Class: Biologic therapy

Generic Name: Rituximab (ri-TUCKS-I-mab)

Trade Name: Rituxan®

How is this drug used? Rituximab is FDA approved for the treatment of some types of CD20+, B-cell non-Hodgkin’s lymphoma (NHL).  It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Rituximab belongs to a class of agents called monoclonal antibodies. A monoclonal antibody is a protein (with or without a carbohydrate component) that can be designed through laboratory processes. Rituximab produces its anti-cancer effects by binding to a portion of B-cells, called the CD20 antigen. The binding action blocks cell activation and growth and may cause direct anti-cancer effects to the cell as well.

How is rituximab given (administered)? Rituximab is administered into a vein (intravenous) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. Patients may receive medication prior to administration of rituximab to reduce the incidence or severity of an infusion-related reaction.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with rituximab.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Patients will also have their lung function monitored.

Patients will be monitored for allergic-type reactions to rituximab and those experiencing fever, chills, flushing, fatigue, headache, low blood pressure, difficulty breathing, chest pain, lightheadedness, swelling of facial features, closing of throat or noticeable changes in heart rhythm should tell their healthcare provider immediately. Fatal infusion reactions have occurred. Patients will also be monitored for skin reactions, as serious, yet uncommon, side effects to the skin have been associated with treatment with rituximab.

Kidney function is closely monitored while patients are being treated with rituximab. Patients are at risk for developing a condition called tumor lysis syndrome in which electrolyte and metabolic disturbances and kidney failure may occur.  Tumor lysis syndrome can be prevented if managed aggressively at the beginning of treatment.  Blood tests will measure levels of electrolyte and metabolic products. Patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.

What are the common (occur in 30% or more of patients) side effects of treatment with rituximab?

• Fever
• Chills
• Infection
• Change in heart rhythm or rate
• Low white blood cell levels – increases risk of infection

What are the less common (occur in 10% to 29% of patients) side effects of treatment with rituximab?

• Weakness
• Nausea and vomiting
• Headache
• Cough
• Runny nose, shortness of breath, inflammation of sinuses (cold-like symptoms)
• Throat swelling/irritation
• Night sweats
• Rash or itching
• Dizziness
• Low blood pressure
• Diarrhea
• Abdominal pain
• Back pain
• Low levels of platelets – increases risk of bleeding
• Muscle or joint pain

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, patients should avoid large crowds or persons who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Difficulty breathing
• Chest pain or changes in heart rhythm
• Signs of allergic-type reaction – difficulty breathing, chest pain, lightheadedness, swelling of facial features, closing of throat or noticeable changes in heart rhythm, dizziness, headache, fever, chills, headache
• Abnormalities of the skin, rash, itching
• Fever, chills, sore throat, cough, flu or cold-like symptoms
• Confusion
• Swelling of the ankles or feet
• Sudden weight gain
• Vision changes
• Unexplained or excessive bleeding (nosebleeds, bruising, black tarry stools, blood in the urine, etc.)

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

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