Zenapax Infusion
Daclizumab
5mg/ml
F. Hoffmann-La Roche Ltd.
| Pack size | 5ml Vial |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | IBN KHALDOON DRUG STORE |
| Retail Price | 2578.50 AED |
Indications
Zenapax Infusion 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.
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.
Note
Zenapax 5mg/ml Infusion manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Daclizumab. Zenapax is availble in United Arab Emirates.
Farmaco UAE drug index information on Zenapax Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.