What are Anti-TNFs?

Anti-TNFs or TNF inhibitor are among a class of RA treatments called biologics, and they're usually the first biologic to be given upon diagnosis with RA. Many people have success with anti-TNFs. But if these treatments stop working well, some may decide to make a change after talking with their doctor. Sometimes those people will try another anti-TNF treatment; however, many have found results with a different type of treatment, like B-cell therapy.

Consider RA Treatement that works differently

Unlike anti-TNFs, B-cell therapy targets a type of white blood cell called a B-cell, which is believed to play a role in the pain, symptoms, and joint damage of RA. B cells are an important part of the body’s immune system, including making antibodies to fight infections. VORTUXI® (rituximab) is an antibody which is directed against B-cells, specifically a marker on certain types of B-cells called CD-20. B-cells are required for the normal functioning of the immune system but are also intimately involved in the inflammatory process in RA. Rituximab was initially approved for the treatment of non-Hodgkin’s B cell lymphoma (a cancer of the lymph nodes) however it was subsequently found to be very effective in the treatment of RA and in a variety of other conditions in which B cells play a role, such as systemic lupus erythematosus (SLE).

If you're not being helped enough by an anti-TNF treatment, and you and your doctor decide to make a change, consider some of the potential benefits of switching to VORTUXI® (rituximab) in combination with methotrexate:

Up to 6 months of relief : Rituximab has been shown to work for up to 6 months after 1 course of treatment (2 infusions given 2 weeks apart; the first infusion usually lasts 4 to 6 hours. Subsequent infusions may take slightly less time, but will still last several hours). In fact, a study showed that at 6 months, 51% of the people taking rituximab (plus methotrexate) experienced RA symptom improvement (called an ACR20 response) as opposed to 18% of people taking methotrexate alone.

Another study also showed that, of the people who saw improvement from their first course of rituximab (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).

VORTUXI dosing schedule : VORTUXI is typically given every 6 months, or based on your doctor's evaluation of your symptoms (but no sooner than every 4 months).

Helps slow the progression of joint damage : Vortuxi can help slow the progression of joint damage caused by RA. Furthermore, a study showed that following 2 years of treatment with rituximab, 57% of people did not experience any further joint damage. And taking rituximab with methotrexate was shown to be more effective at slowing the progression of joint damage than methotrexate alone. Additionally, for the patients who had no progression in the first year, 87% also had no progression in the second year.

VORTUXI 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.

People with serious infections should not receive VORTUXI. It is not known if VORTUXI is safe or effective in children. Please refer to VORTUXI medication guide for more information.

Talk to your doctor about the results others have experienced with VORTUXI, and discuss whether it may be right for you.

Before receiving VORTUXI, tells your doctor if you :

• Have had a severe infusion reaction to VORTUXI in the past
• Have a history of other medical conditions including:
  • Heart problems
  • Irregular heartbeat
  • Chest pain
  • Lung or kidney problems
• Have had an infection, currently having an infection, or have a weakened immune system
• Have recently been vaccinated, plan to get a vaccine, or are in contact with someone who is planning to get a vaccine. You should not get certain vaccines before or after receiving VORTUXI. Some types of vaccines can spread to people with a weakened immune system and cause serious problems
• Have taken VORTUXI in the past
• Have any other medical conditions
• Are pregnant or planning to become pregnant. Talk to your doctor about effective birth control
• Are breast-feeding or plan to breast-feed
• Are taking any medications, including prescription and non prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:
  • A Tumor Necrosis Factor (TNF) inhibitor medicine
  • A Disease Modifying Anti-Rheumatic Drug (DMARD)

• Infusion reactions
• Chills
• Infections
• Body aches
• Tiredness
• Low white blood cell counts

Other side effects include :

• Aching joints during or within hours of receiving an infusion
• More frequent upper respiratory tract infections

There are a few rare but serious side effects from VORTUXI (rituximab) 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 may cause an abnormal heart rhythm

Serious Infections : Serious infections can happen during and after treatment with VORTUXI and can lead to death

Heart Problems : VORTUXI may cause chest pain and irregular heartbeats, which may need treatment, or your doctor may decide to stop your treatment with VORTUXI

Kidney Problems : especially if you are receiving VORTUXI for NHL. Your doctor should do blood tests to check how well your kidneys are working

Stomach and Serious Bowel Problems That Can Sometimes Lead to Death : Tell your doctor right away if you have any stomach area pain during treatment with VORTUXI

Low Blood Cell Counts : Your doctor may do blood tests during treatment with VORTUXI to check your blood cell counts

Progressive Multifocal Leukoencephalopathy (PML) : PML is a rare, serious brain infection cause by the JC virus. People with weakened immune systems can get PML. Your chance of getting PML may be higher if you are treated with VORTUXI 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

Tell your doctor or healthcare team about any side effect mentioned as above that bothers you or does not go away.

These are not all of the possible side effects with VORTUXI. For more information, ask your doctor.

If you have any questions about this information, be sure to discuss them with your doctor.

If you're considering VORTUXI® (rituximab) plus methotrexate with your doctor, don't forget to consider if the dosing schedule suits you, and how VORTUXI is given.

4 INFUSIONS A YEAR

VORTUXI® (rituximab) is typically given every 6 months, or based on your doctor's evaluation of your symptoms (but no sooner than every 4 months).

It's important to know if your symptoms return before it's time for your next course, you and your healthcare provider may decide to treat earlier (but no sooner than 4 months).

If you're considering VORTUXI® (rituximab) plus methotrexate with your doctor, don't forget to consider if the dosing schedule suits you, and how VORTUXI is given.

4 INFUSIONS A YEAR

VORTUXI® (rituximab) is typically given every 6 months, or based on your doctor's evaluation of your symptoms (but no sooner than every 4 months).

• Infusions are a relatively common form of treatment used for a variety of conditions
• One of the advantages of infusions is that they are required less frequently than oral medication or injection
• Infusions are given by a trained healthcare professional who is there with you to help manage the process and monitor for reactions

ABOUT VORTUXI INFUSIONS :

• Your doctor's office will schedule appointments for the first course of treatment (2 infusions given 2 weeks apart), which may be given at your doctor's office, an infusion center, or a hospital
• Infusions can last several hours, so most people take something along to help pass the time, like a book or some music
• There are no special rules for what you can eat or drink before, during, or after an infusion. So some people like to eat before or bring a snack along. Just be sure to check with the facility first that bringing food is OK
• It's important to review the VORTUXI Medication Guide with a healthcare provider before each infusion

VORTUXI® (rituximab) in combination with methotrexate has helped many people see results, but it's not right for everyone. To help you and your doctor decide if it's right for you, review the following questions at your next appointment. Just remember to be open and honest in your discussion. After all, you know your health as well as anyone, and your input can help you and your doctor make a more informed and précised decision.

QUESTIONS TO ASK ABOUT VORTUXI

• How is VORTUXI different from other RA treatments?
• How is VORTUXI thought to work?
• What are the potential benefits of VORTUXI in combination with methotrexate?
• What are the possible VORTUXI side effects?
• What can I expect with VORTUXI treatment?