What are the precautions for taking Toripalimab?

In clinical studies of Toripalimab , warnings and precautions such as immune-mediated adverse reactions, infusion-related reactions, complications and fetal harm in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) will occur.

1. Immune-mediated adverse reactions: Toripalimab is a monoclonal antibody that binds to programmed death receptor -1 (PD-1) Or PD-ligand 1 (PD-L1) drugs that block the PD-1/PD-L1 pathway, thereby unsuppressing the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions may not include all possible serious and fatal immune-mediated reactions, which may be serious or fatal, may occur in any organ system or tissue, and may affect more than one body system simultaneously, including immune-mediated pneumonitis, colitis, hepatitis and hepatotoxicity, endocrine disorders (adrenal insufficiency, hypophysitis), thyroid disorders, diabetic ketoacidosis, nephritis with renal insufficiency, and cutaneous adverse reactions.

Early recognition and management of immune-mediated adverse reactions is critical to ensure the safe use of PD-1/PD-L1 blocking antibodies. Monitor closely for signs and symptoms that may be clinical manifestations of potential immune-mediated adverse reactions. Liver enzymes, creatinine, and thyroid function were assessed at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate testing to rule out alternative causes, including infection. Establish medical management promptly, including appropriate professional consultation. Withhold or permanently discontinue toripalimab based on severity.

2. Infusion-related reactions: Including hypersensitivity reactions and allergic reactions. Monitor patients for signs and symptoms of infusion-related reactions, including chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and pyrexia. For mild (Grade 1) or moderate (Grade 2) infusion-related reactions, interrupt or slow down the infusion rate. For serious (Grade 3) or life-threatening (Grade 4) infusion-related reactions, discontinue the infusion and permanently discontinue toripalimab.

3. Complications in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT):Including hyperacute graft-versus-host disease(GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, and steroid-requiring febrile syndrome (no clear infectious cause). These complications may occur despite therapeutic intervention between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the pros and cons of using PD-1/PD-L1 blocking antibody therapy before or after allogeneic HSCT.

4. Embryo-fetal damage: According to the mechanism of action of toripalimab, taking it by pregnant women may cause harm to the fetus. Animal studies have shown that inhibition of the PD-1/PD-L1 pathway leads to an increased risk of immune-mediated rejection in the developing fetus, leading to fetal death. Inform women of the potential risk to the fetus. Advise females of childbearing potential to use effective contraception during treatment with toripalimab and for 4 months after the last dose.