RITUXAN Distribution
Authorized Distributors and Specialty Pharmacies
Genentech and Biogen have contracted with a network of authorized specialty distributors to service practices choosing to purchase RITUXAN through the buy and bill model. Customers can purchase RITUXAN 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 Biogen and not to distribute RITUXAN through secondary channels.
RITUXAN Access Solutions works with SPs to help patients receive
their medicines. SPs can dispense RITUXAN to your office. The SPs can
also provide coverage and reimbursement support.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Genentech and Biogen do 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
clinically appropriate.
About Specialty Pharmacies
RITUXAN 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
- The ability to manage the specialty handling and shipping needs linked with many specialty therapies
You can work with your preferred SP or contact RITUXAN Access Solutions to learn which SP the patient’s health insurance plan requires.
Genentech and Biogen do 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
- Replacement product generally ships within 11 business days
following receipt of the spoiled product or completed
Certificate of Destruction
Important guidelines:
- 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
Indication
RITUXAN® (Rituximab) is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular, CD20 positive, B cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
BOXED WARNINGS
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
- Infusion-related reactions: RITUXAN administration can result in serious, including fatal infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions
- Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN
- Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation
- Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN
Warnings and Precautions
- Tumor Lysis Syndrome: Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12−24 hours after the first infusion of RITUXAN in patients with NHL. Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
- Infections: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy. RITUXAN is not recommended for use in patients with severe, active infections
- Cardiovascular Adverse Reactions: Discontinue infusions in case of serious or life-threatening events
- Renal Toxicity: Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL. Discontinue in patients with rising serum creatinine or oliguria
- Bowel Obstruction and Perforation: Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy. Consider and evaluate for abdominal pain, vomiting, or related symptoms
- Immunization: Live virus vaccinations prior to or during RITUXAN treatment not recommended
- Embryo-Fetal Toxicity: Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception.
Additional Important Safety Information
- The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and CLL were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials
- The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials
For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.
Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.
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.