Gemvex-200/Gemvex-1000

Gemvex-200/Gemvex-1000

gemcitabine

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Gemcitabine HCl
Indications/Uses
Treatment of locally advanced or metastatic non-small cell lung cancer; adults w/ locally advanced or metastatic adenocarcinoma of the pancreas; patients w/ 5-FU refractory pancreatic cancer; bladder cancer at invasive stage. In combination w/ paclitaxel: Treatment of patients w/ unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. In combination w/ carboplatin: Treatment of patients w/ recurrent epithelial ovarian carcinoma who have relapse >6 mth following platinum-based therapy.
Dosage/Direction for Use
Adult Monotherapy for non-small cell lung cancer 1,000 mg/m² given in IV infusion, repeated once wkly for 3 wk, followed by a 1-wk rest period. Combination w/ cisplatin 3-wk cycle: 1,250 mg/m² given by 30 min IV infusion on days 1 & 8, followed by 1-wk rest period. 4-wk cycle: 1,000 mg/m² given by 30 min IV infusion on days 1, 8 & 15, followed by 1-wk rest period. Pancreatic adenocarcinoma 1,000 mg/m² given by 30 min IV infusion, repeated once wkly for 7 wk, followed by a wk rest. Subsequent cycles should consist of inj once wkly for 3 consecutive wk out of every 4 wk. Bladder cancer at the invasive stage in combination w/ cisplatin 1,000 mg/m² given by 30 min IV infusion on days 1, 8 & 15, followed by 1-wk rest period for a 28-day cycle. Cisplatin is given at a recommended dose of 70 mg/m² on day 2. Breast cancer in combination w/ paclitaxel Paclitaxel 175 mg/m² administered on day 1 over approx 3 hr as IV infusion, followed by gemcitabine 1,250 mg/m² as a 30-min IV infusion on days 1 & 8 of each 21-day cycle. Ovarian cancer in combination w/ carboplatin 1,000 mg/m² administered on days 1 & 8 of each 21-day cycle as a 30-min IV infusion. After gemcitabine, carboplatin should be given on day 1 to attain a target AUC of 4 mg/mL/min.
Contraindications
Hypersensitivity. Risk of radiosensitization & onset of severe pulmonary & esophageal fibrosis. Severe renal failure.
Special Precautions
Closely monitor & check biological parameters. Risk of cumulative bone marrow aplasia. Perform hematological tests including blood cell & platelet count prior to administration. Discontinue use if bone marrow toxicity occurs. Deterioration of peripheral blood levels may occur after treatment discontinuation. Hepatic impairment, concurrent liver metastases or preexisting history of hepatitis, alcoholism or liver cirrhosis. Renal failure. Pregnancy & lactation.
Adverse Reactions
Myelosuppression; febrile neutropenia; nausea & vomiting; diarrhea, stomatitis.
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
Gemvex-1000 lyophilized powd for inj 1 g
Packing/Price
50 mL x 1's
Form
Gemvex-200 lyophilized powd for inj 200 mg
Packing/Price
10 mL x 1's
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