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Obinutuzumab Side Effects

For the Consumer

Applies to obinutuzumab: intravenous solution

Along with its needed effects, obinutuzumab 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
  • troubled breathing with exertion
  • 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

Incidence Not Known

  • Blurred vision
  • confusion
  • dark urine
  • dizziness
  • drowsiness
  • general tiredness and weakness
  • light-colored stools
  • seizures
  • upper right abdominal or stomach pain
  • yellow eyes and skin

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 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]

References

1. "Product Information. Gazyva (obinutuzumab)." Genentech, South San Francisco, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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.

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