TECENTRIQ® (atezolizumab) injection, for intravenous use by Genentech


HCC Indication: Provider Resources
2 FILES

Physician Resources
SCLC Indication: Provider and Patient Resources
7 FILES

Physician Resources
Patient Resources
NSCLC Indication: Provider and Patient Resources
3 FILES

Physician Resources
Patient Resources
Learn about TECENTRIQ's Other FDA-Approved Indications
1 FILES

Physician Resources
Genentech Oncology Access Solutions
3 FILES

Physician Resources
Patient Resources
Genentech Patient Foundation
3 FILES

Physician Resources
Patient Resources
Indications & Usage

INDICATIONS AND USAGE

 

TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:


Non-Small Cell Lung Cancer (NSCLC)

        for the first-line treatment of adult patients with metastatic 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.

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

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

        for the treatment of adult patients with metastatic 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.


Small Cell Lung Cancer (SCLC)

        in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

 

Heptatocellular Carcinoma (HCC)

        in combination with bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.


Melanoma

        in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

 


Please see full Prescribing Information for additional Important Safety Information.

Overview of Dosage & Administration

OVERVIEW OF DOSAGE AND ADMINISTRATION

 

Administer TECENTRIQ intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.


NSCLC

        Administer TECENTRIQ as a single-agent as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.

        When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ 1200 mg every 3 weeks prior to chemotherapy and bevacizumab.

        Following completion of 4-6 cycles of chemotherapy, and if bevacizumab is discontinued, administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.


Small Cell Lung Cancer

        When administering with carboplatin and etoposide, administer TECENTRIQ 1200 mg every 3 weeks prior to chemotherapy.

        Following completion of 4 cycles of carboplatin and etoposide, administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.

 

Hepatocellular Carcinoma

        Administer TECENTRIQ 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks

        If bevacizumab is discontinued, administer TECENTRIQ as:

o  840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks


Melanoma

        Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer TECENTRIQ 840 mg every 2 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily. 


 

Please see full Prescribing Information for additional Important Safety Information.

Dosage Forms & Strengths

DOSAGE FORMS AND STRENGTHS

 

Injection: 840 mg/14 mL (60 mg/mL) and 1200 mg/20 mL (60 mg/mL) solution in a single-dose vial



Please see full Prescribing Information for additional Important Safety Information.

Contraindications

CONTRAINDICATIONS

 

None.

 

 

Please see full Prescribing Information for additional Important Safety Information.

Overview of Warnings & Precautions

OVERVIEW OF WARNINGS AND PRECAUTIONS

 

·        Immune-Mediated Pneumonitis: Withhold or permanently discontinue based on severity of pneumonitis.

·        Immune-Mediated Hepatitis: Monitor for changes in liver function. Withhold or permanently discontinue based on severity of transaminase or total bilirubin elevation.

·        Immune-Mediated Colitis: Withhold or permanently discontinue based on severity of colitis.

·        Immune-Mediated Endocrinopathies:

  • o   Hypophysitis: Withhold based on severity of hypophysitis.
  • o   Thyroid Disorders: Monitor for changes in thyroid function. Withhold based on severity of hyperthyroidism.
  • o   Adrenal Insufficiency: Withhold based on severity of adrenal insufficiency.
  • o   Type 1 Diabetes Mellitus: Withhold based on severity of hyperglycemia.

·        Infections: Withhold for severe or life-threatening infection.

·        Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions.

·        Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

 

 

Please see full Prescribing Information for additional Important Safety Information.

Adverse Reactions

MOST COMMON ADVERSE REACTIONS

 

        Most common adverse reactions (reported in ≥20% of patients) with TECENTRIQ as a single-agent were fatigue/asthenia, nausea, cough, dyspnea, and decreased appetite.

        Most common adverse reactions (reported in ≥20% of patients) with TECENTRIQ in combination with other antineoplastic drugs in patients with NSCLC and SCLC were fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite.

        The most common adverse reactions (reported in ≥20% of patients) with TECENTRIQ in combination with bevacizumab in patients with HCC were hypertension, fatigue and proteinuria.

        The most common adverse reactions (≥20%) with TECENTRIQ in combination with cobimetinib and vemurafenib in patients with melanoma were rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction. 

 

To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please see full Prescribing Information for additional Important Safety Information.

Use in Specific Populations

USE IN SPECIFIC POPULATIONS

 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

 

Immune-Mediated Adverse Reactions

Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of TECENTRIQ, including:

·        Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or  shortness of breath [see Warnings and Precautions (5.1)].

·        Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding [see Warnings and Precautions (5.2)].

·        Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain [see Warnings and Precautions (5.3)].

·        Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, hyperthyroidism, hypothyroidism, adrenal insufficiency, or type 1 diabetes mellitus, including diabetic ketoacidosis [see Warnings and Precautions (5.4)].

·        Other Immune-Mediated Adverse Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of other potential immune-mediated adverse reactions [see Warnings and Precautions (5.5)].

 

Infections

Advise patients to contact their healthcare provider immediately for signs or symptoms of infection [see Warnings and Precautions (5.6)].

 

Infusion-Related Reactions

Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.7)].

 

Embryo-Fetal Toxicity

Advise females of reproductive potential that TECENTRIQ can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1, 8.3)].

 

Advise females of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose of TECENTRIQ [see Use in Specific Populations (8.3)].

 

Lactation

Advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose [see Use in Specific Populations (8.2)].

 

 

Please see full Prescribing Information for additional Important Safety Information.

ICD Codes

Non-small Cell Lung Cancer (NSCLC)

C33

Malignant neoplasm of trachea

C34.00–C34.02

Malignant neoplasm of bronchus and lung; main bronchus

C34.10–C34.12

Malignant neoplasm of bronchus and lung; upper lobe

C34.2

Malignant neoplasm of bronchus and lung; middle lobe

C34.30–C34.32

Malignant neoplasm of bronchus and lung; lower lobe

C34.80–C34.82

Malignant neoplasm of bronchus and lung; overlapping sites

C34.90–C34.92

Malignant neoplasm of bronchus and lung; unspecified part

Small Cell Lung Cancer (SCLC)

C33

Malignant neoplasm of trachea

C34.00–C34.02

Malignant neoplasm of bronchus and lung; main bronchus

C34.10–C34.12

Malignant neoplasm of bronchus and lung; upper lobe

C34.2

Malignant neoplasm of bronchus and lung; middle lobe

C34.30–C34.32

Malignant neoplasm of bronchus and lung; lower lobe

C34.80–C34.82

Malignant neoplasm of bronchus and lung; overlapping sites

C34.90–C34.92

Malignant neoplasm of bronchus and lung; unspecified part

Hepatocellular Carcinoma (HCC)

C22.0

Liver cell carcinoma, hepatocellular carcinoma

C22.8

Malignant neoplasm of liver, primary, unspecified as to type

Malignant Melanoma

C43.0*–C43.9

Malignant melanoma of skin, by site


These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item. 

 

Many payers will not accept unspecified codes. If you use an unspecified code, please check with your payer.


© 2020 Genentech USA, Inc. All rights reserved. This site is intended for US residents only.

                                    M-US-00006143(v1.0)  08/20

Please see full Prescribing Information for additional Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION



  INDICATIONS

 

Metastatic non-small cell lung cancer (NSCLC)

 

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 (nsqNSCLC) 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 (SCLC)

 

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 (HCC)

 

TECENTRIQ, in combination with bevacizumab, is indicated for the treatment of 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 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.


 

IMPORTANT SAFETY INFORMATION

Serious Adverse Reactions

Please refer to the full Prescribing Information for important dose managemeninformation specific to adverse reactions.

 

Immune-Mediated Pneumonitis

·        TECENTRIQ can cause immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of corticosteroids, including fatal cases

·        In clinical studies of TECENTRIQ as a single agent (N=2616), pneumonitis occurred in 2.5% of patients, including Grade 3 (0.6%), Grade 4 (0.1%), and Grade 5 (<0.1%) events. The median time to onset of pneumonitis was 3.6 months (range, 3 days to 20.5 months) and the median duration of pneumonitis was 1.4 months (range, 1 day to 15.1 months). Pneumonitis led to discontinuation of TECENTRIQ in 0.4% of patients

·        In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy (N=2421) for NSCLC and SCLC, pneumonitis occurred in 5.5% of patients, including Grades 3 to 4 (1.4%) events

·        In a clinical study of TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma, immune-mediated pneumonitis occurred in 13% of patients, including Grades 3 to 4 (1.3%) events

·        Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. Administer corticosteroids at a dose of 12 mg/kg/day prednisone or equivalents, followed by a taper for Grade 2 or higher pneumonitis

·        Withhold TECENTRIQ for Grade 2 and permanently discontinue for Grade 3 or 4 pneumonitis

 

Immune-Mediated Hepatitis

·        TECENTRIQ can cause liver test abnormalities and immune-mediated hepatitis, defined as requiring use of corticosteroids. Fatal cases have been reported

·        In clinical studies of TECENTRIQ as a single agent (N=2616), hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events. The median time to onset of hepatitis was 1.4 months (range, 1 day to 25.8 months) and the median duration was 24 days (range, 1 day to 13 months). Hepatitis led to discontinuation of TECENTRIQ in 0.4% of patients

·        In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy (N=2421) for NSCLC and SCLC, hepatitis occurred in 14% of patients, including Grades 3 to 4 (4.1%) events

·        In a clinical study of TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma, immune-mediated hepatitis occurred in 53% of patients, including Grades 3 to 4 (22%) and Grade 5 (<1%) events

·        Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids at a dose of 1–2 mg/kg/day prednisone or equivalents, followed by a taper for Grade 2 or higher elevations of ALT, AST and/or total bilirubin

·        Withhold TECENTRIQ for AST or ALT >3–8 x ULN or total bilirubin >1.5–3 x ULN. Permanently discontinue TECENTRIQ for AST or ALT >8 x ULN or total bilirubin >3 x ULN

 

Immune-Mediated Colitis

·        TECENTRIQ can cause immune-mediated diarrhea or colitis, defined as requiring use of corticosteroids

·        In clinical studies of TECENTRIQ as a single agent (N=2616), diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events. The median time to onset of diarrhea or colitis was 1.5 months (range, 1 day to 41 months). Diarrhea or colitis led to discontinuation of TECENTRIQ in 0.2% of patients

·        In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy (N=2421) for NSCLC and SCLC, diarrhea or colitis occurred in 29% of patients, including Grades 3 to 4 (4.3%) events

·        In a clinical study of TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma, diarrhea or colitis occurred in 50% of patients, including Grades 3 to 4 (3%) events

·        Monitor patients for signs and symptoms of diarrhea or colitis. If symptoms persist for longer than 5 days or recur, administer corticosteroids at a dose of 1–2 mg/kg/day prednisone or equivalents, followed by a taper for Grade 2 diarrhea or colitis

·        Withhold TECENTRIQ for Grade 2 or 3 and permanently discontinue for Grade 4 diarrhea or colitis

 

Immune-Mediated Endocrinopathies

·        TECENTRIQ can cause immune-mediated endocrinopathies, including thyroid disorders; adrenal insufficiency; type 1 diabetes mellitus, including diabetic ketoacidosis; and hypophysitis/hypopituitarism

·        Withhold TECENTRIQ for Grades 2 to 4 endocrinopathies until Grade 1 or resolved and clinically stable on hormone replacement therapy

·        Thyroid Disorders

o       In clinical studies of TECENTRIQ as a single agent (N=2616), hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients. One patient experienced acute thyroiditis

o       In clinical studies of TECENTRIQ in combination with platinum-based chemotherapy (N=2421) for NSCLC and SCLC, hypothyroidism occurred in 11% of patients, including Grades 3 to 4 (0.3%) events

o       In a clinical study of TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma, hypothyroidism occurred in 26% of patients and hyperthyroidism occurred in 19% of patients, including Grades 3 to 4 (0.9%) events

o       Monitor thyroid function prior to and periodically during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated. Continue TECENTRIQ for hypothyroidism and interrupt for hyperthyroidism based on the severity

·        Adrenal Insufficiency

o       In clinical studies of TECENTRIQ as a single agent (N=2616), adrenal insufficiency occurred in 0.4% of patients, including Grade 3 (<0.1%) events. The median time to onset was 5.7 months (range, 3 days to 19 months)

o       Monitor patients for clinical signs and symptoms of adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate prednisone 1–2 mg/kg/day or equivalents, followed by corticosteroid taper and hormone replacement therapy as clinically indicated

·        Type 1 Diabetes Mellitus

o       In clinical studies of TECENTRIQ as a single agent (N=2616), type 1 diabetes mellitus occurred in <0.1% of patients

o       Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated

·        Hypophysitis

o       In clinical studies of TECENTRIQ as a single agent (N=2616), Grade 2 hypophysitis occurred in <0.1% of patients

o       For Grade 2 or higher hypophysitis, initiate prednisone 1–2 mg/kg/day or equivalents, followed by corticosteroid taper and hormone replacement therapy as clinically indicated

·        The frequency and severity of hyperthyroidism, thyroiditis, adrenal insufficiency, diabetes mellitus, and hypophysitis were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC

 

Other Immune-Mediated Adverse Reactions

·        TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system. While immune-mediated reactions usually manifest during treatment with TECENTRIQ, immune-mediated adverse reactions can also manifest after discontinuation of TECENTRIQ

·        In clinical studies of TECENTRIQ as a single agent (N=2616) and in combination with platinum-based chemotherapy (N=2421), or were reported in other products in this class, the immune-mediated adverse reactions occurring at an incidence of <1% were cardiac (myocarditis), dermatologic (bullous dermatitis, pemphigoid, erythema multiforme, Stevens Johnson Syndrome/toxic epidermal necrolysis), gastrointestinal (pancreatitis, including increases in serum amylase or lipase levels), general (systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis), hematological (autoimmune hemolytic anemia, immune thrombocytopenic purpura), musculoskeletal (myositis, rhabdomyolysis), neurological (Guillain-Barré syndrome, myasthenia syndrome/myasthenia gravis, demyelination, immune-related meningoencephalitis, aseptic meningitis, encephalitis, facial and abducens nerve paresis, polymyalgia rheumatica, autoimmune neuropathy, and Vogt-Koyanagi-Harada syndrome), ophthalmological (uveitis, iritis), renal (nephrotic syndrome, nephritis), and vascular (vasculitis)

·        For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. For severe (Grade 3 or 4) adverse reactions, administer corticosteroids at a dose of 1–2 mg/kg/day prednisone or equivalents, followed by a taper

·        If uveitis occurs in combination with other immune-mediated adverse reactions, evaluate for Vogt-Koyanagi-Harada syndrome, which has been observed with other products in this class and may require treatment with systemic steroids to reduce the risk of permanent vision loss

·        Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ

 

Infections

·        TECENTRIQ can cause severe infections including fatal cases

·        In clinical studies of TECENTRIQ as a single agent (N=2616), infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events. In patients with UC, the most common Grade 3 or higher infection was urinary tract infections, occurring in 6.5% of patients. In patients with NSCLC, the most common Grade 3 or higher infection was pneumonia, occurring in 3.8% of patients

·        The frequency and severity of infections were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC

·        In a clinical study of TECENTRIQ in combination with cobimetinib and vemurafenib for melanoma, infections occurred in 60% of patients, including Grade 3 to 4 (9%) and Grade 5 (1.7%) events. The most common infection was upper respiratory tract infection

·        Monitor patients for signs and symptoms of infection. For Grades 3 to 4 infections, withhold TECENTRIQ and resume once clinically stable

 

Infusion-Related Reactions

·        TECENTRIQ can cause severe or life-threatening infusion-related reactions

·        In clinical studies of TECENTRIQ as a single agent (N=2616), infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events

·        The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single agent or in combination with other antineoplastic drugs in NSCLC and SCLC

·        Monitor patients 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. Permanently discontinue TECENTRIQ for Grade 3 or 4 infusion-related reactions

 

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. Advise females of reproductive potential 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

·        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 Prescribing Information for additional Important Safety Information.