Authorized Distributors and Specialty Pharmacies
Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase GAZYVA through the buy and bill model. Customers can purchase GAZYVA through authorized specialty distributors and wholesalers that have made a commitment to product integrity. These partners have agreed to distribute only products purchased directly from Genentech and not to distribute GAZYVA through secondary channels.
GAZYVA Access Solutions works with SPs to help patients receive
their medicines. SPs can dispense Genentech medicines to your office.
The SPs can also provide coverage and reimbursement support.
Distributors for Federal Accounts
|AmerisourceBergen Drug Corporation||844-222-2273||816-464-4140||www.amerisourcebergen.com/abc/|
|Cardinal Health Specialty Distribution||800-926-3161 |
|McKesson US Pharmaceutical||855-625-4677 |
Distributors for Hospitals
|Cardinal Health Specialty Distribution||800-926-3161||888-345-4916||specialtyonline.cardinalhealth.com|
|McKesson Plasma and Biologics (MPB)||877-625-2566||888-752-7626||connect.mckesson.com|
|Morris & Dickson Specialty Distribution||800-710-6100||318-524-3096||www.mdspecialtydist.com|
Distributors for Physician Offices and Federally Qualified Health Centers
|Cardinal Health Specialty Distribution||877-453-3972||888-345-4916||specialtyonline.cardinalhealth.com|
|McKesson Specialty Health||800-482-6700
Distributors for Authorized Specialty Pharmacies
|Cardinal Health Specialty Distribution||877-453-3972||888-345-4916||specialtyonline.cardinalhealth.com|
|Humana Specialty Pharmacy ||800-486-2668 ||877-405-7940 ||www.humanapharmacy.com/specialty |
|McKesson Specialty Health||800-482-6700
Distributors for Puerto Rico
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.
About Buy and Bill
With buy and bill, the practice purchases the medication in advance,
then bills the patient’s health insurance plan for reimbursement. The
practice is responsible for storing and handling the drug as well as
collecting the patient’s co-pay for both the drug and its
administration. With buy and bill, practices can maintain a stock of
the drug, giving them the flexibility to treat patients when
About Specialty Pharmacies
GAZYVA Access Solutions works with specialty pharmacies (SPs) to help patients receive their medicines.
An SP may provide the following services:
- Reimbursement resources
- Clinical services to support patients throughout their treatment
ability to manage the specialty handling and shipping needs linked
with many specialty therapies
You can work with your preferred SP or contact GAZYVA Access Solutions to learn which SP the patient’s health insurance plan requires.
Genentech does not influence or advocate the use of any one
specialty distributor or specialty pharmacy. We make no
representation or guarantee of service or coverage of any item.
Spoilage Replacement Program
The Genentech Spoilage Replacement Program provides for replacement of infused, injected and self-administered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by Genentech. The purpose of the program is to support our commitment to protecting patient safety by preventing the use of spoiled, damaged or contaminated products.
Please contact Genentech Customer Service at (800) 551-2231 to submit a request for replacement of spoiled product or to obtain additional information about the Program.
To request replacement product:
- Complete the Online Spoilage Replacement Form found at the Genentech Customer Service website
- Once the form is complete, you will receive a confirmation number; your request is not complete until you have this number
- If approved, further instructions for returning product or completing a Certificate of Destruction will be provided within 2 business days of the form submission
- The Genentech Spoilage
Replacement Program will continue to accept submissions via fax
- You can download the paper form at the Genentech Customer Service website or contact Genentech Customer Service at (800) 551-2231 to obtain the Genentech Spoilage Replacement Program Form
- Complete the Genentech Spoilage Replacement Program Form and fax it back to Genentech Customer Service at (877) 329-6737 within 30 days of the spoilage event
- The request may take up to 3 business days to review. If approved by Genentech, further instructions for returning product or completing a Certificate of Destruction will be provided
- The spoiled product or
completed Certificate of Destruction must be received by Genentech
within 60 days of approval of the spoilage request
- Replacement product generally ships within 11 business days following receipt of the spoiled product or completed Certificate of Destruction
- Each instance of spoilage replacement requires completion of the Spoilage Replacement Program Form. Replacement is on a case-by-case basis at the sole discretion of Genentech; please retain all original product packaging for returns processing
- Genentech does not ship replacement product if the spoiled product has been used for an off-label indication
- Genentech does not ship replacement product if ANY portion of the product has been administered
- Genentech will only ship replacement product to licensed facilities
- All spoilage replacement requests are subject to review by Genentech; returned product is subject to analysis
- Replacement is not available if any amount has been billed to a patient or an insurance claim has been remitted to a payer
- Requests are subject to certain limitations and conditions. Genentech has the right to modify or discontinue the Spoilage Replacement Program at any time without notice
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
GAZYVA® (obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
GAZYVA® (obinutuzumab), in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL).
Important Safety Information
BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
- Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation
- Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA
- GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g. anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use
Additional Warnings and Precautions
- Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions. Sixty-five percent of patients with CLL experienced a reaction to the first 1000 mg infused of GAZYVA infused. Thirty-eight percent of patients with relapsed or refractory NHL and 60% of patients with previously untreated NHL experienced a reaction on Day 1 of GAZYVA infusion. For patients with Grade 4 infusion reactions, including but not limited to anaphylaxis, acute life-threatening respiratory symptoms, or other life-threatening infusion reaction, stop and permanently discontinue GAZYVA therapy. Premedicate patients with acetaminophen, an antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Infusion reactions within 24 hours of receiving GAZYVA have occurred. Interrupt GAZYVA for Grade 3 reactions until resolution of symptoms. Interrupt or reduce the rate of the infusion for Grade 1 or 2 reactions and manage symptoms
- Hypersensitivity Reactions Including Serum Sickness: Hypersensitivity reactions have been reported in patients treated with GAZYVA. Late-onset hypersensitivity diagnosed as serum sickness has also been reported in patients treated with GAZYVA. If a hypersensitivity reaction is suspected during or after an infusion, the infusion must be stopped and treatment permanently discontinued. Patients with known hypersensitivity reactions to GAZYVA, including serum sickness, must not be retreated
- Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. Patients with high tumor burden, high circulating lymphocyte count (>25 x 109/L) or renal impairment are at greater risk for TLS and should receive appropriate tumor lysis prophylaxis with antihyperuricemics and hydration prior to the infusion of GAZYVA
- Infections: Fatal and serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. Do not administer GAZYVA to patients with an active infection. In GALLIUM, more Grade 3 to 5 infections were reported in the recipients of GAZYVA and bendamustine (117/410 patients, 29%), as compared to GAZYVA plus CHOP or CVP (43/281 patients, 15%)
- Neutropenia: Severe and life-threatening neutropenia can occur. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Neutropenia can also be of late onset and/or prolonged
- Thrombocytopenia: Severe and life threatening thrombocytopenia has been reported during treatment with GAZYVA in combination with chemotherapy. Fatal hemorrhagic events have been reported in patients with NHL and CLL treated with GAZYVA in combination with chemotherapy, including during Cycle 1. Monitor all patients for thrombocytopenia. In patients with Grade 3 or 4 thrombocytopenia, monitor platelet counts more frequently until resolution and consider subsequent dose delays of GAZYVA and chemotherapy or dose reductions of chemotherapy. Transfusion of blood products (i.e., platelet transfusion) may be necessary
- Immunization: The safety and efficacy of immunization with live or attenuated viral vaccines during or following GAZYVA therapy have not been studied. Immunization with live virus vaccines is not recommended during treatment and until B-cell recovery
Additional Important Safety Information
- The most common Grade 3 to 4 adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were neutropenia, infusion reactions, and thrombocytopenia
- The most common adverse reactions (incidence ≥10%) observed in patients with CLL in the GAZYVA containing arm were infusion reactions, neutropenia, thrombocytopenia, anemia, pyrexia, cough, nausea, and diarrhea
- Adverse reactions rates and laboratory abnormalities from the Stage 2 phase are consistent with the rates in Stage 1. In addition to the adverse reactions observed in Stage 2, in Stage 1 back pain (5% vs. 2%), anemia (12% vs. 10%) and cough (10% vs. 7%) were observed at a higher incidence in the GAZYVA treated patients. The incidence of Grade 3 to 4 back pain (<1% vs. 0%), cough (0% vs. <1%) and anemia (5% vs. 4%) was similar in both treatment arms. With regard to laboratory abnormalities, in Stage 1 hyperkalemia (33% vs. 18%), creatinine increased (30% vs. 20%) and alkaline phosphatase increased (18% vs. 11%) were observed at a higher incidence in patients treated with GAZYVA with similar incidences of Grade 3 to 4 abnormalities between the two arms
Relapsed/ Refractory NHL
- The GADOLIN study evaluated safety in 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 adverse reactions was consistent with the overall NHL population
- The most common Grade 3 to 4 adverse reactions (incidence ≥10%) observed in the GAZYVA containing arm were neutropenia, thrombocytopenia and infusion reactions
- The most common adverse reactions (incidence ≥10%) in the GAZYVA containing arm were infusion reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, pyrexia, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, arthralgia, sinusitis, anemia, asthenia and urinary tract infection
- During the monotherapy period with GAZYVA, Grade 3 to 4 adverse reactions included neutropenia (10%), and anemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all at 1%)
- During the monotherapy period with GAZYVA, the most common adverse reactions (incidence ≥5%) were cough (15%), upper respiratory tract infections (12%), neutropenia (11%), sinusitis (10%), diarrhea (8%), infusion related reactions (8%), nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%)
Previously Untreated NHL
- A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of GAZYVA as compared to rituximab product in 1385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%)
- Serious adverse reactions occurred in 50% of patients on the GAZYVA arm and 43% of patients on the rituximab product arm. Fatal adverse reactions were reported during treatment in 3% in the GAZYVA arm and 2% in the rituximab product arm, most often from infections in the GAZYVA arm. During treatment and follow-up combined, fatal adverse reactions were reported in 5% of the GAZYVA arm and 4% of the rituximab product arm, with infections and second malignancies being leading causes. In the GAZYVA arm, fatal infections occurred in 2% of patients compared to <1% in the rituximab product arm
- Neutropenia, infusion related reactions, febrile neutropenia and thrombocytopenia were the most common Grade 3 to 5 adverse reactions (incidence ≥5%) observed more frequently in the GAZYVA arm
- Throughout treatment and follow-up, the most common adverse reactions (incidence ≥20%) observed at least 2% more in the GAZYVA arm were infusion related reactions, neutropenia, upper respiratory tract infection, cough, constipation and diarrhea
- During the monotherapy period, the common adverse reactions (incidence ≥10%) observed at least 2% more with GAZYVA were upper respiratory infection (40%), cough (23%), musculoskeletal pain (20%), neutropenia (19%) and herpesvirus infection (13%)
You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088.
Please see the accompanying full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.