Gemcitabina Glenmark Lyophilized Powder for Injection
Gemcitabine
200mg
GLENMARK GENERICS SA
| Pack size | 1 Glass Vial of 10mL |
|---|---|
| Dispensing mode | POM |
| Source | ARGENTINA |
| Agent | GULF DRUG LLC |
| Retail Price | 73.00 AED |
Available as:
Indications
Gemcitabina Glenmark Lyophilized Powder for Injection is used for:
Lung cancer, pancreatic cancer, bladder cancer, breast cancer, ovarian carcinoma
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
Renal Dose
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
Contra Indications
Concurrent radical radiotherapy; pregnancy, lactation; hypersensitivity.
Precautions
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
Pregnancy-Lactation
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
Interactions
May increase the anticoagulant effect of warfarin when used together.
Adverse Effects
Side effects of Gemcitabine :
>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.
Mechanism 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.
Note
Gemcitabina Glenmark 200mg Lyophilized Powder for Injection manufactured by GLENMARK GENERICS SA. Its generic name is Gemcitabine. Gemcitabina Glenmark is availble in United Arab Emirates.
Farmaco UAE drug index information on Gemcitabina Glenmark Lyophilized Powder for Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.