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P and T Committee Adds Augmentin ES to Formulary; FDA Warns About Arzerra and Rituxan

Pharmacy Focus

The Pharmacy and Therapeutics Committee added Augmentin ES  to the formulary, among other actions at its Aug. 5 meeting. The committee's actions are summarized in the PDF link below.

Also, the U.S. Food and Drug Administration has added warnings about the anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab). And the FDA warned of an increased risk of death when intravenous Tygacil (tigecycline) is used.

P and T Committee Approvals - Aug. 5, 2013 (PDF)

FDA Warns About Hepitatis B Reactivation With Arzerra and Rituxan

The U.S. Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra and Rituxan to add new boxed warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring and managing patients on these drugs to decrease this risk.

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later treated with drugs classified as CD20-directed cytolytic antibodies, including Arzerra and Rituxan. Some cases have resulted in fulminant hepatitis, hepatic failure and death.

Arzerra is used to treat chronic lymphocytic leukemia (CLL). Rituxan is used to treat non-Hodgkin’s lymphoma and CLL. It is also used to treat other medical conditions, including rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

To decrease the risk of HBV reactivation, FDA recommends that healthcare professionals:

  • Screen all patients for HBV infection before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen and hepatitis B core antibody.
  • Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation.
  • Monitor patients with evidence of prior HBV infection for signs of hepatitis B or HBV reactivation during Arzerra or Rituxan therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy with these drugs.
  • In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately discontinue the drug and start appropriate treatment for HBV. Discontinue any chemotherapy the patient is receiving until the HBV infection is controlled or resolved.

Click here for more information.

Warning About Arzerra and Rituxan - Sept. 24, 2013 (PDF)

FDA Warns of Increased Risk of Death with Intravenous Tygacil

The FDA has approved a new boxed warning describing an increased risk of death when intravenous Tygacil is used for FDA-approved uses as well as for nonapproved uses. These changes to the Tygacil prescribing information are based on an additional analysis that was conducted after the agency warned about this safety concern in 2010.

This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5 percent (66/2640) vs. 1.8 percent (48/2628). In general, the deaths resulted from worsening infections, complications of infection or other underlying medical conditions.

Tygacil is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia.

The FDA recommends that healt care professionals reserve Tygacil for use in situations when alternative treatments are not suitable.

Click here for more information.