rituximab (Intravenous route)

ri-TUX-i-mab

Commonly used brand name(s):

In the U.S.

• Rituxan

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

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Uses For rituximab

Rituximab is a monoclonal antibody. It is used to treat a type of cancer called non-Hodgkin's lymphoma. It can be used alone or with other cancer medicines or chemotherapy.

Rituximab may also be used in combination with methotrexate to reduce the signs and symptoms of rheumatoid arthritis and help keep joint damage from getting worse after at least one other medicine has been used and did not work well.

Rituximab is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, rituximab is used in certain patients with the following medical conditions:

• Chronic lymphocytic leukemia (a type of cancer of the blood and lymph system)
• Immune or idiopathic thrombocytopenic purpura (ITP) (a blood disease)
• Waldenstrom's macroglobulinemia (a certain type of cancer of the blood)

Before Using rituximab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rituximab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rituximab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rituximab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab in the elderly. However, elderly patients are more likely to have age-related heart and lung problems, which may require caution in patients receiving rituximab.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using rituximab with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using rituximab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin
• Bacillus of Calmette and Guerin Vaccine, Live
• Cisplatin
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of rituximab. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems (e.g., angina, arrhythmias) or
• Lung problems—Your doctor will want to check you periodically for heart and lung problems, especially if you have had serious problems in the past.

• Hepatitis B virus—Rituximab can cause the hepatitis B virus to worsen, resulting in serious liver problems.

• High number of cancerous cells in your body or
• Kidney problems—You may be at higher risk for very serious unwanted effects.

• Sensitivity or a previous severe allergic reaction to rituximab or to mouse proteins—Your doctor should not administer rituximab if you have experienced a previous allergic reaction.

Proper Use of rituximab

A nurse or other trained health professional will give you rituximab. rituximab is given through a needle placed in one of your veins.

Precautions While Using rituximab

It is very important that your doctor check your progress at regular visits to make sure that rituximab is working properly. Blood tests may be needed to check for unwanted effects.

rituximab may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using rituximab. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using rituximab. Also tell your doctor if you have ever 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 persistent cough, weight loss, night sweats, fever, chills, or flu-like symptoms such as runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you are already having an infection.

While you are being treated with rituximab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Rituximab may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., oral poliovirus vaccine, nasal influenza [flu] virus vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

Rituximab may cause chest pain, fever, chills, itching, hives, flushing of the face, or troubled breathing within a few hours after you receive it. Check with your doctor or nurse immediately if you have any of these symptoms.

Serious skin reactions can occur during treatment with rituximab. Check with your doctor right away if you have any of the following symptoms while taking rituximab: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, or ulcers.

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 pain, fever, or severe tiredness.

rituximab may cause serious stomach and bowel problems especially when used with other anti-cancer medicines. Check with your doctor right away if you start having stomach pain while being treated with rituximab.

rituximab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal pain
• back pain
• black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blurred vision
• chest pain
• confusion
• convulsions
• cough or hoarseness
• difficult breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness
• dry mouth
• feeling of swelling of the tongue or throat
• fever and chills
• flushed, dry skin
• flushing of the face
• fruit-like breath odor
• headache
• hives or welts
• increased hunger
• increased thirst
• increased urination
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• nausea
• nervousness
• noisy breathing
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid weight gain
• runny nose
• shortness of breath
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stuffy or runny nose
• sweating
• swollen glands
• tightness of the chest
• tingling of the hands or feet
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• wheezing

• Blistering, peeling, or loosening of the skin
• blisters in the mouth
• blisters on the trunk, scalp, or other areas
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• decreased frequency and amount of urination
• diarrhea
• difficulty in moving
• discouragement
• feeling of warmth
• feeling sad or empty
• increased thirst
• irregular heartbeat
• irritability
• joint or muscle pain
• loss of appetite
• loss of interest or pleasure
• muscle cramps
• muscle pain or stiffness
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain at the place of injection
• pain, swelling, or redness in the joints
• red skin lesions, often with a purple center
• red, itchy lining of the eye
• redness of the face, neck, arms and occasionally, upper chest
• stabbing pain
• swelling of the face or fingers
• swelling of the feet or lower legs
• trouble concentrating
• trouble sleeping

• Abdominal or stomach cramps or pain
• blindness
• blue-yellow color blindness
• blurred vision or other change in vision
• burning or stinging of the skin
• decreased vision
• dilated neck veins
• dry cough
• extreme fatigue
• eye pain, tearing
• general feeling of discomfort, illness, or weakness
• inflammation of the joints
• irregular breathing
• nosebleed
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• redness of the eye
• redness, soreness, or itching of the skin
• sensitivity of the eye to light
• severe abdominal pain
• severe vomiting, sometimes with blood
• sores, welting, or blisters
• swelling, stiffness, redness, or warmth around many joints
• swollen lymph glands
• vision loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Fear
• increased cough
• lack or loss of strength
• muscle aching or cramping
• night sweats
• swollen joints
• throat irritation

• Agitation or anxiety
• change in taste
• dry eyes
• excessive muscle tone
• feeling of constant movement of self or surroundings
• heartburn
• increase in body movements
• lightheadedness
• muscle tension
• pain at the injection site
• sensation of spinning
• sleepiness
• swelling of the stomach

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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