Gazyva Side Effects
Generic name: obinutuzumab
Note: This document contains side effect information about obinutuzumab. Some dosage forms listed on this page may not apply to the brand name Gazyva.
Applies to obinutuzumab: intravenous solution.
Warning
Intravenous route (Solution)
Hepatitis B virus (HBV) reactivation can occur in patients receiving obinutuzumab or other CD20-directed cytolytic antibodies, which can progress to life-threatening or fatal fulminant hepatitis or hepatic failure. Screen patients at baseline for HBV infection. Monitor HBV-positive patients during and after treatment with obinutuzumab. If HBV reactivation occurs, discontinue obinutuzumab and concomitant medications. Life-threatening or fatal progressive multifocal leukoencephalopathy has also been reported.
Serious side effects of Gazyva
Along with its needed effects, obinutuzumab (the active ingredient contained in Gazyva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking obinutuzumab:
More common
- Back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest tightness
- chills
- cough
- fever
- flushing
- headache
- hoarseness
- lower back or side pain
- nausea
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Joint pain, stiffness, or swelling
- stomach pain
- swelling of the feet or lower legs
Rare
- Bruising
- confusion
- coughing or vomiting blood
- persistent bleeding or oozing from puncture sites, mouth, or nose
- rash
Incidence not known
- Blurred vision
- dark urine
- dizziness
- drowsiness
- general tiredness and weakness
- light-colored stools
- seizures
- upper right abdominal or stomach pain
- yellow eyes and skin
Other side effects of Gazyva
Some side effects of obinutuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For Healthcare Professionals
Applies to obinutuzumab: intravenous solution.
Cardiovascular
Common (1% to 10%): Hypertension, cardiac failure
Frequency not reported: Worsening of preexisting cardiac conditions with fatalities, atrial fibrillation[Ref]
Hematologic
Very common (10% or more): Neutropenia (41%), thrombocytopenia (15%), anemia (12%)
Common (1% to 10%): Leukopenia, lymph node pain[Ref]
Hepatic
Very common (10% or more): AST (SGOT) increased (28%), ALT (SGPT) increased (25%)[Ref]
Metabolic
Very common (10% or more): Hypophosphatemia (36%), hypoalbuminemia (33%), hypoproteinemia (32%), hypocalcemia (32%), hypocalcemia (32%), hyperuricemia (28%), hyponatremia (26%), hyperkalemia (23%), hypernatremia (16%) alkaline phosphatase increased (16%), decreased appetite (14%)
Common (1% to 10%): Tumor lysis syndrome, hyperuricemia[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, back pain, musculoskeletal chest pain, pain in extremity, bone pain[Ref]
Nervous system
Very common (10% or more): Headache (18%), asthenia
Frequency not reported: Progressive multifocal leukoencephalopathy (PML)[Ref]
Other
Very common (10% or more): Pyrexia (18%)[Ref]
Renal
Very common (10% or more): Creatinine increased (30%)[Ref]
Respiratory
Very common (10% or more): Cough (26%), pneumonia (14%), sinusitis (12%), upper respiratory tract infection
Common (1% to 10%): Rhinitis, pharyngitis, nasopharyngitis, lung infection, nasal congestion, rhinorrhea, lung infection[Ref]
Immunologic
Very common (10% or more): Positive test for anti-obinutuzumab (the active ingredient contained in Gazyva) antibodies (13%)
Common (1% to 10%): Infection (9%)
Frequency not reported: Hepatitis B reactivation, immunogenicity[Ref]
Dermatologic
Very common (10% or more): Alopecia (13%)
Common (1% to 10%): Pruritus, night sweats, eczema[Ref]
Local
Very common (10% or more): Infusion related reactions (69%)[Ref]
Ocular
Common (1% to 10%): Ocular hyperemia[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection, urinary incontinence, dysuria[Ref]
Oncologic
Common (1% to 10%): Squamous cell carcinoma of the skin[Ref]
Gastrointestinal
Very common (10% or more): Constipation (19%), diarrhea (10%)
Common (1% to 10%): Oral herpes, dyspepsia, colitis, hemorrhoids[Ref]
Hypersensitivity
Frequency not reported: This drug can cause serious infusion reactions. See Warnings.[Ref]
Frequently asked questions
More about Gazyva (obinutuzumab)
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References
1. Cerner Multum, Inc. UK Summary of Product Characteristics.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Gazyva (obinutuzumab). Genentech. 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
