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Obinutuzumab Side Effects

For the Consumer

Applies to obinutuzumab: intravenous solution

As well as its needed effects, obinutuzumab may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking obinutuzumab, check with your doctor or nurse immediately:

More common:
  • Back pain
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest tightness
  • chills
  • cough or hoarseness
  • fever
  • flushing
  • headache
  • lower back or side pain
  • nausea and vomiting
  • 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
Less common:
  • Joint pain, stiffness, or swelling
  • lower back, side, or stomach pain
  • swelling of the feet or lower legs
Incidence not known:
  • Blurred vision
  • confusion
  • convulsions
  • dark urine
  • dizziness
  • drowsiness
  • general tiredness and weakness
  • headache
  • light-colored stools
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Minor Side Effects

Some obinutuzumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

General

The most frequently reported side effects included infusion reactions, neutropenia, thrombocytopenia, anemia, pyrexia, cough, and musculoskeletal disorders.[Ref]

Cardiovascular

Frequency not reported: Worsening of preexisting cardiac conditions with fatalities, atrial fibrillation[Ref]

Hematologic

Very common (10% or more): Neutropenia (40%), thrombocytopenia (15%), anemia (12%)
Common (1% to 10%): Leukopenia (7%)[Ref]

Hepatic

Very common (10% or more): AST (SGOT) increased (28%), ALT (SGPT) increased (25%)[Ref]

Metabolic

Very common (10% or more): Hypocalcemia (32%), hyperkalemia (31%), hyponatremia (29%), hypoalbuminemia (22%), alkaline phosphatase increased (16%), hypokalemia (13%)
Common (1% to 10%): Grade 3 or 4 tumor lysis syndrome (2%)[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal disorders including pain (17%)[Ref]

Nervous system

Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]

Other

Very common (10% or more): Infusion related reactions (69%), pyrexia (10%)[Ref]

Renal

Very common (10% or more): Creatinine increased (30%)[Ref]

Respiratory

Very common (10% or more): Cough (10%)[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[Ref]

References

1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

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

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

It is possible that some side effects of obinutuzumab may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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