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obinutuzumab

Generic Name: obinutuzumab (OH bi nue TOOZ ue mab)
Brand Name: Gazyva

What is obinutuzumab?

Obinutuzumab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

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

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

If you have ever had hepatitis B, obinutuzumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

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Obinutuzumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.

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

You should not receive obinutuzumab if you are allergic to it.

To make sure obinutuzumab is safe for you, tell your doctor if you have:

  • hepatitis B or other liver problems;

  • heart disease;

  • high blood pressure; or

  • an active or recent infection.

FDA pregnancy category C. It is not known whether obinutuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether obinutuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is obinutuzumab given?

Obinutuzumab is injected into a vein through an IV. A healthcare provider will give you this injection.

Obinutuzumab is given in a 28-day treatment cycle, and you may only need to take the medicine during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with obinutuzumab.

You may be given other medications to prevent certain side effects of obinutuzumab.

If you have ever had hepatitis B, obinutuzumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving obinutuzumab?

Do not receive a "live" vaccine while using obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Obinutuzumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Obinutuzumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy or nauseated, or have chest pain, trouble breathing, vomiting, or diarrhea.

Tell your caregiver right away if you have:

  • fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • dizziness, confusion, vision problems, loss of balance or coordination, problems with speech or walking;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common side effects may include:

  • fever;

  • cough; or

  • muscle or joint pain.

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.

See also: Side effects (in more detail)

Obinutuzumab dosing information

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Initial Cycle: 100 mg IV on Day 1, 900 mg IV on Day 2, then 1000 mg IV on Days 8 and 15.
-If appropriate, patients who do not complete the Initial Cycle, Day 1 dose may proceed to the Initial Cycle, Day 2 dose.
Subsequent Cycles: 1000 mg IV on Day 1 of each subsequent 28 day cycle

Duration of therapy: Obinutuzumab is administered for 6 treatment cycles of 28 days each.

Comments:
-Premedicate before each infusion.
-Do not administer as an intravenous push or bolus.
-Monitor blood counts at regular intervals.
-Administer by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.

Use: The treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil.

What other drugs will affect obinutuzumab?

Other drugs may interact with obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-01-14, 2:13:25 PM.

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