Important Safety Information & Indication
What it treats
Rheumatoid arthritis (RA): 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.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): in adult patients with glucocorticoids.
Pemphigus Vulgaris (PV): in adult patients with moderate to severe PV.
It is not known if Rituxan is safe and effective in children.
Important Safety Information
Rituxan can cause serious side effects that can lead to death, including:
- Infusion Reactions: Infusion reactions are very common side effects of Rituxan treatment. Serious infusion reactions can happen during or within 24 hours of the infusion. The patient’s healthcare provider should give the patient medicines before their infusion of Rituxan
- Severe Skin and Mouth Reactions: The following symptoms can occur during treatment with Rituxan: painful sores or ulcers on the skin, lips, or in the mouth; blisters; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV) Reactivation: If patients have had hepatitis B or are carriers 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. Patients should not receive Rituxan if they have active hepatitis B liver disease. The patient’s healthcare provider will monitor the patient for hepatitis B infection during and for several months following their treatment
- 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
Before receiving Rituxan, patients should tell their healthcare provider if they:
- have had a severe infusion reaction to Rituxan in the past
- currently have or have a history of other medical conditions, especially heart disease
- have had a severe infection, currently have an infection, or have a weakened immune system
- have had a recent vaccination or are scheduled to receive vaccinations
- have taken Rituxan in the past
- are pregnant or planning to become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rituxan and for 12 months after the last dose of Rituxan
- are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment and for at least 6 months after the last dose of Rituxan
- are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements
What are the possible side effects of Rituxan?
Rituxan can cause serious and life‐threatening side effects, including:
- Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, or an abnormal heart rhythm
- Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death. Rituxan can increase the risk of getting infections and can lower the ability of the patient’s 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. The patient’s healthcare provider may monitor the patient during and after treatment with Rituxan if they have symptoms of heart problems or have a history of heart problems
- Kidney Problems: especially if a patient is receiving Rituxan for non–Hodgkin’s lymphoma (NHL). The patient’s doctor should do blood tests to check how well the patient’s kidneys are working
- Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Blockage or tears in the bowel can happen while receiving Rituxan with chemotherapy medicines
Most common side effects during treatment with Rituxan:
- infusion-related reactions
- infections (may include fever, chills)
- body aches
In patients with GPA or MPA, the most common side effects of Rituxan also include:
- low white and red blood cells
- muscle spasms
Other side effects with Rituxan include:
- aching joints during or within hours of receiving an infusion
- more frequent upper respiratory tract infections
These are not all of the possible side effects with Rituxan. For more information, patients should ask their doctor or pharmacist.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
For Important Side Effect Information, please see the full Prescribing Information, including Serious Side Effects, and the Medication Guide.