Daclizumab (Zenapax®)

Purpose:
Used in combination with standard immunosuppressive agents. It is the first genetically engineered drug to reduce the risk of organ rejection in kidney transplant patients without increasing overall side effects.

How to take:
Daclizumab is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. The recommended dose for Daclizumab is 1.0 mg/kg. The calculated volume of Daclizumab should be mixed with 50 mL of sterile 0.9% sodium chloride solution and administered via a peripheral or central vein over a 15-minute period.

Based on the clinical trials, the standard course of Daclizumab therapy is five doses. The first dose should be given no more than 24 hours before transplantation. The four remaining doses should be given at intervals of 14 days.

No dosage adjustment is necessary for patients with severe renal impairment. No dosage adjustments based on other identified covariates (age, gender, proteinuria, race) are required for renal allograft patients. No data are available for administration in patients with severe hepatic impairment.

Precautions:

General: It is not known whether Daclizumab use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during Daclizumab-induced immunosuppression.

Re-administration of Daclizumab after an initial course of therapy has not been studied in humans. The potential risks of such re-administration, specifically those associated with immunosuppression and/or the occurrence of anaphylaxis/anaphylactoid reactions, are not known.

Principal Side effects:

The following adverse events occurred in >5% of Daclizumab-treated patients.

• Gastrointestinal System: constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain not food-related

• Metabolic and Nutritional: edema extremities, edema

• Central and Peripheral Nervous System: tremor, headache, dizziness

• Urinary System: oliguria, dysuria, renal tubular necrosis

• Body as a Whole -- General: post-traumatic pain, chest pain, fever, pain, fatigue

• Autonomic Nervous System: hypertension, hypotension, aggravated hypertension

• Respiratory System: dyspnea, pulmonary edema, coughing

• Skin and Appendages: impaired wound healing without infection, acne

• Psychiatric: insomnia; Musculoskeletal System: musculoskeletal pain, back pain

• Heart Rate and Rhythm: tachycardia; Vascular Extracardiac: thrombosis

• Platelet, Bleeding and Clotting Disorders: bleeding

• Hemic and Lymphatic: lymphocele