Rituximab (Injection)

Introduction

Rituximab (ri-TUX-i-mab)

Treats non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), Wegener's granulomatosis (WG), and microscopic polyangiitis (MPA). Also used as a "maintenance" treatment for patients with advanced follicular lymphoma who responded to initial treatment with this medicine plus chemotherapy (induction treatment). This medicine is a monoclonal antibody that is used with other cancer medicines.

Brand Name(s)

Rituxan

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• Rituximab must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.
• You will be watched closely for unwanted side effects while you are receiving this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also receiving cisplatin (Platinol®). Tell your doctor if you have taken other medicines to treat rheumatoid arthritis such as adalimumab (Humira®), etanercept (Enbrel®), or infliximab (Remicade®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
• If you have rheumatoid arthritis, non-live virus vaccines should be given at least 4 weeks before receiving this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or planning to become pregnant. You must use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Talk to your doctor about effective birth control.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease (including hepatitis B), severe chest pain (angina), heart disease, heart rhythm problems, lung problems, lupus, or stomach or bowel problems. Also tell your doctor if you are scheduled for any surgery.
• Tell your doctor if you have had a reaction to murine (mice or rat) proteins. Murine proteins are also used in other medicines.
• Rituximab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.
• This medicine may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
• If you have a severe skin reaction, you should stop using this medicine and check with your doctor right away. Symptoms may include blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills.
• This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy (PML). Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have had an infection that would not go away or an infection that kept coming back.
• Call your doctor right away if you start to have a cough, weight loss, night sweats, fever, chills, or flu-like symptoms such as a runny or stuffy nose, headache, or feeling generally ill. These may be signs that you already have an infection.
• Stop using this medicine and check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Bloody vomit or vomit that looks like coffee grounds.
• Changes in vision.
• Chest pain, uneven heartbeat, or sudden fainting.
• Confusion, body weakness, shortness of breath, or numbness or tingling in your hands, feet, or lips.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Dizziness, lightheadedness, or drowsiness.
• Fever, chills, cough, runny or stuffy nose, sore throat, night sweats, and body aches.
• General feeling of discomfort or illness.
• Increased hunger or thirst.
• Joint pain, stiffness, or swelling.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Problems with coordination or speech.
• Rapid weight gain.
• Severe stomach pain.
• Swelling in your hands, ankles, or feet.
• Unexplained nosebleeds.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Anxiety.
• Back pain.
• Diarrhea, mild nausea, vomiting, or stomach pain.
• Headache.
• Mild skin rash or itching.
• Muscle pain.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Trouble sleeping.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088