RITUXAN HYCELA: a 5-7 minute subcutaneous injection

RITUXAN HYCELA® (rituximab/hyaluronidase human) is a prescription medicine used to treat adults with:

  • Follicular Lymphoma (FL) as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
  • Follicular Lymphoma as an initial treatment with chemotherapy and, in patients whose initial treatment was successful, as a single-agent follow-up therapy
  • Follicular Lymphoma as a single agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
  • Diffuse Large B-Cell Lymphoma (DLBCL) as an initial treatment in combination with CHOP or other anthracycline-based chemotherapy regimens
  • Chronic Lymphocytic Leukemia (CLL) in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

You can only receive RITUXAN HYCELA after you receive at least 1 full dose of intravenous (IV) RITUXAN® (rituximab). Read the IV RITUXAN Medication Guide for more information about severe infusion reactions, which usually happen during the first dose with IV RITUXAN.

RITUXAN HYCELA is not for use to treat medical conditions other than cancers.

It is not known if RITUXAN HYCELA is safe and effective in children.

Important Safety Information

What is the most important information I should know about RITUXAN HYCELA?

RITUXAN HYCELA can cause serious side effects that can lead to death, including:

  • Severe skin and mouth reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RITUXAN HYCELA: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash or pustules
  • Hepatitis B virus (HBV) reactivation: Before you receive RITUXAN HYCELA, your doctor will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN HYCELA could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN HYCELA. Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RITUXAN HYCELA
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN HYCELA. People with weakened immune systems can get PML. PML can result in death or serious disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms: confusion; dizziness or loss of balance; difficulty walking or talking; decreased strength or weakness on one side of your body; vision problems, such as blurred or loss of vision
  • Serious allergic reactions and other severe reactions: Serious allergic reactions, and reactions due to release of certain substances by your body that can lead to death, can happen with rituximab products, including RITUXAN HYCELA

Skin reactions at or near the injection site (local), including injection site reactions can happen with RITUXAN HYCELA. Symptoms at or near the injection site may include: pain, swelling, hardness, redness, bleeding, itching, and rash. These reactions sometimes happen more than 24 hours after an injection of RITUXAN HYCELA

Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of RITUXAN HYCELA: hives (red itchy welts) or rash; itching; swelling of your lips, tongue, throat, or face; sudden cough; shortness of breath, difficulty breathing, or wheezing; weakness; dizziness or feeling faint; palpitations (feeling like your heart is racing or fluttering); chest pain; fever; chills or shaking chills

These are not all of the possible side effects with RITUXAN HYCELA. Call your doctor for medical advice about side effects.

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

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.