Tislelizumab Dosage

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Usual Adult Dose for Esophageal Carcinoma

200 mg every 3 weeks as an IV infusion
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.

Use: Unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor

Renal Dose Adjustments

Renal Dysfunction:

• Mild and Moderate Renal Dysfunction (ClCr 30 mL/min or greater, estimated by Cockcroft-Gault): No adjustment recommended.
• Severe Renal Dysfunction (ClCr between 15 and 29 mL/min): Data not available
• End Stage Renal Disease (ClCr less than 15 mL/min): Data not available

• In case of Nephritis with Renal Dysfunction:
• Grade 2 or 3 increased blood creatinine: Withhold treatment - Resume in patients with complete or partial resolution (grades 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 with increased blood creatinine: Permanently discontinue

Liver Dose Adjustments

Liver Dysfunction:

• Mild and Moderate Liver Dysfunction (total bilirubin 3 times or lower the upper limit of normal [ULN] and any AST): No adjustment recommended.
• Severe Liver Dysfunction (total bilirubin greater than 3 times ULN and any AST): Data not available

• Hepatitis with no tumor involvement of the liver:
• AST or ALT increases to more than 3 and up to 8 times ULN or total bilirubin increases to more than 1.5 and up to 3 times ULN: Withhold treatment - Resume in patients with complete or partial resolution (grades 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 treatment - Resume in patients with complete or partial resolution (grades 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

Dose Adjustments

General Guidelines:

• No dose reduction of this drug is recommended.
• In general, withhold treatment for severe (grade 3) immune-mediated adverse reactions.
• Permanently discontinue treatment for life-threatening (grade 4) immune-mediated adverse reactions, recurrent grade 3 reactions that require immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for adverse reactions that require management different from the general guidelines:

• Pneumonitis:
• Grade 2: Withhold treatment - Resume in patients with complete or partial resolution (grades 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 or 4 or recurrent grade 2: Permanently discontinue

• Colitis:
• Grade 2 or 3: Withhold treatment - Resume in patients with complete or partial resolution (grades 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

• Endocrinopathies:
• Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity

• Exfoliative Dermatologic Conditions:
• Grade 3, or suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS): Withhold treatment - Resume in patients with complete or partial resolution (grades 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 or confirmed SJS, TEN, or DRESS: Permanently discontinue

• Myocarditis:
• Grade 2,3 or 4: Permanently discontinue

• Other infusion-related adverse reactions:
• Grade 1: Slow infusion rate by 50%
• Grade 2: Interrupt infusion (resume if resolved or decreased to grade 1, and slow rate of infusion by 50% of the previous rate).
• Grade 3 or 4: Permanently discontinue

Precautions

US FDA requires a medication guide to assure safe use. For additional information go to: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

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:

• Inspect visually for particulate matter and discoloration prior to administration.
• Discard the vial if the solution is cloudy, discolored, or contains visible particles.
• Do not shake the vial.
• Administer the first infusion over 60 minutes. If tolerated, subsequent infusions may be administered over 30 minutes.
• Do not coadminister other drugs in the same infusion line.
• Do not administer as an IV push or single bolus injection.
• The IV line should be flushed at the end of the infusion.

Storage requirements:
Diluted Solution:

• This product does not contain any preservatives.
• Store at room temperature for no more than 4 hours (including infusion time) from the time of dilution, or under refrigeration at 2C to 8C (36F to 46F) for no more than 20 hours.
• If refrigerated, allow the diluted solution to come to room temperature prior to administering the infusion.
• Do not freeze the diluted solution.

Preparation techniques:

• This drug must be reconstituted and further diluted before IV infusion.
• Consult the manufacturer product information for further preparation instructions.

IV compatibility:

• Should be diluted into an IV infusion bag containing 0.9% Sodium Chloride

General:

• Report suspected adverse reactions to BeiGene at 1-877-828-5596 or FDA at 1-800-FDA=1088 or www.fda.gov/medwatch.

Monitoring:

• Signs and symptoms of infusion-related reactions
• Liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment
• Symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions
• Hyperglycemia or other signs and symptoms of diabetes

Patient advice:

• Read the US FDA-approved patient medication guide.
• Patients of childbearing potential: Notify health care provider of a known/suspected pregnancy.
• Seek medical attention if any new symptoms of infusion-related reactions occur.

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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