Pronunciation: OH bi nue TOOZ ue mab

Brand: Gazyva

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.

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 is obinutuzumab?

Obinutuzumab is a monoclonal antibody that affects the actions of the body's immune system. Obinutuzumab strengthens your immune system to help your body fight against tumor cells.

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).

After completing combination chemotherapy, some people with advanced follicular lymphoma continue using obinutuzumab by itself 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?

You should not receive this medicine if you have ever had a severe allergic reaction to obinutuzumab, including a condition called serum sickness.

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

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

It is not known whether obinutuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether obinutuzumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How is obinutuzumab given?

Obinutuzumab is injected into a vein through an IV. A healthcare provider will give you this injection. You will receive this medicine in a hospital or infusion clinic.

Obinutuzumab is given in a 28-day treatment cycle, and you may only need to receive 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.

You may be given other medications to help prevent serious side effects or allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

Obinutuzumab can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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?

Call your doctor for instructions if you miss an appointment for your obinutuzumab injection.

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 receiving obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of obinutuzumab?

Get emergency medical help if you have signs of an allergic reaction: hives, rash or itching; fever, swollen glands, joint pain; fast heartbeats, chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Obinutuzumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any mood or behavior changes, confusion, memory problems, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection, or within 24 hours afterward. Tell your caregiver right away if you feel tired, feverish, chilled, sweaty, itchy, tingly, light-headed, nauseated, or if you have a headache, vomiting, diarrhea, chest pain, fast heartbeats, wheezing, trouble breathing, or throat irritation.

Tell your caregiver right away if you have:

  • pain or burning when you urinate;
  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, wheezing, feeling short of breath;
  • confusion, vision problems, problems with speech or walking;
  • dizziness, loss of balance or coordination;
  • low blood cell counts --fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • signs of tumor cell breakdown --muscle cramps, tiredness, confusion, fast or slow heart rate, fluttering in your chest, vomiting, diarrhea, decreased urination, tingling in your hands or feet, tingling around your mouth.

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

Common side effects may include:

  • fever, weakness, loss of appetite;
  • low blood cell counts;
  • diarrhea, constipation;
  • headache, joint pain;
  • cough, runny or stuffy nose, sinus pain; or
  • sleep problems (insomnia).

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?

Make sure your doctor knows if you take blood pressure medication, or if you take a blood thinner or other medicine to prevent blood clots. You may need to stop taking these medications for a short time before and during treatment with obinutuzumab. Do not change your doses or medication schedule without your doctor's advice.

Other drugs may interact with obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines 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.

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