Vortuxi is a prescription medicine that is used to treat moderate to severe rheumatoid arthritis (RA), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) with glucocorticoids. Vortuxi is grouped within a class of medications called biologic response modifiers, or biologics. By working on the immune system, biologics block proteins that contribute to the disease process. Because Vortuxi suppresses the immune system, patients are at a greater risk for getting serious infections.

Vortuxi® (rituximab) is indicated for the treatment of :

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

People with serious infections should not receive Vortuxi. It is not known if Vortuxi is safe or effective in children.

What is the most important information I should know about Vortuxi?

Tell your doctor right away about any side effect you experience. Vortuxi can cause serious side effects 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 Vortuxi could cause the virus to become an active infection again. You should not receive Vortuxi 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

What are the additional possible serious side effects of Vortuxi?

Tell your doctor right away about any side effect you experience. Vortuxi 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 Vortuxi are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.

Other side effects with Vortuxi 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 Vortuxi may harm your unborn baby or pass into your breast milk. Women should use birth control while using Vortuxi 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 Vortuxi. For more information, ask your doctor or pharmacist.

Please see the Vortuxi full Prescribing Information, including the Medication Guide, for additional important safety information.