For Patients and Caregivers
Print Page

Monitoring select TECENTRIQ side effects1

Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated ARs. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated ARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Share the information below with your patients when they begin treatment with TECENTRIQ. For more information on the Serious ARs listed below, please refer to the Important Safety Information page.

ARs that may occur during treatment with TECENTRIQ

The most common side effects of TECENTRIQ when used alone include:

  • Feeling tired or weak
  • Decreased appetite
  • Nausea
  • Cough
  • Shortness of breath

Serious ARs that may occur during treatment with TECENTRIQ

Counsel patients to inform their healthcare provider immediately if they experience lung problems, such as:

  • Cough
  • Shortness of breath
  • Chest pain

Counsel patients to inform their healthcare provider immediately if they experience intestinal problems, such as:

  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky, or have blood or mucus
  • Severe stomach area (abdomen) pain or tenderness

Counsel patients to inform their healthcare provider immediately if they experience liver problems, such as:

  • Yellowing of the skin or whites of the eyes
  • Severe nausea or vomiting
  • Pain on the right side of the stomach area (abdomen)
  • Dark urine (tea colored)
  • Bleeding or bruising more easily than normal

Counsel patients to inform their healthcare provider immediately if they experience hormonal gland problems, such as:

  • Headaches that will not go away or unusual headaches
  • Eye sensitivity to light
  • Eye problems
  • Rapid heartbeat
  • Increased sweating
  • Extreme tiredness
  • Weight gain or weight loss
  • Feeling more hungry or thirsty than usual
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • Voice gets deeper
  • Dizziness or fainting
  • Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Counsel patients to inform their healthcare provider immediately if they experience kidney problems, such as:

  • Decrease in amount of urine
  • Blood in urine
  • Swelling of ankles
  • Loss of appetite

Counsel patients to inform their healthcare provider immediately if they experience skin problems, such as:

  • Rash
  • Itching
  • Skin blistering or peeling
  • Painful sores or ulcers in mouth or nose, throat, or genital area
  • Fever or flu-like symptoms
  • Swollen lymph nodes

Counsel patients to inform their healthcare provider immediately if they experience problems related to other organs, such as:

  • Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

Counsel patients to inform their healthcare provider immediately if they experience infusion reactions, such as:

  • Chills or shaking
  • Itching or rash
  • Flushing
  • Shortness of breath or wheezing
  • Dizziness
  • Feeling like passing out
  • Fever
  • Back or neck pain

Follow patients closely for evidence of transplant-related complications, including 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), and intervene promptly.

AR=adverse reaction; HSCT=hematopoietic stem cell transplantation; PD-1=programmed cell death 1 protein; PD-L1=programmed death-ligand 1.
*Immune-mediated ARs include cardiac/vascular, nervous system, ocular, gastrointestinal, musculoskeletal and connective tissue, endocrine, and other hematologic/immune ARs.

TECENTRIQ® (atezolizumab) AR management icon
Learn about managing adverse reactions

View recommendations from the TECENTRIQ Prescribing Information

Learn more
NEXT: IMpower010 safety profile

Important Safety Information and Indication

Indication

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.

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 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 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
  • 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

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 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 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%).

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 Prescribing Information for additional Important Safety Information.

Important Safety Information and Indication

Indication

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.

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 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 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
  • 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

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 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 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%).

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 Prescribing Information for additional Important Safety Information.

TOP

    • TECENTRIQ Prescribing Information. Genentech, Inc.

      TECENTRIQ Prescribing Information. Genentech, Inc.

    • Felip E, Altorki N, Zhou C, et al; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398:1344-​1357.

      Felip E, Altorki N, Zhou C, et al; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398:1344-​1357.

    • Wakelee HA, Altorki N, Zhou C, et al. IMpower010: disease-free survival final analysis and second overall survival interim analysis results after ≥5 years of follow-up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer. Poster presented at: Annual Meeting of the American Society of Clinical Oncology; May 31-June 4, 2024; Chicago, Illinois.

      Wakelee HA, Altorki N, Zhou C, et al. IMpower010: disease-free survival final analysis and second overall survival interim analysis results after ≥5 years of follow-up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer. Poster presented at: Annual Meeting of the American Society of Clinical Oncology; May 31-June 4, 2024; Chicago, Illinois.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to www.NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.10.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed September 23, 2024. To view the most recent and complete version of the guideline, go online to www.NCCN.org.

    • Pignon J-P, Tribodet H, Scagliotti GV, et al; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-​3559.

      Pignon J-P, Tribodet H, Scagliotti GV, et al; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-​3559.

    • Lung cancer. ASCO Cancer Progress Timeline. https://old-prod.asco.org/news-initiatives/cancer-progress-timeline/lung-cancer. Accessed October 18, 2021.

      Lung cancer. ASCO Cancer Progress Timeline. https://old-prod.asco.org/news-initiatives/cancer-progress-timeline/lung-cancer. Accessed October 18, 2021.

    • Heymach JV, Harpole D, Mitsudomi T, et al. AEGEAN: a phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC. Presented at: Annual Meeting of the American Association for Cancer Research; April 14-19, 2023; Orlando, Florida.

      Heymach JV, Harpole D, Mitsudomi T, et al. AEGEAN: a phase 3 trial of neoadjuvant durvalumab + chemotherapy followed by adjuvant durvalumab in patients with resectable NSCLC. Presented at: Annual Meeting of the American Association for Cancer Research; April 14-19, 2023; Orlando, Florida.

    • Wakelee H, Liberman M, Kato T, et al; KEYNOTE-671 Investigators. Perioperative pembrolizumab for early-stage non-small-cell lung cancer. N Engl J Med. 2023;389:491-​503.

      Wakelee H, Liberman M, Kato T, et al; KEYNOTE-671 Investigators. Perioperative pembrolizumab for early-stage non-small-cell lung cancer. N Engl J Med. 2023;389:491-​503.

    • Lu S, Wu L, Zhang W, et al. Perioperative toripalimab + platinum-doublet chemotherapy vs chemotherapy in resectable stage II/III non-small cell lung cancer: interim event-free survival analysis of the phase III Neotorch study. Presented at: Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2023; Chicago, Illinois.

      Lu S, Wu L, Zhang W, et al. Perioperative toripalimab + platinum-doublet chemotherapy vs chemotherapy in resectable stage II/III non-small cell lung cancer: interim event-free survival analysis of the phase III Neotorch study. Presented at: Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2023; Chicago, Illinois.

    • Yi C, He Y, Xia H, Zhang H, Zhang P. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC. Onco Targets Ther. 2019;12:7329-​7336.

      Yi C, He Y, Xia H, Zhang H, Zhang P. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC. Onco Targets Ther. 2019;12:7329-​7336.

    • Sandler JE, D’Aiello A, Halmos B. Changes in store for early-stage non-small cell lung cancer. J Thorac Dis. 2019;11:2117-​2125.

      Sandler JE, D’Aiello A, Halmos B. Changes in store for early-stage non-small cell lung cancer. J Thorac Dis. 2019;11:2117-​2125.

    • Tuminello S, Sikavi D, Veluswamy R, et al. PD-L1 as a prognostic biomarker in surgically resectable non-small cell lung cancer: a meta-analysis. Transl Lung Cancer Res. 2020;9:1343-​1360.

      Tuminello S, Sikavi D, Veluswamy R, et al. PD-L1 as a prognostic biomarker in surgically resectable non-small cell lung cancer: a meta-analysis. Transl Lung Cancer Res. 2020;9:1343-​1360.

    • De Marchi P, Leal LF, Duval da Silva V, Albino da Silva EC, Cordeiro de Lima VC, Reis RM. PD-L1 expression by tumor proportion score (TPS) and combined positive score (CPS) are similar in non-small cell lung cancer (NSCLC). J Clin Pathol. 2021;74:735-​740.

      De Marchi P, Leal LF, Duval da Silva V, Albino da Silva EC, Cordeiro de Lima VC, Reis RM. PD-L1 expression by tumor proportion score (TPS) and combined positive score (CPS) are similar in non-small cell lung cancer (NSCLC). J Clin Pathol. 2021;74:735-​740.

    • VENTANA PD-L1 (SP263) Assay Interpretation Guide for Non-Small Cell Lung Cancer 1% and 50% Tumor Cell (TC) Scoring Algorithm. Ventana Medical Systems, Inc. publication 1020383US Rev B. Updated 2023.

      VENTANA PD-L1 (SP263) Assay Interpretation Guide for Non-Small Cell Lung Cancer 1% and 50% Tumor Cell (TC) Scoring Algorithm. Ventana Medical Systems, Inc. publication 1020383US Rev B. Updated 2023.

    • Lantuejoul S, Sound-Tsao M, Cooper WA, et al. PD-L1 testing for lung cancer in 2019: perspective from the IASLC Pathology Committee. J Thorac Oncol. 2020;15:499-​519.

      Lantuejoul S, Sound-Tsao M, Cooper WA, et al. PD-L1 testing for lung cancer in 2019: perspective from the IASLC Pathology Committee. J Thorac Oncol. 2020;15:499-​519.

    • Data on file. Genentech Inc.

      Data on file. Genentech Inc.

    • Data on file. Roche.

      Data on file. Roche.

    • TECENTRIQ HYBREZA Prescribing Information. Genentech, Inc.

      TECENTRIQ HYBREZA Prescribing Information. Genentech, Inc.