Generic Name: rituximab (ri-TUX-i-mab)
Brand Name: Rituxan
Severe and sometimes fatal infusion reactions may occur with Rituxan. These reactions may occur while you receive Rituxan or within 24 hours after you receive it. Tell your doctor right away if you develop blurred vision, chest pain, cough, dizziness, drowsiness, fainting, fast or irregular heartbeat, headache, hives, itching, numbness of an arm or leg, shortness of breath, swelling (eg, lips, tongue, throat, face), trouble breathing, weakness, or wheezing while you receive or after you receive Rituxan.
Severe and sometimes fatal skin and mouth reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur during treatment with Rituxan. Tell your doctor right away if you experience red, swollen, peeling, or blistered skin; or sores or ulcers on your skin, lips, or in your mouth.
If you have had hepatitis B before or carry the virus, Rituxan can cause the virus to become active again. This can lead to severe and sometimes deadly liver problems. Your doctor will watch you for hepatitis B infection before treatment, while you take Rituxan, and for several months after you stop Rituxan. Do not take Rituxan if you have active hepatitis liver disease.
A rare viral infection of the brain (progressive multifocal leukoencephalopathy [PML]) can occur with the use of Rituxan in certain patients. PML is serious and sometimes fatal. Most cases of PML have occurred within 12 months of the last dose of Rituxan. Tell your doctor right away if you notice new or worsening medical problems, such as confusion, disorientation, or problems thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination.
Rituxan is used for:
Treating patients who have certain types of non-Hodgkin lymphoma. It may be used alone or in combination with other medicines. It is also used along with another medicine (methotrexate) to treat certain patients who have rheumatoid arthritis (RA). It is used along with other medicines (fludarabine and cyclophosphamide) to treat a certain type of chronic lymphocytic leukemia (CLL). It is also used along with corticosteroids (eg, methylprednisolone) to treat certain blood vessel disorders (Wegener granulomatosis [WG], microscopic polyangiitis [MPA]). It may also be used for other conditions as determined by your doctor.
Rituxan is a monoclonal antibody. It works by lowering the number of certain types of white blood cells (B cells) in the body. This helps to treat the non-Hodgkin lymphoma. This also helps to decrease pain, swelling, and inflammation in certain patients with RA.
Do NOT use Rituxan if:
- you are allergic to any ingredient in Rituxan or to mouse or rat protein
- you have RA, unless you have tried certain other medicines (tumor necrosis factor [TNF] antagonists [eg, infliximab]) and they did not work well enough
- you have a severe infection
- you are taking tocilizumab
Contact your doctor or health care provider right away if any of these apply to you.
Before using Rituxan:
Some medical conditions may interact with Rituxan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have symptoms of an infection (eg, chills, fever, persistent sore throat), an infection that will not go away or keeps coming back, a history of frequent infections, or a weakened immune system
- if you have a history of hepatitis B, hepatitis C, or other viral infections (eg, chickenpox, cytomegalovirus, herpes, JC virus, parvovirus, shingles, West Nile virus); an autoimmune disorder (eg, lupus); other cancers; or if you are receiving chemotherapy or immunosuppressants (eg, cyclosporine)
- if you have a history of kidney, liver, lung, or blood problems; heart problems (eg, irregular heartbeat, chest pain); bowel problems; or electrolyte problems
- if you are scheduled to have surgery
- if you have had a recent vaccination or are scheduled to receive vaccination
- if you have developed an infusion reaction, heart or lung problems, or serious skin problems from a previous dose of Rituxan
- if you take medicine for high blood pressure
- if you have RA and are taking or have taken a TNF inhibitor or a disease-modifying antirheumatic drug (DMARD)
- if you have taken Rituxan for WG or MPA in the past
Some MEDICINES MAY INTERACT with Rituxan. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cisplatin because serious kidney toxicity or kidney failure may occur
- Tocilizumab because the risk of infection may be increased
- Medicines for high blood pressure because they may increase the risk of low blood pressure when you receive Rituxan
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rituxan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Rituxan:
Use Rituxan as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Rituxan comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rituxan refilled.
- Rituxan must be administered in an appropriate medical setting under close medical supervision.
- Do not use Rituxan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- You may receive other medicines before your dose of Rituxan. This is to decrease the chance of an infusion reaction. Discuss any questions with your doctor.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Rituxan, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Rituxan.
Important safety information:
- Rituxan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rituxan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Rituxan may lower the ability of your body to fight infection. This may increase the risk of serious and sometimes fatal bacterial, fungal, or viral infections. After receiving Rituxan, some patients have developed low levels of certain antibodies for a long period of time (longer than 11 months), which may increase the risk of infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- A rare viral infection of the brain (PML) can occur with the use of Rituxan in certain patients. PML is serious and sometimes fatal. Most cases of PML have occurred within 12 months of the last dose of Rituxan. Signs of PML may include confusion, disorientation, or trouble thinking; decreased strength or weakness; unusual vision problems (eg, blurred vision, loss of vision); trouble walking or talking; or loss of balance or coordination. Tell your doctor right away if you notice any of these effects.
- Serious liver problems may develop with the use of Rituxan in patients who have hepatitis B infection or who carry the hepatitis B virus. Tell your doctor right away if you develop signs of liver problems, including dark urine, pale stools, severe stomach pain, or yellowing of the eyes or skin.
- Patients with non-Hodgkin lymphoma who take Rituxan have a risk of developing a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Rituxan. Talk with your doctor before you receive any vaccine.
- Rituxan may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Tell your doctor or dentist that you take Rituxan before you receive any medical or dental care, emergency care, or surgery.
- Women who may become pregnant must use effective birth control while they use Rituxan and for 12 months after they stop using it. Check with your doctor if you have questions about effective birth control.
- Lab tests, including kidney and liver function, complete blood cell counts, and blood electrolytes, may be performed while you use Rituxan and for several months after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Rituxan with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat, breathing problems, and lung infection.
- Rituxan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Rituxan can cause harm to the fetus. Do not become pregnant while you use Rituxan and for 12 months after you stop using it. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rituxan while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Rituxan, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Rituxan:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; flushing; indigestion; light-headedness; mild fever and chills, especially with the first dose; mild muscle or joint pain; muscle spasms; nausea; night sweats; sneezing; throat irritation; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision or other vision changes; changes in thinking or strength; chest pain; confusion; decreased amount of urine or dark urine; decreased balance or coordination; disorientation; dizziness; drowsiness; fainting; fast or irregular heartbeat; numbness of an arm or leg; persistent muscle, back, or joint pain; red, swollen, peeling, or blistered skin; severe or persistent stomach pain; severe weakness or fatigue; shortness of breath; skin or mouth sores or ulcers; sudden leg pain; swelling of the hands, legs, or feet; symptoms of infection (eg, cold symptoms, such as runny nose; cuts, scrapes, or surgery sites that are red, warm, swollen, or painful; earache; headache; fever, chills, cough, or persistent sore throat; flu-like symptoms, such as tiredness or body aches; painful urination; white patches in the mouth or throat); trouble walking or talking; unusual bleeding or bruising; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Rituxan:
Rituxan is usually handled and stored by a health care provider. If you are using Rituxan at home, store Rituxan as directed by your pharmacist or health care provider. Do not freeze or shake Rituxan. Keep Rituxan out of the reach of children and away from pets.
- If you have any questions about Rituxan, please talk with your doctor, pharmacist, or other health care provider.
- Rituxan is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Rituxan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rituxan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rituxan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rituxan.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.