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
Adverse reaction | Severity of adverse reaction* | Dosage modifications |
---|---|---|
Pneumonitis | Grade 2 | Withhold dose until grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) |
Grade 3 or 4 | Permanently discontinue | |
Hepatitis | AST or ALT >3 and ≤8 times
ULN or total bilirubin >1.5 and ≤3 times ULN |
Withhold dose until grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) |
AST or ALT >8 times ULN or total bilirubin >3 times
ULN | Permanently discontinue | |
Hepatitis (for patients with HCC) |
| Withhold dose until grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) |
AST or ALT increases to more than 10 times the ULN or total
bilirubin increases to more than 3 times the ULN |
Permanently discontinue | |
Colitis or diarrhea | Grade 2 or 3 | Withhold dose until grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) |
Grade 4 | Permanently discontinue | |
Endocrinopathies†
| Grade 2, 3, or 4 | Withhold dose
until grade 1 or resolved and clinically stable on hormone
replacement therapy |
Other immune-mediated adverse reactions involving a major organ | Grade 3 | Withhold dose until grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent) |
Grade 4 | Permanently discontinue | |
Infections | Grade 3 or 4 | Withhold dose until
grade 1 or resolved |
Infusion-related reactions | Grade 1 or 2 | Interrupt or slow the rate of infusion |
Grade 3 or 4 | Permanently discontinue | |
Persistent grade 2 or 3 adverse reaction (excluding endocrinopathies) | Grade 2 or 3 adverse reaction that does
not recover to grade 0 or 1 within 12 weeks after last TECENTRIQ
dose | Permanently discontinue |
Inability to taper corticosteroid | Inability to reduce
to less than or equal to prednisone 10 mg per day (or
equivalent) within 12 weeks after last TECENTRIQ dose | Permanently discontinue |
Recurrent grade 3 or 4 adverse reactions | Recurrent
grade 3 or 4 (severe or life-threatening) adverse
reactions | Permanently discontinue |
ALT=alanine aminotransferase; AST=aspartate
aminotransferase; ULN=upper limit of normal.
*Graded per
National Cancer Institute Common Terminology Criteria for Adverse
Events version 4.0 (NCI CTCAE v4.0).
†Including
but not limited to hypophysitis, adrenal insufficiency,
hyperthyroidism, and type 1 diabetes mellitus.
Refer to the Prescribing Information for COTELLIC and ZELBORAF for dosage modification information.