Toripalimab Dosage

Medically reviewed by Drugs.com. Last updated on Dec 22, 2023.

Usual Adult Dose for Nasopharyngeal Carcinoma

Initial dose:

• First-line treatment: 240 mg IV every 3 weeks

Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

• For recurrent treatment: 3 mg/kg every 2 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Uses:

• In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC)
• As a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Pneumonitis:

• Grade 2: Withhold; resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Grades 3 or 4: Permanently discontinue

Colitis:

• Grade 2 or 3: Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Grade 4: Permanently discontinue

Hepatitis with no tumor involvement of the liver:

• AST/ALT increases to more than 3 and up to 8 times upper limit of normal (ULN) OR total bilirubin increases to more than 1.5 and up to 3 times ULN: Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• AST or ALT increases to more than 8 times ULN OR total bilirubin increases to more than 3 times ULN: Permanently discontinue

Hepatitis with tumor involvement of the liver:

• Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN OR Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN: Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Baseline AST or ALT is above the ULN and increases to more than 10 times ULN OR total bilirubin increases to more than 3 times ULN: Permanently discontinue

Endocrinopathies:

• Grades 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity. Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.

Nephritis with Renal Dysfunction:

• Grade 2 or 3 increased blood creatinine: Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Grade 4 increased blood creatinine: Permanently discontinue

Exfoliative Dermatologic Conditions:

• Suspected Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS): Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Confirmed SJS, TEN, or DRESS: Permanently discontinue

Myocarditis:

• Grades 2, 3, or 4: Permanently discontinue

Neurological toxicities:

• Grade 2: Withhold; Resume this drug in patients with complete or partial resolution to Grade 0 to 1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
• Grade 3 to 4: Permanently discontinue

Infusion-related reactions:

• Grade 1 or 2: Interrupt or slow the rate of infusion
• Grade 3 or 4: Stop infusion. Permanently discontinue.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer diluted solution intravenously.
• First Infusion: Infuse over at least 60 minutes.
• Subsequent infusions: If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.
• Do not co-administer other drugs through the same intravenous line.
• When administered on the same day as chemotherapy, this drug should be administered prior to chemotherapy.
• Refer to the Prescribing Information for cisplatin and gemcitabine for recommended dosing information.

Storage requirements:

• Store vials refrigerated at 2C to 8C (36F to 46F) in original carton to protect from light.
• Do not freeze.
• Do not shake.

If the diluted solution is not administered immediately, store either:

• At room temperature, 20 to 25 (68F to 77F), for no more than 8 hours from the time of dilution to the completion of the infusion. Discard diluted solution stored at room temperature after 8 hours.
• Refrigerated at 2C to 8C (36F to 46F) for no more than 24 hours from the time of dilution to the completion of the infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Discard the refrigerated diluted solution after 24 hours.

Reconstitution/preparation techniques:

• Refer to manufacturer product information.

IV compatibility:

• Do not co-administer other drugs through the same intravenous line.

Monitoring:
Monitor patients for hyperglycemia or other signs and symptoms of diabetes.

Patient advice:

• Advise the patient to read the US-FDA approved patient labeling (Medication Guide).
• Inform patients about the potential risks associated with immune-mediated adverse reactions, some of which may be severe or fatal, and emphasize that these reactions may occur even after discontinuation of this drug. In such cases, corticosteroid treatment, as well as interruption or discontinuation of this drug, may be necessary.
• Pneumonitis: Patients should promptly contact their healthcare provider if they experience new or worsening cough, chest pain, or shortness of breath.
• Colitis: Patients should seek immediate medical attention for symptoms such as diarrhea or severe abdominal pain.
• Hepatitis: Immediate medical attention is needed for jaundice, severe nausea or vomiting, or easy bruising or bleeding.
• Endocrinopathies: Patients should contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or Type 1 diabetes mellitus.
• Nephritis: Immediate medical attention is necessary for signs or symptoms of nephritis.

Severe skin reactions: Patients should promptly contact their healthcare provider if they notice any signs or symptoms of severe skin reactions, Stevens-Johnson Syndrome (SJS), or toxic epidermal necrolysis (TEN).

• Other immune-mediated adverse reactions: Patients should be aware that these reactions may affect any organ system, and they should seek immediate medical attention for any new or worsening signs or symptoms.
• Solid organ transplant rejection: Patients should be aware of the risk and contact their healthcare provider immediately if they experience signs or symptoms of organ transplant rejection.
• For infusion-related reactions, patients should contact their healthcare provider immediately if any signs or symptoms arise.
• Patients should be informed about the potential complications associated with allogeneic hematopoietic stem cell transplantation (HSCT).
• Females of reproductive potential should be advised that this drug can harm a fetus. They should inform their healthcare provider of any known or suspected pregnancy, use effective contraception during treatment, and continue contraception for 4 months after the last dose.
• Women should be advised not to breastfeed during this drug treatment and for 4 months after the last dose.
• Stress the importance of keeping scheduled appointments for blood work or other laboratory tests.

Frequently asked questions

• What are monoclonal antibodies?
• What is the MOA of Loqtorzi (toripalimab)?
• How does Loqtorzi work for nasopharyngeal carcinoma?
• How Accurate is Screening for Nasopharyngeal Carcinoma?

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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