IN THE NEWS:
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 panel’s recommendations for the management of CDI are based upon evidence derived from topic-specific systematic literature reviews,” Stuart Johnson, MD, infectious disease clinician and researcher at the Edward Hines Jr. Veterans Administration Hospital, and colleagues wrote.
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.
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:
Patient Assistance Programs
https://www.merckhelps.com/DIFICID%20TABLETS
Program Contact Information
800-727-5400
915-849-1037
Hours: 8 AM – 8 PM ET
Days: Monday – Friday
February 2018 – Update Published
To review the new update, please click on the link below to be redirected:
ZINPLAVA (bezlotoxumab) is now available for prescription.
Ordering information is available on the brand website:
What is Zinplava
ZINPLAVA
ZINPLAVA is not indicated for the treatment of CDI.
ZINPLAVA is not an antibacterial drug.
ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.
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.
SEPSIS AWARENESS INFORMATION:
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
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
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
Merck anticipates making ZINPLAVA available in first quarter of 2017.
ZINPLAVA is indicated to reduce the recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.
ZINPLAVA is not indicated for the treatment of CDI.
ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.
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
CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI, include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI 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.
Selected safety information about ZINPLAVA
Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had a serious adverse reaction of heart failure during the 12-week study period. Additionally, in patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients [19.5% (23/118)] than in placebo-treated patients [12.5% (13/104)] during the 12-week study period. The causes of death varied and included cardiac failure, infections, and respiratory failure. In patients with a history of CHF, ZINPLAVA (bezlotoxumab) should be reserved for use when the benefit outweighs the risk.
The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy included nausea (7% vs 5%), pyrexia (5% vs 3%) and headache (4% vs 3%).
Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of ZINPLAVA-treated patients and 1.0% of placebo-treated patients.
In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%) and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% of patients experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.
As with all therapeutic proteins, there is a potential for immunogenicity following the administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, the timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bezlotoxumab in two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. Following treatment with ZINPLAVA in these two studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.
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
FDA Approved Treatment of CDAD
Dificid (fidaxomicin)
DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for the treatment of Clostridium difficile-associated diarrhea (CDAD).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C difficile.
Healthcare Professionals please click on the following links to review additional information
https://www.merckconnect.com/dificid/overview.html#
FOR PATIENTS AND PHYSICIANS: PATIENT ASSISTANCE PROGRAM INFORMATION *
To learn more about the parameters and eligibility requirements for the Patient Assistance Program for DIFICID, and all Merck medicines, call 1-800-727-5400
or (908) 423-1000,
Press option 1 for the Patient Assistance Program. A Merck representative will assist the patient and physicians with program guidelines and document forms.
-
For general questions about MERCK products
1-800-442-5624
Monday – Thursday 8 AM – 8 PM ET
Friday 8 AM – 6 PM ET
Hours are subject to change. -
For adverse event reporting
1-866-342-5683
If you wish to report an adverse event for a specific Merck product, please call the Merck National Service Center at any time. -
For general questions about Merck Connect
1-800-489-5119
Monday – Friday 8 AM – 7 PM ET
Voice messages left after business hours will be returned by the end of the next business day.
Network Pharmacies Can Help Support Patients Prescribed DIFICID
Patient support features include: Information and assistance regarding access to therapy (including benefits investigation and reimbursement requirements), Product availability, Next-day delivery of medications, Disease-related educational materials for patients, and 24-hour patient counseling services
For more information, please visit: https://www.merckconnect.com/dificid/pharmacy-network.html
Savings Coupon and Information For Patients – click on the link below to access coupon:
*Please note – The C Diff Foundation does not endorse this product or any product and postings are strictly for informational purposes only.
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)
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Contact us at 1-844-FOR-CDIF to receive your complimentary DVD “Raising C. diff. Awareness for Healthcare Providers” since 2013 and share this important information with your office staff and colleagues.
