Administer as an intravenous infusion over 30 minutes. Do not administer as an intravenous push or bolus. Use an in-line, sterile, non-pyrogenic, low protein-binding filter (0.2 to 1.2 micron) for infusion. Administer under the supervision of a healthcare professional experienced in anticancer therapy and management of immune-related adverse reactions.

Oncodex is a monoclonal antibody that binds to the PD-1 (Programmed Death-1) receptor, blocking its interaction with PD-L1 and PD-L2 ligands. This blockade releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, and thereby restores the activity of effector T cells.

• •Hypersensitivity to the active substance or any excipients.
• •Patients with severe autoimmune conditions requiring systemic immunosuppression.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Reconstituted solution (if applicable) should be used immediately or within 24 hours.

There is no specific information on overdose with Oncodex. In case of an overdose, patients should be closely monitored for signs and symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.

Pregnancy Category D. Oncodex can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment and for 5 months following the last dose. It is not known whether Oncodex is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment and for 5 months following the last dose.