This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

On October 27, 2023, the U.S. FDA approved Toripalimab, a monoclonal antibody used as an immune checkpoint inhibitor. It helps treat cancers by blocking the PD-1 receptor, enhancing the immune system's ability to attack cancer cells.

A study on toripalimab showed that it was well tolerated, with common treatment-related adverse events being fatigue (64%) and rash (24%). No severe side effects or treatment-related deaths occurred. The objective response rate was 12.5%, and most patients maintained high PD-1 receptor occupancy on T cells. Toripalimab demonstrated anti-tumour activity in treatment-refractory advanced malignant tumours, suggesting it is a promising therapy with the potential for further exploration in other cancers and combination treatments.

Mechanism of Action of undefined

Toripalimab blocks the PD-1 receptor, preventing its interaction with the PD-L1 and PD-L2 ligands. This action releases the inhibition on T cells, enhancing their activity and restoring immune surveillance, which promotes an anti-tumour immune response. In preclinical models, blocking PD-1 activity decreased tumour growth.

Uses of undefined

Toripalimab is indicated for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine. It is also used as a single agent for the treatment of adults with recurrent, unresectable, or metastatic NPC that has progressed after platinum-containing chemotherapy.

undefined Drug administaration and Dosage available

Toripalimab is administered by your healthcare provider through an intravenous (IV) line into your vein over 30 to 60 minutes. It is typically given every two or three weeks as an IV infusion. Your healthcare provider will determine the number of treatments you need and will monitor your blood for any potential side effects. If you miss any appointments, it is important to contact your healthcare provider promptly to reschedule.

Warnings, Precautions and Side Effects of undefined

Warnings

  • Severe and fatal immune-mediated adverse reactions: Toripalimab can cause severe and fatal immune-mediated adverse reactions, affecting any organ system or tissue.
  • Timing of reactions: Immune-mediated reactions can occur at any time during treatment or even after discontinuation of Toripalimab.
  • Monitoring and intervention: Close monitoring for signs of immune-mediated reactions is essential, with immediate medical intervention required if necessary.
  • Infusion-related reactions: Toripalimab may cause severe hypersensitivity and anaphylaxis during administration.
  • Allogeneic hematopoietic stem cell transplantation (HSCT) Complications: Serious complications may arise in patients treated with Toripalimab before or after HSCT, including graft-versus-host disease (GVHD) and other transplant-related issues.
  • Embryo-fetal toxicity: Toripalimab can cause fetal harm when administered to a pregnant woman, potentially leading to fetal death.

Precautions

Doctors should closely monitor patients for any signs of immune-mediated reactions, including liver, thyroid, or lung problems, and conduct regular assessments for adverse effects. If severe reactions occur, they may need to interrupt or discontinue therapy. Additionally, they should exercise caution when administering the treatment to pregnant women due to the risk of fetal harm.

Side Effects

Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them.

Common side effects of Toripalimab are:

  • Nausea and vomiting
  • Burning or feeling of pins and needles in feet and toes
  • Decreased appetite
  • Diarrhea
  • Constipation
  • Muscle and bone pain
  • Low levels of thyroid hormone
  • Upper respiratory infection
  • Rash
  • Sleep problems
  • Fever and cough
  • Dizziness
  • Feeling generally unwell

Serious side effects of Toripalimab are:

  • Severe allergic reactions (e.g., difficulty breathing, swelling of face or throat)
  • Liver problems (e.g., yellowing of skin or eyes, dark urine)
  • Lung problems (e.g., shortness of breath, cough, chest pain)
  • Immune system problems leading to inflammation in organs (e.g., colitis, hepatitis, or pneumonitis)
  • Endocrine problems (e.g., adrenal or thyroid problems)
  • Severe infections

Word Of Advice

Monitor for immune-mediated side effects, such as pneumonitis or hepatitis, and report any unusual symptoms immediately. Regular blood tests are essential to track liver, kidney, and thyroid function. Women of reproductive age must use contraception during treatment and for 4 months after. Follow your healthcare provider’s instructions for dosage, side effect management, and timely intervention. Toripalimab does not contain a preservative. Use the diluted solution within 8 hours at room temperature (20°C to 25°C) or within 24 hours if refrigerated (2°C to 8°C). Do not freeze and discard any unused solution after these time frames.

Frequently Asked Question

References

1. Wei XL, Ren C, Wang FH, Zhang Y, Zhao HY, Zou BY, Wang ZQ, Qiu MZ, Zhang DS, Luo HY, Wang F, Yao S, Xu RH. A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors. 

https://pubmed.ncbi.nlm.nih.gov/32589350/

2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761240s000lbl.pdf

3. Zhang L, Hao B, Geng Z, Geng Q. Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China. https://pmc.ncbi.nlm.nih.gov/articles/PMC8789657/

4. https://www.ema.europa.eu/en/documents/product-information/loqtorzi-epar-product-information_en.pdf

Disclaimer

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.