Genentech Access Solutions
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South San Francisco, CA 94080-4990
Main website: Genentech-Access.com
(866) 4ACCESS/(866) 422-2377
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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
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
- 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
- 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
- Live virus vaccinations prior to or during treatment not recommended
- Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception.
- 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.