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.
Important Safety Information
RITUXAN HYCELA can cause serious side effects that can lead to death, including:
- Severe skin and mouth reactions: Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms at any time during treatment with RITUXAN HYCELA: painful sores or ulcers on the skin, lips, or in the mouth; blisters; peeling skin; rash or pustules.
- Hepatitis B virus (HBV) reactivation: Before a patient receives RITUXAN HYCELA, the patient’s doctor will do blood tests to check for HBV infection. If the patient has had hepatitis B or is 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. The patient’s healthcare provider will monitor for hepatitis B infection during and for several months after the patient stops receiving RITUXAN HYCELA. Patients must tell their healthcare provider right away if they get worsening tiredness, or yellowing of the skin or white part of the 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. Patients must tell their healthcare provider right away if they have any new or worsening symptoms or if anyone close to them notices these symptoms: confusion; dizziness or loss of balance; difficulty walking or talking; decreased strength or weakness on one side of the 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 the 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.
Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms during or after an injection of RITUXAN HYCELA: hives (red itchy welts) or rash; itching; swelling of the lips, tongue, throat, or face; sudden cough; shortness of breath, difficulty breathing, or wheezing; weakness; dizziness or feeling faint; palpitations (feeling the 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 the patient to have kidney failure, the need for dialysis treatment, and an abnormal heart rhythm. TLS can happen within 12 to 24 hours after an injection of RITUXAN HYCELA. The patient’s healthcare provider may do blood tests to check for TLS. The patient’s healthcare provider may give medicine to help prevent TLS. Patients must tell their healthcare provider right away if they 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 death. Rituximab products can increase the risk of getting infections and can lower the ability of the 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. Patients must tell their healthcare provider right away if they 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. The patient’s healthcare provider may monitor the patient’s heart during and after treatment with RITUXAN HYCELA if they have symptoms of heart problems or have a history of heart problems. Patients must tell their healthcare provider right away if they 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. The patient’s healthcare provider should do blood tests to check how well the patient’s 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 the patient receives RITUXAN HYCELA with chemotherapy medicines. Patients must tell their healthcare provider right away if they have severe stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN HYCELA.
The patient’s healthcare provider will stop treatment with RITUXAN HYCELA if the patient has 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, patients must tell their healthcare provider about all of their medical conditions, including if they:
- Have had a severe reaction to a rituximab product or RITUXAN HYCELA.
- Have had a recent vaccination or are scheduled to receive vaccinations. Patients should not receive certain vaccines before or during treatment with RITUXAN HYCELA.
- Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Patients should talk to their healthcare provider about the risks to their unborn baby if they receive RITUXAN HYCELA during pregnancy. 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. Patients should talk to their healthcare provider about effective birth control. It is not known if RITUXAN HYCELA passes into the patient’s breast milk. Patients must not breastfeed during treatment and for at least 6 months after receiving their 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.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835- 2555.
"With today’s approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion. People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”