"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Sterile Concentrate For Injection
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe ZENAPAX (daclizumab). The physician responsible for ZENAPAX (daclizumab) administration should have complete information requisite for the follow-up of the patient. ZENAPAX (daclizumab) should only be administered by healthcare personnel trained in the administration of the drug who have available adequate laboratory and supportive medical resources.
ZENAPAX (daclizumab) is an immunosuppressive, humanized IgG1 monoclonal antibody produced by recombinant DNA technology that binds specifically to the alpha subunit (p55 alpha, CD25, or Tac subunit) of the human high-affinity interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes.
Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. The molecular weight predicted from the DNA sequence is 144 kilodaltons.
ZENAPAX (daclizumab) 25 mg/5 mL is supplied as a clear, sterile, colorless concentrate for further dilution and intravenous administration. Each milliliter of ZENAPAX contains 5 mg of daclizumab and 3.6 mg sodium phosphate monobasic monohydrate, 11 mg sodium phosphate dibasic heptahydrate, 4.6 mg sodium chloride, 0.2 mg polysorbate 80, and may contain hydrochloric acid or sodium hydroxide to adjust the pH to 6.9. No preservatives are added.
What are the possible side effects of daclizumab (Zenapax)?
There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.
Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.
If you experience a serious allergic reaction (difficulty breathing;...
What are the precautions when taking daclizumab (Zenapax)?
Last reviewed on RxList: 10/28/2008
This monograph has been modified to include the generic and brand name in many instances.
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