LOQTORZI: Uses, Dosage & Side Effects
A PD-1 immune checkpoint inhibitor (monoclonal antibody) for the treatment of recurrent or metastatic nasopharyngeal carcinoma and advanced esophageal squamous cell carcinoma
LOQTORZI (toripalimab) is a humanized monoclonal antibody and PD-1 immune checkpoint inhibitor used in the treatment of certain advanced cancers in adults. It works by blocking the PD-1 receptor on T cells, restoring the immune system’s ability to recognize and destroy cancer cells. LOQTORZI is approved for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin-based chemotherapy, and for advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. Administered as an intravenous infusion every three weeks in a hospital or clinic setting, LOQTORZI represents an important advancement in immuno-oncology for these difficult-to-treat malignancies.
Quick Facts: LOQTORZI
Key Takeaways
- LOQTORZI (toripalimab) is a PD-1 immune checkpoint inhibitor that restores the immune system’s ability to fight cancer by blocking the PD-1 receptor on T cells, preventing cancer cells from evading immune detection.
- It is approved for two indications in adults: recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin-based chemotherapy, and advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy.
- LOQTORZI can cause serious immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin reactions, and myocarditis – these require close monitoring and may necessitate corticosteroid treatment or discontinuation.
- The recommended dose is 240 mg administered as an intravenous infusion every 3 weeks, with the first infusion given over at least 60 minutes and subsequent infusions potentially shortened to 30 minutes if well tolerated.
- Women of childbearing potential must use effective contraception during treatment and for at least 4 months after the last dose; breastfeeding must be avoided during the same period.
What Is LOQTORZI and What Is It Used For?
LOQTORZI contains the active substance toripalimab, a humanized immunoglobulin G4 (IgG4) monoclonal antibody designed to target the programmed death-1 receptor (PD-1) on the surface of T cells. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to bind to specific targets in the body. Toripalimab was developed to specifically recognize and bind to PD-1, a key immune checkpoint receptor that plays a central role in regulating T-cell activity and immune responses against cancer.
The PD-1 pathway is one of the most important immune checkpoints exploited by cancer cells to evade destruction. Under normal circumstances, PD-1 serves as a “brake” on the immune system, preventing T cells from attacking healthy tissues. However, many types of cancer cells produce proteins called PD-L1 and PD-L2 that bind to PD-1 on T cells, effectively sending an inhibitory signal that switches off the T cells and prevents them from attacking the tumor. By binding to PD-1, toripalimab blocks this interaction and prevents the inhibitory signal from being transmitted. This restores the T cells’ ability to recognize and destroy cancer cells, essentially releasing the immune system’s natural “brakes” and allowing a more vigorous antitumor response.
This mechanism of action – known as immune checkpoint inhibition – has transformed the treatment landscape for many types of cancer over the past decade. PD-1 inhibitors have shown remarkable clinical activity across a wide range of tumor types, and toripalimab has demonstrated particular effectiveness in nasopharyngeal carcinoma and esophageal squamous cell carcinoma, two cancers that are more prevalent in certain geographic regions and for which effective systemic treatment options have historically been limited.
LOQTORZI is approved for use in adults for the following indications:
- Recurrent or metastatic nasopharyngeal carcinoma (NPC): LOQTORZI is used in combination with cisplatin-based chemotherapy (typically cisplatin and gemcitabine) for the treatment of nasopharyngeal carcinoma that has spread to other parts of the body or has returned after previous treatment and cannot be removed by surgery. Nasopharyngeal carcinoma is a type of head and neck cancer that originates in the nasopharynx – the upper part of the throat behind the nose, near the base of the skull. This cancer is closely associated with Epstein-Barr virus (EBV) infection and is particularly common in Southeast Asia, southern China, and North Africa. The JUPITER-02 trial demonstrated that adding toripalimab to gemcitabine-cisplatin chemotherapy significantly improved progression-free survival compared with chemotherapy alone.
- Advanced or metastatic esophageal squamous cell carcinoma (ESCC): LOQTORZI is used in combination with chemotherapy for the treatment of esophageal squamous cell carcinoma that cannot be removed by surgery, has returned after previous treatment, or has spread to other parts of the body. Esophageal squamous cell carcinoma is a type of cancer affecting the lining of the esophagus (the tube connecting the throat to the stomach) and is one of the most common and aggressive forms of esophageal cancer worldwide. The RATIONALE-306/JUPITER-06 studies supported the efficacy of toripalimab combined with chemotherapy in this setting.
In both approved indications, LOQTORZI is given in combination with chemotherapy, not as a standalone treatment. The combination approach leverages the direct cytotoxic effects of chemotherapy together with the immune-boosting action of toripalimab to achieve more comprehensive and durable tumor control. Your oncologist will determine the most appropriate chemotherapy regimen to pair with LOQTORZI based on your specific diagnosis, disease characteristics, and overall health status.
LOQTORZI belongs to a class of cancer immunotherapy drugs called PD-1 inhibitors. Unlike chemotherapy, which directly kills cancer cells, LOQTORZI works by empowering your own immune system to fight the cancer. By blocking the PD-1 “off switch” on T cells, it prevents cancer cells from hiding from immune detection. Because the immune system can develop a “memory” against cancer cells, some patients may continue to benefit from treatment even after it has ended.
What Should You Know Before Receiving LOQTORZI?
Contraindications
There are specific situations in which LOQTORZI must not be used. Your doctor will assess these before starting treatment.
- Hypersensitivity: Do not receive LOQTORZI if you are allergic to toripalimab or any of the other ingredients in the product, including citric acid monohydrate, mannitol, polysorbate 80, sodium chloride, or sodium citrate dihydrate.
Warnings and Precautions
LOQTORZI can cause your immune system to attack healthy organs and tissues in your body. These immune-mediated reactions can affect virtually any organ system and may be severe or life-threatening. They can occur at any time during treatment or even weeks to months after your last dose. Seek immediate medical attention if you develop new or worsening symptoms affecting your lungs, liver, bowels, kidneys, skin, heart, muscles, or hormone-producing glands.
Before starting treatment with LOQTORZI, inform your doctor if any of the following conditions apply to you:
- Autoimmune disease: If you have an autoimmune condition (a disease in which the body attacks its own cells), such as rheumatoid arthritis, lupus, inflammatory bowel disease, or multiple sclerosis. LOQTORZI works by activating the immune system, which could potentially worsen autoimmune conditions.
- Lung problems: If you have or have had lung inflammation (pneumonitis) or breathing difficulties. LOQTORZI can cause immune-mediated pneumonitis, which may be more dangerous in patients with pre-existing lung disease.
- Brain metastases: If you have been told that your cancer has spread to the brain, as this may affect treatment decisions and monitoring requirements.
- Viral hepatitis: If you have active hepatitis B (HBV) or hepatitis C (HCV) infection. LOQTORZI can cause immune-mediated hepatitis, and pre-existing viral hepatitis may complicate the clinical picture and treatment decisions.
- Active tuberculosis (TB): If you have or are being treated for active tuberculosis, as immunotherapy may affect the course of the infection.
- HIV/AIDS: If you have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), as the immune-modulating effects of LOQTORZI may interact with this condition.
- Liver or kidney damage: If you have significant liver or kidney impairment, as this may affect how LOQTORZI is handled by your body and may increase the risk of certain side effects.
- Organ or bone marrow transplant: If you have previously received a solid organ transplant (e.g., kidney, lung, heart, or liver) or an allogeneic stem cell (bone marrow) transplant using donor cells. LOQTORZI can trigger transplant rejection or graft-versus-host disease (GvHD), both of which can be severe and potentially fatal.
- Immunosuppressive medications: If you are currently taking medications that suppress the immune system, such as systemic corticosteroids (e.g., prednisone). These drugs may reduce the effectiveness of LOQTORZI. However, once treatment has started, your doctor may prescribe corticosteroids to manage immune-mediated side effects.
During treatment with LOQTORZI, you should be aware of the following potentially serious immune-mediated adverse reactions. Contact your doctor immediately if you experience any of these:
- Pneumonitis (lung inflammation): Symptoms include shortness of breath, chest pain, and new or worsening cough. This can be life-threatening and may require treatment with high-dose corticosteroids and possibly permanent discontinuation of LOQTORZI.
- Colitis (inflammation of the colon): Symptoms include diarrhea (often watery or bloody), increased frequency of bowel movements, severe abdominal pain or cramping, and mucus or blood in stool. Severe colitis can lead to bowel perforation if not treated promptly.
- Hepatitis (liver inflammation): Symptoms include nausea, vomiting, loss of appetite, pain on the right side of the abdomen, yellowing of the skin or whites of the eyes (jaundice), dark urine, and a tendency to bleed or bruise more easily than usual. Liver function tests will be monitored regularly during treatment.
- Endocrinopathies (hormonal gland inflammation): These include thyroid disorders (hypothyroidism and hyperthyroidism), adrenal insufficiency, pituitary inflammation (hypophysitis), and type 1 diabetes including diabetic ketoacidosis. Symptoms vary widely and may include fatigue, weight changes, rapid heartbeat, increased sweating, hair loss, cold sensitivity, constipation, muscle pain, dizziness, headaches, increased thirst, increased urination, and changes in blood sugar levels.
- Nephritis (kidney inflammation): Symptoms include changes in the amount or color of urine, blood in urine, swelling of the ankles, or loss of appetite. Kidney function will be monitored through regular blood and urine tests.
- Skin reactions: Symptoms include rash, itching, blisters, peeling skin, sores, and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area. Severe skin reactions can be life-threatening.
- Myocarditis (heart muscle inflammation): Symptoms include shortness of breath, irregular heartbeat, chest pain, and fatigue. This is a rare but potentially fatal complication that requires immediate medical attention.
- Myositis (muscle inflammation): Symptoms include muscle pain, tenderness, and weakness. In severe cases, myositis can affect the muscles involved in breathing.
- Pancreatitis (pancreas inflammation): Symptoms include severe abdominal pain, nausea, and vomiting.
- Infusion reactions: Symptoms during or shortly after infusion may include fever, chills, itching, rash, nausea, and low blood pressure. Your medical team will monitor you during each infusion.
Your doctor will perform regular blood tests and clinical assessments before and during treatment to monitor for these potential complications. Before treatment begins, baseline blood tests will be taken to check your liver function, kidney function, thyroid function, and blood cell counts. These tests will be repeated at regular intervals throughout your treatment course.
Children and Adolescents
LOQTORZI should not be used in children and adolescents under 18 years of age, as it has not been studied in this age group. The safety and efficacy of toripalimab in pediatric patients have not been established.
Other Medications and LOQTORZI
Tell your doctor or nurse about all medications you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. In particular, inform your doctor if you are taking immunosuppressive medications such as systemic corticosteroids (e.g., prednisone, dexamethasone), as these may reduce the effectiveness of LOQTORZI by dampening the immune response that the drug is designed to enhance.
When you are already on LOQTORZI treatment, your doctor may prescribe corticosteroids to manage immune-mediated side effects. You may also receive corticosteroids before your LOQTORZI infusion as part of the chemotherapy premedication regimen to prevent nausea, vomiting, and allergic reactions caused by the chemotherapy agents. Do not start any new medications during treatment without first discussing them with your doctor.
Pregnancy and Breastfeeding
LOQTORZI should not be used during pregnancy unless your doctor specifically recommends it due to compelling clinical necessity. Based on its mechanism of action – blocking PD-1 to activate the immune system – toripalimab has the potential to cause fetal harm or fetal death. The PD-1/PD-L1 pathway plays an important role in maintaining immune tolerance during pregnancy, and disrupting this pathway could lead to immune-mediated rejection of the fetus.
If you are a woman of childbearing potential, you must use an effective method of contraception while being treated with LOQTORZI and for at least 4 months after receiving the last dose. If you are pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor before receiving LOQTORZI.
You must not breastfeed during treatment with LOQTORZI and for at least 4 months after the last dose. It is not known whether toripalimab passes into breast milk, and a risk to the breastfed infant cannot be excluded.
Driving and Operating Machinery
LOQTORZI may have a minor effect on the ability to drive and use machines. Dizziness and fatigue are possible side effects. Do not drive or operate machinery if you are experiencing these symptoms until you are confident that you can do so safely.
Important Information About Ingredients
LOQTORZI contains less than 1 mmol (23 mg) of sodium per dose and is therefore essentially sodium-free. However, before administration, LOQTORZI is diluted with a sodium chloride solution. If you are on a sodium-restricted diet, discuss this with your doctor.
How Does LOQTORZI Interact with Other Drugs?
Drug interactions with LOQTORZI differ from those of conventional small-molecule drugs because toripalimab is a large protein (monoclonal antibody) that is degraded through normal protein catabolism rather than being metabolized by liver enzymes. This means it has a lower potential for traditional pharmacokinetic drug interactions. However, pharmacodynamic interactions – where the combined effects of drugs on the body are altered – are clinically important and must be considered.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Systemic corticosteroids (e.g., prednisone, dexamethasone) | May reduce the immune-activating effect of toripalimab, potentially decreasing anticancer efficacy | Avoid at baseline before starting LOQTORZI; acceptable for managing immune-related side effects or as chemotherapy premedication |
| Other immunosuppressive agents (e.g., azathioprine, mycophenolate, tacrolimus) | Counteract the immune activation produced by LOQTORZI, potentially reducing antitumor activity | Avoid use before or during treatment unless clinically essential for immune-mediated toxicity management |
| Live vaccines (e.g., MMR, varicella, BCG, yellow fever) | Risk of vaccine-strain infection due to altered immune function; vaccine efficacy may also be compromised | Avoid during treatment and for several months after the last dose; inactivated vaccines are preferred |
| Other PD-1/PD-L1 inhibitors or immunotherapy agents | Increased risk of immune-mediated adverse reactions due to additive or synergistic immune activation | Do not combine with other checkpoint inhibitors unless part of a supervised clinical trial |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Cisplatin/Gemcitabine (combination chemotherapy) | No significant pharmacokinetic interaction; additive myelosuppressive effects expected | Approved combination; monitor blood counts closely as per standard practice |
| 5-Fluorouracil/Cisplatin (combination chemotherapy) | No significant pharmacokinetic interaction; additive side effects (mucositis, myelosuppression) | Used in combination for ESCC; standard monitoring applies |
| Antiemetics (ondansetron, granisetron) | No known interaction with toripalimab | Commonly co-administered as supportive care during chemotherapy |
| Growth factors (G-CSF: filgrastim, pegfilgrastim) | No negative interaction; used to manage chemotherapy-induced neutropenia | May be given as supportive care; standard practice when combined with myelosuppressive chemotherapy |
LOQTORZI is given in combination with established chemotherapy regimens. When administered with cisplatin-based chemotherapy for NPC or with platinum-fluoropyrimidine-based chemotherapy for ESCC, the safety profiles of the individual agents must also be considered. Always inform your oncologist about every medication, supplement, or herbal product you are taking, as interactions may be identified on an individual basis.
What Is the Correct Dosage of LOQTORZI?
LOQTORZI is always administered by a doctor or nurse as an intravenous infusion in a hospital or clinic setting, under the supervision of a physician experienced in cancer treatment. You will not self-administer this medication at home. Your medical team will monitor you during and after each infusion for potential reactions.
Standard Dosing
LOQTORZI for Nasopharyngeal Carcinoma (NPC)
Dose: 240 mg intravenously every 3 weeks (21-day cycles)
Combination: Given with cisplatin-based chemotherapy (typically gemcitabine and cisplatin)
Sequence: LOQTORZI is administered first, followed by the chemotherapy drugs
Duration: Treatment continues until disease progression, unacceptable toxicity, or as determined by the treating physician
LOQTORZI for Esophageal Squamous Cell Carcinoma (ESCC)
Dose: 240 mg intravenously every 3 weeks (21-day cycles)
Combination: Given with chemotherapy (platinum-based and/or fluoropyrimidine-based regimens)
Sequence: LOQTORZI is administered first, followed by the chemotherapy drugs
Duration: Treatment continues until disease progression, unacceptable toxicity, or as determined by the treating physician
Infusion Details
Each dose of LOQTORZI is given as an intravenous infusion (drip into a vein). The timing is as follows:
- First infusion: Administered over at least 60 minutes. This longer infusion time allows your medical team to monitor you closely for any infusion-related reactions.
- Subsequent infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be shortened to approximately 30 minutes.
Before administration, the concentrated LOQTORZI solution is diluted in a 100 mL or 250 mL infusion bag containing sodium chloride 9 mg/mL (0.9%) injection solution. The final concentration of the diluted solution should be between 1 mg/mL and 3 mg/mL. The diluted solution is administered through an infusion pump via an in-line filter with a pore size of 0.2 or 0.22 micrometers. No other medications should be given through the same intravenous line simultaneously.
Missed Dose
If you miss a scheduled appointment for your LOQTORZI infusion, contact your doctor or the hospital immediately to reschedule. It is very important not to miss a dose of this medication. Your doctor will determine the best schedule for continuing your treatment if a dose has been delayed.
Dose Modifications
LOQTORZI does not have dose reductions in the traditional sense. Instead, your doctor may manage immune-mediated side effects by:
- Withholding treatment: Temporarily delaying LOQTORZI until the side effect improves to an acceptable level, typically with the help of corticosteroid therapy.
- Permanently discontinuing treatment: Stopping LOQTORZI entirely if a severe or life-threatening immune-mediated reaction occurs that does not respond adequately to corticosteroids, or if the same type of severe reaction recurs.
Children
LOQTORZI is intended for use in adult patients only. The safety and efficacy of toripalimab in children and adolescents below 18 years of age have not been established, and it is not recommended for use in this population.
LOQTORZI is always prepared and administered by trained healthcare professionals in a hospital or specialized clinic setting. Each infusion is prepared individually, and you will be monitored during and after administration for any adverse reactions. The treating physician determines the number of treatment cycles based on your response and tolerability.
Patient Card
You will receive a patient card from your doctor that contains important safety information from the patient information leaflet. It is important to carry this card with you at all times and to show it to your partner, caregivers, or any healthcare professionals you may visit, as the immune-mediated side effects of LOQTORZI can occur even after treatment has ended and may require specific management by a physician familiar with these effects.
What Are the Side Effects of LOQTORZI?
Like all medicines, LOQTORZI can cause side effects, although not everyone gets them. Because LOQTORZI activates the immune system, many of its side effects are caused by the immune system attacking healthy tissues – these are known as immune-mediated adverse reactions. These can be serious, may occur at any time during treatment or even after the last dose, and may require treatment with corticosteroids or permanent discontinuation of LOQTORZI. Your medical team will monitor you closely throughout treatment.
Immune-Mediated Adverse Reactions
The following immune-mediated side effects have been reported with LOQTORZI. These can be serious and life-threatening. If you experience any of these, seek immediate medical attention.
Uncommon Immune-Mediated Reactions
May affect up to 1 in 100 people
- Pneumonitis (lung inflammation)
- Immune-related skin reactions (dermatitis)
- Hepatitis (liver inflammation)
- Myocarditis (heart muscle inflammation)
- Myositis (muscle inflammation)
- Colitis (colon inflammation)
- Adrenal insufficiency
- Nephritis (kidney inflammation)
- Immune-mediated thrombocytopenia (low platelets)
- Thyroid disorders (hyperthyroidism, thyroiditis, hypothyroidism)
- Type 1 diabetes / hyperglycemia
- Hypophysitis (pituitary inflammation)
- Infusion-related reactions
Rare Immune-Mediated Reactions
May affect up to 1 in 1,000 people
- Pancreatitis (pancreas inflammation)
- Cystitis (bladder inflammation)
- Arthritis / arthralgia (joint inflammation)
Not Known (Reported for This Drug Class)
Frequency cannot be estimated from available data
- Encephalitis (brain inflammation) – confusion, fever, memory problems, seizures
- Myasthenic syndrome – muscle weakness and rapid fatigue
- Guillain-Barré syndrome – limb weakness, tingling, double vision
- Rhabdomyolysis – muscle stiffness, spasms, dark urine
- Organ transplant rejection
- Uveitis (eye inflammation)
General Side Effects from Clinical Trials
Very Common
May affect more than 1 in 10 people
- Decreased appetite and weight loss
- Fatigue and fever
- Cough
- Abdominal pain, nausea, vomiting
- Diarrhea / colitis and constipation
- Neuropathy (nerve damage – numbness, tingling, pain)
- Pain (general)
- Anemia (low red blood cells)
- Thrombocytopenia (low platelets)
- Leukopenia (low white blood cells) and neutropenia (low neutrophils)
- Upper respiratory tract infection
- Hyponatremia (low sodium), hypokalemia (low potassium), hypoproteinemia (low protein)
- Hyperglycemia (high blood sugar) and hyperuricemia (high uric acid)
- Hyperbilirubinemia (elevated bilirubin)
- Proteinuria (protein in urine) and hematuria (blood in urine)
- Rash, dermatitis, itching (pruritus)
- Musculoskeletal pain
- Hypothyroidism (underactive thyroid)
- Arrhythmia (irregular heartbeat)
- Abnormal liver function tests, thyroid tests, lipid levels, and urinalysis
Common
May affect up to 1 in 10 people
- Gastrointestinal: vomiting, bloating, acid reflux, blood in stool, decreased bowel motility
- Oral problems: mouth ulcers, dry mouth, toothache
- Hyperthyroidism (overactive thyroid)
- Chills, flu-like illness
- Eye problems: dry or itchy eyes, cataracts
- Kidney damage
- Shortness of breath, lung inflammation, pleural effusion, nosebleeds
- Sleep problems, mood changes
- Night sweats, increased sweating
- Neuropathy (numbness, weakness, tingling, burning), headache, dizziness
- Lung, urinary tract, ear, and oral fungal infections; herpes virus infection
- Skin color changes (vitiligo), hair loss, dry skin, photosensitivity
- Muscle weakness, liver inflammation
- High or low blood pressure, blood clots
- Hearing loss, tinnitus, blurred vision
Uncommon
May affect up to 1 in 100 people
- Stomach inflammation (gastritis)
- Pancreatitis (pancreas inflammation)
- Type 1 diabetes, including diabetic ketoacidosis
- Difficulty regulating body temperature, increased thirst
- Breathing difficulties, wheezing, hoarseness
- Infusion-related reactions
- Change in taste, drowsiness, speech disturbance
- Conjunctivitis, gum inflammation, skin infections
- Joint inflammation, muscle spasms
- Liver pain, gallbladder inflammation
- Adrenal insufficiency, hypophysitis, thyroiditis
- Pericardial effusion, myocarditis, cardiac damage
- Tumor hemorrhage, tumor rupture
- Eye inflammation, optic nerve swelling
- Allergic reaction
Rare
May affect up to 1 in 1,000 people
- Pneumomediastinum (air in chest cavity), increased sputum production
- Vocal cord thickening, intestinal diverticula
- Severe skin inflammation (thickened, scaly skin, chronic itching)
- Myositis with rash (dermatomyositis)
- Subcutaneous fat inflammation, skin bruising
- Hyperparathyroidism, decreased pituitary activity
- Limb paralysis, attention disturbance
- Aortic aneurysm
- Menstrual irregularities, vaginal discharge
- Hearing loss, balance disturbance
- Eyelid swelling, farsightedness
Changes in Laboratory Test Results
LOQTORZI, alone or in combination with chemotherapy, can cause changes in laboratory test results. Your doctor will perform regular blood tests to monitor these. Important changes may include:
- Abnormal liver function tests (elevated AST, ALT, GGT, alkaline phosphatase)
- Abnormal kidney function tests (elevated creatinine, uric acid, urea)
- Elevated pancreatic enzymes (lipase and amylase)
- Electrolyte disturbances (low or high levels of potassium, calcium, sodium, magnesium, phosphate)
- Elevated muscle enzymes (CK/CPK)
- Abnormal thyroid tests and thyroid antibodies
- Changes in blood cell counts (white blood cells, red blood cells, platelets)
- Abnormal blood lipids and proteins
- Abnormal acid-base balance
If you experience any side effects, including those not mentioned here, tell your doctor or nurse. You can also report suspected side effects to your national medicines regulatory authority (e.g., the EMA in Europe, FDA MedWatch in the United States, or MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing safety profile of LOQTORZI.
How Should LOQTORZI Be Stored?
LOQTORZI will be administered to you at a hospital or clinic, and healthcare professionals will be responsible for its storage. Keep this medicine out of the sight and reach of children.
- Unopened vials: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Light protection: Keep the vial in the original carton to protect from light.
- Diluted solution: If not used immediately, the diluted solution may be stored at room temperature (up to 25°C) for up to 8 hours, or at 2°C to 8°C for up to 24 hours from the time of dilution to the end of administration.
- Expiry date: Do not use after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
- Inspection: Do not use if the solution contains visible particles. LOQTORZI should appear as a clear to slightly opalescent, colorless to slightly yellow solution.
Do not save any unused medicine for reuse. Unused medicine and waste material should be disposed of in accordance with local regulations. These measures help protect the environment.
What Does LOQTORZI Contain?
Active Substance
The active substance is toripalimab. Each single-use vial contains 240 mg of toripalimab in 6 mL of concentrate for solution for infusion, providing a concentration of 40 mg/mL. Toripalimab is a humanized IgG4 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Inactive Ingredients (Excipients)
- Citric acid monohydrate (E330)
- Mannitol (E421)
- Polysorbate 80 (E433)
- Sodium chloride
- Sodium citrate dihydrate (E331)
- Water for injections
Appearance
LOQTORZI is supplied as a clear to slightly opalescent, colorless to slightly yellow solution, essentially free of visible particles. It is provided in glass vials containing 6 mL of concentrate. Each carton contains one vial.
Manufacturer
The marketing authorization holder is Topalliance Biosciences Europe Limited, Dublin, Ireland. The manufacturer is Eurofins PHAST GmbH, Homburg, Germany. For more information, contact the local representative of the marketing authorization holder in your country.
Frequently Asked Questions About LOQTORZI
LOQTORZI (toripalimab) is a PD-1 immune checkpoint inhibitor approved for two cancer types in adults: recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin-based chemotherapy, and advanced or metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. In both indications, it is used when the cancer has spread, returned after previous treatment, or cannot be surgically removed.
LOQTORZI is given as an intravenous infusion every 3 weeks (21-day cycles). The first infusion takes at least 60 minutes. If well tolerated, subsequent infusions may be shortened to approximately 30 minutes. Treatment continues until disease progression, unacceptable side effects, or as decided by the treating oncologist. On days when both LOQTORZI and chemotherapy are given, LOQTORZI is always administered first.
Immune-mediated side effects occur because LOQTORZI removes the “brakes” on the immune system by blocking PD-1. While this helps T cells attack cancer, it can also lead to the immune system mistakenly attacking healthy organs and tissues. These reactions can affect virtually any part of the body – including the lungs, liver, colon, kidneys, skin, heart, muscles, and hormone-producing glands. They can be serious or life-threatening and may occur at any time during or even after treatment. Early recognition and treatment (usually with corticosteroids) is essential for managing these reactions effectively.
LOQTORZI should not be used during pregnancy unless absolutely necessary due to its potential to cause fetal harm. The PD-1 pathway plays a role in maintaining immune tolerance during pregnancy. Women who can become pregnant must use effective contraception during treatment and for at least 4 months after the last dose. Breastfeeding is not recommended during treatment and for at least 4 months after the last dose, as it is not known whether toripalimab passes into breast milk.
LOQTORZI (toripalimab) shares the same mechanism of action as other PD-1 inhibitors such as pembrolizumab and nivolumab – blocking the PD-1 receptor to unleash the immune response against cancer. However, toripalimab has a unique binding epitope on PD-1 and was specifically studied and approved for nasopharyngeal carcinoma and esophageal squamous cell carcinoma. It was the first PD-1 inhibitor to receive FDA approval specifically for nasopharyngeal carcinoma, filling an important unmet medical need for this cancer type. The flat dosing regimen of 240 mg every 3 weeks also offers a simplified dosing approach compared to weight-based dosing used by some other PD-1 inhibitors.
If you experience any new or worsening symptoms during treatment with LOQTORZI, contact your doctor or medical team immediately. This is especially important for symptoms that could indicate immune-mediated reactions: shortness of breath, persistent cough, severe diarrhea, abdominal pain, skin rash or blistering, yellowing of skin or eyes, dark urine, severe fatigue, excessive thirst or urination, chest pain, or irregular heartbeat. Carry your patient card at all times so any healthcare provider can identify that you are receiving immunotherapy and provide appropriate care.
References
- European Medicines Agency (EMA). LOQTORZI (toripalimab) – Summary of Product Characteristics. Authorized 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). LOQTORZI (toripalimab-tpzi) Prescribing Information. Approved October 2023. Available from: FDA Drug Label.
- Mai HQ, Chen QY, Chen D, et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: the JUPITER-02 randomized clinical trial. JAMA. 2023;330(20):1961–1970. doi:10.1001/jama.2023.20181.
- Mai HQ, Chen QY, Chen D, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial (JUPITER-02). Nat Med. 2021;27(9):1536–1543. doi:10.1038/s41591-021-01444-0.
- Xu RH, Luo H, Lu J, et al. JUPITER-06: A randomized, double-blind, phase III study of toripalimab versus placebo in combination with first-line chemotherapy for treatment-naive advanced or metastatic esophageal squamous cell carcinoma. J Clin Oncol. 2022;40(suppl 4):abstr 294. doi:10.1200/JCO.2022.40.4_suppl.294.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Head and Neck Cancers. Version 1.2025.
- Bossi P, Chan AT, Licitra L, et al. Nasopharyngeal carcinoma: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(4):452–465. doi:10.1016/j.annonc.2020.12.007.
- Ajani JA, D’Amico TA, Bentrem DJ, et al. Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023;21(4):393–422.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Tang B, Chi Z, Chen Y, et al. Safety, efficacy, and biomarker analysis of toripalimab in previously treated advanced melanoma: results of the POLARIS-01 multicenter phase II trial. Clin Cancer Res. 2020;26(16):4250–4259. doi:10.1158/1078-0432.CCR-19-3922.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, immuno-oncology, and clinical pharmacology.
Medical Content
iMedic Oncology Editorial Team – specialist physicians in medical oncology with clinical experience in immunotherapy and head and neck cancers
Medical Review
iMedic Medical Review Board – independent panel verifying accuracy against EMA SmPC, FDA label, NCCN, and ESMO guidelines
Pharmacology Review
iMedic Clinical Pharmacology Team – specialists in immunotherapy pharmacology, drug interactions, and medication safety
Accessibility & SEO
iMedic Digital Health Team – ensuring WCAG 2.2 AAA compliance and optimal search visibility
All content follows the GRADE evidence framework and is reviewed according to international medical guidelines. iMedic receives no commercial funding from pharmaceutical companies.