Tislelizumab Dosage

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

Usual Adult Dose for Esophageal Carcinoma

150 mg IV every 2 weeks OR 200 mg IV every 3 weeks OR 300 mg IV every 4 weeks
Duration/timing of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer by IV infusion.
• For 150 and 200 mg doses: Administer the initial infusion over 60 minutes; if tolerated, all subsequent infusions may be administered over 30 minutes.
• For 300 mg doses: Administer the initial infusion over 90 minutes; if tolerated, administer the second infusion over 60 minutes. If the second infusion is tolerated, administer subsequent infusions over 30 minutes.
• Selection of patients for the first-line treatment of unresectable/metastatic esophageal squamous cell carcinoma should be based on the presence of programmed death ligand-1 (PD-L1) in tumor specimens.
• A US FDA-approved companion diagnostic for the detection of PD-L1 in such patients is not available.
• The manufacturer product information for each coadministered agent should be consulted for recommended dosing information, as appropriate.

Uses:

• In combination with platinum-containing chemotherapy, for the first-line treatment of patients with unresectable/metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (at least 1)
• As a single agent, for the treatment of patients with unresectable/metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor

Usual Adult Dose for Gastric Cancer

150 mg IV every 2 weeks OR 200 mg IV every 3 weeks OR 300 mg IV every 4 weeks
Duration/timing of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer by IV infusion.
• For 150 and 200 mg doses: Administer the initial infusion over 60 minutes; if tolerated, all subsequent infusions may be administered over 30 minutes.
• For 300 mg doses: Administer the initial infusion over 90 minutes; if tolerated, administer the second infusion over 60 minutes. If the second infusion is tolerated, administer subsequent infusions over 30 minutes.
• Selection of patients for the first-line treatment of unresectable/metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma should be based on the presence of PD-L1 in tumor specimens.
• A US FDA-approved companion diagnostic for the detection of PD-L1 in such patients is not available.
• The manufacturer product information for each coadministered agent should be consulted for recommended dosing information, as appropriate.

Use: In combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of patients with unresectable/metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (at least 1)

Renal Dose Adjustments

Renal dysfunction: Data not available

If Immune-Mediated Nephritis With Renal Dysfunction Develops During Therapy:

• Grade 2 or 3 increased blood creatinine: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• Grade 4 increased blood creatinine: Permanently discontinue this drug.

Comments:

• No clinically significant differences in the pharmacokinetics of this drug were observed based on mild to moderate renal dysfunction (CrCl at least 30 mL/min [estimated by Cockcroft-Gault]).
• The effect of severe renal dysfunction (CrCl 15 to 29 mL/min) or ESRD (CrCl less than 15 mL/min) on the pharmacokinetics of this drug is unknown.

Liver Dose Adjustments

Liver dysfunction: Data not available

If Immune-Mediated Hepatitis With No Tumor Involvement of The Liver Develops During Therapy:

• AST or ALT increases to greater than 3 to 8 times the upper limit of normal (3 to 8 x ULN) OR total bilirubin increases to greater than 1.5 to 3 x ULN: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• AST or ALT increases to greater than 8 x ULN OR total bilirubin increases to greater than 3 x ULN: Permanently discontinue this drug.

If Immune-Mediated Hepatitis With Tumor Involvement of The Liver Develops During Therapy:

• Baseline AST and ALT are up to 1 x ULN: Withhold or permanently discontinue this drug based on recommendations for hepatitis with no liver involvement.
• Baseline AST or ALT is greater than 1 to 3 x ULN and increases to greater than 5 to 10 x ULN OR baseline AST or ALT is greater than 3 to 5 x ULN and increases to greater than 8 to 10 x ULN: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• AST or ALT increases to greater than 10 x ULN OR total bilirubin increases to greater than 3 x ULN: Permanently discontinue this drug.

Comments:

• No clinically significant differences in the pharmacokinetics of this drug were observed based on mild to moderate liver dysfunction (total bilirubin up to 3 x ULN and any AST [estimated by National Cancer Institute criteria]).
• The effect of severe liver dysfunction (total bilirubin greater than 3 x ULN and any AST) on the pharmacokinetics of this drug is unknown.

Dose Adjustments

No dose reduction of this drug is recommended.

General Guidelines:

• For severe (grade 3) immune-mediated adverse reactions: Withhold this drug.
• For life-threatening (grade 4) immune-mediated adverse reactions, recurrent severe (grade 3) immune-mediated reactions that require systemic immunosuppressive therapy, or an inability to reduce corticosteroid dose to 10 mg/day or less of prednisone equivalent within 12 weeks of starting steroids: Permanently discontinue this drug.

Dosage Modifications for Immune-Mediated Adverse Reactions:
Colitis:

• Grade 2 or 3: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• Grade 4: Permanently discontinue this drug.

Endocrinopathies:

• Grade 3 or 4: This drug should be withheld until clinically stable or permanently discontinued depending on severity.

Exfoliative dermatologic conditions:

• Grade 3, or suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS): Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• Grade 4, or confirmed SJS, TEN, or DRESS: Permanently discontinue this drug.

Myocarditis:

• Grade 2, 3, or 4: Permanently discontinue this drug.

Neurological toxicities:

• Grade 2: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• Grade 3 or 4: Permanently discontinue this drug.

Pneumonitis:

• Grade 2: Withhold this drug.
• Complete or partial resolution (grades 0 to 1) after corticosteroid taper: Resume this drug.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of starting steroids: Permanently discontinue this drug.
• Grade 3 or 4 or recurrent grade 2: Permanently discontinue this drug.

Dosage Modifications for Other Adverse Reactions:
Infusion-related reactions:

• Grade 1: Slow the infusion rate by 50%.
• Grade 2: Interrupt infusion.
• Resume infusion if resolved or reduced to grade 1 and slow the infusion rate by 50% of the previous rate.
• Grade 3 or 4: Permanently discontinue this drug.

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 by IV infusion through an IV line with a sterile, nonpyrogenic, low-protein-binding 0.2 or 0.22 micron in-line or add-on filter.
• Do not coadminister other drugs through the same infusion line.
• Do not administer this drug as an IV push or single bolus injection.
• Flush the IV line at the end of infusion.

Storage requirements:

• Before dilution: Store vials in a refrigerator (2C to 8C [36F to 46F]) in the original carton to protect from light; do not freeze or shake.
• Diluted solution: If not used immediately, store IV infusion bag either at room temperature or under refrigeration.
• Store at room temperature (20C to 25C [68F to 77F]) for up to 4 hours, including preparation and infusion duration. Discard after 4 hours.
• Store under refrigeration (2C to 8C [36F to 46F]) for up to 20 hours, including preparation and infusion duration; allow to come to room temperature before administration. Discard after 20 hours.
• Do not freeze.

Reconstitution/preparation techniques:

• The solution must be diluted before administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP

Monitoring:

• Endocrine: Thyroid function (at baseline and periodically during therapy)
• General: For signs/symptoms of infusion-related reactions
• Hepatic: Liver enzymes (at baseline and periodically during therapy)
• Immunologic: For signs/symptoms of underlying immune-mediated adverse reactions
• Metabolic: For hyperglycemia or other signs/symptoms of diabetes
• Renal: Creatinine (at baseline and periodically during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Contact health care provider immediately for: new/worsening cough, chest pain, or shortness of breath; diarrhea or severe abdominal pain; or jaundice, severe nausea/vomiting, pain on the right side of the abdomen, or easy bruising/bleeding.
• Contact health care provider immediately for signs/symptoms of: hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, thyroiditis, or type 1 diabetes mellitus; nephritis; organ transplant rejection; or infusion-related reactions.
• Contact health care provider immediately for any signs/symptoms of severe skin reactions, SJS, TEN, or DRESS.
• Because immune-mediated adverse reactions can occur and may involve any organ system, contact health care provider immediately for any new/worsening signs/symptoms.
• For patients of childbearing potential: Inform health care provider of a known/suspected pregnancy; use effective contraception during therapy and for 4 months after the last dose.
• Do not breastfeed during therapy and for 4 months after the last dose.

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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