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Prescribing Information
including BOXED WARNING.
VANCO READY™, Vancomycin Injection is FDA approved and commercially prepared1
Compounded drugs and IV drug delivery systems are associated with numerous procedural and operational barriers to adequate drug delivery, including:2
- Supply-chain disruptions
- Quality control problems
- Shortage of pharmacy staff
With commercially prepared products,
institutions can more effectively deliver drugs to
the patient with the goal of honouring service level commitments and minimizing risks of harm, medication errors, contamination,
and/or overdose.2
Only VANCO READY™
comes ready to infuse1
No thawing, compounding,
or activating1
- Room temperature stable
- 16-month shelf life in overwrap
- Fits in automated dispensing units
FDA recommends using a commercially produced,
FDA approved product whenever possible.2
VANCO READY™ aligns with current guidelines for commercially prepared ready
to use3,4
The American Society of Health-System Pharmacists (ASHP), The Joint Commission, and the Institute for Safe Medication Practices (ISMP) have released guidelines for commercially prepared ready to use products.
VANCO READY™ meets these requirements and can help eliminate the errors associated with manually compounded sterile products.
To the maximum extent possible, COMMERCIALLY-PREPARED, premixed parenteral products and unit dose syringes should be used versus manually compounded sterile products.
– Institute for Safe MedicationPractices (ISMP)
Whenever possible, medications should be available for inpatient use in unit-of-use and ready-to-administer packaging without further manipulation by the person administering the medication.
– American Society of Health- SystemPharmacists (ASHP)
Time to first dose
When it comes to sepsis, VANCO READY™ could help reduce antimicrobial lead time.
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VANCO READY™ is fully ready
With 7 available doses, VANCO READY™ covers most of your vancomycin needs.
Learn MoreGET FULLY READY
VANCO READY™ is available in
7 different dose amounts to cover most
of your patients' vancomycin needs.
IMPORTANT SAFETY INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VANCOMYCIN INJECTION, safely and effectively. See full prescribing information for VANCOMYCIN INJECTION. Reference numbers in Highlights correspond to full Package Insert.
VANCOMYCIN injection, for intravenous use Initial U.S. Approval: 1958
WARNING: RISK OF EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS
See full prescribing information for complete boxed warning. 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)
INDICATIONS AND USAGE
Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of:
- Septicemia (1.1)
- Infective Endocarditis (1.2)
- Skin and Skin Structure Infections (1.3)
- Bone Infections (1.4)
- Lower Respiratory Tract Infections (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.6)
DOSAGE AND ADMINISTRATION- Use this formulation of Vancomycin Injection only in patients who require the entire (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g) dose and not any fraction thereof. (2.1)
- For intravenous use only. Do Not administer orally.
- Administer Vancomycin Injection by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions (2.1)
- Adult Patients: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours (2.2)
- Pediatric Patients (1 Month and Older): 10 mg/kg per dose given every 6 hours (2.3)
- Patients with Renal Impairment: See full prescribing information for recommended doses in patients with renal impairment (2.4)
- See full prescribing information for further important administration and preparation instructions (2.1, 2.5)
DOSAGE FORMS AND STRENGTHS
Vancomycin Injection, USP: Single-dose flexible bags containing 500 mg vancomycin in 100 mL, 750 mg vancomycin in 150 mL, 1 g vancomycin in 200 mL, 1.25 g vancomycin in 250 mL, 1.5 g vancomycin in 300 mL, 1.75 g vancomycin in 350 mL and 2 g vancomycin in 400 mL of liquid. (3)
CONTRAINDICATIONS
- Hypersensitivity to vancomycin (4)
- 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)
- Severe dermatologic reactions: Discontinue Vancomycin Injection at the rst appearance of skin rashes, mucosal lesions, or blisters. (5.5)
- Clostridioides Difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6).
- Neutropenia: Periodically monitor leukocyte count. (5.8)
- Phlebitis: To reduce the risk of local irritation and phlebitis administer Vancomycin Injection by a secure intravenous route of administration. (5.9)
- 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. (5.10)
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
- 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)
Reference:
1: IQVIA. IV vancomycin hospital market sizing analysis. December 2019.
1: IQVIA. IV vancomycin hospital market sizing analysis. December 2019.
References:
1. VANCO READY. Prescribing information. Xellia Pharmaceuticals; 2021.
2. Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the Federal Food, Drug, and Cosmetic Act guidance for industry. US Food and Drug Administration website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-commercially-available-drug-product-undersection. Published January 2018. Accessed February 17, 2020.
3. Institute for Safe Medication Practices. ISMP guidelines for safe preparation of compounded sterile preparations. https://www.ismp.org/sites/default/files/attachments/2017-11/Guidelines for Safe Preparation of Compounded Sterile Preperations_revised 2016.pdf. Published 2013. Updated 2016.
4. Billstein-Leber M, Carrillo CJD, Cassano AT, et al. ASHP guidelines on preventing medication errors in hospitals. Am J Health-Syst Pharm. 2018;75(19):1493-1517.
1. VANCO READY. Prescribing information. Xellia Pharmaceuticals; 2021.
2. Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the Federal Food, Drug, and Cosmetic Act guidance for industry. US Food and Drug Administration website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-commercially-available-drug-product-undersection. Published January 2018. Accessed February 17, 2020.
3. Institute for Safe Medication Practices. ISMP guidelines for safe preparation of compounded sterile preparations. https://www.ismp.org/sites/default/files/attachments/2017-11/Guidelines for Safe Preparation of Compounded Sterile Preperations_revised 2016.pdf. Published 2013. Updated 2016.
4. Billstein-Leber M, Carrillo CJD, Cassano AT, et al. ASHP guidelines on preventing medication errors in hospitals. Am J Health-Syst Pharm. 2018;75(19):1493-1517.