Gazyva

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor. Your doctor may direct you to receive this medication in a treatment cycle (for example, only on certain days each month). Carefully follow your doctor's instructions.

The dosage is based on your medical condition and response to treatment.

Obinutuzumab may cause very serious infusion-related reactions during or up to 24 hours after treatment. These reactions occur more often with the first and second treatments. Your doctor will monitor you closely and increase your dose slowly to reduce the chance of these serious side effects. Your doctor may also prescribe other medications before each treatment, including acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as methylprednisolone) to prevent these side effects. If you have a reaction, your treatment may be temporarily stopped. Tell your doctor or nurse right away if any of these side effects occur: dizziness, fainting, fast heartbeat, chest pain, trouble breathing, wheezing, itching/swelling of the throat, nausea, vomiting, diarrhea, flushing, headache, fever, or chills.

If you take drugs for high blood pressure, ask your doctor ahead of time if you should change the way you take your blood pressure medication right before and after your dose of obinutuzumab. Some people have had reactions (such as dizziness/fainting) due to taking blood pressure medication too close to the time of their obinutuzumab infusion.

See also Warning and How to Use sections.

Cough or muscle pain may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.

Obinutuzumab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using obinutuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), active/current infection, heart disease, kidney disease, lung disease.

Obinutuzumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Missed Doses:

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Notes:

Do not share this medication with others.

Lab tests (such as kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.