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Atezolizumab / hyaluronidase

Class
Targeted therapy
Subclass
Anti-PD-L1 monoclonal antibody / recombinant human hyaluronidase combination
Substance name
Atezolizumab / hyaluronidase, atezolizumab / hyaluronidase-tqjs
Brand names
Tecentriq Hybreza®
Contains
Atezolizumab
Hyaluronidase (recombinant)
Common formulations
Solution for injection
Dosage and administration
Adults patients
Alveolar soft part sarcoma • Unresectable or metastatic
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered subcutaneously in the thigh over approximately 7 minutes.
HCC • Unresectable or metastatic, not treated with systemic therapy
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered in combination with bevacizumab (before bevacizumab if given on the same day). Administered subcutaneously in the thigh over approximately 7 minutes.
Melanoma in patients with BRAF V600 mutation • Unresectable or metastatic
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered in combination with cobimetinib and vemurafenib, following a 28-day cycle of cobimetinib and vemurafenib. Administered subcutaneously in the thigh over approximately 7 minutes.
Non-small cell lung cancer • Stage II-IIIA, PD-L1 expression on ≥ 1% of tumor cells, adjuvant setting
•
1,875/30,000 mg/unit(s) SC q3 weeks for up to 1 year or until disease progression or unacceptable toxicity
Administered after resection and up to 4 cycles of platinum-based chemotherapy. Administered subcutaneously in the thigh over approximately 7 minutes.
Non-small cell lung cancer • Metastatic, progressing during or after platinum-based chemotherapy
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered subcutaneously in the thigh over approximately 7 minutes.
Non-small cell lung cancer without EGFR mutation, ALK rearrangement • Metastatic, PD-L1 expression on ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥ 10% of the tumor area
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered subcutaneously in the thigh over approximately 7 minutes.
Non-small cell lung cancer without EGFR mutation, ALK rearrangement • Non-squamous, metastatic
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered in combination with paclitaxel protein-bound and carboplatin (before chemotherapy if given on the same day). Administered subcutaneously in the thigh over approximately 7 minutes.
Small cell lung cancer • Extensive-stage
•
1,875/30,000 mg/unit(s) SC q3 weeks until disease progression or unacceptable toxicity
Administered in combination with carboplatin and etoposide (before bevacizumab if given on the same day). Administered subcutaneously in the thigh over approximately 7 minutes.
Indications for use
Labeled indications
Adults
•
Treatment of alveolar soft part sarcoma (unresectable or metastatic)
•
Treatment of HCC (unresectable or metastatic, not treated with systemic therapy)
•
Treatment of melanoma in patients with BRAF V600 mutation (unresectable or metastatic)
•
Treatment of non-small cell lung cancer (metastatic, progressing in patients undergoing or after platinum-based chemotherapy)
•
Treatment of non-small cell lung cancer (stage II-IIIA, PD-L1 expression on ≥ 1% of tumor cells, adjuvant setting)
•
Treatment of non-small cell lung cancer without EGFR mutation, ALK rearrangement (metastatic, PD-L1 expression on ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥ 10% of the tumor area)
•
Treatment of non-small cell lung cancer without EGFR mutation, ALK rearrangement (non-squamous, metastatic)
•
Treatment of small cell lung cancer (extensive-stage)
Safety risks
Contraindications
Hypersensitivity to atezolizumab/hyaluronidase or its components
Warnings and precautions
GvHD, hepatic veno-occlusive disease
•
Use caution in patients undergoing allogeneic HSCT before or after PD-1/PD-L1 blocking antibody treatment.
Immune-mediated adverse reactions
•
Maintain a high level of suspicion, as atezolizumab has been associated with an increased risk of severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, thyroid disorders, T1DM, nephritis, dermatitis, and others. Obtain baseline and periodic LFTs, serum creatinine, and thyroid function tests to minimize immune-mediated adverse reactions. Monitor closely for symptoms and signs. Consider administering preemptive corticosteroids for grade ≥ 2 reactions. Withhold atezolizumab/hyaluronidase for grade 2 adverse reactions, and monitor closely. Consider administering corticosteroids if symptoms persist or worsen. Withhold atezolizumab/hyaluronidase for grade 3 reactions and administer corticosteroids at 1-2 mg/kg/day of prednisone (or equivalent). Taper corticosteroids gradually over at least 1 month, aiming to reach ≤ 10 mg/day. Discontinue both corticosteroids and treatment if there is no improvement within 12 weeks or corticosteroids cannot be tapered. Permanently discontinue treatment for grade 4 reactions or recurrent grade 3 reactions requiring systemic immunosuppressive therapy. Consider administering additional systemic immunosuppressants if corticosteroids alone are insufficient to control symptoms.
Infusion-related reactions
•
Maintain a high level of suspicion, as atezolizumab/hyaluronidase can cause severe or life-threatening infusion-related reactions, including grade 3 adverse reactions. Consider administering premedication with subsequent doses in patients with a history of grade 1-2 infusion-related reactions. Pause or slow the rate of injection for grade 1 or 2 reactions, and permanently discontinue atezolizumab/hyaluronidase for grade 3 or 4 reactions.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 30 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Evidence of fetal harm in animals. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for at least 5 months after the last dose.
Breastfeeding
Do not use during breastfeeding.
•
Advise females not to breastfeed for 5 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, ↓ blood lymphocyte count, ↓ serum albumin, ↓ serum calcium, ↓ serum sodium, ↑ serum ALP, ↑ serum calcium, ↑ INR, ↑ serum creatinine, ↑ serum potassium, ↑ serum transaminases, arthralgia, constipation, cough, dyspnea, fatigue, loss of appetite, musculoskeletal pain
Common 1-10%
•
Fever, injection site reactions
Unknown frequency
•
Pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, thyroiditis, nephritis, dermatitis, myocarditis, pericarditis, vasculitis, meningitis, encephalitis, myelitis, myasthenia gravis, Guillain-Barré syndrome, uveitis, iritis, acute pancreatitis, gastritis, myositis, rhabdomyolysis, hypoparathyroidism, hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, immune thrombocytopenic purpura, graft-versus-host disease, hepatic veno-occlusive disease
Interactions
Drug(s)
Check Interactions
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