TECENTRIQ + COTELLIC® (cobimetinib) + ZELBORAF® (vemurafenib)

Targeted Therapy Run-in Followed by Triplet Dosing With TECENTRIQ 1

Dosing information for COTELLIC and ZELBORAF is based on the IMspire150 trial; TECENTRIQ was administered q2w in IMspire150. Visualization of vials is illustrative and does not represent actual vial usage.
bid=twice a day; IV=intravenous; qd=every day; q2w=every 2 weeks.

TECENTRIQ can be administered in 30-minute infusions, if the initial 60-minute infusion is tolerated 1


  • Do not administer TECENTRIQ as an IV push or bolus
  • Do not co-administer other drugs through the same IV line
  • Refer to the Prescribing Information for COTELLIC and ZELBORAF for recommended dosing information 

Dosage modifications from the TECENTRIQ Prescribing Information 1*

No dose reduction for TECENTRIQ is recommended. In general, withhold TECENTRIQ for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TECENTRIQ 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 or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for TECENTRIQ for adverse reactions that require management different from these general guidelines are summarized in the following table:
 

Adverse reaction Severity Dosage modification
Pneumonitis Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 or 3 Withhold
Grade 4 Permanently discontinue
Hepatitis with no tumor involvement of the liver AST or ALT >3 and ≤8 times ULN
or
Total bilirubin >1.5 and ≤3 times ULN
Withhold
AST or ALT >8 times ULN
or
Total bilirubin >3 times ULN
Permanently discontinue
Hepatitis with tumor involvement of the liver§ Baseline AST or ALT is >1 and ≤3 times ULN and increases to >5 and ≤10 times ULN
or
Baseline AST or ALT is >3 and ≤5 times ULN and increases to >8 and ≤10 times ULN
Withhold
AST or ALT >10 times ULN
or
Total bilirubin >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 Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Neurological toxicities Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Infusion-related reactions Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue


ALT=alanine aminotransferase; AST=aspartate aminotransferase; DRESS=drug rash with eosinophilia and systemic symptoms; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.
*Refer to the Prescribing Information for nab-pac for dosage modification and AR management.
Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
Resume in patients with complete or partial resolution (grade 0-1) 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 TECENTRIQ based on recommendations for hepatitis with no liver involvement.

Refer to the Prescribing Information for COTELLIC and ZELBORAF for dosage modification information.