Rituximab (Rituxan and MabThera) is a drug used to treat rheumatoid arthritis that has not improved with other types of medications, as well as certain forms of vasculitis. It works by turning off a part of the immune system that is not working properly in autoimmune diseases.
Rituximab, sold under the brand name Rituxan among others, is a medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, pemphigus vulgaris and myasthenia gravis. It is given by slow injection into a vein.
Rituximab is used in combination with methotrexate to treat rheumatoid arthritis that has not responded to one or more types of treatment, including TNF inhibitors. Rituximab also is used to treat certain types of vasculitis (an inflammatory condition affecting blood vessels), such as granulomatosis with polyangiitis or MPA.
Occasionally rituximab is used to treat other immune problems, including lupus, and inflammatory muscle diseases. Rituximab also is used in the treatment of some blood disorders, including chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.
Common side effects, which often occur within two hours of the medication being given, include rash, itchiness, low blood pressure, and shortness of breath. Other severe side effects include reactivation of hepatitis B in those previously infected, progressive multifocal leukoencephalopathy, and toxic epidermal necrolysis.
It is unclear if use during pregnancy is safe for the baby. Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. When it binds to this protein it triggers cell death.
How to Take It
Rituximab is given as an intravenous infusion (IV or “drip”) into a vein. The infusion usually takes two – four hours, although occasionally it can take longer. A course of rituximab for rheumatoid arthritis usually consists of two 1000mg doses given 15 days apart. To treat vasculitis, a smaller dose is given once a week for four weeks in a row.
The effects of rituximab begin about six weeks after the infusions. Usually by the third month the full effect occurs, and can last up to nine months.
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
Side Effects
Sometimes, patients’ blood pressure can drop during the treatment. Those who take medication to lower their blood pressure may have to stop it before the infusion.
Some patients feel mild side effects during or up to 24 hours after receiving rituximab. These usually occur with the first infusion, and can include mild throat tightening, flu-like symptoms, rash, itchiness, dizziness, back pain, nausea, upset stomach, sweating, nervousness, muscle stiffness, and numbness. These symptoms can be reduced by receiving a steroid injection before the infusion, along with acetaminophen (Tylenol) and diphenhydramine (Benadryl).
The infusion is sometimes stopped for a short while and then restarted at a slower rate if the symptoms get better. Rarely, patients will have more serious symptoms, such as wheezing, mouth or throat swelling, trouble breathing, or chest pain. Patients who experience these symptoms should tell their health care providers immediately; patients may receive stronger medications to treat those symptoms.
In the months after the treatment, some people may notice more frequent infections, such as colds or sinusitis. Usually, these are not severe. There are a few rare but serious side effects from rituximab. These include severe skin reactions and mouth sores. Patients who experience vision changes, loss of balance, difficulty walking, or confusion should contact their doctors immediately.
Combining treatment with other biologic drugs, which suppress the immune system, including etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia), golimumab (Simponi), abatacept (Orencia), and tocilizumab (Actemra) may increase the risk of serious infections and medication side effects. Blood pressure medications may increase the risk of low blood pressure during the infusion.
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.
Other side effects with Rituxan include:
- aching joints during or within hours of receiving an infusion
- more frequent upper respiratory tract infection
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.
Treatment
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 CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on 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
- Rheumatoid arthritis 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 tumor necrosis factor (TNF) antagonist has been used and did not work well enough
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) with glucocorticoids
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