Efficacy and Safety

ZENAPAX® (daclizumab) selectively targets IL-2 receptors for immunosuppressive efficacy and long-term safety.

Significantly reduced acute rejection at 6 months
Improved patient survival up to 3 years
No increase in lymphomas up to 3 years
Incidence of adverse events is similar to placebo
Pediatric safety profile comparable to adults
Established efficacy in pediatric patients

Incidence of adverse events is similar to placebo:

The most frequently reported adverse events were GI disorders (eg, constipation, nausea, diarrhea, vomiting): ZENAPAX-treated patients, 67%; placebo-treated patients, 68%.
Cellulitis and wound infections occurred in 8.4% of ZENAPAX-treated patients and in 4.1% of placebo-treated patients.

Safety Information

Severe, acute (onset within 24 hours) hypersensitivity reactions including anaphylaxis have been observed both on initial exposure to ZENAPAX and following re-exposure. If a severe hypersensitivity reaction occurs, therapy with ZENAPAX should be permanently discontinued. Medications for the treatment of severe hypersensitivity reactions including anaphylaxis should be available for immediate use. Patients previously administered ZENAPAX should only be re-exposed to a subsequent course of therapy with caution. The potential risks of such re-administration, specifically those associated with immunosuppression, are not known.

ZENAPAX is contraindicated in patients with known hypersensitivity to daclizumab or to any components of this product.

While the incidence of lymphoproliferative disorders and opportunistic infections in the limited clinical trial experience was no higher in patients treated with ZENAPAX compared with placebo-treated patients, patients on immunosuppressive therapy are at increased risk for developing lymphoproliferative disorders and opportunistic infections and should be monitored accordingly.

The most frequently reported adverse events were GI disorders (eg, constipation, nausea, diarrhea, vomiting): ZENAPAX-treated patients, 67%; placebo-treated patients, 68%. Cellulitis and wound infections occurred in 8.4% of ZENAPAX-treated patients and in 4.1% of placebo-treated patients.

The use of ZENAPAX was associated with a higher incidence of mortality when compared to placebo in a large randomized controlled study of patients receiving cardiac transplants. Some, but not all, increase in mortality appeared related to a higher incidence of severe infections. Concomitant use of anti-lymphocyte antibody therapy may also be a factor in some fatal infections.

WARNING: Only physicians experienced in immunosuppressive therapy and management or 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.

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