Sun Pharma’s gemcitabine in sodium chloride injection (Infugem), for intravenous use, is now commercially available in the United States. This is the first chemotherapy product that comes in a premixed, ready-to-infuse formulation, according to the company.
Gemcitabine in sodium chloride injection was approved by the FDA in July 2018 in combination with other drugs for the treatment of adults with breast, ovarian, and/or non-small cell lung cancers, and as a single agent for the treatment of pancreatic cancer.
This chemotherapy 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.
This injection 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, according to Sun Pharma.
“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.,” said Abhay Gandhi, CEO-North America, Sun Pharma, in a prepared statement.
Sun Pharma’s gemcitabine in sodium chloride injection is the first product using the company’s proprietary technology, which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in ready-to-infuse final dosage bags. The product is stable at room temperature storage conditions for 2 years, even without the use of alcohol and other preservatives in the bag. By contrast, other gemcitabine products require reconstitution and/or dilution for patient use, and remain stable at room temperature for only 24 hours, according to Sun Pharma.
“The availability of gemcitabine in ready-to-infuse bags is a welcome development, simplifying the complex delivery of this vital chemotherapy medication,” commented Jeff Lombardo PharmD, BCOP, Research Assistant Professor, Center of Integrated Global Biomedical Sciences, University at Buffalo, in a prepared statement.
According to Sun Pharma, a prescription for gemcitabine in sodium chloride injection comes with warnings and precautions regarding schedule-dependent toxicity, myelosuppression, pulmonary toxicity and respiratory failure, hemolytic uremic syndrome, hepatic toxicity, and embryo-fetal toxicity, as well as exacerbation of radiation therapy toxicity, capillary leak syndrome and posterior reversible encephalopathy syndrome.
The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, hepatic transaminitis, neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea and peripheral edema.
Gemcitabine in sodium chloride injection is contraindicated in patients with a known hypersensitivity to gemcitabine. In addition, the safety and effectiveness of this product has not been established in the pediatric patient population.