Note: This document contains side effect information about obinutuzumab. Some dosage forms listed on this page may not apply to the brand name Gazyva.
Summary
Common side effects of Gazyva include: infection, fever, hyperkalemia, hypocalcemia, hypokalemia, hypophosphatemia, and neutropenia. Continue reading for a comprehensive list of adverse effects.
Applies to obinutuzumab: parenteral injection concentrate.
Warning
-
HBV Reactivation
- Reactivation of HBV infection (including fulminant hepatitis and hepatic failure), sometimes fatal, reported.1 5 6 7 8
- Screen all patients for HBV infection prior to initiation of therapy.1
- Discontinue obinutuzumab and concomitant chemotherapy if HBV reactivation occurs.1 (See HBV Reactivation under Cautions.)
-
Progressive Multifocal Leukoencephalopathy (PML)
- PML, sometimes fatal, can occur.1 (See Progressive Multifocal Leukoencephalopathy under Cautions.)
Side effects include:
Infusion-related reactions, pyrexia, cough, musculoskeletal disorders, neutropenia, lymphopenia, leukopenia, thrombocytopenia, hypocalcemia, hyperkalemia, hyponatremia, elevated aminotransferase (i.e., AST, ALT) concentrations, elevated Scr, hypoalbuminemia, elevated serum alkaline phosphatase concentration, hypokalemia.
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]
