No

Immunosuppressant Agent

Prophylaxis of acute organ rejection in patients receiving renal transplants; used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids

C

Hypersensitivity to any component of the product

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe daclizumab. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. Readministration of daclizumab after an initial course of therapy has not been studied in humans. The potential risks of such readministration, specifically those associated with immunosuppression or the occurrence of anaphylaxis/anaphylactoid reactions, are not known.

>10%: Endocrine & metabolic: Hyperglycemia (32%)

1% to 10%:

Cardiovascular: Peripheral edema, hypertension, hypotension, aggravated hypertension, tachycardia, thrombosis, bleeding, chest pain

Central nervous system: Headache, dizziness, prickly sensation, depression, anxiety, fever, fatigue, insomnia, shivering, generalized weakness

Dermatologic: Impaired wound healing without infection, acne, pruritus, hirsutism, rash

Endocrine & metabolic: Fluid overload, diabetes mellitus, dehydration, edema

Gastrointestinal: Constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, epigastric pain (not food-related), flatulence, gastritis, hemorrhoids

Genitourinary: Dysuria, urinary tract disorder, urinary retention

Hematologic: Urinary tract bleeding

Local: Injection site pain

Neuromuscular & skeletal: Tremor, musculoskeletal pain, back pain, arthralgia, leg cramps, myalgia, pain

Ocular: Blurred vision

Renal: Oliguria, renal tubular necrosis, renal damage, hydronephrosis, renal insufficiency

Respiratory: Dyspnea, pulmonary edema, coughing, atelectasis, congestion, rhinitis, pharyngitis, hypoxia, rales, abnormal breath sounds, pleural effusion

Miscellaneous: Increased diaphoresis, night sweats, post-traumatic pain

Overdose has not been reported; a maximum tolerated dose has not been determined in patients. A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events.

Refrigerate vials at 2°C to 8°C/36°F to 46°F. Do not shake or freeze; protect undiluted solution against direct sunlight. Dose should be further diluted in 50 mL 0.9% sodium chloride solution. Diluted solution is stable for 24 hours at 4°C or for 4 hours at room temperature.

Inhibits the binding of IL-2 to the high affinity IL-2 receptor, thus suppressing T cell activity against allografts. Its active ingredient, daclizumab, a humanized monoclonal antibody, binds to the alpha subunit of the high affinity interleukin-2 receptor (IL-2R) which is expressed on activated T cells.

Volume of central compartment: 2.5 L

Volume of peripheral compartment: 3.4 L

Estimated half-life (terminal elimination): 20 days (480 hours)

Children and Adults: IVPB: 1 mg/kg, used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids for a total of 5 doses; give the first dose less than or equal to 24 hours before transplantation. The 4 remaining doses should be administered at intervals of 14 days.

Daclizumab dose should be diluted in 50 mL NS solution. When mixing the solution, gently invert the bag to avoid foaming; do not shake. Daclizumab solution should be administered within 4 hours of preparation if stored at room temperature; infuse over a 15-minute period via a peripheral or central vein

May cause depression, anxiety, or insomnia

None reported

No information available to require special precautions

No effects or complications reported

Injection: 5 mg/mL (5 mL)

Vincenti F, Kirkman R, Light S, et al, "Interleukin-2-Receptor Blockade With Daclizumab to Prevent Acute Rejection in Renal Transplantation. Daclizumab Triple Therapy Study Group," N Engl J Med, 1998, 338(3):161-5.