What is RITUXAN (Rituximab)?
Rituxan is a prescription medicine used to treat:
- Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
- Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
- Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well enough.
It is not known if Rituxan is safe or effective in children
What is the most important information I should know about RITUXAN?
RITUXAN can cause serious side effects. These serious side effects include:
-
Infusion reactions. Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your doctor should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction.
Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion of Rituxan:
- 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
- Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus. People with weakened immune system can get PML. Your chance of getting PML may be higher if you are treated with Rituxan alone or with other medicines that weaken your immune system. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your doctor right away if you have any of the following symptoms or if anyone close to you notices these 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
- Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
- Kidney failure and the need for dialysis treatment
- Abnormal heart rhythm
- Severe skin and mouth reactions. 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
- Peeling skin
- Blisters
- Rash
- Pustules
- Hepatitis B virus (HBV) reactivation. If you have had hepatitis B or are a 1076 carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. This may cause serious liver problems including liver failure, and death. You should not receive Rituxan if you have active hepatitis B liver disease
- Serious infections. Serious infections that happen with Rituxan can lead to 1081 death. Call your doctor right away if you have any symptoms of infection:
- Fever
- Flu symptoms, such as cough, tiredness, and body aches
- Pain during urination
- Cuts, scrapes or incisions that are red, warm, swollen or painful
- Cold symptoms, such as runny nose or sore throat that do not go away
- Earache or headache
- Pustules
- White patches in the mouth or throat
- Heart problems. Rituxan may cause chest pain and irregular heart beats which 1090 may need treatment, or your doctor may decide to stop your treatment with Rituxan.
- Kidney problems, especially if you are receiving Rituxan for NHL. Your doctor 1093 should do blood test 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 with chemotherapy medicines to treat non-Hodgkin’s lymphoma. Tell your doctor right away if you have any stomach area pain during treatment with Rituxan
- Low blood cell counts. Your doctor may do blood test during treatment with Rituxan to check you blood cell counts: White blood cells, Red blood cells, Platelets.
- Common side effects during Rituxan treatment include:
- Infusion reactions
- Infections
- Tiredness
- Aching joints during or within hours of receiving an infusion
- Chills
- Body aches
- Low white blood cells
- More frequent upper respiratory tract infection
How should I take RITUXAN?
- Rituxan is given by infusion through a needle placed in a vein (IV or intravenous infusion), in your arm. Talk to your doctor about how you will receive Rituxan.
- Your doctor may prescribe medicines before each infusion of Rituxan to reduce side effects of infusions such as fever and chills.
- Your doctor should do regular blood tests to check for side effects to Rituxan.
Important Safety Information
- Rituxan may affect the white blood cell counts of your unborn baby. It is not known if Rituxan may harm your unborn baby in other ways.
- Women who are able to become pregnant should use effective birth-control (contraception) while using Rituxan and for 12 months after you finish treatment. Talk to your doctor about effective birth control.
- It is not known if Rituxan passes into your breast milk. You and your doctor should decide the best way to feed your baby if you receive Rituxan.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking RITUXAN?
Before receiving Rituxan, tell your doctor if you:
- Have had a severe infusion reaction to Rituxan in the past
- Have a history of heart problems, irregular heart beat or chest pain
- Have lung or kidney problems
- Have an infection or weakened immune system.
- Have or have had any severe infections including: Hepatitis B virus (HBV), Hepatitis C virus (HCV), Cytomegalovirus (CMV), Herpes simplex virus (HSV), Parvovirus B19, Varicella zoster virus (chickenpox or shingles), West Nile Virus
- Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or after you receive Rituxan. Tell your doctor if anyone in your household is scheduled to receive a vaccination. Some types of vaccines can spread to people with a weakened immune system, and cause serious problems.
- Have any other medical conditions
-
Are pregnant or planning to become pregnant. Rituxan may affect the white blood cell counts of your unborn baby. It is not known if Rituxan may harm your unborn baby in other ways.
Women who are able to become pregnant should use effective birth-control (contraception) while using Rituxan and for 12 months after you finish treatment. Talk to your doctor about effective birth control. - Are breast-feeding or plan to breast-feed. It is not known if Rituxan passes into your breast milk. You and your doctor should decide the best way to feed your baby if you receive Rituxan.
-
Especially tell your doctor if you take or have taken:
a Tumor Necrosis Factor (TNF) inhibitor medicine,
a Disease Modifying Anti-Rheumatic Drug (DMARD).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
General information about RITUXAN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide provides a summary of the most important information about Rituxan. If you would like more information talk with your doctor. You can ask your doctor for information about Rituxan that is written for healthcare professionals.
What are the ingredients in RITUXAN?
Active ingredient: Rituximab
Inactive ingredient: Sodium chloride, sodium citrate dihydrate, polysorbate 80, and water for injection.