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H/C Professionals
Additional Information
Healthcare Professional Resources
The Infectious Diseases Society of America and The Society for Healthcare Epidemiology of America, or SHEA, have released new guidelines for the management of Clostridioides difficile.
June 2021
The new guidance for CDI management in adults is as follows:
- For patients with an initial C. difficile episode, fidaxomicin is recommended rather than a standard course of vancomycin.
- For patients with recurrent C. difficile episodes, a standard or extended-pulsed regimen of fidaxomicin should be used rather than a standard course of vancomycin.
- For patients with a recurrent C. difficile episode within the past 6 months, bezlotoxumab and standard-of-care antibiotics should be used rather than standard-of-care antibiotics alone.
“Head-to-head trials of differing anti-CDI recurrence strategies using narrow-spectrum antibiotics that target C. difficile, restoration of the microbiome using biotherapeutics or [fecal microbiota transplantation], or augmentation of the host immune response with agents such as bezlotoxumab given alone or in combination (eg, in combination with fidaxomicin) are needed,” the authors wrote.
2017 Guidelines in their entirety
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The American College of Gastroenterology (ACG) released updated clinical guidelines on the prevention, diagnosis, and treatment of Clostridioides difficile infections (CDI), which was recently published in The American Journal of Gastroenterology. These guidelines represent the official practice recommendations of the ACG and indicate the preferred approach to the management of adults with CDI. (2021)
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DIFICID®
(fidaxomicin) tablets
This private and confidential program provides product free of charge to eligible individuals, primarily the uninsured who, without our assistance, could not afford needed Merck medicines. Individuals who don’t meet the insurance criteria may still qualify for this program if they attest that they have special circumstances of financial and medical hardship, and their income meets the program criteria. A single application may provide for up to 1 year of product free of charge to eligible individuals and an individual may reapply as many times as needed.
PATIENT ASSISTANCE PROGRAM:
See a video on how to fill out the enrollment form here
Download an enrollment form checklist
Program Contact Information
800-727-5400
915-849-1037
Hours: 8 AM – 8 PM ET
Days: Monday – Friday
https://www.merckhelps.com/DIFICID%20TABLETS
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Duration of Contact Precautions for Acute-Care Settings
February 2018 – Update Published
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ZINPLAVA (bezlotoxumab) is now available for prescription.
Ordering information is available on the brand website:
What is Zinplava™ ?
ZINPLAVA™ is indicated to reduce the recurrence of Clostridium difficile infection in patients 18 years of age or older who are receiving antibacterial drug treatment of a
C. difficile infection and are at a high risk for C. difficile infection recurrence.
ZINPLAVA is not indicated for the treatment of C. difficile infection.
ZINPLAVA is not an antibacterial drug.
ZINPLAVA should only be used in conjunction with antibacterial drug treatment of a
C. difficile infection.
Full prescribing information can be read at
http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf
The Merck Access Program can help answer physician’s questions about:
Insurance coverage for patients
Prior Authorizations and Appeals
Coding and Billing
Potential financial assistance options for eligible patients
Full program details can be found at:
https://www.merckaccessprogram-zinplava.com/hcp/
Also, Information about co-pay assistance for eligible, privately insured patients
Information about available independent assistance foundation support.
*PLEASE NOTE – The C Diff Foundation does not endorse any product, medication, and/or clinical study in progress and available. All website postings are strictly for informational purposes only.
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June 01, 2021 – in a 24-hour period without an alternative explanation and a positive stool test for C. difficile.1 … to severe or fulminant colitis.2,3 • Up to 50 percent of nursing home residents are colonized with C. difficile for the results of C. difficile test results.1 • C. difficile testing recommendations1 − Do not test … C. diff (Clostridioides difficile). Centers for Disease Control and Prevention. November 2020. … Fidaxomicin versus vancomycin for Clostridium difficile infection.
Agency for Healthcare Research and Quality
Office of Communications
5600 Fishers Lane, 7th Floor
Rockville, MD 20857
Communicating by Phone with AHRQ: The public inquiries number is: (301) 427-1104.
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SEPSIS AWARENESS INFORMATION:
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ANTIBIOTIC INFORMATION:
Antibiotic-Resistance CDC Links Of Interest:
Core Elements:
https://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html
https://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html
Links to Patient Safety Atlas
Antibiotic Resistance Patient Safety Atlas: Hospital Antibiotic Stewardship Programs by State Data (2014-2015) https://gis.cdc.gov/grasp/PSA/indexST.html
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CDC Standard Precautions and OSHA Mandated PPE
Utilize healthcare professional prevention guidelines and stay safe.
For Clinicians: 6 Steps to C. diff. Prevention
- Prescribe and use antibiotics carefully. About 50% of all antibiotics given are not needed, unnecessarily raising the risk of C. difficile infections.
- Test for C. difficile when patients have diarrhea while on antibiotics or within several months of taking them.
- Isolate patients with C. difficile immediately.
- Wear gloves and gowns when treating patients with C. difficile, even during short visits. Hand sanitizer does not kill C. difficile, and handwashing may not be sufficient.
- Cleanroom surfaces with bleach or another EPA-approved, spore-killing disinfectant after a patient with C. difficile has been treated there.
- When a patient transfers, notify the new facility if the patient has a C. difficile infection.
(1) CDC
Released by the CDC: February 2015
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Merck — known as MSD outside the United States and Canada, on October 22, 2016, announced that the U.S. Food and Drug Administration (FDA) has approved
ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.
Merck anticipates making ZINPLAVA available in first quarter of 2017.
ZINPLAVA is indicated to reduce the recurrence of Clostridioides difficile infection in patients 18 years of age or older who are receiving antibacterial drug treatment of a
C. difficile infection and are at high risk for a
C. difficile infection recurrence.
ZINPLAVA is not indicated for the treatment of a C. difficile infection
ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of C. difficile.
Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf
Patient Information for ZINPLAVA at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_ppi.pdf
C-diff is caused by bacteria that produce toxins, including toxin B.
Symptoms of a Clostridioides difficile infection
include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent
C. difficile is higher in certain patient populations, including people 65 years of age or older and those with compromised immune systems.
“For generations, Merck has been steadfast in its commitment to fighting infectious diseases – and that commitment continues today. ZINPLAVA is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects,” said Dr. Nicholas Kartsonis, vice president of clinical development, infectious diseases, Merck Research Laboratories.
About bezlotoxumab
Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and was licensed to Merck in 2009.
Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf
FIRVANQ® comes in 25 mg/mL or 50 mg/mL kits.
Each kit contains a bottle of vancomycin hydrochloride USP powder for oral solution and a bottle of grape‑flavored diluent for simple reconstitution.
IMPORTANT SAFETY INFORMATION AND
INDICATIONS
FIRVANQ® is a glycopeptide antibacterial indicated in adults and pediatric patients less than 18 years of age for the treatment of:
- Clostridium difficile-associated diarrhea
- Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
References: 1. FIRVANQ® Prescribing Information. Wilmington, MA: CutisPharma, Inc; 2018. 2. Centers for Disease Control and Prevention (CDC). 2013 annual report for the emerging infections program for Clostridium difficile infection. https://www.cdc.gov/hai/eip/pdf/cdiff/2013-annual-report.pdf. Accessed March 9, 2018. 3. Centers for Disease Control and Prevention (CDC). 2014 annual report for the emerging infections program for Clostridium difficile infection. https://www.cdc.gov/hai/eip/pdf/cdiff/2014-annual-cdi-report.pdf. Accessed March 9, 2018. 4. Centers for Disease Control and Prevention (CDC). 2015 annual report for the emerging infections program for Clostridium difficile infection. https://www.cdc.gov/hai/eip/pdf/cdiff/2015-cdi-report.pdf. Accessed March 9, 2018
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