Committed to Helping You Get Your Genentech Medicine
Knowing what to expect can make all the difference. We can help you
through each step of getting your Genentech medicine.
Frequently Asked Questions
About GAZYVA Access Solutions
What is GAZYVA Access Solutions?
GAZYVA Access Solutions is a resource for people who take a Genentech
medicine. We connect you to the medicine you need.
I Am Concerned About Paying for GAZYVA
My co-pays for GAZYVA are too high. How can you help me?
There may be options to help you get the Genentech medicine your doctor has prescribed. GAZYVA Access Solutions can refer you to patient assistance options.
Where can I find information about the Genentech® Access to Care Foundation (GATCF)?
Getting My Medicine
How long will it take to get my medicine?
You might not be able to get your Genentech medicine right away. First, your doctor’s office or specialty pharmacy will have to check to make sure your health insurance plan covers your medicine. This is called a “benefits investigation.” They also might have to send some more information before your plan covers your medicine. This is called a “prior authorization.”
Enrolling in GAZYVA Access Solutions
How do I enroll in GAZYVA Access Solutions?
- You fill out the Patient Consent Form.
- Your doctor fills out the Prescriber Service Form. You do not have to fill out anything on this form.
- Your doctor sends both of these forms to GAZYVA Access Solutions.
There are 3 ways to send us the Patient Consent Form:
- Complete it online at Genentech-Access.com/PatientConsent
- Fill out a paper copy and fax or mail it to us (or give it to your doctor to do so)
- Text a picture of the completed form to (650) 877-1111
Why do I need to sign the Patient Consent Form?
The Patient Consent Form lets us discuss your health information with your doctor and your health insurance plan. We can’t work with you without a signed Patient Consent Form.
I submitted the Patient Consent Form online or gave the signed Patient Consent Form to my doctor. Is there anything else I need to do to enroll?
You do not need to do anything else, but your doctor does. He or she needs to submit the Prescriber Service Form. This form tells us your doctor wants to treat you with GAZYVA. Make sure your doctor has sent us the Prescriber Service Form so you get help from us.
You do not need to fill out anything on the Prescriber Service Form.
I already submitted a PAN form. Do I also need to fill out the Patient Consent Form?
The Patient Consent Form replaces the PAN. The PAN and the Patient Consent Form are valid for 3 years in all states (except Maryland, where it is valid for 1 year).
If your PAN is still valid, you do not need to fill out the Patient Consent Form yet.
My Health Plan Denied Coverage for GAZYVA
My health insurance plan will not cover GAZYVA. What do I do?
If your health insurance plan will not cover your Genentech medicine, you and your doctor’s office can file an appeal. Contact your doctor to ask if you should file an appeal.
We have resources to help you and your doctor file an appeal.
Does GAZYVA Access Solutions send the appeal to my health insurance plan?
We have resources to help you and your doctor file an appeal. You or
your doctor’s office has to file the appeal directly with your health
How long does an appeal take?
This depends on your health insurance plan. You should ask your plan directly about its process. Sometimes the appeals process is quick. However, it can take several months if you have to appeal several times.
My Insurance Might Change
I am enrolled in GAZYVA Access Solutions and my health insurance plan has changed. What do I do next?
If your insurance changes while you’re taking your Genentech
medicine, call us. We can help you understand your new coverage.
I no longer have a health insurance plan. What should I do?
The Genentech Patient Foundation gives free Genentech medicine to
people who don't have insurance coverage or who have financial
concerns and to people who meet certain income criteria.
It is your and your doctor's responsibility to complete and submit
all required paperwork to your health insurance plan. Genentech
cannot guarantee your plan will cover any treatments.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
Important Safety Information & Indication
What it Treats
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.
GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.
GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.
Important Safety Information
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 Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. 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 infusion reaction 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 infusion reactions 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 administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. 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. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP
- 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 reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea
The safety of GAZYVA was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81%), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which GAZYVA is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of GAZYVA were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection
A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of GAZYVA as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%). The most common side effects of GAZYVA were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea
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, plan to become pregnant, or are breastfeeding. 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. It is not known if GAZYVA may pass into your breast milk. Speak to your doctor about using GAZYVA if you are breastfeeding
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.