Potential GAZYVA Side Effects for Relapsed/Refractory Follicular Lymphoma



Investigator-reported adverse reactions

Adverse reactions (incidence ≥10% and ≥2% greater in the GAZYVA arm) in patients with relapsed or refractory NHL1
Body system adverse reactionsa,b GAZYVA + bendamustine followed by GAZYVA monotherapy (n=204) Bendamustine (n=203)
  ALL GRADES % GRADES 3 TO 5 % ALL GRADES % GRADES 3 TO 5 %
Infusion-related reactionsc 67 11 63 5
Fatigue 40 3 36 3
Pyrexia 19 1 15 1
Neutropenia 37 35d 29 27
Upper respiratory tract infection 36 3 23 1
Respiratory tract infection, unspecified 14 1 8 0
Urinary tract infection 13 3 7 0
Cough 31 <1 21 0
Musculoskeletal pain 28 1 20 0
Arthralgia 12 <1 5 0
Rash 17 <1 14 <1
Pruritus 11 0 6 0
GAZYVA + chemotherapy followed by GAZYVA monotherapy (n=691) rituximab product + chemotherapy followed by rituximab product monotherapy (n=694)
Body system adverse reactionsa,b
Infusion-related reactionsc
ALL GRADES %
67 63
GRADES 3 TO 5 %
11 5
Fatigue
ALL GRADES %
40 36
GRADES 3 TO 5 %
3 3
Pyrexia
ALL GRADES %
19 15
GRADES 3 TO 5 %
1 1
Neutropenia
ALL GRADES %
37 29
GRADES 3 TO 5 %
35d 27
Upper respiratory tract infection
ALL GRADES %
36 23
GRADES 3 TO 5 %
3 1
Respiratory tract infection, unspecified
ALL GRADES %
14 8
GRADES 3 TO 5 %
1 0
Urinary tract infection
ALL GRADES %
13 7
GRADES 3 TO 5 %
3 0
Cough
ALL GRADES %
31 21
GRADES 3 TO 5 %
<1 0
Musculoskeletal pain
ALL GRADES %
28 20
GRADES 3 TO 5 %
1 0
Arthralgia
ALL GRADES %
12 5
GRADES 3 TO 5 %
1 0
Rash
ALL GRADES %
17 14
GRADES 3 TO 5 %
<1 <1
Pruritus
ALL GRADES %
11 6
GRADES 3 TO 5 %
0 0
  • aIncludes adverse reactions reported throughout study treatment and follow-up.
  • bIncludes grouped terms.
  • cExcept where noted, individual events that meet the definition of “infusion-related reaction” are excluded from the table above, as they are already included in the group term “Infusion-related reaction.”
  • dIncludes 1 fatal event.

GAZYVA monotherapy investigator-reported adverse reactions1
  • During GAZYVA monotherapy (158 patients), adverse reactions in ≥10% of patients included upper and lower respiratory tract infections, cough, neutropenia, musculoskeletal pain, fatigue, diarrhea, rash, and urinary tract infection

  • The most common adverse reactions (incidence ≥20%) in GAZYVA recipients included infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, and musculoskeletal pain

Adverse events leading to treatment withdrawal5
  • Discontinuation of any study drug due to adverse reactions occurred in 20% of the GAZYVA + bendamustine followed by GAZYVA monotherapy arm vs 17% in the bendamustine-only arm

The GADOLIN study evaluated safety in 407 patients with relapsed or refractory NHL, including follicular lymphoma (81%), small lymphocytic lymphoma, and marginal zone lymphoma. In the population of patients with follicular lymphoma, the profile of adverse reactions was consistent with the overall NHL population


Laboratory abnormalities

New or worsening laboratory abnormalities (incidence ≥10% and ≥2% greater in the GAZYVA arm1,a) in patients with relapsed or refractory NHL
Laboratory Abnormalities GAZYVA + bendamustine followed by GAZYVA monotherapy (n=204) Bendamustine (n=203)
 

ALL GRADES %

GRADES 3 TO 4 %

ALL GRADES %

GRADES 3 TO 4 %

Lymphopenia

97

92

96

84

Leukopenia 84 47 87 34
Neutropenia 76 53 75 42
Hypophosphatemia 41 8 38 7
Hypocalcemia 39 3 24 1
AST/SGPT increased 36 2 31 3
Alkaline phosphatase increased 27 0 23 0
Hyperbilirubinemia 21 2 17 2
Hyperkalemia 20 3 18 0
GAZYVA + bendamustine followed by GAZYVA monotherapy (n=204) Bendamustine (n=203)
Laboratory abnormalities
Lymphopenia
ALL GRADES %
97 96
GRADES 3 TO 4 %
92 84
Leukopenia
ALL GRADES %
84 87
GRADES 3 TO 4 %
47 34
Neutropenia
ALL GRADES %
76 75
GRADES 3 TO 4 %
53 42
Hypophosphatemia
ALL GRADES %
41 38
GRADES 3 TO 4 %
8 7
Hypocalcemia
ALL GRADES %
39 24
GRADES 3 TO 4 %
3 1
ALT/SGPT increased
ALL GRADES %
36 31
GRADES 3 TO 4 %
2 3
Alkaline phosphatase increased
ALL GRADES %
27 23
GRADES 3 TO 4 %
0 0
Hyperbilirubinemia
ALL GRADES %
21 17
GRADES 3 TO 4 %
2 2
Hyperkalemia
ALL GRADES %
20 18
GRADES 3 TO 4 %
3 0

aTwo percent difference in either any-grade or Grade 3 to 4 laboratory abnormalities.


GAZYVA monotherapy hematologic laboratory abnormalities1
  • Adverse reactions in ≥10% of patients included upper and lower respiratory tract infections, neutropenia, musculoskeletal pain, fatigue, diarrhea, nausea, and urinary tract infection

  • New or worsening Grade 3 or 4 abnormalities included neutropenia in 25% of patients (Grade 4, 10%) and lymphopenia in 23% (Grade 4, 5%)

Hematologic laboratory abnormalities in the GAZYVA treated arm1
  • The most frequently reported hematologic Grade 3-4 laboratory abnormalities were lymphopenia (92%), neutropenia (53%), and leukopenia (47%)

Non-hematologic laboratory abnormalities in the GAZYVA treated arm1
  • The most frequently reported non-hematologic Grade 3-4 laboratory abnormalities were hypophosphatemia (8%), hypocalcemia (3%), hyperkalemia (3%), ALT/SGPT increased (2%), and hyperbilirubinemia (2%)

  • The GADOLIN study evaluated safety in 407 patients with relapsed or refractory NHL, including follicular lymphoma (81%), small lymphocytic lymphoma, and marginal zone lymphoma. In the population of patients with follicular lymphoma, the profile of adverse reactions was consistent with the overall NHL population.

SELECT GADOLIN TRIAL SAFETY INFORMATION

Adverse reactions for GAZYVA + bendamustine followed by GAZYVA monotherapy vs bendamustine

Infusion-Related Reactions: Overall, 67% of patients in the GADOLIN study experienced an IRR (all grades) during treatment with GAZYVA in combination with bendamustine. The incidence of Grade 3 to 4 IRRs in GADOLIN was 11%. In Cycle 1, the incidence of IRRs (all grades) was 53% in patients receiving GAZYVA in combination with bendamustine of which 34 (9%) were Grade 3 to 4 in severity. In patients receiving GAZYVA in combination with bendamustine, the incidence of IRRs was highest on Day 1 (37%), and gradually decreased on Days 2, 8 and 15 (23%, 6% and 4%, respectively). During Cycle 2, the incidence of IRRs was 24% in patients receiving GAZYVA in combination with bendamustine and decreased with subsequent cycles. During GAZYVA monotherapy in GADOLIN, IRRs (all grades) were observed in 8% of patients. One Grade 3 and no Grade 4 IRRs were reported during GAZYVA monotherapy. Overall, 2% of patients in GADOLIN experienced an IRR leading to discontinuation of GAZYVA.

Neutropenia: The incidence of neutropenia in GADOLIN was higher in the GAZYVA plus bendamustine arm (37%) compared to the arm treated with bendamustine alone (30%). Cases of prolonged neutropenia (3%) and late onset neutropenia (8%) were also reported in the GAZYVA plus bendamustine arm. The incidence of neutropenia was higher during treatment with GAZYVA in combination with bendamustine (30%) compared to the GAZYVA monotherapy treatment phase (13%).

Infections: The incidence of infection in GADOLIN was 68% in the GAZYVA plus bendamustine arm and 59% in the bendamustine arm, with Grade 3 to 4 events reported in 20% and 16%, respectively. Fatal events were reported in 3% of patients in the GAZYVA plus bendamustine arm and 3% in the bendamustine arm.

Thrombocytopenia: The incidence of thrombocytopenia in GADOLIN was lower in the GAZYVA plus bendamustine arm (15%) compared to the arm treated with bendamustine alone (25%). The incidence of hemorrhagic events in GAZYVA plus bendamustine treated patients compared to bendamustine alone was 12% and 11%, respectively. Grade 3 to 4 hemorrhagic events were similar in both treatment arms (4% in the GAZYVA plus bendamustine arm and 2% in the bendamustine arm).

Tumor Lysis Syndrome: The incidence of Grade 3 or 4 tumor lysis syndrome in GADOLIN was 0.5% in GAZYVA treated patients.

Musculoskeletal Disorders: Adverse reactions related to musculoskeletal disorders (all events from the body system), including pain, have been reported in the GAZYVA plus bendamustine treated arm with higher incidence than in the bendamustine alone arm (44% vs 30%). 

Gastrointestinal Perforation: Cases of gastrointestinal perforation have been reported in patients receiving GAZYVA, mainly in NHL.

Worsening of Pre-existing Cardiac Conditions: Fatal cardiac events have been reported in patients treated with GAZYVA.

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Indications
GAZYVA® (obinutuzumab), in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
 
GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL).
 
GAZYVA® (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

 

BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA
 
Contraindications
  • GAZYVA is contraindicated in patients with known hypersensitivity reactions (eg, anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use
 
Warnings and Precautions

Hepatitis B Virus Reactivation

  • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with anti-CD20 antibodies including GAZYVA. HBV reactivation has been reported in patients who are hepatitis B surface antigen (HBsAg) positive and in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation has also occurred in patients who appear to have resolved hepatitis B infection (ie, HBsAg negative, anti-HBc positive, and hepatitis B surface antibody [anti-HBs] positive)
  • HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level, or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, ie, increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death
  • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with GAZYVA. For patients who show evidence of hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult healthcare providers with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy
  • Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with GAZYVA
  • In patients who develop reactivation of HBV while receiving GAZYVA, immediately discontinue GAZYVA and any concomitant chemotherapy and institute appropriate treatment. Resumption of GAZYVA in patients whose HBV reactivation resolves should be discussed with healthcare providers with expertise in managing hepatitis B. Insufficient data exist regarding the safety of resuming GAZYVA in patients who develop HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML)

  • JC virus infection resulting in PML, which can be fatal, occurred in patients treated with GAZYVA. Consider the diagnosis of PML in any patient presenting with new onset or changes to preexisting neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue GAZYVA therapy and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Infusion-Related Reactions

  • GAZYVA can cause severe and life-threatening infusion-related reactions (IRRs). Sixty-five percent of patients with CLL experienced a reaction to the first 1,000 mg of GAZYVA infused. Thirty-seven percent of patients with relapsed or refractory NHL and 60% of patients with previously untreated NHL experienced a reaction on Day 1 of GAZYVA infusion. IRRs have occurred within 24 hours of receiving GAZYVA. IRRs can also occur with subsequent infusions. Symptoms may include hypotension, tachycardia, dyspnea, and respiratory symptoms (eg, bronchospasm, larynx and throat irritation, wheezing, and laryngeal edema). The most frequently reported symptoms include nausea, fatigue, chest discomfort, dyspnea, dizziness, vomiting, diarrhea, rash, hypertension, hypotension, flushing, headache, pyrexia, and chills
  • Premedicate patients with acetaminophen, an antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Reduce infusion rate, interrupt infusion or permanently discontinue GAZYVA for IRRs based on severity. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, and/or oxygen) for IRRs as needed
  • For patients with preexisting cardiac or pulmonary conditions, monitor more frequently throughout the infusion and the post-infusion period since they may be at greater risk of experiencing more severe reactions. Hypotension may occur as part of the GAZYVA infusion-related reaction. Consider withholding antihypertensive treatments for 12 hours prior to, during each GAZYVA infusion, and for the first hour after administration until blood pressure is stable. For patients at increased risk of hypertensive crisis, consider the benefits versus the risks of withholding their antihypertensive medication

Hypersensitivity Reactions Including Serum Sickness

  • Hypersensitivity reactions have been reported in patients treated with GAZYVA. Signs of immediate-onset hypersensitivity included dyspnea, bronchospasm, hypotension, urticaria and tachycardia. Late-onset hypersensitivity diagnosed as serum sickness has also been reported, with symptoms that include chest pain, diffuse arthralgia and fever. Hypersensitivity reactions may be difficult to clinically distinguish from infusion-related reactions. However, hypersensitivity very rarely occurs with the first infusion and, when observed, often occurs after previous exposure
  • If a hypersensitivity reaction is suspected during or after an infusion, stop the infusion and permanently discontinue treatment. GAZYVA is contraindicated in patients with known hypersensitivity reactions to GAZYVA, including serum sickness with prior obinutuzumab use

Tumor Lysis Syndrome (TLS)

  • Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. Patients with high tumor burden, high circulating lymphocyte count (>25 x 109/L) or renal impairment are at greater risk for TLS
  • Administer appropriate tumor lysis prophylaxis with antihyperuricemics (eg, allopurinol or rasburicase) and hydration prior to the infusion of GAZYVA for patients at risk for TLS. During the initial days of GAZYVA treatment, monitor the laboratory parameters of patients considered at risk for TLS. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections

  • Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. When GAZYVA is administered with chemotherapy followed by GAZYVA monotherapy, Grade 3 to 5 infections have been reported in up to 8% of patients during combination therapy, up to 13% of patients during monotherapy, and up to 8% of patients after treatment
  • In GALLIUM, more Grade 3 to 5 infections were reported in the recipients of GAZYVA and bendamustine (117/410 patients, 29%), as compared to GAZYVA plus CHOP or CVP (43/281 patients, 15%). More fatal infections were reported in patients treated with GAZYVA and bendamustine (3%), as compared to GAZYVA plus CHOP or CVP (<1%), including during the monotherapy phase and after completion of treatment
  • Do not administer GAZYVA to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection

Neutropenia

  • Severe and life-threatening neutropenia, including febrile neutropenia, has been reported during treatment with GAZYVA. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Anticipate, evaluate, and treat any symptoms or signs of developing infection. Consider dose delays for Grade 3 or 4 neutropenia. Consider administration of granulocyte colony-stimulating factors (GCSF) in patients with Grade 3 or 4 neutropenia
  • Neutropenia can also be of late onset (occurring more than 28 days after completion of treatment) and/or prolonged (lasting longer than 28 days)
  • Patients with severe and long lasting (>1 week) neutropenia are strongly recommended to receive antimicrobial prophylaxis until resolution of neutropenia to Grade 1 or 2. Consider antiviral and antifungal prophylaxis

Thrombocytopenia

  • Severe and life-threatening thrombocytopenia has been reported during treatment with GAZYVA in combination with chemotherapy. Fatal hemorrhagic events have been reported in patients with NHL treated with GAZYVA in combination with chemotherapy, including during Cycle 1
  • Monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially during the first cycle. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more frequently until resolution and consider dose delays of GAZYVA and chemotherapy or dose reductions of chemotherapy. Transfusion of blood products (ie, platelet transfusion) may be necessary. Consider withholding concomitant medications that may increase bleeding risk (platelet inhibitors or anticoagulants), especially during the first cycle

Immunization

  • The safety and efficacy of immunization with live or attenuated viral vaccines during or following GAZYVA therapy have not been studied. Immunization with live virus vaccines is not recommended during treatment and until B-cell recovery

Embryo-Fetal Toxicity

  • Based on its mechanism of action and findings in animals, GAZYVA can cause B-cell depletion in infants exposed to obinutuzumab in-utero. Advise pregnant women of the potential risk to a fetus. Mothers who have been exposed to GAZYVA during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. Advise females of reproductive potential to use effective contraception while receiving GAZYVA and for 6 months after the last dose

Lactation

  • Human IgG is known to be present in human milk. Because of the potential of serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with GAZYVA and for 6 months after the last dose

Geriatric Use

  • Of 336 patients with previously untreated CLL who received GAZYVA in combination with chlorambucil, 81% were 65 years and older, while 46% were 75 and older. Of the patients 75 years and older, 46% experienced serious adverse reactions and 7% experienced adverse reactions leading to death. Of the patients younger than 75, 33% experienced a serious adverse reaction and 2% an adverse reaction leading to death. No significant differences in efficacy were observed between younger and older patients
  • Of 204 patients in GADOLIN with relapsed or refractory NHL treated with GAZYVA plus bendamustine, 44% were 65 and over, while 14% were 75 and over. In patients 65 and over, 55% of patients experienced serious adverse reactions and 28% experienced adverse reactions leading to treatment withdrawal while in patients under 65, 37% and 14% experienced serious adverse reactions and adverse reactions leading to treatment withdrawal, respectively. No clinically meaningful differences in efficacy were observed between these patients and younger patients in GADOLIN
  • Of the 691 patients in GALLIUM treated with GAZYVA plus chemotherapy as first-line therapy, 33% were 65 and over, while 7% were 75 and over. Of patients 65 and over, 63% experienced serious adverse reactions and 26% experienced adverse reactions leading to treatment withdrawal, while in patients under 65, 43% experienced serious adverse reactions and 13% had an adverse reaction leading to treatment withdrawal. No clinically meaningful differences in efficacy were observed between these patients and younger patients
     
Additional Important Safety Information

Previously Untreated CLL

  • The most common Grade 3 to 4 adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were neutropenia, infusion-related reactions, and thrombocytopenia

  • The most common adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were infusion-related reactions, neutropenia, thrombocytopenia, and diarrhea

  • Adverse reactions rates and laboratory abnormalities from the Stage 2 phase are consistent with the rates in Stage 1. In addition to the adverse reactions observed in Stage 2, in Stage 1 back pain (5% vs 2%), anemia (12% vs 10%) and cough (10% vs 7%) were observed at a higher incidence in the GAZYVA treated patients. The incidence of Grade 3 to 4 back pain (<1% vs 0%), cough (0% vs <1%) and anemia (5% vs 4%) was similar in both treatment arms. With regard to laboratory abnormalities, in Stage 1 hyperkalemia (33% vs 18%), creatinine increased (30% vs 20%) and alkaline phosphatase increased (18% vs 11%) were observed at a higher incidence in patients treated with GAZYVA with similar incidences of Grade 3 to 4 abnormalities between the two arms

Relapsed/Refractory NHL

  • The GADOLIN study evaluated safety in 407 patients with relapsed or refractory NHL, including FL (81%), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which GAZYVA is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of adverse reactions was consistent with the overall NHL population

  • Serious adverse reactions occurred in 45% of the GAZYVA arm and 37% of the bendamustine-only arm. Fatal adverse reactions within 90 days of treatment occurred in 3.4% and 2.5%, respectively. Throughout follow-up, fatal adverse reactions occurred in 10% of GAZYVA recipients and in 7.4% of recipients of bendamustine alone, with infection and second primary malignancies being the leading causes

  • The most common adverse reactions (incidence ≥20%) in GAZYVA recipients included infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, and musculoskeletal pain

  • During GAZYVA monotherapy (158 patients), adverse reactions in ≥10% of patients included upper and lower respiratory tract infections, cough, neutropenia, musculoskeletal pain, fatigue, diarrhea, rash, and urinary tract infection

  • In the GAZYVA monotherapy phase, new or worsening Grade 3 or 4 abnormalities included neutropenia in 25% of patients (Grade 4, 10%) and lymphopenia in 23% (Grade 4, 5%)

Previously Untreated NHL

  • A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of GAZYVA as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%)
  • Serious adverse reactions occurred in 50% of patients on the GAZYVA arm and 43% of patients on the rituximab product arm. Fatal adverse reactions were reported during treatment in 3% in the GAZYVA arm and 2% in the rituximab product arm, most often from infections in the GAZYVA arm. During treatment and follow-up combined, fatal adverse reactions were reported in 5% of the GAZYVA arm and 4% of the rituximab product arm, with infections and second malignancies being leading causes. In the GAZYVA arm, fatal infections occurred in 2% of patients compared to <1% in the rituximab product arm
  • Neutropenia, infusion-related reactions, febrile neutropenia and thrombocytopenia were the most common Grade 3 to 5 adverse reactions (incidence ≥5%) observed more frequently in the GAZYVA arm
  • Throughout treatment and follow-up, the most common adverse reactions (incidence ≥20%) observed at least 2% more in the GAZYVA arm were infusion-related reactions (72%), neutropenia (53%), upper respiratory tract infection (50%), cough (35%), constipation (32%) and diarrhea (30%)
  • During the monotherapy period, the common adverse reactions (incidence ≥10%) observed at least 2% more with GAZYVA were upper respiratory infection (40%), cough (23%), musculoskeletal pain (20%), neutropenia (19%) and herpesvirus infection (13%)

 

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088.

Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.

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      GAZYVA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2021.

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      CALQUENCE® (acalabrutinib) Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

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      IMBRUVICA® (ibrutinib) Prescribing Information. Horsham, PA: Janssen Biotech, Inc.; 2019.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.