Atezolizumab / Hyaluronidase Dosage

Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.

Usual Adult Dose for Non-Small Cell Lung Cancer

Atezolizumab 1875 mg-hyaluronidase 30,000 units subcutaneously every 3 weeks
Duration of therapy:

• As adjuvant monotherapy: Up to 1 year, unless there is disease recurrence or unacceptable toxicity
• For all other indications: Until disease progression or unacceptable toxicity

Comments:

• Administer this drug subcutaneously into the thigh over approximately 7 minutes.
• During combination therapy, this drug should be given before chemotherapy and bevacizumab when administered on the same day.
• When selecting patients for treatment, perform genomic tumor testing using an FDA-approved test.
• Consult the manufacturer product information of the therapeutic agents given in combination with this drug for dosing recommendations.

Use: Non-small cell lung cancer (NSCLC):

• As adjuvant monotherapy following resection and platinum-based chemotherapy, for the treatment of stage II to IIIA NSCLC with tumors that have programmed death-ligand 1 (PD-L1) expression on at least 1% of tumor cells
• As monotherapy, for the first-line treatment of metastatic NSCLC with tumors that have high PD-L1

expression (PD-L1 stained at least 50% of tumor cells, or PD-L1 stained tumor-infiltrating immune cells covering at least 10% of the tumor area) with no EGFR or ALK genomic tumor aberrations

• As monotherapy, for the treatment of metastatic NSCLC with disease progression during or following platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should

have had disease progression on an FDA approved therapy for NSCLC while harboring these aberrations prior to receiving this drug.

• In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of 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 metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations

Usual Adult Dose for Small Cell Lung Cancer

Atezolizumab 1875 mg-hyaluronidase 30,000 units subcutaneously every 3 weeks, in combination with carboplatin and etoposide
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer this drug subcutaneously into the thigh over approximately 7 minutes.
• This drug should be given prior to chemotherapy when administered on the same day.
• Refer to the manufacturer product information of carboplatin and etoposide for dosing recommendations.

Use: In combination with carboplatin and etoposide, for the first-line treatment of extensive-stage small cell lung cancer

Usual Adult Dose for Hepatocellular Carcinoma

Atezolizumab 1875 mg-hyaluronidase 30,000 units subcutaneously every 3 weeks, in combination with bevacizumab 15 mg/kg IV every 3 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer this drug subcutaneously into the thigh over approximately 7 minutes.
• This drug should be given prior to bevacizumab when administered on the same day.
• Refer to the bevacizumab manufacturer product information before starting treatment.

Use: In combination with bevacizumab, for the treatment of unresectable or metastatic hepatocellular carcinoma not previously treated with systemic therapy

Usual Adult Dose for Melanoma - Metastatic

Atezolizumab 1875 mg-hyaluronidase 30,000 units subcutaneously every 3 weeks, in combination with cobimetinib and vemurafenib
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• A 28-day treatment cycle of cobimetinib and vemurafenib is recommended prior to initiating therapy.
• Administer this drug subcutaneously into the thigh over approximately 7 minutes.
• Confirm the presence of a BRAF V600 tumor mutation using an FDA-approved test.
• Refer to the manufacturer product information of cobimetinib and vemurafenib before starting treatment.

Use: In combination with cobimetinib and vemurafenib, for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma

Usual Adult Dose for Soft Tissue Sarcoma

Atezolizumab 1875 mg-hyaluronidase 30,000 units subcutaneously every 3 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Administer this drug subcutaneously into the thigh over approximately 7 minutes.

Use: As monotherapy, for the treatment of unresectable or metastatic alveolar soft part sarcoma

Renal Dose Adjustments

IMMUNE-MEDIATED NEPHRITIS WITH RENAL DYSFUNCTION:

• Grades 2 or 3 increased blood creatinine: Withhold treatment. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved or unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue.
• Grades 4 increased blood creatinine: Permanently discontinue therapy

Liver Dose Adjustments

IMMUNE-MEDIATED HEPATITIS:
Hepatitis With Tumor Involvement of Liver:

• If baseline AST or ALT is more than 1 to 3 times the upper limit of normal (3 x ULN) and increases greater than 5 to 10 x ULN, OR if baseline AST or ALT is more than 3 to 5 x ULN and increases greater than 8 to 10 x ULN: Withhold treatment. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved or unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue therapy.
• If AST or ALT increases to more than 10 x ULN, OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy
• If baseline AST and ALT are at the ULN or below: Withhold or permanently discontinue therapy based on recommendations for hepatitis with no liver involvement.

Hepatitis WithOUT Tumor Involvement of Liver:

• If AST or ALT increases more than 3 to 8 x ULN, OR total bilirubin increases more than 1.5 to 3 x ULN: Withhold treatment. Withhold treatment. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved or unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue therapy.
• If AST or ALT increases more than 8 x ULN, OR total bilirubin increases more than 3 x ULN: Permanently discontinue therapy

Dose Adjustments

GENERAL CONSIDERATIONS:

• No dose reductions are recommended.
• In general, withhold therapy for severe (Grade 3) immune-mediated adverse reactions.
• Permanently discontinue treatment for:
• Life-threatening (Grade 4) immune-mediated adverse reactions
• Recurrent severe (Grade 3) immune-mediated adverse reactions requiring systemic immunosuppression
• Inability to reduce the daily corticosteroid dosage to 10 mg or less of prednisone (or equivalent) within 12 weeks of initiating corticosteroids

IMMUNE MEDIATED ADVERSE REACTIONS:
Colitis:

• Grade 2 or 3: Withhold treatment. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved OR unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue therapy.
• Grade 4: Permanently discontinue therapy

Endocrinopathies:

• Grades 3 or 4: Withhold therapy until clinically stable, or permanently discontinue depending on severity

Exfoliative Dermatologic Conditions:

• Suspected Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis (TEN): Withhold treatment
• Confirmed SJS, DRESS, or TEN: Permanently discontinue therapy

Myocarditis or Pericarditis:

• Grades 2, 3, or 4: Permanently discontinue therapy

Neurological Toxicities:

• Grade 2: Withhold therapy. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved OR unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue therapy.
• Grade 3 or 4: Permanently discontinue therapy

Pneumonitis:

• Grade 2: Withhold treatment. May resume therapy after complete or partial resolution (Grade 0 to 1) after corticosteroid taper. If within 12 weeks of initiating steroids either complete or partial resolution is not achieved OR unable to reduce prednisone to 10 mg per day or less [or equivalent], then permanently discontinue therapy.
• Grade 3 or 4: Permanently discontinue therapy

OTHER ADVERSE REACTIONS:
Infusion-Related Reactions:

• Grade 1 or 2: Pause or slow the rate of injection; consider premedication with antipyretic and antihistamines for subsequent doses.
• Grade 3 or 4: Permanently discontinue therapy

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to hyaluronidase or to any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous use in the thigh only; do NOT administer IV.
• This drug should be given by a health care professional.
• Inject subcutaneously into healthy skin over about 7 minutes, avoiding red, bruised, tender, or hard areas.
• Do not administer any remaining volume in the tubing to the patient.
• Alternate injection sites ensuring at least 2.5 cm between sites.
• When using concomitant subcutaneous drugs, administer those products at sites other than the thigh.
• This drug cannot be substituted for IV atezolizumab products due to different dosage recommendations.
• Patients currently on IV atezolizumab may switch to subcutaneous atezolizumab at the time of the next scheduled dose.

Pretreatment for patients with melanoma: Administer cobimetinib and vemurafenib prior to initiating therapy

• Days 1 to 21: Cobimetinib 60 mg orally once a day in combination with vemurafenib 960 mg orally twice a day.
• Days 22 to 28: Withhold cobimetinib, and administer vemurafenib 720 mg orally twice a day

Storage requirements:

• Refrigerate vials at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze or shake.
• Unpunctured vial: May be stored at room temperature [up to 25C (77F)] under ambient light for up to 4 hours prior to preparation for administration.
• Prepared syringe: If not for immediate use, do not attach a subcutaneous administration set. Store capped syringe at room temperature under ambient light for up to 8 hours OR refrigerated for up to 72 hours.
• Do not store prepared syringe attached to an already-primed subcutaneous administration set.

Reconstitution/preparation techniques:

• Consult the manufacturer product information prior to product preparation.
• Avoid potential errors by checking vial label to ensure formulation is for subcutaneous use.
• Allow refrigerated vials to come to room temperature before preparation; do not shake or dilute.
• The priming volume of the subcutaneous administration set should NOT exceed 0.5 mL.
• Immediately administer syringe with primed subcutaneous administration set to avoid needle clogging.

Compatibility:

• This drug is compatible with stainless steel transfer and injection needles, and polypropylene, polycarbonate, polyvinyl chloride, and polyurethane syringe material and subcutaneous administration sets.

General:

• Information on FDA-approved tests for the determination of PD-L1 expression in NSCLC or for detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

Monitoring:

• Immunologic: For signs/symptoms of immune-mediated adverse reactions (during therapy); monitor liver

enzymes, creatinine, and thyroid function for early identification of immune reactions (at baseline and periodically during therapy)

• Local: For signs/symptoms of infusion-related reactions (during therapy)
• Metabolic: For hyperglycemia or other signs/symptoms of diabetes (during therapy)
• Other: For complications in patients who received allogenic hematopoietic stem cell transplant (HSCT) before or after treatment with this drug (during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Understand the risk of immune-mediated adverse reactions associated with use of this drug.
• Contact your health care provider immediately if signs/symptoms of immune-mediate reactions occur.
• Notify your health care provider for signs or symptoms of infusion-related adverse events.
• Recognize the risk associated with therapy if this drug is used prior to or after an allogeneic HSCT.
• Patients of childbearing potential: Understand this drug may cause fetal harm. Use effective contraception during therapy and for 5 months after the last dose.
• Breastfeeding is not recommended during therapy and for 5 months after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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