obinutuzumab

What is the most important information I should know about obinutuzumab?

If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

What is obinutuzumab?

Obinutuzumab is used in combination with another cancer medicine called chlorambucil to treat chronic lymphocytic leukemia.

Obinutuzumab is also used in combination with other cancer medicines to treat follicular lymphoma (a type of non-Hodgkin lymphoma), or to help delay the progression of this disease.

Obinutuzumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving obinutuzumab?

Tell your doctor if you have ever had:

• high blood pressure;
• hepatitis B or other liver problems;
• kidney disease;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• if you have an active infection.

How is obinutuzumab given?

Obinutuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Obinutuzumab is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with obinutuzumab.

On the days you receive this medicine, plan to spend most of the day at the hospital or infusion clinic.

Obinutuzumab can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

If you've ever had hepatitis B, using obinutuzumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving obinutuzumab?

Do not receive a "live" vaccine while receiving obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What are the possible side effects of obinutuzumab?

Some side effects may occur during the injection, or within 24 hours afterward. Tell your caregiver if you feel sudden warmth, redness, tingly feeling, feverish, chilled, light-headed, nauseated, or if you have headache, pounding in your neck or ears, tiredness, rash, dizziness, diarrhea, vomiting, chest discomfort, or trouble breathing.

• easy bruising, unusual bleeding, purple or red spots under your skin;
• weakness, cough, diarrhea, burning when you urinate;
• right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes;
• dizziness, loss of balance or coordination;
• confusion, vision problems, problems with speech or walking;
• low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• signs of tumor cell breakdown --tiredness, muscle cramps, nausea, vomiting, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• a reaction during or shortly after the injection;
• tiredness;
• low white blood cell counts;
• diarrhea, constipation;
• muscle or joint pain; or
• cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect obinutuzumab?

Tell your doctor about all your other medicines, especially:

• a blood thinner --warfarin, Coumadin, Jantoven; or
• medicine to treat or prevent blood clots --cilostazol, clopidogrel, dipyridamole, ticagrelor, ticlopidine, and others.

This list is not complete. Other drugs may affect obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about obinutuzumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. 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 drugs you are taking, check with your doctor, nurse or pharmacist.

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