic anaemia. Prolonged infusion time (>60 minutes) and more frequent than wkly dosing may increase toxicity. Monitor CBC before every dose. Increased risk of haemolytic uraemic syndrome and/or thrombocytcpenic purpura which may lead to irreversible renal failure. Lactation: not known if excreted in breast milk; do not nurse

Indication

Lung cancer, pancreatic cancer, bladder cancer, breast cancer, ovarian carcinoma

Contra Indication

Concurrent radical radiotherapy; pregnancy, lactation; hypersensitivity.

Dose

N/A

Side Effect

>10% N/V (69%),Anemia (65%),Elev LFTs (68%),Neutropenia (63%),Leukopenia (62%),Pain (48%),Proteinuria (45%),Fever (41%),Hematuria (35%),Rash (30%),Thrombocytopenia (24%),Dyspnea (23%),Constipation (23%),Diarrhea (19%),Flu-like syndrome (19%),Hemorrhage (17%),BUN increased (16%),Infection (16%),Alopecia (15%),Edema (13%),Elev bilirubin (13%) 1-10% Paresthesia (2-10%),Creatinine increased (2-8%),Inj site reactions (4%),Bronchospasm (2%) Potentially Fatal: Oesophagitis and pneumonitis when given with radical radiotherapy to the thorax.

Pregnancy Category

Mode of Action

Gemcitabine is a synthetic pyrimidine nucleoside and cytarabine analogue which is metabolised intracellularly to active diphosphate and triphosphate nucleosides. It inhibits DNA synthesis by inhibiting DNA polymerase and ribonucleotide reductase. It also induces apoptosis and is primarily active against cells in the S-phase, but may also arrest cells at the G1-S border.

Interaction

May increase the anticoagulant effect of warfarin when used together.

Pregnancy Category Note

Pregnancy Based on animal data and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; therapy is expected to result in adverse reproductive effects; drug was teratogenic, embryotoxic, and fetotoxic in mice and rabbits; advise pregnant women of potential risk to a fetus Contraception Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final dose Advise male patients with female partners of reproductive potential to use effective contraception during and for 3 months following final dose Infertility Based on animal studies, Gemcitabine Injection may impair fertility in males of reproductive potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating therapy Contraception Therapy can cause fetal harm when administered to a pregnant woman Females Because of potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment and for 6 months after final dose Males Because of potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final dose Lactation There are no data on presence of drug in human milk, or effects of gemcitabine on breastfed infant or milk production; because of potential for serious adverse reactions in nursing infants from therapy, advise a lactating woman not to breastfeed during treatment and for one week after the final dose

Adult Dose

Pancreatic Cancer Indicated as first-line treatment for locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas 1000 mg/m² IV infusion over 30 minutes once/week x7 weeks; rest 1 week, THEN 1000 mg/m² IV on Days 1, 8, and 15 of each 28-day cycle Various regimens exist including monotherapy and in combination with other chemotherapy agents (eg, erlotinib, paclitaxel protein bound, capecitabine) Non-small Cell Lung Cancer 1000 mg/m² IV infusion over 30 minutes on days 1, 8, and 15 of each 28-day cycle, OR 1250 mg/m² IV infusion over 30 minutes on days 1 and 8 of each 21-day cycle Administer cisplatin 100 mg/m² IV after gemcitabine on day 1 Breast Cancer 1250 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle With paclitaxel 175 mg/m² on Day 1 as a 3 hr infusion before gemcitabine Ovarian Cancer 1000 mg/m² IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle With carboplatin AUC 4 on Day 1 after gemcitabine

Child Dose

N/A

Renal Dose

N/A

Administration

IV Preparation Reconstitute 200 mg vial with 5 mL 0.9% NaCl OR 1000 mg vial with 25 mL 0.9% NaCl IV Administration For IV infusion only Concentrated injection (10 mg/mL) must be diluted to 2 mg/mL prior to administration Infuse over 30 min Avoid rapid infusions