FDA Approves New Time-Saving Treatment Option for People with Certain Blood Cancers

June 22nd, 2017

On June 22, the FDA approved RITUXAN HYCELA^™ (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL). This new treatment includes the same monoclonal antibody as intravenous Rituxan^® (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver medicine under the skin.

News in brief

• Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan.
• The approval of Rituxan Hycela was based on results from clinical studies that together represented nearly 2,000 people.
• One of the studies showed the majority (77 percent) of patients preferred RITUXAN HYCELA over intravenous Rituxan, with the most common reason being that administration required less time in the clinic.

Supporting Information

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 severe 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.

What are possible side effects of RITUXAN HYCELA?

RITUXAN HYCELA can cause serious side effects, including:

• Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have kidney failure, the need for dialysis treatment, and an abnormal heart TLS can happen within 12 to 24 hours after an injection of RITUXAN HYCELA. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy.
• Serious Infections: Serious infections can happen during and after treatment with RITUXAN HYCELA and can lead to Rituximab products can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RITUXAN HYCELA include bacterial, fungal, and viral infections. After receiving RITUXAN HYCELA, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. Tell your healthcare provider right away if you have any symptoms of infection: fever; cold symptoms, such as runny nose or sore throat that do not go away; flu symptoms, such as cough, tiredness, and body aches; earache or headache; pain during urination; white patches in the mouth or throat; cuts, scrapes, or incisions that are red, warm, swollen, or painful.
• Heart Problems: RITUXAN HYCELA may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RITUXAN HYCELA if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with RITUXAN HYCELA.
• Kidney Problems: RITUXAN HYCELA can cause severe kidney problems that can lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working.
• Stomach and serious bowel problems that can sometimes lead to death: Bowel problems, including blockage or tears in the bowel, can happen if you receive RITUXAN HYCELA with chemotherapy medicines. Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN HYCELA.

Your healthcare provider will stop treatment with RITUXAN HYCELA if you have severe, serious, or life-threatening side effects.

The most common side effects of RITUXAN HYCELA in people with:

• FL: infections, low white blood cell count, nausea, constipation, cough, and tiredness.
• DLBCL: infections, low white blood cell count, loss of hair, nausea, and low red blood cell count.
• CLL: infections, low white blood cell count, nausea, low platelet count, fever, vomiting, and injection site redness.

Additional Important Safety Information

Before receiving RITUXAN HYCELA, tell your healthcare provider about all of your medical conditions, including if you:

• Have had a severe reaction to a rituximab product or RITUXAN HYCELA.
• Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RITUXAN HYCELA.
• Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. RITUXAN HYCELA may harm your unborn baby. Females who are able to become pregnant 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. RITUXAN HYCELA may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RITUXAN HYCELA.

These are not all of the possible side effects with RITUXAN HYCELA. Patients should call their 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.