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 administration
should have complete information requisite for the follow-up of
the patient. ZENAPAX 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 DNA sequencing
is 144 kilodaltons.
ZENAPAX 25 mg/5mL 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.