Trade Names:Zenapax- Injection 25 mg per 5 mL
Binds with high-affinity to the Tac subunit of the high-affinity interleukin-2 (IL-2) complex and inhibits IL-2 binding, thereby impairing the response of the immune system to antigenic challenges.
At recommended doses, the Tac subunit of the IL-2 receptor is saturated for about 90 and 120 days posttransplant in children and adult patients, respectively.
Prophylaxis of acute organ rejection in patients receiving renal transplants.
IV 1 mg/kg for 5 doses as part of an immunosuppressive regimen that contains cyclosporine and corticosteroids. Give the first dose no more than 24 h before transplantation and the remaining 4 doses at intervals of 14 days.
Administer infusion solution within 4 h of preparation or within 24 h if stored in refrigerator. Store unopened vials in refrigerator (36° to 46°F). Do not freeze or shake. Protect from direct light. Diluted infusion solution is stable for 4 h at room temperature or for 24 h if refrigerated.
None well documented.
None well documented.
The safety of daclizumab was determined in patients receiving concomitant cyclosporine and corticosteroids.
Hypertension, hypotension, aggravated hypertension, tachycardia (at least 5%).
Tremor, headache, dizziness, insomnia (at least 5%); depression, anxiety (2% to less than 5%).
Impaired wound healing without infection, acne (at least 5%); pruritus, hirsutism, rash, night sweats, increased sweating, application site reaction (2% to less than 5%).
Pharyngitis, rhinitis, blurred vision (2% to less than 5%).
Constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain (at least 5%); flatulence, gastritis, hemorrhoids (2% to less than 5%).
Oliguria, dysuria, renal tubular necrosis (at least 5%); renal damage, hydronephrosis, urinary tract bleeding, urinary tract disorder, renal function impairment, urinary retention (2% to less than 5%).
Thrombosis, bleeding, lymphocele (at least 5%).
Edema of the extremities, edema (at least 5%); fluid overload, diabetes mellitus, dehydration (2% to less than 5%).
Muscular pain, back pain (at least 5%); leg cramps, arthralgia, myalgia (2% to less than 5%).
Dyspnea, pulmonary edema, coughing (at least 5%); atelectasis, congestion, hypoxia, rales, abnormal breath sounds, pleural effusion (2% to less than 5%).
Posttraumatic pain, chest pain, fever, pain, fatigue (at least 5%); shivering, generalized weakness, prickly sensation (2% to less than 5%).
Only physicians experienced with immunosuppressive therapy and management of organ transplant patients should prescribe daclizumab. Daclizumab should be given by health care personnel trained in the administration of the drug and who have available laboratory and supportive medical resources.
Monitor patient for signs and symptoms of bacterial, viral, or fungal infection.
Category C .
Safety and efficacy not established in children younger than 11 mo of age.
Use with caution.
Anaphylactic reactions can occur.
It is not known if there will be a long-term effect on the ability of the immune system to respond to antigens first encountered during daclizumab-induced immunosuppression.
Copyright © 2009 Wolters Kluwer Health.