Side Effect Reporting
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.
What it Treats
RITUXAN®(rituximab) is indicated for the treatment of:
- Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
- Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
- Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who responded to initial treatment with CVP chemotherapy
- CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
- CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred
People with serious infections should not receive RITUXAN.
Important Safety Information and Serious Side Effects
Rituxan can cause serious side effects that can lead to death, including:
- Infusion Reactions: may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before their treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain
- Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving Rituxan could cause the virus to become an active infection again. Patient should not receive Rituxan if they have active HBV liver disease. The patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment
- Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body, or blurred or lost vision
Additional possible serious side effects of Rituxan:
Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:
- Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. The patient’s doctor may give the patient medicines before their treatment to help prevent TLS
- Serious Infections:can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful
- Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. The patient’s doctor may need to stop their treatment
- Kidney Problems: the patient’s doctor should do blood tests to check how well the patient’s kidneys are working
- Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom
- Low Blood Cell Counts: the patient’s blood cell counts may be monitored during treatment
The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.
Patients must tell their doctor if they are pregnant, plan to become pregnant, or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.
Patients must tell their doctor about any side effect that bothers them or that does not go away.
These are not all of the possible side effects of Rituxan. For more information, patients should ask their doctor or pharmacist.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see the Rituxan full Prescribing Information, including Most Serious Side Effects, for additional important safety information at www.rituxan.com.