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Rituxan Hycela is the brand name for rituximab and hyaluronidase human subcutaneous injection.

Rituxan Hycela is available as a single dose vial containing one of the following:

• 1,400 mg rituximab and 23,400 Units hyaluronidase human per 11.7 mL (120 mg/2,000 Units per mL)
• 1,600 mg rituximab and 26,800 Units hyaluronidase human per 13.4 mL (120 mg/2,000 Units per mL)

Rituxan Hycela is monoclonal antibody that is used to treat:

Blood cancers

• Certain types of CD20-positive non-Hodgkin’s lymphoma (NHL) in adults and children ages 6 months and older
• CD20-positive chronic lymphocytic leukemia (CLL) in adults

Autoimmune conditions

• Moderate to severe rheumatoid arthritis (RA) in adults
  Granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA) in adults and children ages 2 years and older
• Moderate to severe pemphigus vulgaris in adults

Rituxan Hycela is a monoclonal antibody. It targets specific immune cells called B cells that can be involved in a range of different health conditions. For example, B cells sometimes turn into cancer cells. Other times, they become overly active and cause autoimmune conditions. Rituxan Hycela works by attaching a specific protein on the B cells called CD20. When it does so, it signals to the body to attack and kill that cell. As a result, these abnormal or overly active B cells can’t grow, spread, or work as well.

All patients must receive at least one full dose of a rituximab product by intravenous infusion before receiving Rituxan Hycela by subcutaneous injection.

Rituxan Hycela is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Rituxan Hycela:

• Fever
• Lower white blood cell counts
• Chills
• Infection
• Weakness
• Nausea
• Headache
• Night sweats
• Rash

Serious side effects are rare with Rituxan Hycela.

The following medications may interact with Rituxan Hycela:

• Renal toxicity when used in combination with cisplatin.

Genentech, Inc.

Rituxan Hycela may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should check to see if you are pregnant before you receive Rituxan Hycela. You should use effective birth control (contraception) during treatment with Rituxan Hycela and for 12 months after the last dose of Rituxan Hycela. Talk to your healthcare provider about effective birth control. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Rituxan Hycela.

• Rituximab/Hyaluronidase Human