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Trumab

Brand Name:

AtemabTM

Generic Name:

Atezolizumab Injection

Strength:

60 mg/mL

Description:

Solution/concentrate for intravenous infusion

Pack Size:

1's





Trumab

Brand Name:

AtemabTM

Generic Name:

Atezolizumab Injection

Strength:

840 mg/14 mL

Description:

Solution/concentrate for intravenous infusions

Pack Size:

1's





Trumab

Brand Name:

AtemabTM

Generic Name:

Atezolizumab Injection

Strength:

1200 mg/20 mL

Description:

Solution/concentrate for intravenous infusions

Pack Size:

1's





* Storage Conditions: Store the vial under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the vial in the original carton/package to protect from light until time of use. After dilution, the prepared infusion solution may be stored at room temperature at 20°C to 25°C (68°F to 77°F) for no more than 8 hours from preparation to the end of infusion, or under refrigeration at 2°C to 8°C (36°F to 46°F), protected from light, for no more than 7 days from preparation to the end of infusion. Discard unused portion.

FDA Approved Indications


Atezolizumab is indicated for the treatment of:

  1. Urothelial Carcinoma:
    • For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test, or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)
  2. Non-Small Cell Lung Cancer (NSCLC):
    • As adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
    • For the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA approved test, with no EGFR or ALK genomic tumor aberrations.
    • In combination with bevacizumab, paclitaxel, and carboplatin, for the first line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
    • In combination with paclitaxel protein-bound and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
    • For the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Atezolizumab.
  3. Small Cell Lung Cancer (SCLC)
    • In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
  4. Hepatocellular Carcinoma (HCC)
    • In combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
  5. Melanoma
    • In combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

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