Important safety information
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.
Indications and important safety information
INDICATIONS
RITUXAN® (Rituximab) is indicated in combination with fludarabine and cyclophosphamide (FC chemotherapy) for the treatment of patients with:
- Previously untreated CD20-positive CLL
- Previously treated CD20-positive CLL
People with serious infections should not receive RITUXAN.
IMPORTANT SAFETY INFORMATION
RITUXAN® (Rituximab) can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
Infusion Reactions
Serious infusion reactions can happen during your infusion or within 24 hours of receiving RITUXAN. Your doctor should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion reaction. If a serious reaction occurs, the infusion may be stopped and you should receive medical care.
Tell your doctor or get medical help right away if you get any of these symptoms
- 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 feel faint
- Palpitations (feel like your heart is racing or fluttering)
- Chest pain
Tumor Lysis Syndrome (TLS)
TLS is caused by the fast breakdown of cancer cells and can occur after treatment with RITUXAN. TLS can cause you to have kidney failure and the need for dialysis treatment. TLS may also cause abnormal heart rhythm. Your doctor may give you medicines to help prevent TLS and do blood tests to check you for TLS.
Severe Skin and Mouth Reactions
Severe skin and mouth reactions can occur in patients who receive RITUXAN. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment with RITUXAN:
- Painful sores or ulcers on your skin, lips or in your mouth
- Blisters
- Peeling skin
- Rash
- Pustules
Progressive Multifocal Leukoencephalopathy (PML)
PML is a rare, serious brain infection caused by a virus. People with a weakened immune system can get PML. Tell your doctor right away if you have any of the following symptoms:
- Confusion or problems thinking
- Loss of balance
- Change in the way you walk or talk
- Decreased strength or weakness on one side of your body
- Blurred vision or loss of vision
RITUXAN has also been associated with serious and life-threatening side effects, including:
- The return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death
- Other serious infections that can lead to death
- Heart problems
- Kidney problems
- Stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death
The most common side effects of RITUXAN in patients with chronic lymphocytic leukemia (CLL) were infusion reactions and low white blood cells.
Most CLL patients treated with RITUXAN plus FC chemotherapy had at least one serious side effect. In clinical trials, CLL patients 70 years or older who received RITUXAN with FC chemotherapy were more likely to experience severe side effects compared with younger patients who received the same 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 with RITUXAN. For more information, ask your doctor.
Please see full Prescribing Information, including Medication Guide, in PDF format.
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.
