Tecentriq Hybreza Dosage

Generic name: ATEZOLIZUMAB 1875mg in 15mL, HYALURONIDASE (HUMAN RECOMBINANT) 30000U in 15mL
Dosage form: injection, solution
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Drugs.com. Last updated on Sep 25, 2024.

Patient Selection for Treatment of Non-Small Cell Lung Cancer and Melanoma

Select adult patients with:

Stage II to IIIA NSCLC for adjuvant treatment with TECENTRIQ HYBREZA as a monotherapy (following tumor resection and platinum-based chemotherapy) based on PD-L1 expression on tumor cells.
Metastatic NSCLC for first-line treatment with TECENTRIQ HYBREZA as monotherapy based on the PD-L1 expression on tumor cells or on tumor-infiltrating immune cells.
Unresectable or metastatic melanoma for treatment with TECENTRIQ HYBREZA in combination with cobimetinib and vemurafenib after confirming the presence of a BRAF V600 mutation.

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

Important Dosage and Administration Information

TECENTRIQ HYBREZA has different recommended dosage and administration than intravenous atezolizumab products.
- To reduce the risk of medication errors, prior to administration, check the vial labels to ensure that the drug being prepared is subcutaneously administered TECENTRIQ HYBREZA and not intravenously administered atezolizumab.
- Do not substitute TECENTRIQ HYBREZA for or with intravenous atezolizumab products because they have different recommended dosages.
- Adult patients who are treated with intravenous atezolizumab can switch to subcutaneous TECENTRIQ HYBREZA at their next scheduled dose.
- Adult patients who are treated with TECENTRIQ HYBREZA can switch to intravenous atezolizumab at their next scheduled dose.
TECENTRIQ HYBREZA is not indicated for use in pediatric patients.
TECENTRIQ HYBREZA is for subcutaneous use in the thigh only. Administer over approximately 7 minutes. Inject in healthy skin and never into areas where the skin is red, bruised, tender, or hard.
When possible, alternate injections between the left and right thigh. Ensure the injection site is at least 2.5 cm from the previous site.
Do not administer TECENTRIQ HYBREZA intravenously.
TECENTRIQ HYBREZA must be administered by a healthcare professional.
Do not administer the remaining volume in the tubing to the patient.
If using concomitant subcutaneous drugs, administer at sites other than the thighs.

Recommended Dosage and Administration Instructions

The recommended dosage of TECENTRIQ HYBREZA is one 15 mL injection (containing 1,875 mg of atezolizumab and 30,000 units of hyaluronidase, referred to as TECENTRIQ HYBREZA) administered subcutaneously in the thigh over approximately 7 minutes every 3 weeks.

Administration instructions for TECENTRIQ HYBREZA as monotherapy and in combination with other therapeutic agents are presented in Table 1. For the recommended dosage of each therapeutic agent administered in combination with TECENTRIQ HYBREZA refer to the product's respective Prescribing Information.

Table 1: TECENTRIQ HYBREZA Administration Instructions and Duration of Therapy
Indication	Administration Instructions for TECENTRIQ HYBREZA	Duration of Therapy
Adjuvant Treatment of Non-Small Cell Lung Cancer	Administer TECENTRIQ HYBREZA as monotherapy	Up to one year, unless there is disease recurrence or unacceptable toxicity
Metastatic Non-Small Cell Lung Cancer	Administer TECENTRIQ HYBREZA as monotherapy	Until disease progression or unacceptable toxicity
Non-Small Cell Lung Cancer	Administer TECENTRIQ HYBREZA prior to chemotherapy and bevacizumab when given on the same day.	Until disease progression or unacceptable toxicity
Small Cell Lung Cancer	Administer TECENTRIQ HYBREZA prior to chemotherapy when given on the same day.
Hepatocellular Carcinoma	Administer TECENTRIQ HYBREZA prior to bevacizumab when given on the same day. Bevacizumab is administered intravenously at 15 mg/kg every 3 weeks.
Melanoma	Prior to initiating TECENTRIQ HYBREZA, patients should receive the following 28-day treatment cycle of cobimetinib and vemurafenib: Days 1 to 21: cobimetinib 60 mg orally once daily in combination with 960 mg of oral vemurafenib twice daily Days 22 to 28: withhold cobimetinib and administer vemurafenib 720 mg orally twice daily
Alveolar Soft Part Sarcoma	Administer TECENTRIQ HYBREZA as monotherapy	Until disease progression or unacceptable toxicity

Dosage Modifications for Adverse Reactions

No dose reduction for TECENTRIQ HYBREZA is recommended. In general, withhold TECENTRIQ HYBREZA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue TECENTRIQ HYBREZA 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 the daily corticosteroid dosage to 10 mg or less of prednisone or equivalent corticosteroid dosage within 12 weeks of initiating corticosteroids.

Dosage modifications for TECENTRIQ HYBREZA for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
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
* Based on Common Terminology Criteria for Adverse Events (CTCAE), version 5 † Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids ‡ If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue TECENTRIQ HYBREZA based on recommendations for hepatitis with no liver involvement
Immune-Mediated Adverse Reactions
Pneumonitis	Grade 2	Withhold†
Pneumonitis	Grades 3 or 4	Permanently discontinue
Colitis	Grades 2 or 3	Withhold†
Colitis	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†
Hepatitis with no tumor involvement of the liver	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†
Hepatitis with tumor involvement of the liver‡	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†
Nephritis with Renal Dysfunction	Grade 4 increased blood creatinine	Permanently discontinue
Exfoliative Dermatologic Conditions	Suspected SJS, TEN, or DRESS	Withhold
Exfoliative Dermatologic Conditions	Confirmed SJS, TEN, or DRESS	Permanently discontinue
Myocarditis or pericarditis	Grades 2, 3, or 4	Permanently discontinue
Neurological Toxicities	Grade 2	Withhold†
Neurological Toxicities	Grades 3 or 4	Permanently discontinue
Other Adverse Reactions
Infusion-Related Reactions	Grades 1 or 2	Pause or slow the rate of injection Premedication with antipyretic and antihistamines may be considered for subsequent doses.
Infusion-Related Reactions	Grades 3 or 4	Permanently discontinue

Preparation Instructions

TECENTRIQ HYBREZA does not contain any antimicrobial preservative. If the TECENTRIQ HYBREZA dose is not administered immediately, refer to "Storage Instructions".

Remove the vial from the refrigerator and allow the solution to acclimate to room temperature. Visually inspect for particulate matter and discoloration prior to administration. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
Do not shake, freeze, or dilute.
The unpunctured vial may be stored at room temperature in ambient light for a maximum of 4 hours prior to the preparation for administration.
Use an 18-gauge transfer needle and syringe to withdraw the entire contents of the TECENTRIQ HYBREZA solution from the vial. Discard the vial and any residual drug remaining.
TECENTRIQ HYBREZA is compatible with stainless steel transfer and injection needles, and polypropylene, polycarbonate, polyvinyl chloride, and polyurethane syringe material and subcutaneous administration sets.
Remove the transfer needle from the syringe and replace it with a subcutaneous administration set (e.g. winged/butterfly) containing 23-gauge, 24-gauge, or 25-gauge hypodermic needle and with a priming volume that does not exceed 0.5 mL for administration.
Prime the subcutaneous administration line with TECENTRIQ HYBREZA to eliminate the air in the line and stop when the fluid reaches the needle.
Ensure the syringe contains exactly 15 mL of TECENTRIQ HYBREZA after priming the administration line by expelling any excess volume from the syringe.
Administer immediately to avoid needle clogging.
Discard any unused portion remaining.

Storage Instructions

Do not store the prepared syringe that has been attached to the already-primed subcutaneous administration set.
If the prepared syringe containing TECENTRIQ HYBREZA is not for immediate use, do not attach a subcutaneous administration set. The capped syringe may be stored at room temperature [at up to 25°C (77°F)] in ambient room lighting for up to 8 hours and in the refrigerator [2°C to 8°C (36°F to 46°F)] for up to 72 hours. Do not shake or freeze.
If the prepared syringe is stored at 2°C to 8°C (36°F to 46°F), allow the syringe to acclimate to room temperature prior to administration.