Drug Detail:Tecentriq (Atezolizumab [ a-te-zoe-liz-ue-mab ])
Generic Name: ATEZOLIZUMAB 1200mg in 20mL
Dosage Form: injection, solution
Drug Class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
Patient Selection for Treatment of Non-Small Cell Lung Cancer and Melanoma
Select patients with Stage II to IIIA non-small cell lung cancer for treatment with TECENTRIQ as a single agent based on PD-L1 expression on tumor cells [see Clinical Studies (14.1)].
Select patients with first-line metastatic non-small cell lung cancer for treatment with TECENTRIQ as a single agent based on the PD-L1 expression on tumor cells or on tumor-infiltrating immune cells [see Clinical Studies (14.1)].
Information on FDA-approved tests for the determination of PD-L1 expression in metastatic non-small cell lung cancer are available at: http://www.fda.gov/CompanionDiagnostics.
Select patients with unresectable or metastatic melanoma for treatment with TECENTRIQ in combination with cobimetinib and vemurafenib after confirming the presence of a BRAF V600 mutation [see Clinical Studies (14.4)]. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
Recommended Dosage
The recommended dosages of TECENTRIQ administered intravenously as a single agent are presented in Table 1.
| * 60-minute intravenous infusion. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. | ||
| Metastatic NSCLC |
|
Until disease progression or unacceptable toxicity |
| Adjuvant Treatment of NSCLC |
|
Up to one year, unless there is disease recurrence or unacceptable toxicity |
| ASPS (adult) |
|
Until disease progression or unacceptable toxicity |
| ASPS (pediatric, 2 years of age and older) | 15 mg/kg (up to a maximum 1200 mg) every 3 weeks | |
The recommended intravenous dosages of TECENTRIQ in combination with other therapeutic agents are presented in Table 2. Refer to the respective Prescribing Information for each therapeutic agent administered in combination with TECENTRIQ for the recommended dosage information, as appropriate.
| Indication | Recommended Dosage of TECENTRIQ* | Duration of Therapy |
|---|---|---|
|
||
| NSCLC |
|
Until disease progression or unacceptable toxicity |
| SCLC |
|
|
| HCC |
|
|
| Melanoma |
Prior to initiating TECENTRIQ, patients should receive a 28 day treatment cycle of cobimetinib 60 mg orally once daily (21 days on and 7 days off) and vemurafenib 960 mg orally twice daily from Days 1-21 and vemurafenib 720 mg orally twice daily from Days 22-28. |
|
Dosage Modifications for Adverse Reactions
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 Table 3.
| Adverse Reaction | Severity* | Dosage Modification |
|---|---|---|
| ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson syndrome, TEN = toxic epidermal necrolysis | ||
|
||
| Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)] | ||
| Pneumonitis | Grade 2 | Withhold† |
| Grades 3 or 4 | Permanently discontinue | |
| Colitis | Grades 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 10 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue | |
| Endocrinopathies | Grades 3 or 4 | Withhold until clinically stable or permanently discontinue depending on severity |
| Nephritis with Renal Dysfunction | Grades 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 or Pericarditis | Grades 2, 3, or 4 | Permanently discontinue |
| Neurological Toxicities | Grade 2 | Withhold† |
| Grades 3 or 4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Infusion-Related Reactions [see Warnings and Precautions (5.2)] | Grades 1 or 2 | Interrupt or slow the rate of infusion |
| Grades 3 or 4 | Permanently discontinue | |
Preparation and Administration
Preparation
Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial.
Prepare the solution for infusion as follows:
- Select the appropriate vial(s) based on the prescribed dose.
- Withdraw the required volume of TECENTRIQ from the vial(s) using sterile needle and syringe.
- Dilute to a final concentration between 3.2 mg/mL and 16.8 mg/mL in a polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag containing 0.9% Sodium Chloride Injection, USP.
- Dilute with only 0.9% Sodium Chloride Injection, USP.
- Mix diluted solution by gentle inversion. Do not shake.
- Discard used or empty vials of TECENTRIQ.
Storage of Infusion Solution
This product does not contain a preservative.
Administer immediately once prepared. If diluted TECENTRIQ infusion solution is not used immediately, store solution either:
- At room temperature for no more than 6 hours from the time of preparation. This includes room temperature storage of the infusion in the infusion bag and time for administration of the infusion, or
- Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from time of preparation.
Do not freeze.
Do not shake.
Administration
Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
Do not coadminister other drugs through the same intravenous line.
Do not administer as an intravenous push or bolus.
