Ready-to-Administer Gemcitabine Formulation Gets FDA Approval

Through dose banding, standardized doses of IV cytotoxic drugs are used for ranges of doses calculated for individual patients.
Through dose banding, standardized doses of IV cytotoxic drugs are used for ranges of doses calculated for individual patients.

Sun Pharma announced that the Food and Drug Administration (FDA) has approved Infugem (gemcitabine in 0.9% sodium chloride injection) 10mg/mL for intravenous (IV) use in a ready-to-administer (RTA) bag. 

Infugem, a nucleoside metabolic inhibitor, is indicated in combination with carboplatin to treat advanced ovarian cancer, in combination with paclitaxel to treat metastatic breast cancer, in combination with cisplatin to treat non-small cell lung cancer, and as a single agent to treat pancreatic cancer.  

Infugem utilizes a novel technology that enables cytotoxic oncology products to be premixed in a sterile setting and to be supplied to prescribers in RTA infusion bags. Through dose banding, standardized doses of IV cytotoxic drugs are used for ranges of doses calculated for individual patients. Using RTA bags can help prevent over- or under-dosing as well as possible contamination that can cause infections. 

The premixed bags are ready for infusion and do not require any further preparation prior to use. 

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“The technology used to formulate Infugem eliminates the risks associated with compounding, an extra step in the administration of cytotoxic infusion products, providing improved safety for healthcare professionals and cancer patients,” said Abhay Gandhi, CEO - North America, Sun Pharma. 

Infugem will be available as 1200mg/120mL, 1300mg/130mL, 1400mg/140mL, 1500mg/150mL, 1600mg/160mL, 1700mg/170mL, 1800mg/180mL, 1900mg/190mL, 2000mg/200mL, and 2200mg/220mL. 

For more information call or visit SunPharma.com.