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IMPORTANT SAFETY INFORMATION

INDICATIONS

RITUXAN HYCELA® (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with:

  • Relapsed or refactory, 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 predinsone (CVP) chemotherapy.
  • Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, predinsone (CHOP) or other anthracycline-based chemotherapy regimens.
  • Previous untreated and previously treated chronic lymphoacytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC)

Initiate Treatment with RITUXAN HYCELA only after patients have recieved at least one full dose of RITUXAN®

RITUXAN HYCELA is not indicated for the treatment of non-maglignant conditions.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITUS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOIL LEUKOENCEPHALOPATHY

  • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA. Discontinue RITUXAN HYCELA in patients who experiance a severe mucocutaneous reaction. The safety of re-administration of rituximab-containing product, including RITUXAN HYCELA, to patients with severe mucocutaneous reactions has not been determined.
  • 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 death. Screen all patients for HBV infection before treament 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. Discontinue RITUXAN HYCELA and consider discontinuation of reduction of any concomitant chemotherapy or immunosuppressive therapy in parients who develop PML

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions

Systemic Reactions
  • Patients must receive at least one full dose of RITUXAN before receiving RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion. Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping the intravenous infusion.
  • Rituximab-containing products, including RITUXAN HYCELA, are associated with hypersensitivity and other administration reactions, which may be related to the release of cytokines and/or other chemical mediators.
  • Severe infusion-related reactions with fatal outcome have been reported with the use of RITUXAN, with an onset ranging within 30 minutes to 2 hours after starting the first intravenous infusion. Anaphylactic and other hypersensitivity reactions can also occur.
  • Severe cytokine release syndrome may be associated with acute respritory failure and death. Cytokine release syndrome may occur 1-2 hours of initiating the infusion. Patients with a history of pulmonary insufficiency or those with pulmonary tumor infiltration may be at a greater risk of poor outcome. Rituximab product administration should be interrupted immediately and agressive symptomatic treatment initiated.
  • During RITUXAN HYCELA administration, the injection should be interrupted immediately when observing signs of a severe reaction and aggressive symptomatic treatment should be initiated. Closely monitor those patients: with pre-existing cardiac or pulmonary conditions, who experienced prior cardiopulmonary adverse reactions, and with high numbers of circulating malignant cells (≥ 25,000/mm3).
  • Premedicate patients with an antihistamine and acetominophen (also consider glucocorticoids) prior to each administration of RITUXAN HYCELA. Observe patients for at least 15 minutes following RITUXAN HYCELA. A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions.
Local Cutaneous Reactions
  • Local cutaneous reactions, including injection site reactions, have been reported in patients receiving RITUXAN HYCELA. Some local cutaneous reactions occured more than 24 hours after RITUXAN HYCELA administration.

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 and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections

  • Serious, 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. Infections have been reported in some patients with prolonged hypogammaglobulinemia (> 11 months after rituximab exposure). Discontinue RITUXAN HYCELA for serious infections and institute appropriate anti-infective therapy.

Cardiovascular Adverse Reactions

  • Cardiac adverse reactions, including ventricular fibrilation, myocardial infarction, and cardiogenic shock, may occur with rituximab-containing products, including RITUXAN HYCELA.
  • Discontinue RITUXAN HYCELA for serious or life-threatening cardiac arrhythmias. Perfomr cardiac monitoring during and after all administrations of RITUXAN HYCELA for patients who develop clinically significant arrythmias, or who have a history of arrythmia or angina.

Renal Toxicity

  • Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA. Monitor closely for signs of renal failure and discontinue RITUXAN HYCELA in patients with a 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. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization

  • The safety of immunization with live viral vaccines following rituximab-containing products, including RITUXAN HYCELA, has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

Embro-Fetal Toxicity

  • Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving RITUXAN HYCELA and for 12 months following the last dose of rituximab-containing products, including RITUXAN HYCELA.

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.

Pregnancy and Lactation

  • Based on human data, rituximab-containing products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus.
  • Advise lactating women not to breastfeed during treatment and for at least 6 months after the last dose of RITUXAN HYCELA due to the potential for serious adverse reactions in breastfed infants.

Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

Attention Healthcare Provider: Provide Medication Guide to the patient prior to RITUXAN HYCELA treatment.

You man 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.