Rituximab injection, rituximab-abbs injection, rituximab-arrx injection, and rituximab-pvvr injection are biologic medications (medications made from living organisms). Biosimilar rituximab-abbs injection, rituximab-arrx injection, and rituximab-pvvr injection are highly similar to rituximab injection and work the same way as rituximab injection in the body. Therefore, the term rituximab products will be used to represent these medications in this discussion.

You may experience a serious reaction while you receive or within 24 hours after receiving a dose of a rituximab injection product. These reactions usually happen during the first dose of a rituximab injection product and may cause death. You will receive each dose of a rituximab injection product in a medical facility, and a doctor or nurse will monitor you carefully while you are receiving the medication. You will receive certain medications to help prevent an allergic reaction before you receive each dose of a rituximab injection product. Tell your doctor if you have ever had a reaction to a rituximab product or if you have or have ever had an irregular heartbeat, chest pain, other heart problems, or lung problems. If you experience any of the following symptoms, tell your doctor or other healthcare provider immediately: hives; rash; itching; swelling of the lips, tongue, or throat; difficulty breathing or swallowing; dizziness; fainting; shortness of breath, wheezing; headache; pounding or irregular heartbeat; fast or weak pulse; pale or bluish skin; pain in the chest that may spread to other parts of the upper body; weakness; or heavy sweating. Your doctor may stop the infusion, and may treat the reaction with other medications.

Rituximab injection products have caused severe, life-threatening skin and mouth reactions. If you experience any of the following symptoms, tell your doctor immediately: painful sores or ulcers on the skin, lips, or mouth; blisters; rash; or peeling skin.

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, receiving a rituximab injection product may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or ever had a severe infection, including hepatitis B virus infection. Your doctor will order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor may give you medication to treat this infection before and during your treatment with a rituximab injection product. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, stomach pain, or dark urine.

Some people who received a rituximab injection product developed progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability) during or after their treatment. If you experience any of the following symptoms, call your doctor immediately: new or sudden changes in thinking or confusion; difficulty talking or walking; loss of balance; loss of strength; new or sudden changes in vision; or any other unusual symptoms that develop suddenly.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to a rituximab injection product.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with rituximab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of using a rituximab injection product.