Obinutuzumab Side Effects
Applies to obinutuzumab: intravenous solution.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 6 months after your treatment ends. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause hepatitis B virus reactivation. Check with your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.
This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.
This medicine may cause an infusion reaction within a few hours after you receive it. Check with your doctor right away if you have chest pain, itching, hives, a rash, flushing of the face, dizziness, fainting, lightheadedness, trouble breathing, swelling of the face, tongue, and throat, a fever, or chills.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Obinutuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause serious blood clotting problem, including disseminated intravascular coagulation (DIC). Check with your doctor right away if you have blood in the stools, blood in the urine, bruising, confusion, coughing or vomiting blood, persistent bleeding or oozing from puncture sites, mouth, or nose, rash, or trouble breathing.
While you are being treated with obinutuzumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Obinutuzumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Serious side effects of obinutuzumab
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 side effects
- 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 side effects
- joint pain, stiffness, or swelling
- stomach pain
- swelling of the feet or lower legs
Rare side effects
- 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 obinutuzumab
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 adverse events
- 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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2013) "Product Information. Gazyva (obinutuzumab)." Genentech
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Further information
Obinutuzumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.