COPENHAGEN, Denmark--(BUSINESS WIRE)--Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, has launched the latest product in what is now marketed as its VANCO READYTM range of room temperature stable, ready-to-use (RTU) Vancomycin injection premix bags in the US.
The new 500 mg in 100 mL VANCO READYTM offering is now available for purchase from US wholesalers, following FDA approval in February 2019. This is the fourth presentation of Xellia’s RTU premixed vancomycin to be made available in the US market so far this year. Three other presentations – 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL – were launched to the US market earlier this year following FDA approval, having received Qualified Infectious Disease Product designation in February 2018.
Progress is underway to file three additional VANCO READYTM doses to expand the portfolio to seven doses, which should be made available to the US as early as 2020. The expanded doses will include 750 mg in 150 mL, 1.25 g in 250 mL and 1.75 g in 350 mL.
Carl-Åke Carlsson, Xellia’s CEO said: “With four of our seven VANCO READYTM presentations now launched, Xellia is well on the way to be able to service the full needs of the vancomycin injection market. The success of our first three products already this year has resulted in over 1,000 US institutions using VANCO READYTM and is an important validation of our US strategy. Our focus remains to provide life-saving medicine in novel and ready forms to improve patient safety and reliable supply.”
Craig Boyd, Xellia’s North American President said: “Our room temperature stable VANCO READYTM premix has been critical in providing a truly ready Vancomycin Injection product. It aligns with recommendations from US agencies – such as the American Society of Hospital Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP) and Joint Commission – to use manufacturer-prepared products as part of safe medication practice. We will continue to build on this success and focus on our ready-to-use product pipeline and partnerships during 2020.”
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Full prescribing information for Vancomycin Injection Premix RTU can be found at www.xellia.com/us
About Vancomycin Injection
Vancomycin Injection, Ready to use (RTU) is a proprietary formulation of vancomycin, provided as a premixed solution in single-dose flexible bags, stable at room temperature (up to 25 °C) for 16 months.
Vancomycin Injection RTU is provided as 100 mL, 200 mL, 300 mL or 400 mL solution containing 500 mg, 1 g, 1.5 g or 2 g vancomycin, respectively. Each 100 mL of solution contain 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment.
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
The FDA approval of this novel vancomycin formulation was obtained on the basis of more than 60 non-clinical experiments, including studies to confirm that the new formulation does not adversely impact the efficacy profile of the active ingredient, vancomycin. The product safety profile has been extensively evaluated in vitro and in vivo, including 5 repeat dose toxicity studies of the novel vancomycin formulation in rats and dogs with dosing up to 13 weeks, in addition to full safety qualification of excipient N-acetyl-D-alanine including safety pharmacology and repeat dose toxicity studies in 2 animal species with dosing up to 13 weeks, and animal reproduction studies of N-acetyl-D-alanine and polyethylene glycol 400.
IMPORANT SAFETY INFORMATION
WARNING: RISK OF EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS
This formulation of Vancomycin Injection is not recommended for use during pregnancy because it contains the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which caused fetal malformations in animal reproduction studies. If use of vancomycin is needed during pregnancy, use other available formulations of vancomycin. (5.1, 8.1)
WARNINGS AND PRECAUTIONS
• Infusion Reactions: Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular and chest pain and “red man syndrome” which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Injection over a period of 60 minutes or greater and also prior to intravenous anesthetic agents. (2.1, 5.2)
• Nephrotoxicity: Systemic vancomycin exposure may result in acute kidney injury (AKI) including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. Monitor serum vancomycin concentrations and renal function. (5.3)
• Ototoxicity: Ototoxicity has occurred in patients receiving vancomycin. Monitor for signs and symptoms of ototoxicity during therapy. Monitor serum vancomycin concentrations and renal function. Assessment of auditory function may be appropriate in some instances. (5.4)
• Clostridium Difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.5).
• Neutropenia: Periodically monitor leukocyte count. (5.7)
• Phlebitis: To reduce the risk of local irritation and phlebitis administer Vancomycin Injection by a secure intravenous route of administration. (5.8)
• Development of Drug-Resistant Bacteria: Prescribing Vancomycin Injection in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. (5.9)
The common adverse reactions are anaphylaxis, “red man syndrome”, acute kidney injury, hearing loss, neutropenia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at 1-833-295-6953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• Anesthetic Agents: Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. (2.1, 7.1)
• Piperacillin/Tazobactam: Increased incidence of acute kidney injury in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients (7.2)
Please see full Prescribing Information, including Boxed WARNING (1).
1. Vancomycin Injection Full Prescribing Information (U.S.). Feb 2019, Xellia Pharmaceuticals ApS.
About Xellia Pharmaceuticals
Xellia Pharmaceuticals (“Xellia”) is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections.
With over 100 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia and North America and is investing significantly to expand its sales and manufacturing capabilities within the United States. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,600 people.