Infusion preparation for first-line follicular lymphoma

Here are the steps to take in order to be prepared for your treatment.

One week before GAZYVA® (obinutuzumab) infusion:

  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicine, vitamins, and herbal supplements
  • Speak to your doctor if you take medications to control your blood pressure. Your doctor may instruct you not to take them on the day of your GAZYVA infusion
  • Arrange a ride. After your infusion, you may feel drowsy or dizzy. It is a good idea to have someone else drive you home


One day before GAZYVA infusion:

  • Remember to follow any changes your doctor has made to your regular medication schedule

The day of your GAZYVA infusion

AT HOME:

Wear or bring loose clothing so you can be comfortable during your infusion
Pack food and drink—bringing some snacks or a packed meal can help you get through the day
Bring a book or activities to help pass the time

AT THE CLINIC OR INFUSION CENTER:

Take the medications your doctor prescribed to help reduce the side effects of the infusion process
Relax during your infusion, but be aware of what is happening to your body. Tell your doctor or nurse right away if you feel any side effects, including the symptoms of an infusion reaction
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QUESTIONS FOR YOUR DOCTOR?

Explore questions you may want to ask your doctor.

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Call our Patient Resource Center

1 (877) 218-3996

This is not meant to replace the advice of your healthcare team.

SIDE EFFECTS

Read about possible side effects with GAZYVA® (obinutuzumab) treatment.

Indication

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
 

What is the most important safety information I should know about GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

  • Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes

  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA?

  • Do NOT receive GAZYVA if you have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past

What are the additional possible serious side effects of GAZYVA?

Tell your doctor right away about any side effect you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

  • Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the IRR is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort

  • Hypersensitivity Reactions Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA

  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. Your doctor may prescribe medication to help prevent TLS. Your doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness

  • Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections may be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA

  • Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections

  • Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

What other information should I tell my doctor before receiving GAZYVA?

You should talk to your doctor about:

  • Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines

  • Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment

  • Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose

Tell your doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.

GAZYVA is available by prescription only.

You may report side effects to the FDA at (800) FDA-1088, or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the accompanying full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.