Important Safety Information
RITUXAN® (rituximab) is a prescription infusion medication used to treat several medical conditions in adult patients. These conditions include non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), pemphigus Vulgaris (PV), granulomatosis with polyangiitis (GP), and microscopic polyangiitis (MPA).
Prior to starting treatment, talk to your doctor about your medical history — especially if you have heart disease, a severe infection, or a weakened immune system. In addition, let your doctor know about all medications you’re currently taking, regardless of whether they’re prescription, over-the-counter, herbal supplements, or vitamins, as some of them could have a harmful effect when combined with RITUXAN®. You should not receive certain vaccines before or during treatment with RITUXAN®.
Let your healthcare provider know if you’re pregnant or trying to conceive so that you can discuss your options. If you’re not pregnant but are of childbearing age, you should use birth control during treatment, and continue taking it for 12 months after your last infusion therapy. You should not breastfeed during treatment or for at least six months after treatment has been completed.
What is the most important information I should know about RITUXAN®?
While RITUXAN® is an effective form of treatment, it could also increase the risk of life-threatening reactions. These include anaphylaxis, severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy (PML) — a rare and serious brain infection that could lead to severe disability or death. Tell your doctor immediately if you experience any of the following symptoms:
- Chest pain or tightness
- Breathing difficulties
- Swelling of the mouth, tongue, and/or lips
- Painful sores or blisters
- Peeling skin
- Stomach pain
- Pale or light-colored bowel movements
- Dark urine
- Severe nausea and vomiting
- Yellowing of the skin and/or whites of eyes (jaundice)
- Bloated or swollen abdomen
- Lack of coordination
- Facial drooping
- Loss of vision
- Speech difficulties
- Muscle weakness
Side Effects of RITUXAN®
As with any prescription medication, RITUXAN® carries the risk of side effects. The most common ones include:
- Body aches
- Upper respiratory tract infections
- Infusion-related reactions — such as itching or burning sensation at the site of injection
Some treatments may produce additional side effects. Patients who are being treated for granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are more likely to experience the following side effects:
- Muscle spasms
- Low white and red blood cells
In rare cases, RITUXAN® could increase the risk of more serious side effects. These risks include:
Tumor Lysis Syndrome (TLS)
This condition is caused when breaking down cancer cells and could occur between 12 to 24 hours after an infusion treatment with RITUXAN®. Tell your doctor immediately if you experience a lack of energy, nausea, vomiting, and/or diarrhea — as TLS could lead to kidney failure and/or abnormal heart rhythm.
RITUXAN® could increase the risk of a heart attack. Tell your doctor immediately if you have a history of heart problems or if you start experiencing chest pain and/or tightness, irregular heartbeats, shortness of breath, lightheadedness, cold sweat, and/or discomfort in your arms, back, neck, or jaw.
RITUXAN® could cause severe kidney problems that may lead to death. Prior to starting treatment, your doctor should run blood tests to determine your renal health. Tell your healthcare provider immediately if you experience decreased urination, fluid retention, confusion, fatigue, swelling of the legs, ankles, and/or feet, chest pain or pressure, and/or irregular heartbeat.
Stomach and Bowel Problems
RITUXAN® could result in blockage or tears in the bowel — especially if you are concurrently undergoing chemotherapy. Tell your doctor immediately if you have stomach pain or repeated vomiting during treatment. Do not wait it out, as these conditions could lead to death.
RITUXAN® can increase the risk of serious, life-threatening infections due to how it lowers your immune system’s ability to fight them. Do not start treatment if you already have an infection. Tell your doctor immediately if you experience a fever, runny nose, sore throat, flu symptoms, headaches, pain during urination, cold sores, earaches, and/or cuts or scrapes that are red, warm, painful, or swollen.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
RITUXAN® is used to treat several medical conditions in adult patients — including non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), pemphigus Vulgaris (PV), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). The dosage will vary depending on the condition being treated.
Please refer to the full prescribing information.