Toripalimab is an anticancer drug classified as a PD-1 inhibitor. Its main ingredient is a monoclonal antibody targeting the PD-1 receptor on the surface of T cells, and it is primarily indicated for the treatment of malignant tumors including melanoma. The drug acts by activating the body’s own immune system to fight against cancer cells.
【Generic Name】
Toripalimab
【Main Ingredient】
Monoclonal antibody targeting the PD-1 receptor on the surface of T cells
【Indications】
For patients with unresectable or metastatic advanced melanoma who have failed prior systemic therapy.
In combination with cisplatin + gemcitabine, for the first-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma.
In combination with paclitaxel + cisplatin, for the first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma.
In combination with pemetrexed + platinum-based drugs, for unresectable advanced non-squamous non-small cell lung cancer in patients with no EGFR mutation and negative ALK.
Perioperative combination with chemotherapy, followed by single-agent maintenance therapy after surgery, for adult patients with resectable stage IIA–IIIB non-small cell lung cancer.
In combination with axitinib, for the first-line treatment of intermediate- or high-risk unresectable or metastatic renal cell carcinoma.
In combination with etoposide + platinum-based drugs, for the first-line treatment of extensive-stage small cell lung cancer.
In combination with albumin-bound paclitaxel, for the first-line treatment of recurrent or metastatic triple-negative breast cancer with PD-L1 positivity (CPS ≥ 1).
【Mechanism of Action】
Under normal conditions, binding of PD-L1/PD-L2 ligands expressed by tumor cells to the PD-1 receptor on T cells inhibits T-cell proliferation and immune activity, allowing tumor cells to evade immune recognition and attack.
Toripalimab binds specifically to the PD-1 receptor on T cells, blocking the interaction between PD-L1/PD-L2 and PD-1. This “releases the brake” on immune cells, reactivating the suppressed immune system, promoting T-cell proliferation, and restoring antitumor function, thereby inhibiting tumor growth.
【Dosage Form and Strength】
Injection, two strengths:
240 mg (6 mL) per vial；
80 mg (2 mL) per vial。
【Dosage and Administration】
Route of Administration
Intravenous infusion, via a dedicated intravenous line; must not be mixed or infused with other medicinal products.
Standard Regimen
Dosed at 3 mg/kg based on body weight, once every 2 weeks. Treatment is continued until disease progression or unacceptable severe toxicity.
Special Notes
Some patients may experience transient increases in tumor size or new small lesions at the initial stage of treatment, known as pseudoprogression, which may gradually resolve subsequently.
This product must be used under the full guidance of a physician. Patients must NOT formulate a treatment regimen based solely on this leaflet.
If there is a discrepancy between the product leaflet and the dosage instructions provided by the doctor, contact the physician or pharmacist immediately for confirmation.
【Combination Therapy Regimens】
Depending on the cancer type, toripalimab may be used in combination with the following drugs as first-line therapy; perioperative regimens are marked separately:
Nasopharyngeal carcinoma: cisplatin + gemcitabine。
Esophageal squamous cell carcinoma: paclitaxel + cisplatin。
Advanced non-squamous non-small cell lung cancer (EGFR wild-type, ALK-negative): pemetrexed + platinum-based drugs。
Resectable stage IIA–IIIB non-small cell lung cancer: perioperative combination chemotherapy + single-agent maintenance after surgery。
Intermediate-/high-risk unresectable or metastatic renal cell carcinoma: axitinib。
Extensive-stage small cell lung cancer: etoposide + platinum-based drugs。
PD-L1-positive (CPS ≥ 1) recurrent or metastatic triple-negative breast cancer: albumin-bound paclitaxel。
【Contraindications】
Hypersensitivity to any ingredient of this product.
Pregnant or lactating women.
【Special Caution Populations】
Patients who drive or operate machinery: this product may cause fatigue, which may impair safety.
Elderly patients: due to special physical conditions, the risk of use requires comprehensive medical evaluation.
Precautions for Use
The above populations should be prepared with emergency measures before use, closely monitored for reactions during treatment, and instructed to contact a doctor immediately if discomfort occurs. Elderly patients require continuous monitoring throughout treatment.
【Use in Special Populations】
Pregnant/lactating women: strictly contraindicated. Use during pregnancy may increase the risk of miscarriage or fetal death, and may aggravate infection and inflammatory reactions.
Elderly patients: to be used only if judged necessary by a physician, with full monitoring.
Patients with hepatic or renal impairment: safety data are limited; use with caution.
Pediatric population: clinical studies have not been conducted; use is not recommended.
Special Tip
Women who are planning pregnancy or breastfeeding must inform their doctor before treatment.
【Drug Interactions】
Systemic corticosteroids (e.g., prednisone, dexamethasone) and other immunosuppressants (e.g., cyclosporine, tacrolimus): use before treatment may reduce the efficacy of toripalimab; these agents may be used after dosing to manage immune-related adverse reactions caused by toripalimab.
The timing and dosage of all concomitant medications must be strictly controlled by a physician. Self-administration of combination drugs is prohibited.
【Warnings and Precautions】
Before Administration
Patients taking other medications or with underlying diseases must inform their doctor in advance.
Confirm no history of hypersensitivity to any ingredient of this product; exclude pregnancy and lactation.
Use a dedicated intravenous infusion line; do not mix with other medicinal products.
During Administration
Avoid driving or operating machinery if fatigue occurs after dosing.
Closely monitor vital signs including blood pressure, heart rate, and respiration. Be alert for immune-related adverse reactions (irAEs). Continuous monitoring is required during treatment and for at least 5 months after discontinuation, as irAEs may occur at any time during or after treatment.
Do not use if the product shows abnormal color, shape, or other physical changes.
Store out of reach of children.
After Administration
If suspected immune-related reactions occur, complete examinations are required to confirm the cause. The physician will decide whether to suspend treatment based on severity, and corticosteroid therapy may be administered.
Corticosteroid therapy for irAEs requires gradual tapering over at least 1 month; abrupt discontinuation may cause recurrence or worsening of symptoms. If corticosteroids are ineffective, alternative immunosuppressive therapy should be initiated promptly.
【Adverse Reactions】
Common Adverse Reactions
Hematological abnormalities: anemia, leukopenia, thrombocytopenia, etc.
Hepatic function abnormalities: elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST).
Endocrine disorders: elevated blood glucose, hypothyroidism.
Gastrointestinal reactions: decreased appetite, upper gastrointestinal bleeding.
Others: fatigue, rash, pyrexia, pruritus, cough.
Special Immune-Related Adverse Reactions (Key Monitoring).
Organ inflammation: pneumonitis, hepatitis, nephritis, myocarditis, etc.
Endocrine diseases: thyroid dysfunction, diabetes mellitus, adrenal insufficiency.
Skin reactions: severe rash, toxic epidermal necrolysis.
Neurological symptoms: meningitis, neuritis, myasthenia gravis.
Rare Adverse Reactions (incidence ≤ 1%).
Ocular inflammation: iritis, uveitis.
Muscular injury: polymyositis, rhabdomyolysis.
Hypersensitivity-related: hemophagocytic lymphohistiocytosis, transplant rejection.
Warning Symptoms
Seek immediate medical attention if any of the following occur: persistent high fever, severe dyspnea, extensive blistering or peeling of the skin, severe headache with confusion, etc.
【Missed Dose】
This product must be used strictly under the guidance of a physician or pharmacist. Self-adjustment of the treatment regimen is not recommended. If a dose is missed, contact a healthcare professional promptly for further management.
【Overdosage】
Use strictly according to the prescribed dosage. In case of accidental overdose, monitor for reactions. If any discomfort such as dizziness, nausea, or chest tightness occurs, contact a doctor immediately for professional management, including medical observation and relevant examinations if necessary.
【Treatment Discontinuation Criteria】
Discontinuation is determined by the physician based on the type and severity of immune-related reactions and the patient’s overall condition:
Grade 2 (moderate) immune-related reactions: may require temporary treatment interruption.
Grade 3–4 (severe) immune-related reactions: temporary or permanent discontinuation.
Life-threatening Grade 4 immune-related reactions: permanent discontinuation and immediate active treatment.
Corticosteroid Therapy After Discontinuation
Corticosteroid administration for immune-related reactions must follow:
Daily dose equivalent to prednisone 1–2 mg/kg.
Gradual tapering over at least 1 month; abrupt withdrawal is prohibited.
If corticosteroids are ineffective, switch to other immunosuppressive agents promptly.
