COPENHAGEN, Denmark--(BUSINESS WIRE)--Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing of specialty anti-infective treatments, has received approval for 3 additional dosages of VANCO READYTM, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.
The VANCO READYTM approvals now cover all relevant doses from 500 mg to 2 g in 250 mg increments. The recent approval of 750 mg in 150 mL, 1.25 g in 250 mL and 1.75 g in 350 mL are expected to launch in October 2020 and will join the other presentations launched in 2019 – 500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL and 2 g in 400 mL.
VANCO READYTM should not be administered during pregnancy, please see boxed warning below.
Carl-Åke Carlsson, Xellia’s CEO said: “With all seven VANCO READYTM presentations now approved, Xellia can service the majority of needs in the vancomycin injection market. The success of our first four products has resulted in over 2,000 US institutions using VANCO READYTM and we expect the new codes to be quickly adopted given the positive feedback from healthcare professionals.”
He added, “Our focus continues to be to provide life-saving medicine in novel and ready forms to improve patient safety and ensure reliable supply.”
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: septicaemia (sepsis), infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
Craig Boyd, Xellia’s North American President said: “One of the uses for Vancomycin in the US is in the treatment of sepsis. The timely initiation of effective antibiotic treatments is universally recognized as a key intervention in the management of this life-threatening state as well as other infections. We are pleased to have been able to expand the range of doses available to clinicians, broadening their options to aid rapid and effective treatment.”
In the United States, sepsis is the third leading cause of death after heart disease and cancer, affecting more than 1.7 million people and killing more than 270,000 people within a single year1.
“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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1 Rhee, C. et al. Incidence and trends of sepsis in US hospitals using clinical vs claims data, 2009-2014. JAMA 318, 1241–1249 (2017).
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, 150 mL 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 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.
IMPORANT SAFETY INFORMATION
WARNING: RISK OF EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS
WARNING: RISK OF EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS
See full prescribing information for complete boxed warning.
This formulation of Vancomycin Injection, USP 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.). Jan 2020, 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 115 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, the Middle East 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 1,800 people.