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Benzigem 200/100 Lyophilized Injection

Generic Name– Gemcitabine hydrochloride
Drug Class – Antineoplastic agent
Gemcitabine is a pyrimidine nucleoside antimetabolite which exhibits anti-tumor activity against a variety of solid tumors including non-small cell lung cancer, pancreatic, bladder, ovarian and breast cancer. It acts by inhibiting ribonucleotide reductase and also competes with deoxycytidine triphosphate for incorporation into DNA. Both these processes results in inhibition of DNA synthesis, leading to apoptosis and cell death.

Product Description

Benzigem 200/100 (Gemcitabine for injection) is a lyophilized powder available in a single use glass vial.

Indications and Usage

Gemcitabine is indicated:
• In combination with cisplatin for the treatment of non-small cell lung cancer (NSCLC)
• In combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
• In combination with carboplatin for treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy
• As a single agent for the treatment of pancreatic cancer

Limitations of use:
• Gemcitabine shows minimal activity in renal carcinoma, prostate and colon cancer

Dosage and Administration

•Dosage Regimen for NSCLC
Gemcitabine/Cisplatin Regimen
Gemcitabine-1000 mg/m2 over 30 minutes on days 1, 8, and 15 of each 28-day cycle or 1250 mg/m2 over 30 minutes on days 1 and 8 of each 21-day cycle
Cisplatin -100 mg/m2 on day 1 after the infusion of gemcitabine

•Dosage Regimen for Breast Cancer
Gemcitabine/Paclitaxel Regimen
Gemcitabine-1250 mg/m2 over 30 minutes on days 1 and 8 of each 21-day cycle
Paclitaxel -175 mg/m2 on day 1 as a 3 hour intravenous infusion before infusion of gemcitabine

•Dosage Regimen for Ovarian Cancer
Gemcitabine/Carboplatin Regimen
Gemcitabine-1000 mg/m2 over 30 minutes on days 1 and 8 of each 21-day cycle
Carboplatin-AUC 4 intravenously cycle after gemcitabine infusion on day 1 of each 21-day cycle

•Dosage Regimen for Pancreatic Cancer
Gemcitabine Monotherapy
Gemcitabine-1000 mg/m2 over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle

Dosage Form and Strength
• Supplied as a single-use vial containing lyophilized powder for intravenous use only
• Available as 100mg and 200mg for injection

Clinical Efficacy

• Produces objective tumor regression rate of 20% and objective tumor response rate of 26 -54% in NSCLC patients, when used as a single agent and in combination with cisplatin respectively
• Effective and tolerable in treatment of metastatic breast cancer and can be used as an excellent alternative to palliative treatment of metastatic breast cancer
• Shows promising activity and a favorable toxicity profile as a single agent in the treatment of platinum-resistant ovarian cancer
• Valuable chemotherapy option for patients with advanced pancreatic cancer, providing clinical benefit and symptoms improvement in 20-30% of patients

Adverse reactions
• The most common adverse reactions for gemicitabine are nausea/vomiting, fever, skin rash, anemia, neutropenia, thrombocytopenia, hepatic transaminitis, increased alkaline phosphatase, proteinuria, hematuria, dyspnea, and peripheral edema

Contraindications
• The use of gemcitabine is contraindicated in patients with a known hypersensitivity to gemcitabine

Special Precautions

• Dose adjustments should be considered in cases of hematologic and non-hematologic toxicities
• Patients should be monitored for risk of infections caused due to myelosuppression prior to each cycle and during therapy
• Discontinue use of gemcitabine, if any sign of unexplained new or worsening dyspnea or evidence of severe pulmonary toxicity experienced
• Renal and hepatic function should be carefully monitored prior to initiation and during therapy and use of gemcitabine should be discontinued in cases of severe renal or hepatic impairment
• It is not recommended for use in pregnant and breast feeding mothers due to potential harm to the fetus
• It can cause severe and life threatening toxicity when administered during or within 7 days of radiation therapy
• Increased toxicity may occur with infusion time greater than 60 minutes or dosing more frequently than once weekly
• The use of gemcitabine should be discontinued, if capillary leak syndrome and posterior reversible encephalopathy syndrome (PRES) occurs.

Benzigem 200/100 Lyophilized Injection - ADMAC Life Science