For Patients and Caregivers

Financial Assistance Options

No matter what type of health insurance your patient has, they may have options to help them afford their medicine. Options may be available to your patient even if they have no insurance at all.

Get Started with Financial Assistance Tool

Use our financial assistance tool to see which programs may be right for your patient.

Get started

If you would rather talk through some potential options, call us at 888-249-4918 (6AM-5PM PST, Monday through Friday).

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Genentech Oncology Co-pay Assistance Program
Independent Co-pay Assistance Foundations
Genentech Patient Foundation

Help With Co-pay Costs

These programs help your patient pay for TECENTRIQ HYBREZA if they have insurance but still need help with costs:

Help With Costs for TECENTRIQ HYBREZA

Co-pay Card Assistance

With the Genentech Oncology Co-pay Assistance Program, eligible patients with commercial insurance could pay as little as $0 per treatment for TECENTRIQ HYBREZA. Co-pay assistance of up to $25,000 is provided per calendar year.

Your patient may be eligible if they:

  • Are taking TECENTRIQ HYBREZA for an FDA-approved use
  • Are 18 years of age or older or have a Legally Authorized Person over the age of 18 to manage the program
  • Have commercial (private or non-governmental) insurance. This includes plans available through state and federal health insurance exchanges
  • Live and receive treatment in the United States or U.S. Territories
  • Are not receiving assistance through the Genentech Patient Foundation or any other charitable organization for the same expenses covered by the program
  • Do not use a state or federal healthcare plan to pay for your medication. This includes, but is not limited to, Medicare, Medicaid and TRICARE

The Co-pay Program (“Program”) is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. Patients using Medicare, Medicaid or any other federal or state government program (collectively, “Government Programs”) to pay for their Genentech medicine are not eligible.

Under the Program, the patient may be required to pay a co-pay. The final amount owed by a patient may be as little as $0 for the Genentech medicine (see Program specific details available at the Program website). The total patient out-of-pocket cost is dependent on the patient’s health insurance plan. The Program assists with the cost of the Genentech medicine only. It does not assist with the cost of other medicines, procedures or office visit fees. After reaching the maximum annual Program benefit amount, the patient will be responsible for all remaining out-of-pocket expenses. The Program benefit amount cannot exceed the patient’s out-of-pocket expenses for the Genentech medicine.

All participants are responsible for reporting the receipt of all Program benefits as required by any insurer or by law. The Program is only valid in the United States and U.S. Territories, is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. No party may seek reimbursement for all or any part of the benefit received through the Program. The value of the Program is intended exclusively for the benefit of the patient. The funds made available through the Program may only be used to reduce the out-of-pocket costs for the patient enrolled in the Program. The Program is not intended for the benefit of third parties, including without limitation third party payers, pharmacy benefit managers, or their agents. If Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the Program from counting towards the patient’s deductible or out-of-pocket cost limitations, Genentech may impose a per fill cap on the cost-sharing assistance available under the Program. Submission of true and accurate information is a requirement for eligibility and Genentech reserves the right to disqualify patients who do not comply from Genentech programs. Genentech reserves the right to rescind, revoke or amend the Program without notice at any time.

Additional terms and conditions apply. Please visit the Co-pay Program website for the full list of Terms and Conditions.

View full TERMS AND CONDITIONS

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Independent Co-pay Assistance

An independent co-pay assistance foundation is a charitable organization providing financial assistance to patients with specific disease states, regardless of treatment. Patients who are commercially or publicly insured, including those covered by Medicare and Medicaid, can contact the foundations directly to request assistance. Eligibility requirements, all aspects of the application process, turnaround times and the type or amount of assistance available (if any) can vary by foundation. 

These foundations may be able to help. Please check their websites for up-to-date information.

Advise your patient that these organizations are independent of Genentech and may require the patient to provide personal or financial information directly to the organization to enroll in their respective programs. Genentech cannot share any information the patient has provided to us.

Independent co-pay assistance foundations have their own rules for eligibility. We have no involvement or influence in independent foundation decision-making or eligibility criteria and do not know if a foundation will be able to help your patient. We can only refer your patient to a foundation that supports their disease state. This information is provided as a resource for you. We do not endorse or show preference for any particular foundation. The foundations in this list may not be the only ones that might be able to help your patient.

Genentech Patient Foundation

If patients don’t have health insurance coverage for TECENTRIQ HYBREZA or have financial concerns and meet eligibility criteria, this program may help:

Genentech Patient Foundation

The Genentech Patient Foundation gives free TECENTRIQ HYBREZA to people who have been prescribed this medicine and don’t have insurance or that have financial concerns and meet certain eligibility criteria.

Your patient may be eligible if their insurance coverage and income match one of these situations:

  • Uninsured patients with incomes under $150,000
  • Insured patients without coverage for TECENTRIQ HYBREZA with incomes under $150,000
  • Insured patients with coverage for a Genentech medicine:
    • With an out-of-pocket maximum set by their health insurance plan that exceeds 7.5% of their household income
    • With household size and income within certain guidelines

For any of these situations, add $25,000 for each extra person in households larger than 4 people.

We encourage insured patients to try other financial assistance options before applying for help from the Genentech Patient Foundation, if possible.

Enrollment Process for the Genentech Patient Foundation

Get started with enrollment by following the steps below.

Option 1: Submit online

If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.

Don't have an account?

Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.

  • An online tool to help you enroll patients in TECENTRIQ HYBREZA Access Solutions and manage your service requests at your convenience.

Option 2: Print & fax or text

Step 1: Print one of the Patient Consent Forms below for your patient to complete.

Step 2: Print and complete the Prescriber Foundation Form below.

Step 3: Submit the completed forms via fax or text.

Both forms are required. We must have both the Patient Consent Form and the Prescriber Foundation Form before we can help you. 

What to expect next:

  • The request will be processed within five business days upon receipt of both required forms.
  • Your office will be contacted to discuss any next steps.

If you have any questions about the criteria, please contact a Foundation Specialist at 888-941-3331 (Mon.–Fri., 6AM–5PM PST).

Get Started with Financial Assistance Tool

Use our financial assistance tool to see which programs may be right for your patient.

Get started

  • Commercial insurance: An insurance plan you get from a private health insurance company. This can be insurance from your job, from a plan you bought yourself or from a Health Insurance Marketplace. Medicare and Medicaid are not considered commercial insurance. 

  • Public insurance: A health insurance plan you get from the federal or state government. This includes Medicare, Medicaid, TRICARE and DoD/VA insurance.

  • For example, a household size of 1 with income of less than $75,000 may meet the criteria for assistance. Add $25,000 for each additional person in the household. There is no maximum number of people you may add.

Important Safety Information and Indications

TECENTRIQ HYBREZA (atezolizumab and hyaluronidase-tqjs)

TECENTRIQ (atezolizumab)

TECENTRIQ HYBREZA Indications

Non-Small Cell Lung Cancer
TECENTRIQ HYBREZA, as monotherapy, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test.

TECENTRIQ HYBREZA, as monotherapy, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (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.

TECENTRIQ HYBREZA, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ HYBREZA, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ HYBREZA, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 TECENTRIQ HYBREZA.

Extensive-Stage Small Cell Lung Cancer
TECENTRIQ HYBREZA, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Unresectable or Metastatic Hepatocellular Carcinoma
TECENTRIQ HYBREZA, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Unresectable or Metastatic Melanoma
TECENTRIQ HYBREZA, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; PD-L1=programmed death-ligand 1.

TECENTRIQ HYBREZA Important Safety Information

Contraindications
TECENTRIQ HYBREZA is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

Warnings and Precautions
Severe and Fatal Immune-Mediated Adverse Reactions
TECENTRIQ HYBREZA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. The following immune-mediated adverse reactions may not include all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions can occur in any organ system or tissue and at any time after starting TECENTRIQ HYBREZA. While immune-mediated adverse reactions usually manifest during treatment with TECENTRIQ HYBREZA, they can also manifest after discontinuation of treatment. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of TECENTRIQ HYBREZA.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue TECENTRIQ HYBREZA depending on severity. In general, if TECENTRIQ HYBREZA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less, then initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

  • TECENTRIQ HYBREZA can cause immune-mediated pneumonitis, including fatal adverse reactions. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation
  • Immune-mediated pneumonitis occurred in 2% (5/247) of patients receiving TECENTRIQ HYBREZA, including Grade 2 (0.8%) and Grade 1 (1.2%) adverse reactions. Pneumonitis led to withholding of TECENTRIQ HYBREZA in 1 patient
  • Systemic corticosteroids were required in 40% (2/5) of patients with pneumonitis. Pneumonitis resolved in both patients. The single patient in whom TECENTRIQ HYBREZA was withheld for pneumonitis reinitiated TECENTRIQ HYBREZA after symptom improvement
  • Immune-mediated pneumonitis occurred in 13% (29/230) of patients receiving intravenous atezolizumab in combination with cobimetinib and vemurafenib, including Grade 3 (1.3%) and Grade 2 (7%) adverse reactions. Pneumonitis led to permanent discontinuation of intravenous atezolizumab in 2.6% and withholding of intravenous atezolizumab in 7.4% of patients. Systemic corticosteroids were required in 55% (16/29) of patients with pneumonitis. Pneumonitis resolved in 97% of the 29 patients. Of the 17 patients in whom intravenous atezolizumab was withheld for pneumonitis, 10 reinitiated intravenous atezolizumab after symptom improvement; of these, 50% had recurrence of pneumonitis

Immune-Mediated Colitis

  • TECENTRIQ HYBREZA can cause immune-mediated colitis, including Grade 3 adverse reactions. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies

Immune-Mediated Hepatitis

  • TECENTRIQ HYBREZA can cause immune-mediated hepatitis, including fatal adverse reactions
  • Immune-mediated hepatitis occurred in 1.2% (3/247) of patients receiving TECENTRIQ HYBREZA, including Grade 1 (0.4%) and Grade 3 (0.8%) adverse reactions. Hepatitis led to withholding of TECENTRIQ HYBREZA in 0.4% of patients
  • Systemic corticosteroids were required in 67% (2/3) of patients with hepatitis who received TECENTRIQ HYBREZA. Hepatitis resolved in 1 of the 3 patients
  • Immune-mediated hepatitis occurred in 6.1% (14/230) of patients receiving intravenous atezolizumab in combination with cobimetinib and vemurafenib, including Grade 4 (1.3%), Grade 3 (1.7%), and Grade 2 (1.3%) adverse reactions. Hepatitis led to permanent discontinuation of intravenous atezolizumab in 2.2% and withholding of intravenous atezolizumab in 1.7% of patients. Systemic corticosteroids were required in 50% (7/14) of patients with hepatitis. Hepatitis resolved in 93% of the 14 patients. Of the 4 patients in whom intravenous atezolizumab was withheld for hepatitis, 3 reinitiated intravenous atezolizumab after symptom improvement; of these, 33% had recurrence of hepatitis

Immune-Mediated Endocrinopathies
Adrenal Insufficiency

  • TECENTRIQ HYBREZA can cause primary or secondary adrenal insufficiency, including Grade 3 adverse reactions. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated 
  • Immune-mediated adrenal insufficiency occurred in 0.8% (2/247) of patients receiving TECENTRIQ HYBREZA, including Grade 2 (0.4%) adverse reactions. Adrenal insufficiency led to withholding of TECENTRIQ HYBREZA in both patients. Systemic corticosteroids were required in 50% (1/2) of patients with adrenal insufficiency who received TECENTRIQ HYBREZA; this patient remained on systemic corticosteroids

Hypophysitis

  • TECENTRIQ HYBREZA can cause immune-mediated hypophysitis, including Grade 2 adverse reactions. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated
  • Immune-mediated hypophysitis occurred in 0.4% (1/247) of patients receiving TECENTRIQ HYBREZA, including Grade 1 (0.4%) adverse reactions. Hypophysitis led to withholding of TECENTRIQ HYBREZA in this patient

Thyroid Disorders

  • TECENTRIQ HYBREZA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or medical management for hyperthyroidism as clinically indicated
  • Immune-mediated thyroiditis occurred in 0.8% (2/247) of patients receiving TECENTRIQ HYBREZA, including Grade 2 (0.4%) adverse reactions. Thyroiditis resolved in 50% of patients
  • Immune-mediated hyperthyroidism occurred in 2% (5/247) of patients receiving TECENTRIQ HYBREZA, including Grade 2 (1.2%) adverse reactions. Hyperthyroidism led to withholding of TECENTRIQ HYBREZA in 0.8% of patients. Antithyroid therapy was required in 40% (2/5) of patients with hyperthyroidism who received TECENTRIQ HYBREZA. Of these 2 patients, 1 remained on antithyroid treatment. Of the 2 patients in whom TECENTRIQ HYBREZA was withheld for hyperthyroidism, 1 patient reinitiated TECENTRIQ HYBREZA; this patient did not have recurrence of hyperthyroidism
  • Hyperthyroidism occurred in 19% (43/230) of patients receiving intravenous atezolizumab in combination with cobimetinib and vemurafenib, including Grade 3 (0.9%) and Grade 2 (7.8%) adverse reactions. Hyperthyroidism led to permanent discontinuation of intravenous atezolizumab in 0.4% and withholding of intravenous atezolizumab in 10% of patients. Antithyroid therapy was required in 53% (23/43) of patients with hyperthyroidism. Of these 23 patients, the majority remained on antithyroid treatment. Of the 24 patients in whom intravenous atezolizumab was withheld for hyperthyroidism, 18 patients reinitiated intravenous atezolizumab; of these, 28% had recurrence of hyperthyroidism
  • TECENTRIQ HYBREZA can cause immune-mediated hypothyroidism, including Grade 4 adverse reactions. Immune-mediated hypothyroidism occurred in 10% (25/247) of patients receiving TECENTRIQ HYBREZA. Hormone replacement was required in 68% (17/25) of patients with hypothyroidism who received TECENTRIQ HYBREZA. Two patients with hypothyroidism remained on thyroid hormone replacement
  • Hypothyroidism occurred in 11% (277/2421) of patients with NSCLC or SCLC receiving intravenous atezolizumab in combination with platinum-based chemotherapy, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (5.7%) adverse reactions. Hypothyroidism led to permanent discontinuation of intravenous atezolizumab in 0.1% and withholding of intravenous atezolizumab in 1.6% of patients. Hormone replacement therapy was required in 71% (198/277) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 39 patients in whom intravenous atezolizumab was withheld for hypothyroidism, 9 reinitiated intravenous atezolizumab after symptom improvement
  • Hypothyroidism occurred in 26% (60/230) of patients receiving intravenous atezolizumab in combination with cobimetinib and vemurafenib, including Grade 2 (9.1%) adverse reactions. Hypothyroidism led to withholding of intravenous atezolizumab in 2.6% of patients. Hormone replacement therapy was required in 52% (31/60) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 6 patients in whom intravenous atezolizumab was withheld for hypothyroidism, 4 reinitiated intravenous atezolizumab after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid replacement

Type 1 Diabetes Mellitus, Which Can Present With Diabetic Ketoacidosis

  • TECENTRIQ HYBREZA can cause type 1 diabetes mellitus, including Grade 3 adverse reactions and diabetic ketoacidosis. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated

Immune-Mediated Nephritis With Renal Dysfunction

  • TECENTRIQ HYBREZA can cause immune-mediated nephritis, including Grade 3 adverse reactions
  • Immune-mediated nephritis with renal dysfunction occurred in 1.3% (3/230) of patients receiving intravenous atezolizumab in combination with cobimetinib and vemurafenib, including Grade 2 (1.3%) adverse reactions. Nephritis led to permanent discontinuation of intravenous atezolizumab in 0.4% and withholding of intravenous atezolizumab in 0.9% of patients. Systemic corticosteroids were required in 67% (2/3) of patients with nephritis. Nephritis resolved in all 3 of these patients. Of the 2 patients in whom intravenous atezolizumab was withheld for nephritis, both reinitiated intravenous atezolizumab after symptom improvement and neither had recurrence of nephritis

Immune-Mediated Dermatologic Adverse Reactions

  • TECENTRIQ HYBREZA can cause immune-mediated rash or dermatitis, including Grade 3 and fatal adverse reactions. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), DRESS, and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes
  • One fatal case of an immune-mediated dermatologic adverse reaction, due to TEN, occurred (0.4%, 1/247) in patients receiving TECENTRIQ HYBREZA

Other Immune-Mediated Adverse Reactions

  • The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received intravenous atezolizumab or were reported with the use of other PD-1/PD-L1 blocking antibodies
    • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
    • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
    • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
    • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis
    • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic
    • Endocrine: Hypoparathyroidism
    • Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection
       

Infusion-Related Reactions

  • TECENTRIQ HYBREZA can cause severe or life-threatening infusion-related reactions, including Grade 3 adverse reactions. Monitor for signs and symptoms of infusion-related reactions. Pause, slow the rate of, or permanently discontinue TECENTRIQ HYBREZA based on the severity. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses

Complications of Allogeneic HSCT After PD-1/PD-L1 Inhibitors

  • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody
  • Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockage and allogeneic HSCT
  • Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT
     

Embryo-Fetal Toxicity

  • Based on its mechanism of action, TECENTRIQ HYBREZA can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ HYBREZA in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death
  • Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ HYBREZA. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with TECENTRIQ HYBREZA and for at least 5 months after the last dose
     

Use in Specific Populations
Nursing Mothers

  • There is no information regarding the presence of atezolizumab or hyaluronidase in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown
  • Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ HYBREZA, advise female patients not to breastfeed while taking TECENTRIQ HYBREZA and for at least 5 months after the last dose

Fertility

  • Based on animal studies, TECENTRIQ HYBREZA may impair fertility in females of reproductive potential while receiving treatment
     

 

Most Common Adverse Reactions
The most common adverse reactions (rate ≥10%) in patients who received TECENTRIQ HYBREZA were fatigue (19%), musculoskeletal pain (15%), cough (13%), dyspnea (12%), and decreased appetite (11%).

The most common adverse reactions (rate ≥20%) in patients who received intravenous atezolizumab alone were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%).

The most common adverse reactions (rate ≥20%) in patients who received intravenous atezolizumab in combination with other antineoplastic drugs for NSCLC and SCLC were fatigue/asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%), and decreased appetite (27%).

The most common adverse reactions (rate ≥20%) in patients who received intravenous atezolizumab in combination with bevacizumab for HCC were hypertension (30%), fatigue/asthenia (26%), and proteinuria (20%).

The most common adverse reactions (rate ≥20%) in patients who received intravenous atezolizumab in combination with cobimetinib and vemurafenib for melanoma were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full TECENTRIQ HYBREZA Prescribing Information for additional Important Safety Information.

TECENTRIQ Indications

Non-Small Cell Lung Cancer
TECENTRIQ, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test.

TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (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.

TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, as a single agent, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 TECENTRIQ.

Extensive-Stage Small Cell Lung Cancer
TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Unresectable or Metastatic Hepatocellular Carcinoma
TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Unresectable or Metastatic Melanoma
TECENTRIQ, in combination with cobimetinib and vemurafenib, is indicated for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; PD-L1=programmed death-ligand 1.

TECENTRIQ Important Safety Information

Severe and Fatal Immune-Mediated Adverse Reactions
TECENTRIQ is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. The following immune-mediated adverse reactions may not include all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions can occur in any organ system or tissue and at any time after starting TECENTRIQ. While immune-mediated adverse reactions usually manifest during treatment with TECENTRIQ, they can also manifest after discontinuation of treatment. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of TECENTRIQ.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue TECENTRIQ depending on severity. In general, if TECENTRIQ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less, then initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

  • TECENTRIQ can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation
  • Immune-mediated pneumonitis occurred in 3% (83/2616) of patients receiving TECENTRIQ alone, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.8%), and Grade 2 (1.1%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 0.5% and withholding of TECENTRIQ in 1.5% of patients
  • Systemic corticosteroids were required in 55% (46/83) of patients with pneumonitis. Pneumonitis resolved in 69% of the 83 patients. Of the 39 patients in whom TECENTRIQ was withheld for pneumonitis, 25 reinitiated TECENTRIQ after symptom improvement; of these, 4% had recurrence of pneumonitis
  • Immune-mediated pneumonitis occurred in 3.8% (19/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including fatal (0.2%), Grade 4 (0.2%), and Grade 3 (0.6%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 2.2% and withholding of TECENTRIQ in 0.8% of patients. Systemic corticosteroids were required in 63% (12/19) of patients with pneumonitis. Pneumonitis resolved in 84% of the 19 patients
  • Immune-mediated pneumonitis occurred in 13% (29/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 3 (1.3%) and Grade 2 (7%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 2.6% and withholding of TECENTRIQ in 7.4% of patients. Systemic corticosteroids were required in 55% (16/29) of patients with pneumonitis. Pneumonitis resolved in 97% of the 29 patients. Of the 17 patients in whom TECENTRIQ was withheld for pneumonitis, 10 reinitiated TECENTRIQ after symptom improvement; of these, 50% had recurrence of pneumonitis

Immune-Mediated Colitis

  • TECENTRIQ can cause immune-mediated colitis. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
  • Immune-mediated colitis occurred in 1% (26/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.5%) and Grade 2 (0.3%) adverse reactions. Colitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.5% of patients. Systemic corticosteroids were required in 50% (13/26) of patients with colitis. Colitis resolved in 73% of the 26 patients. Of the 12 patients in whom TECENTRIQ was withheld for colitis, 8 reinitiated TECENTRIQ after symptom improvement; of these, 25% had recurrence of colitis

Immune-Mediated Hepatitis

  • TECENTRIQ can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.8% (48/2616) of patients receiving TECENTRIQ alone, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.5%), and Grade 2 (0.5%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 25% (12/48) of patients with hepatitis. Hepatitis resolved in 50% of the 48 patients. Of the 6 patients in whom TECENTRIQ was withheld for hepatitis, 4 reinitiated TECENTRIQ after symptom improvement; of these, none had recurrence of hepatitis
  • Immune-mediated hepatitis occurred in 6.1% (14/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 4 (1.3%), Grade 3 (1.7%), and Grade 2 (1.3%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 2.2% and withholding of TECENTRIQ in 1.7% of patients. Systemic corticosteroids were required in 50% (7/14) of patients with hepatitis. Hepatitis resolved in 93% of the 14 patients. Of the 4 patients in whom TECENTRIQ was withheld for hepatitis, 3 reinitiated TECENTRIQ after symptom improvement; of these, 33% had recurrence of hepatitis

Immune-Mediated Endocrinopathies
Adrenal Insufficiency

  • TECENTRIQ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated
  • Adrenal insufficiency occurred in 0.4% (11/2616) of patients receiving TECENTRIQ alone, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of TECENTRIQ in 1 patient and withholding of TECENTRIQ in 1 patient. Systemic corticosteroids were required in 82% (9/11) of patients with adrenal insufficiency; of these, 3 patients remained on systemic corticosteroids. The single patient in whom TECENTRIQ was withheld for adrenal insufficiency did not reinitiate TECENTRIQ
  • Adrenal insufficiency occurred in 1.2% (6/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 3 (0.4%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of TECENTRIQ in 0.6% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 83% (5/6) of patients with adrenal insufficiency; of these, 4 patients remained on systemic corticosteroids

Hypophysitis

  • TECENTRIQ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated
  • Hypophysitis occurred in <0.1% (2/2616) of patients receiving TECENTRIQ alone, including Grade 2 (1 patient, <0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of TECENTRIQ in 1 patient and no patients required withholding of TECENTRIQ. Systemic corticosteroids were required in 50% (1/2) of patients with hypophysitis. Hypophysitis did not resolve in these 2 patients

Thyroid Disorders

  • TECENTRIQ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or medical management for hyperthyroidism as clinically indicated
  • Thyroiditis occurred in 0.2% (4/2616) of patients receiving TECENTRIQ alone, including Grade 2 (<0.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 1 patient. Hormone replacement therapy was required in 75% (3/4) of patients with thyroiditis. Systemic corticosteroids were required in 25% (1/4) of patients with thyroiditis. Thyroiditis resolved in 50% of patients. The single patient in whom TECENTRIQ was withheld for thyroiditis reinitiated TECENTRIQ; this patient did not have recurrence of thyroiditis
  • Thyroiditis occurred in 1.2% (6/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 2 (0.4%) adverse reactions. Thyroiditis led to withholding of TECENTRIQ in 1 patient. Hormone replacement therapy was required in 67% (4/6) of patients with thyroiditis. Systemic corticosteroids were required in 33% (2/6) of patients with thyroiditis. Thyroiditis resolved in 50% of patients
  • Hyperthyroidism occurred in 0.8% (21/2616) of patients receiving TECENTRIQ alone, including Grade 2 (0.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.1% of patients. Antithyroid therapy was required in 29% (6/21) of patients with hyperthyroidism. Of these 6 patients, the majority remained on antithyroid treatment. Of the 3 patients in whom TECENTRIQ was withheld for hyperthyroidism, 1 patient reinitiated TECENTRIQ; this patient did not have recurrence of hyperthyroidism
  • Hyperthyroidism occurred in 6% (32/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment, including Grade 3 (0.4%) adverse reactions. Hyperthyroidism led to permanent discontinuation of TECENTRIQ in 0.8% and withholding of TECENTRIQ in 2.8% of patients. Antithyroid therapy was required in 38% (12/32) of patients with hyperthyroidism. Of these 12 patients, the majority remained on antithyroid treatment. Of the 14 patients in whom TECENTRIQ was withheld for hyperthyroidism, 9 patients reinitiated TECENTRIQ
  • Hyperthyroidism occurred in 19% (43/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 3 (0.9%) and Grade 2 (7.8%) adverse reactions. Hyperthyroidism led to permanent discontinuation of TECENTRIQ in 0.4% and withholding of TECENTRIQ in 10% of patients. Antithyroid therapy was required in 53% (23/43) of patients with hyperthyroidism. Of these 23 patients, the majority remained on antithyroid treatment. Of the 24 patients in whom TECENTRIQ was withheld for hyperthyroidism, 18 patients reinitiated TECENTRIQ; of these, 28% had recurrence of hyperthyroidism
  • Hypothyroidism occurred in 4.9% (128/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.2%) and Grade 2 (3.4%) adverse reactions. Hypothyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.6% of patients. Hormone replacement therapy was required in 81% (104/128) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 17 patients in whom TECENTRIQ was withheld for hypothyroidism, 8 reinitiated TECENTRIQ after symptom improvement
  • Hypothyroidism occurred in 17% (86/495) of patients with NSCLC receiving TECENTRIQ alone as adjuvant treatment. Hypothyroidism led to permanent discontinuation of TECENTRIQ in 1.6% and withholding of TECENTRIQ in 1.6% of patients. Hormone replacement was required in 57% (49/86) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 8 patients in whom TECENTRIQ was withheld for hypothyroidism, 3 reinitiated TECENTRIQ after symptom improvement
  • Hypothyroidism occurred in 11% (277/2421) of patients with NSCLC and SCLC receiving TECENTRIQ in combination with platinum-based chemotherapy, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (5.7%) adverse reactions. Hypothyroidism led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 1.6% of patients. Hormone replacement therapy was required in 71% (198/277) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 39 patients in whom TECENTRIQ was withheld for hypothyroidism, 9 reinitiated TECENTRIQ after symptom improvement
  • Hypothyroidism occurred in 26% (60/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 2 (9.1%) adverse reactions. Hypothyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 2.6% of patients. Hormone replacement therapy was required in 52% (31/60) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 6 patients in whom TECENTRIQ was withheld for hypothyroidism, 4 reinitiated TECENTRIQ after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid replacement

Type 1 Diabetes Mellitus, Which Can Present With Diabetic Ketoacidosis

  • Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated
  • Type 1 diabetes mellitus occurred in 0.3% (7/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.2%) and Grade 2 (<0.1%) adverse reactions. Type 1 diabetes mellitus led to permanent discontinuation of TECENTRIQ in 1 patient and withholding of TECENTRIQ in 2 patients. Treatment with insulin was required for all patients with confirmed Type 1 diabetes mellitus and insulin therapy was continued long-term. Of the 2 patients in whom TECENTRIQ was withheld for Type 1 diabetes mellitus, both reinitiated TECENTRIQ treatment

Immune-Mediated Nephritis With Renal Dysfunction

  • TECENTRIQ can cause immune-mediated nephritis
  • Immune-mediated nephritis with renal dysfunction occurred in <0.1% (1/2616) of patients receiving TECENTRIQ alone, and this adverse reaction was a Grade 3 (<0.1%) adverse reaction. Nephritis led to permanent discontinuation of TECENTRIQ in this patient. This patient required systemic corticosteroids. In this patient, nephritis did not resolve
  • Immune-mediated nephritis with renal dysfunction occurred in 1.3% (3/230) of patients receiving TECENTRIQ in combination with cobimetinib and vemurafenib, including Grade 2 (1.3%) adverse reactions. Nephritis led to permanent discontinuation of TECENTRIQ in 0.4% and withholding of TECENTRIQ in 0.9% of patients. Systemic corticosteroids were required in 67% (2/3) of patients with nephritis. Nephritis resolved in all 3 of these patients. Of the 2 patients in whom TECENTRIQ was withheld for nephritis, both reinitiated TECENTRIQ after symptom improvement and neither had recurrence of nephritis

Immune-Mediated Dermatologic Adverse Reactions

  • TECENTRIQ can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), DRESS, and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes 
  • Immune-mediated dermatologic adverse reactions occurred in 0.6% (15/2616) of patients receiving TECENTRIQ alone, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Dermatologic adverse reactions led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 20% (3/15) of patients with dermatologic adverse reactions. Dermatologic adverse reactions resolved in 87% of the 15 patients. Of the 4 patients in whom TECENTRIQ was withheld for immune-mediated dermatologic adverse reactions, none reinitiated TECENTRIQ

Other Immune-Mediated Adverse Reactions

  • The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received TECENTRIQ or were reported with the use of other PD-1/PD-L1 blocking antibodies
    • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
    • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
    • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
    • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis
    • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic
    • Endocrine: Hypoparathyroidism
    • Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

  • TECENTRIQ can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue TECENTRIQ based on the severity. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses
  • Infusion-related reactions occurred in 1.3% of patients receiving TECENTRIQ alone, including Grade 3 (0.2%) reactions
  • The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single agent, in combination with other antineoplastic drugs in NSCLC and SCLC, and across the recommended dose range

Complications of Allogeneic HSCT After PD-1/PD-L1 Inhibitors

  • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody
  • Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockage and allogeneic HSCT
  • Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT

Embryo-Fetal Toxicity

  • Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death
  • Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose

Use in Specific Populations
Nursing Mothers

  • There is no information regarding the presence of TECENTRIQ in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown
  • Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose

Fertility

  • Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment

Most Common Adverse Reactions
The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ alone were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with other antineoplastic drugs for NSCLC and SCLC were fatigue/asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%), and decreased appetite (27%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with bevacizumab for HCC were hypertension (30%), fatigue/asthenia (26%), and proteinuria (20%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full TECENTRIQ Prescribing Information for additional Important Safety Information.

    • TECENTRIQ HYBREZA Prescribing Information. Genentech, Inc.

      TECENTRIQ HYBREZA Prescribing Information. Genentech, Inc.

    • TECENTRIQ Prescribing Information. Genentech, Inc.

      TECENTRIQ Prescribing Information. Genentech, Inc.

    • Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34:693-702.

      Burotto M, Zvirbule Z, Mochalova A, et al. IMscin001 part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023;34:693-702.

    • Burotto M, Zvirbule Z, Alvarez R, et al. Brief report: updated data from IMscin001 part 2, a randomized phase III study of subcutaneous versus intravenous atezolizumab in patients with locally advanced or metastatic NSCLC. J Thorac Oncol. Published online May 9, 2024. doi:10.1016/j.jtho.2024.05.005

      Burotto M, Zvirbule Z, Alvarez R, et al. Brief report: updated data from IMscin001 part 2, a randomized phase III study of subcutaneous versus intravenous atezolizumab in patients with locally advanced or metastatic NSCLC. J Thorac Oncol. Published online May 9, 2024. doi:10.1016/j.jtho.2024.05.005

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Cappuzzo F, Zvirbule Z, Korbenfed E, et al. Primary results from IMscin002: A study to evaluate patient- and healthcare professional-reported preferences for atezolizumab subcutaneous vs intravenous for the treatment of non-small cell lung cancer. Presented at: European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic.

      Cappuzzo F, Zvirbule Z, Korbenfed E, et al. Primary results from IMscin002: A study to evaluate patient- and healthcare professional-reported preferences for atezolizumab subcutaneous vs intravenous for the treatment of non-small cell lung cancer. Presented at: European Lung Cancer Congress; March 20-23, 2024; Prague, Czech Republic.