Safety Information


Bone marrow:

The soft, spongy material that fills the inside of bones. Bone marrow is the source of new blood cells. Red blood cells, white blood cells, and platelets are made in the bone marrow.




A drug treatment that kills cancer cells. For CLL, 2 chemotherapy drugs—fludarabine and cyclophosphamide—are often used together. Also called FC chemotherapy.

Chronic lymphocytic leukemia (CLL):

One type of blood cancer or leukemia. CLL is a cancer where the blood or bone marrow has too many white blood cells, known as lymphocytes.

CT scan:

Computed tomography scan. A medical test that uses a computer linked to an X-ray machine to take pictures of the inside of the body.



Flow cytometry:

This test identifies the type of cancer and number of cells involved.



Immune cells:

Cells that defend the body from infection. These cells are part of the immune system.

Immune system:

The group of organs and cells that defends the body from infection.


A treatment (such as monoclonal antibodies) that uses your body’s immune system to help fight cancer. See also monoclonal antibodies.

Initial treatment:

The first type of treatment given for a condition or disease.




A cancer that starts in the bone marrow. Leukemia causes too many abnormal blood cells to enter the bloodstream.

Lymph node:

A small, bean-shaped organ that stores white blood cells and helps remove cell waste, germs, and other harmful substances from the body.


A type of white blood cell that has an important role in fighting infection.



MRI scan:

Magnetic resonance imaging scan. A medical test that uses magnetic waves to create pictures of areas inside the body.

Monoclonal antibodies:

A type of targeted therapy used to find and destroy specific cells within the body (for example, the cells where most CLL starts). This is a type of immunotherapy.




A doctor who specializes in treating cancer.



PET scan:

Positron emission tomography scan. A medical test that uses a small amount of radioactive molecules to create pictures of the inside of the body. These pictures can be used to help find cancer cells.


A type of cell found in the blood. Platelets help prevent bleeding by forming blood clots.




A term used to describe the return of disease after it has responded to treatment.


A term used to describe a response to treatment; a period of time where the signs and symptoms of cancer are not evident. Partial remission means the cancer is significantly improved by treatment, but evidence of the cancer remains. Complete remission means all evidence of the disease is gone for a period of time.



Targeted therapy:

A type of treatment that attacks specific cancer cells. This includes the group of healthy cells from which cancer cells derive.




A period of time where patients watch the disease along with their doctor and do not start treatment unless needed.

White blood cell:

A type of immune cell that helps the body fight infections and other diseases.




A type of high-energy radiation. In low doses, X-rays are used to take pictures of the inside of the body.


This information does not take the place of talking with your doctor. Discuss with your doctor any questions you have about your medical condition or your treatment.


RITUXAN® (Rituximab) is indicated for the treatment of:

  • 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

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

Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including:

  • Infusion Reactions: may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your 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 your 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 you have had hepatitis B or are a carrier of HBV, receiving RITUXAN could cause the virus to become an active infection again. You should not receive RITUXAN if you have active HBV liver disease. Your doctor will do blood tests to check for HBV infection prior to treatment and will monitor you during and for several months following your 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 your body, or blurred or lost vision

What are the additional possible serious side effects of RITUXAN?

Tell your doctor right away about any side effect you 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. Your doctor may give you medicines before your 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. Your doctor may need to stop your treatment
  • Kidney Problems: your doctor should do blood tests to check how well your 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: your 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.

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if RITUXAN may harm your unborn baby or pass into your breast milk. Women should use birth control while using RITUXAN and for 12 months after treatment.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of RITUXAN. For more information, ask your doctor or pharmacist.

Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional important safety information at

You may report side effects to the FDA at (800) FDA-1088 or

You may also report side effects to Genentech at (888) 835-2555.