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Cancel ConfirmUS Home - VANCO READY™ - Compounding
Is compounding
creating
unnecessary
risk?
Click here to see full
Prescribing Information
including BOXED WARNING.
Compounded drugs are associated with increased risk1,2
According to the FDA, there is a 1 in 10 error rate associated with compounding. Many serious patient illnesses and deaths have been linked to poorly compounded drugs.3
503b facilities face growing supply and administration issues1
Between 2013 and 2017, * the FDA has
The FDA does not evaluate compounded drugs for safety, effectiveness, or quality before they are administered to the patient. Because of this, institutions must carefully adhere to the Drug Quality and Security Act (DQSA) to avoid poorly compounded drugs that can cause potentially serious adverse events, including death.1
*According to FDA Website
Since the DSQA went into effect in 2013, the FDA has issued over 180 warning letters and recalled 150 compounded drugs. These warning letters and recalls have a direct impact on an institution's operational efficiency and ability to obtain certain drugs.1
Mitigate the risk of compounding
VANCO READY™, Vancomycin Injection requires no thawing, compounding, or activating:4
- Room temperature stable
- 16-month shelf life in overwrap
- Fits in automated dispensing units
Time to first dose
When it comes to sepsis, VANCO READY™ could help reduce antimicrobial lead time.
Learn More
Compounded vs. commercially prepared
View the FDA guidelines for compounded drugs vs. commercially prepared products.
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. 2018 compounding policy priorities plan: US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/2018-compounding-policy-priorities-plan. Published January 2018. Accessed February 17, 2020.
2. Compounding risk alerts. US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/compounding-risk-alerts. Updated June 7, 2019. Accessed February 17, 2020.
3. Flynn EA, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm. 1997;54:904-912.
4.VANCO READY. Prescribing information. Xellia Pharmaceuticals; 2021.
1. 2018 compounding policy priorities plan: US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/2018-compounding-policy-priorities-plan. Published January 2018. Accessed February 17, 2020.
2. Compounding risk alerts. US Food and Drug Administration website. https://www.fda.gov/drugs/human-drug-compounding/compounding-risk-alerts. Updated June 7, 2019. Accessed February 17, 2020.
3. Flynn EA, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm. 1997;54:904-912.
4.VANCO READY. Prescribing information. Xellia Pharmaceuticals; 2021.