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

Pregnancy There are no adequate data on the developmental risk associated with use of daclizumab in pregnant women Administration of the drug to monkeys during gestation resulted in embryofetal death and reduced fetal growth at maternal exposures >30 times that expected clinically Lactation Unknown if distributed in human breast milk Daclizumab was excreted in the milk of daclizumab-treated monkeys Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

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

Side 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%)

Mode 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.