Sun Pharma introduces Infugem
Sun Pharma is launching Infugem (gemcitabine in sodium chloride injection), for intravenous use.
Infugem is the first chemotherapy product that comes in a premixed, ready-to-infuse formulation. It was approved by the Food and Drug Administration in July 2018 in combination with other drugs for the treatment of breast, ovarian, non-small cell lung cancers, and as a single agent for the treatment of pancreatic cancer.
The product is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges of doses calculated for individual patients.
Infugem is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors, the company said.
“Infugem is an example of our focus at Sun Pharma, which is to improve provider and patient experiences by using high-tech delivery systems and/or novel formulations for gold-standard medicines,” Sun Pharma CEO North America Abhay Gandhi said. “With an increasing number of organizations strongly recommending the use of premixed parenteral products due to concerns related to manual compounding, and with the broad use of gemcitabine to treat various cancers, the timing couldn’t be better to launch Infugem in the U.S.”
Infugem is the first chemotherapy product that comes in a premixed, ready-to-infuse formulation. It was approved by the Food and Drug Administration in July 2018 in combination with other drugs for the treatment of breast, ovarian, non-small cell lung cancers, and as a single agent for the treatment of pancreatic cancer.
The product is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges of doses calculated for individual patients.
Infugem is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors, the company said.
“Infugem is an example of our focus at Sun Pharma, which is to improve provider and patient experiences by using high-tech delivery systems and/or novel formulations for gold-standard medicines,” Sun Pharma CEO North America Abhay Gandhi said. “With an increasing number of organizations strongly recommending the use of premixed parenteral products due to concerns related to manual compounding, and with the broad use of gemcitabine to treat various cancers, the timing couldn’t be better to launch Infugem in the U.S.”