RITUXAN HYCELA 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 HYCELA through the buy and bill model. Customers can purchase RITUXAN HYCELA 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 HYCELA through secondary channels.
Genentech BioOncology® Access Solutions works with SPs to help
patients receive their medicines. SPs can dispense RITUXAN HYCELA 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
Genentech BioOncology® Access Solutions for RITUXAN HYCELA 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 Genentech BioOncology 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:
- 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
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.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
Indication
RITUXAN HYCELA® (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with:
- Relapsed or refractory, follicular lymphoma (FL) as a single agent.
- Previously untreated follicular lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy.
- Non-progressing (including stable disease) follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
- Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline based-chemotherapy regimens.
- Previously untreated and previously treated chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC).
Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of RITUXAN®
RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions.
Important Safety Information
BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
- Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA.
- Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic failure, and Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation.
- Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA.
Warnings and Precautions
Hypersensitivity and Other Administration Reactions
- Local cutaneous reactions may occur more than 24 hours after administration. Interrupt injection if severe reaction develops. Premedicate before injection
Tumor Lysis Syndrome (TLS)
- TLS can occur within 12-24 hours after administration of a rituximab-containing product, including RITUXAN HYCELA. Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
Infections
- Severe, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy with rituximab-containing products, including RITUXAN HYCELA. Withhold and institute appropriate anti-infective therapy.
Cardiovascular Adverse Reactions
- Discontinue in case of serious or life-threatening events
Renal Toxicity
- Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA. 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 rituximab-containing products, including RITUXAN HYCELA, in combination with chemotherapy. Consider and evaluate for abdominal pain, vomiting, or related symptoms
Immunization
- Live virus vaccinations prior to or during treatment not recommended
Embryo-Fetal Toxicity
- Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception.
Adverse Reactions
- The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with FL in SABRINA were: infections, neutropenia, nausea, constipation, cough, and fatigue.
- The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with DLBCL in MabEASE were: infections, neutropenia, alopecia, nausea, and anemia.
- The most common adverse reactions (≥ 20%) of RITUXAN HYCELA observed in patients with CLL in part 2 of SAWYER were: infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.
Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.
Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN HYCELA treatment.
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.