October 21, 2016 – The U.S. Food and Drug Administration (FDA) approved Zinplava™ (bezlotoxumab), manufactured by Merck. Zinplava is a monoclonal antibody, indicated as ancillary treatment to decrease the likelihood of a relapse with a specific bacterial infection. Zinplava is approved for use in combination with an antibacterial drug, for preventing recurrence of Clostridium difficile (C. diff) infection for patients who are at least 18 years old, who are undergoing antibacterial treatment for C. diff and who are at high risk of acquiring the infection again. The chance of an initial C. diff infection is greater for patients who recently have taken antibiotics, especially individuals with immunocompromising conditions, those who are hospitalized and those living in a nursing facility. About 25% of patients once infected with C. diff will become reinfected, and around 10% will have more than one additional C. diff infection. Toxic substances produced by C. diff attack the linings of the stomach and intestines to cause abdominal pain, diarrhea and fever. Although it is not an antibacterial drug, Zinplava sticks to toxin B, reducing its ability to damage gastrointestinal (GI) cells. Recommended dosing is 10mg/Kg given as a single intravenous (IV) infusion over a one-hour period. It must be used in conjunction with an antibacterial agent. Zinplava, which will be packaged in single-use, 40mL vials containing 25mg/mL (1,000mg total), will be launched early in 2017.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.