Rituxan

Rituxan is used to treat certain types of blood cancer. Rituxan is also used to treat rheumatoid arthritis and a certain disease that causes inflammation of the blood vessels. Rituxan is in a class of medications called monoclonal antibodies. It works by killing cancer cells. It treats rheumatoid arthritis by blocking the activity of the part of the immune system that may damage the joints, veins, and other blood vessels.

This medication comes in an injectable form that is given directly into a vein (IV) by a healthcare provider.

Common side effects include infections, chills, body aches, and tiredness.

Rituxan is a prescription medicine used to treat:

• Non-Hodgkin's Lymphoma (NHL, a type of blood cancer): Rituxan is used alone or with other chemotherapy medicines for NHL.
• Chronic Lymphocytic Leukemia (CLL, a type of blood cancer): Rituxan is used alone or with the chemotherapy medicines fludarabine and cyclophosphamide.
• Rheumatoid Arthritis (RA, a disease of inflammation of the joints): Rituxan is used with another medication called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults.
• Granulomatosis with Polyangiitis (GPA, or Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): These are two diseases causing inflammation of the blood vessels. Rituxan is used with glucocorticoids, to treat GPA and MPA.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

Serious side effects may occur. See "Rituxan Precautions" section.

Common side effects during Rituxan treatment include:

• infusion reactions
• chills
• infections
• body aches
• tiredness
• low white blood cells

Other side effects with Rituxan include:

• aching joints during or within hours of receiving an infusion
• more frequent upper respiratory tract infection

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects with Rituxan. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:

• a Tumor Necrosis Factor (TNF) inhibitor medicine
• a Disease Modifying Anti-Rheumatic Drug (DMARD)

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

Rituxan can cause serious side effects that can lead to death, including:

• Infusion reactions. Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your doctor should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction.

• Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus. People with weakened immune systems can get PML. Your chance of getting PML may be higher if you are treated with Rituxan alone or with other medicines that weaken your immune system. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.

• Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:

• Severe skin and mouth reactions. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment with Rituxan:

Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion of Rituxan

• hives (red itchy welts) or rash
• itching
• swelling of your lips, tongue, throat or face
• sudden cough
• shortness of breath, difficulty breathing, or wheezing
• weakness
• dizziness or feel faint
• palpitations (feel like your heart is racing or fluttering)
• chest pain

Tell your doctor right away if you have any of the following symptoms or if anyone close to you notices these symptoms:

• confusion or problems thinking
• loss of balance
• change in the way you walk or talk
• decreased strength or weakness on one side of your body
• blurred vision or loss of vision

• kidney failure and the need for dialysis treatment
• abnormal heart rhythm

Your doctor may do blood tests to check you for TLS. Your doctor may give you medicine to help prevent TLS.

• painful sores or ulcers on your skin, lips or in your mouth
• blisters
• peeling skin
• rash
• pustules

• Hepatitis B virus (HBV) reactivation. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. You should not receive Rituxan if you have active hepatitis B liver disease. Your doctor should monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan.
• Serious infections. Serious infections can happen during and after treatment with Rituxan, and can lead to death. Rituxan can lower the ability of your immune system to fight infections. Types of serious infections that can happen with Rituxan include bacterial, fungal, and viral infections. After receiving Rituxan, some patients have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. Call your doctor right away if you have any symptoms of infection:
  • fever
  • cold symptoms, such as runny nose or sore throat that do not go away
  • flu symptoms, such as cough, tiredness, and body aches
  • earache or headache
  • pain during urination
  • white patches in the mouth or throat
  • cuts, scrapes or incisions that are red, warm, swollen or painful
• Heart problems. Rituxan may cause chest pain and irregular heart beats which may need treatment, or your doctor may decide to stop your treatment with Rituxan.
• Kidney problems, especially if you are receiving Rituxan for NHL. Your doctor should do blood tests to check how well your kidneys are working.
• Stomach and Serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel can happen if you receive Rituxan with chemotherapy medicines to treat non-Hodgkin's lymphoma. Tell your doctor right away if you have any stomach area pain during treatment with Rituxan.
• Low blood cell counts. Your doctor may do blood tests during treatment with Rituxan to check your blood cell counts.
  • White blood cells. White blood cells fight against bacterial infections. Low white blood cells can cause you to get infections,  which may be serious. See "Increased risk of infections" above for a list of symptoms of infection.
  • Red blood cells. Red blood cells carry oxygen to your body tissues and organs.
  • Platelets. Platelets are blood cells that help your blood to clot.

Do not have any vaccinations during your Rituxan treatment without talking to your doctor.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Rituxan there are no specific foods that you must exclude from your diet when receiving Rituxan.

Before receiving Rituxan, tell your doctor if you:

• have had a severe infusion reaction to Rituxan in the past
• have a history of heart problems, irregular heart beat or chest pain
• have lung or kidney problems
• have an infection or weakened immune system
• have or have had any severe infections including:
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Cytomegalovirus (CMV)
  • Herpes simplex virus (HSV)
  • Parvovirus B19
  • Varicella zoster virus (chickenpox or shingles)
  • West Nile Virus
• have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or after you receive Rituxan. Tell your doctor if anyone in your household is scheduled to receive a vaccination. Some types of vaccines can spread to people with a weakened immune system, and cause serious problems.
• have taken Rituxan for WG or MPA in the past
• have any other medical conditions
• are pregnant or planning to become pregnant. Rituxan may affect the white blood cell counts of your unborn baby. It is not known if Rituxan may harm your unborn baby in other ways. Women who are able to become pregnant should use effective birth-control (contraception) while using Rituxan and for 12 months after you finish treatment. Talk to your doctor about effective birth control.
• are breastfeeding or plan to breastfeed. It is not known if Rituxan passes into your breast milk. You and your doctor should decide the best way to feed your baby if you receive Rituxan.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Rituxan is excreted in human breast milk or if it will harm your nursing baby.

• Rituxan is given by infusion through a needle placed in a vein (intravenous infusion), in your arm. Talk to your doctor about how you will receive Rituxan.
• Your doctor may prescribe medicines before each infusion of Rituxan to reduce side effects of infusions such as fever and chills.
• Your doctor should do regular blood tests to check for side effects to Rituxan.

Before each Rituxan treatment, your doctor or nurse will ask you questions about your general health. Tell your doctor or nurse about any new symptoms.

Non-Hodgkin's Lymphoma (NHL)

The recommended dose is 375 mg/m2 as an intravenous (into the vein) infusion according to the following schedules:

• Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: given once weekly for 4 or 8 doses.
• Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: given once weekly for 4 doses.
• Previously Untreated, Follicular, CD20-Positive, B-Cell NHL: given on Day 1 of each cycle of chemotherapy, for up to 8 doses. With complete or partial response, Rituxan maintenance therapy is 8 weeks following completion of Rituxan in combination with chemotherapy. Rituxan is to be given as a single-agent every 8 weeks for 12 doses.
• Non-progressing, Low-Grade, CD20-Positive, B-cell NHL, after first-line CVP chemotherapy: following completion of 6–8 cycles of chemotherapy, Rituxan is to be given once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
• Diffuse Large B-Cell NHL: given on Day 1 of each cycle of chemotherapy for up to 8 infusions.

Chronic Lymphocytic Leukemia (CLL)

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Always let your doctor know what other medications or supplements you may be taking. Talk to your doctor before taking a new medicine. Always keep doctor’s appointments as they may need to check your laboratory tests.

WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Infusion Reactions

Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions.

Tumor Lysis Syndrome (TLS)

Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) with Rituxan monotherapy.

Severe Mucocutaneous Reactions

Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Progressive Multifocal Leukoencephalopathy (PML)

JC virus infection resulting in PML and death can occur in patients receiving Rituxan.