- What is Rituxan?
- How can Rituxan treat my rheumatoid arthritis (RA) and what are the potential benefits?
- When may I expect results with Rituxan?
- Will I need to be retreated with Rituxan?
- How is Rituxan thought to work?
- How will I receive Rituxan?
- How should I prepare for my Rituxan infusion?
- Can I take other medicines on the days of my Rituxan infusions?
- What are the possible side effects of Rituxan?
- Where can I learn more about Rituxan treatment for RA?
Please keep in mind that the information provided here should not replace a conversation with your doctor.
A: Rituxan plus methotrexate is used to treat adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies (also known as TNF inhibitors or anti-TNF agents).
Rituxan is not recommended for use in patients with severe, active infections.
- The REFLEX Trial (on which the FDA based their approval of Rituxan) showed that Rituxan plus methotrexate has worked for many people for whom TNF inhibitor treatments have not worked well enough, providing symptom improvement for up to 6 months with 1 course of treatment (2 infusions)
- Also in the REFLEX Trial, at 6 months, 51% of people taking Rituxan plus methotrexate experienced RA symptom improvement (which is called an ACR20 response), as opposed to 18% of people taking methotrexate alone. Individual results may vary
- Another study showed that, of the people who saw improvement from their first course of Rituxan plus methotrexate and then went on to receive a second course, 54% saw an additional 6 months of improvement (as opposed to 45% of people who received methotrexate alone)
A: In the REFLEX Trial, both patients who received Rituxan plus methotrexate and patients who received methotrexate alone saw a benefit at Week 4. At Week 8, more patients who received Rituxan plus methotrexate experienced symptom improvement. Individual results may vary.
This study showed that at 6 months, 51% of the people taking Rituxan plus methotrexate experienced RA symptom improvement (called an ACR20 response) as opposed to 18% of people taking methotrexate alone.
Q: Will I need to be retreated with Rituxan?
A: Rituxan should be dosed every 6 months or based on clinical evaluation, but no sooner than every 4 months (16 weeks). A study showed that among people who received a first course of Rituxan plus methotrexate, 54% saw another 6 months of improvement from a second course of treatment. (Of those who received methotrexate alone, 45% saw improvement.)
Before each Rituxan treatment, your doctor or nurse practitioner will ask you questions about your general health to make sure Rituxan is still right for you. Tell your doctor or nurse practitioner about any side effects or new symptoms you have, symptoms that have gotten worse over time, or symptoms that will not go away.
A: Rituxan selectively targets a specific type of white blood cell in the immune system. These cells are called B cells, and they are believed to play a key role in the immune system’s attack on the joints. It is important to note that Rituxan targets only certain B cells that have a marker on their surface called CD20.
- Because they lack CD20, stem cells and plasma cells are not selectively targeted by Rituxan
A: Like some other treatments for RA, Rituxan must be given directly into the bloodstream. So instead of being taken as a pill or an injection, it is given at a dose of 1000 mg as an IV infusion, which is a needle placed in a vein by a trained healthcare professional. When you receive your Rituxan infusion, it will be given to you in combination with another medication called methotrexate. You may receive Rituxan at your doctor’s or nurse practitioner’s office, an infusion center, or a hospital. Each infusion typically lasts 4 to 6 hours, so it’s a good idea to plan accordingly. You may be given additional medicine before each infusion to reduce the risk of side effects (this will add to the total time of your treatment). If you experience any discomfort during the infusion, seek immediate medical attention.
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.
A: A Rituxan infusion can last several hours, so it helps to plan ahead. Be sure to read the Medication Guide before each infusion. On the day of the infusion, you should consider wearing comfortable clothes and taking something along to help you pass the time—a book, some music, or even a friend to chat with. Also, ask your doctor, nurse practitioner, or nurse if the infusion facility allows you to take food in case you get hungry.
A: Follow your doctor’s or nurse practitioner’s instructions about taking your medicines, including blood pressure medicine, before your infusion. Talk to your doctor or nurse practitioner about all of your medical conditions, all the medications you are taking, and any vaccinations you, or anyone in your household, have received or are scheduled to receive. Your doctor may prescribe premedications on the day of your infusion. Tell your doctor or nurse practitioner if you are pregnant, planning to become pregnant, or breast-feeding. Tell your doctor about all the medicines you take, or have taken, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:
- a TNF inhibitor medicine
- a disease-modifying antirheumatic drug (DMARD)
A: When starting a treatment, there are many important factors to understand, consider, and discuss with your doctor or nurse practitioner, including the potential risks and benefits. The FDA-approved Rituxan safety information includes the risk of some potentially serious and life-threatening side effects. With Rituxan, they include the following:
- Infusion Reactions: Infusion reactions are very common side effects of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction
- Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with Rituxan: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV) Reactivation: If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You should not receive Rituxan if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan
- Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML
Rituxan can cause serious side effects, including:
- 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 or an abnormal heart rhythm. TLS can happen within 12-24 hours after an infusion of Rituxan. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy
- Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death. Rituxan can increase your risk of getting infections and can lower the ability of your immune system to fight infections. People with serious infections should not receive Rituxan
- Heart Problems: Rituxan may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with Rituxan
- Kidney Problems: especially if you are receiving Rituxan for non–Hodgkin’s lymphoma (NHL). Rituxan can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests 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. Tell your healthcare provider right away if you have any stomach-area pain during treatment with Rituxan
A: If you have any additional questions about Rituxan or your RA, your doctor is your best source of information. You can also call the Rituxan Support Line at 1-877-474-8892.
Hours of operation are 9 AM–8 PM ET Monday–Friday with no Saturday hours.
For information about insurance coverage and reimbursement, you can contact Genentech Access Solutions® at 1-877-474-8892 or their website, www.GenentechAccessSolutions.com.