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Tevimbra Dosage

Generic name: TISLELIZUMAB 10mg in 1mL
Dosage form: injection, solution, concentrate

Medically reviewed by Drugs.com. Last updated on Mar 16, 2024.

Recommended Dosage

The recommended dose of TEVIMBRA is 200 mg administered as an intravenous infusion once every 3 weeks, until disease progression or unacceptable toxicity.

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

Dosage Modifications for Adverse Reactions

No dose reduction of TEVIMBRA is recommended. In general, withhold TEVIMBRA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TEVIMBRA for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic 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 [see Warnings and Precautions (5.1)].

Dosage modifications for TEVIMBRA for adverse reactions that require management different from these general guidelines are summarized in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity of Adverse Reaction* Dosage Modifications
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal, SJS = Stevens-Johnson syndrome, TEN = toxic epidermal necrolysis.
*
Based on Common Terminology Criteria for Adverse Events Version 4.
†
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.
‡
If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue TEVIMBRA based on recommendations for hepatitis with no liver involvement.
§
Resume infusion if resolved or decreased to Grade 1, and slow rate of infusion by 50% of the previous rate.
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis Grade 2 Withhold†
Grade 3 or 4 or recurrent Grade 2 Permanently discontinue
Colitis Grade 2 or 3 Withhold†
Grade 4 Permanently discontinue
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†
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†
AST or ALT increases to more than 8 times ULN
or
Total bilirubin increases to more than 3 times ULN		 Permanently discontinue
Endocrinopathies Grade 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with Renal Dysfunction Grade 2 or 3 increased blood creatinine Withhold†
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative Dermatologic Conditions Grade 3, or suspected SJS, TEN, or DRESS Withhold†
Grade 4, or confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Other Adverse Reactions
Infusion-Related Reactions [see Warnings and Precautions (5.2)]. Grade 1 Slow infusion rate by 50%
Grade 2 Interrupt infusion§
Grade 3 or 4 Permanently discontinue

Preparation and Administration

Preparation

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. TEVIMBRA is a clear to slightly opalescent, colorless to slightly yellow solution. Discard the vial if the solution is cloudy, discolored, or contains visible particles. Do not shake the vial.

Prepare the solution for infusion as follows:

  • Withdraw 20 mL of TEVIMBRA from two vials of TEVIMBRA 100 mg (for a total of 200 mg in 20 mL).
  • Transfer solution into an intravenous (IV) infusion bag containing 0.9% Sodium Chloride Injection, USP to prepare an infusion with a final concentration between 2 mg/mL to 5 mg/mL.
  • Mix diluted solution by gentle inversion to avoid foaming or excessive shearing of the solution. Do not shake.
  • TEVIMBRA is for single use only. Discard any unused portion left in the vial.

Storage of Diluted Solution

This product does not contain any preservatives. Store the TEVIMBRA diluted solution either:

  • At room temperature for no more than 4 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of the infusion
  • Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 20 hours. If refrigerated, allow the diluted solution to come to room temperature prior to administration

Discard the diluted solution after 4 hours at room temperature or after 20 hours under refrigeration.

Do not freeze the diluted solution.

Administration

  • Administer diluted solution by intravenous infusion through an intravenous line with a sterile, nonpyrogenic, low-protein binding 0.2 micron or 0.22 micron in-line or add-on filter.
  • The initial infusion should be delivered over 60 minutes. If tolerated, all subsequent infusions may be administered over 30 minutes.
  • Do not coadminister other drugs through the same infusion line.
  • Do not administer TEVIMBRA as an intravenous push or single bolus injection.
  • The intravenous line must be flushed at the end of infusion.

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