Deerfield, Ill., - April 19, 2016
Only Manufacturer to Offer the Antibiotic in a Ready-to-Use Premixed Presentation
Advancing Baxter’s longstanding commitment to provide hospitals with convenient presentations of medications that drive efficiency during drug preparation and enhance patient safety in administration, Baxter International Inc. (NYSE: BAX) today announced the launch of a ready-to-use VANCOMYCIN injection in 0.9% Sodium Chloride (Normal Saline) in 500 mg, 750 mg and 1 gram presentations. VANCOMYCIN injection is an antibiotic used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci bacteria.
Baxter is the only manufacturer to offer VANCOMYCIN in a premixed presentation, which uses the company’s proprietary frozen GALAXY container technology. Baxter’s innovative frozen premix technology is specifically designed for unstable molecules that are often administered using standardized doses. Premixed molecules offered in the GALAXY container are illustrative of the leading innovation in medical manufacturing that Baxter has been bringing to the healthcare industry for more than 80 years.
VANCOMYCIN saline injection augments Baxter’s expanding portfolio of generic injectable drugs in the United States available in easy-to-use presentations that hospitals, physicians and patients can rely on because they are manufactured to the Current Good Manufacturing Practice (cGMP) regulations established by the U.S. Food and Drug Administration (FDA). Premixed medications in standardized drug concentrations can help support hospitals’ goals for safe and efficient medication preparation because compounding is not necessary.
“As a company whose mission is focused on saving and sustaining lives, Baxter’s launch of VANCOMYCIN injection in an innovative premixed saline presentation provides new options of an important antibiotic to address patient needs and demonstrates our commitment to making premixed preparations of medications more efficient for healthcare practitioners,” said Brik Eyre, president of Baxter’s Hospital Products business.
The launch is an extension of Baxter’s existing VANCOMYCIN injection in 5% dextrose in 500 mg, 750 mg and 1 gram presentations and provides an alternative to certain patients who may need to avoid receiving additional dextrose. By providing VANCOMYCIN in both saline and dextrose presentations, Baxter makes additional therapy options available of a critical antibiotic that has appeared on and off of the FDA Drug Shortage list.
VANCOMYCIN saline injection is the second of nine clinically important molecules coming out of a collaborative partnership with Celerity Pharmaceuticals, LLC, a company of Water Street Healthcare Partners, to develop new products that use Baxter’s proprietary container technology, enhanced packaging platform, and aseptic filling manufacturing process.
Baxter’s VANCOMYCIN saline injection in 500 mg, 750 mg and 1 gram presentations are available in the United States.
INDICATIONS for Vancomycin Injection, USP:
- For the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
- Vancomycin is effective in the treatment of staphylococcal endocarditis. Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
IMPORTANT RISK INFORMATION for Vancomycin Injection, USP:
- Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic and in patients with known allergy to corn or corn products.
- Vancomycin should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions, such as exaggerated hypotension, including shock, and, rarely, cardiac arrest. Stopping the infusion usually results in prompt cessation of these reactions.
- Ototoxicity has occurred in patients receiving vancomycin and may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside.
- Patients with renal insufficiency should undergo serial monitoring of renal function and receive appropriate dosing schedules. The risk of toxicity and nephrotoxicity is increased with high, prolonged blood concentrations and concomitant therapy with an aminoglycoside.
- Clostridium difficile associated diarrhea (CDAD) has been reported with Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
- Risk of High Sodium Load: Avoid use of Vancomycin in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake.
- Reversible neutropenia has been reported in patients receiving vancomycin. Patients who will undergo prolonged therapy with vancomycin or who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.
- Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness, and necrosis occur with inadvertent extravasation.
- The safety and efficacy of vancomycin administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well controlled trials.
- Reports revealed administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This release includes forward-looking statements concerning VANCOMYCIN, including expectations with regard to its availability in the U.S. and risks and benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
BAXTER and GALAXY are trademarks of Baxter International Inc.