Rituxan

DRUG DESCRIPTION

Rituxan® (rituximab) is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.

Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. Rituxan (rituximab) is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous administration. Rituxan (rituximab) is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials. The product is formulated in 9 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dihydrate, 0.7 mg/mL polysorbate 80, and Water for Injection. The pH is 6.5.

What are the possible side effects of rituximab (Rituxan)?

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing;...

Read All Potential Side Effects and See Pictures of Rituxan »

What are the precautions when taking rituximab (Rituxan)?

Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., thrombocytopenia), heart problems (e.g., irregular heartbeat, angina), current or returning infections, lung problems (e.g., pulmonary infiltrates), previous severe reaction to monoclonal antibody treatment, planned surgery/vaccinations, virus infection (e.g., chickenpox, hepatitis B or C, herpes).

This drug may make you dizzy. Do not drive, use machinery, or...

Read All Potential Precautions of Rituxan »


Rituxan Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, fever, chills, nausea, heartburn, flushing, weakness, or dizziness may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back/joint/muscle pain, increased thirst/urination, swelling of the hands/feet, tingling of the hands/feet.

If you have a current or past infection with hepatitis B or other virus infections (e.g., herpes, JC virus), rituximab may infrequently cause the infection to return or worsen. This may happen during treatment or up to 1 year after treatment is finished. Very serious liver disease could occur. If you have hepatitis B, you may be given antiviral medications to control the disease. Get medical help right away if you develop signs of a new or returning infection or liver disease such as: persistent stomach/abdominal pain, extreme tiredness, dark urine, yellowing eyes/skin.

This medication can cause a decrease in blood cells (cytopenia), which can cause bleeding problems and lower the body's ability to fight an infection. This serious side effect can happen days, weeks, or months after your treatment has finished. Notify your doctor promptly if you develop any of the following side effects: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (e.g., fever, chills, persistent sore throat, painful urination).

A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., thrombocytopenia), heart problems (e.g., irregular heartbeat, angina), current or returning infections, lung problems (e.g., pulmonary infiltrates), previous severe reaction to monoclonal antibody treatment, planned surgery/vaccinations, virus infection (e.g., chickenpox, hepatitis B or C, herpes).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Wash your hands well to prevent the spread of infections.

Caution should be used when using this in the elderly because they may be at greater risk for heart problems (e.g., irregular heartbeat) or lung problems (e.g., pneumonia).

During pregnancy, this medication must not be used unless clearly needed due to a risk of harm to the unborn baby. Discuss the risks and benefits with your doctor. Becoming pregnant is not recommended during treatment with this medication and for at least 12 months after treatment is finished. Consult your doctor or pharmacist about using a reliable form of birth control (e.g., condoms, birth control pills).

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. You should not begin breast-feeding until treatment is finished and blood test show that there is no more rituximab in your body. Consult your doctor to decide when it is safe to start breast-feeding.


Rituxan Patient Information Including Side Effects

Brand Names: Rituxan

Generic Name: rituximab (Pronunciation: ri TUX i mab)

  • What is rituximab (Rituxan)?
  • What are the possible side effects of rituximab (Rituxan)?
  • What is the most important information I should know about rituximab (Rituxan)?
  • What should I discuss with my healthcare provider before receiving rituximab (Rituxan)?
  • How is rituximab given (Rituxan)?
  • What happens if I miss a dose (Rituxan)?
  • What happens if I overdose (Rituxan)?
  • What should I avoid while receiving rituximab (Rituxan)?
  • What other drugs will affect rituximab (Rituxan)?
  • Where can I get more information?

What is rituximab (Rituxan)?

Rituximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Rituximab is used in combination with other cancer medicines to treat non-Hodgkin's lymphoma. Rituximab is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.

Rituximab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of rituximab (Rituxan)?

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have any of these serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

  • sudden numbness or weakness, especially on one side of the body;
  • confusion, dizziness, loss of balance, blurred vision, and problems with speech or walking; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • uneven heartbeats, wheezing or trouble breathing;
  • urinating more or less than usual;
  • fever, chills, cough, body aches, flu symptoms;
  • easy bruising or bleeding;
  • a red, raised, blistering, scaly, itchy, or peeling skin rash;
  • severe constipation or stomach pain;
  • black, bloody, or tarry stools; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • pain where the IV needle is placed;
  • headache, back pain;
  • mild stomach pain, nausea, or diarrhea;
  • swelling in your hands or feet;
  • muscle or joint pain;
  • runny or stuffy nose; or
  • night sweats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rituximab (Rituxan)?

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Do not miss any scheduled visits.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

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