Daclizumab

Indications

Daclizumab is used for: Acute graft rejection in renal transplantation

Adult Dose

Intravenous Prophylaxis of acute graft rejection in renal transplantation Adult: As part of an immunosuppressive regimen: 1 mg/kg over 15 minutes within 24 hr before surgery. Repeat at 2-wkly intervals for a total of 5 doses.

Child Dose

Intravenous Prophylaxis of acute graft rejection in renal transplantation Child: 1-18 yr: 1 mg/kg over 15 minutes within 24 hr before surgery. Repeat at 2-wk intervals for a total of 5 doses.

Renal Dose

Administration

Reconstitution: Dilute 25 mg of daclizumab in 50 ml of sterile 0.9% sodium chloride solution before IV admin.

Contra Indications

Patients with known hypersensitivity to daclizumab or to any components of this product.

Precautions

It is not known whether use will have a long-term effect on the ability of the immune system to respond to antigens first encountered during induced immunosuppression. Re-administration 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. Lactation Unknown if distributed in human breast milk

Pregnancy-Lactation

Interactions

Increased risk of mortality when used with anti-lymphocyte antibody therapy.

Adverse Effects

Side effects of Daclizumab : >10% Immune-mediated disorders (28-32%),Nasopharyngitis (25%),Skin reactions (19%),Upper respiratory tract infection (9-17%),Rash (9-11%) 1-10% Influenza (9%),Oropharyngeal pain (8%),Bronchitis (7%),Depression (7%),Pharyngitis (6%),Increased ALT or AST >5 x ULN (4-6%),Eczema (5%),Lymphadenopathy (5%),Rhinitis (4%),Tonsillitis (4%),Anemia (3%),Pyrexia (3%),Dermatitis (3%),Acne (3%),Seizures (1%) <1% Serious drug-related hepatic injury (0.7%),Autoimmune hepatitis (0.3%)

Mechanism of Action

Daclizumab is a humanised monoclonal murine antibody that acts as an interleukin-2 receptor antagonist. It binds to the ?-chain (CD25) of the interleukin-2 receptor on the surface of activated T-lymphocytes.