Truxima

Truxima is a prescription medication used to treat certain Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

Truxima belongs to a group of drugs called monoclonal antibodies. Truxima is a CD20 antibody therapy. CD20 proteins live on the surface of cancer cells and some healthy blood cells. CD20 antibodies find and attack cancer cells by targeting and attaching to the CD20 proteins.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include infusion-related reactions, infections, body aches, tiredness and nausea.

Truxima is a prescription medicine used to treat adults with:

• Non-Hodgkin's Lymphoma (NHL) alone or with other chemotherapy medicines
• Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide

It is not known if Truxima is safe and effective in children.

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

Serious side effects have been reported with Truxima. See the “Truxima Precautions” section.

The most common side effects of Truxima include:

• infusion-related reactions
• infections (may include fever, chills)
• body aches
• tiredness
• nausea

Other side effects with Truxima include:

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

This is not a complete list of Truxima side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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 healthcare provider.

Serious side effects have been reported with Truxima including the following:

• Infusion-related reactions. Infusion-related reactions are very common side effects of Truxima treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Truxima. Your healthcare provider should give you medicines before your infusion of Truxima to decrease your chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of Truxima:
  • 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
• Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with Truxima:
  • painful sores or ulcers on your skin, lips or in your mouth
  • blisters
  • peeling skin
  • rash
  • pustules
• Hepatitis B virus (HBV) reactivation. Before you receive your Truxima treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Truxima 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 Truxima if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Truxima.
  Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes, during treatment with Truxima.
• Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive Truxima. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
  Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms:

• confusion
• dizziness or loss of balance
• difficulty walking or talking
• decreased strength or weakness on one side of your body
• vision problems

• Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
  • kidney failure and the need for dialysis treatment
  • abnormal heart rhythm

TLS can happen within 12 to 24 hours after an infusion of Truxima. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:

• nausea
• vomiting
• diarrhea
• lack of energy

• Serious infections. Serious infections can happen during and after treatment with Truxima, and can lead to death. Truxima can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with Truxima include bacterial, fungal, and viral infections. After receiving Truxima, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive Truxima. Tell your healthcare provider 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
  • cold sores in the mouth or throat
  • cuts, scrapes or incisions that are red, warm, swollen or painful
• Heart problems. Truxima may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Truxima if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with Truxima.
• Kidney problems, especially if you are receiving Truxima for NHL. Truxima can cause severe kidney problems that lead to death. Your healthcare provider 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 Truxima with chemotherapy medicines. Tell your healthcare provider right away if you have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with Truxima.

Your healthcare provider will stop treatment with Truxima if you have severe, serious or life-threatening side effects.

Do not receive Truxima if you are allergic to Truxima or to any of its ingredients

Medications 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 Truxima, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Truxima, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have had a severe reaction to Truxima or a rituximab product
• 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 during treatment with Truxima.
• are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive Truxima during pregnancy. 
  Females who are able to become pregnant should use effective birth control (contraception) during treatment with Truxima and for 12 months after the last dose of Truxima. Talk to your healthcare provider about effective birth control.
  Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with Truxima.
• are breastfeeding or plan to breastfeed. It is not known if Truxima passes into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of Truxima.

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

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

It has been shown that use of Truxima in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby. 

Talk to your healthcare provider about the risks to your unborn baby if you receive Truxima during pregnancy. 
Females who are able to become pregnant should use effective birth control (contraception) during treatment with Truxima and for 12 months after the last dose of Truxima. Talk to your healthcare provider about effective birth control.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with Truxima.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Truxima crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, it is recommended not to breastfeed while receiving Truxima. Do not breastfeed for at least 6 months after the last dose of Truxima. 

• Truxima is given by infusion through a needle placed in a vein (intravenous infusion), in your arm. Talk to your healthcare provider about how you will receive Truxima.
• Your healthcare provider may prescribe medicines before each infusion of Truxima to reduce infusion side effects such as fever and chills.
• Your healthcare provider should do blood tests regularly to check for side effects to Truxima.
• Before each Truxima treatment, your healthcare provider or nurse will ask you questions about your general health. Tell your healthcare provider or nurse about any new symptoms.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• The condition being treated
• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication
• Your weight
• Your height

Recommended Dose for Non-Hodgkin's Lymphoma (NHL):

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

• Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL 
  Administer once weekly for 4 or 8 doses.
• Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL 
  Administer once weekly for 4 doses.
• Previously Untreated, Follicular, CD20-Positive, B-Cell NHL 
  Administer on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Truxima maintenance eight weeks following completion of a rituximab product in combination with chemotherapy. Administer Truxima 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 CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
• Diffuse Large B-Cell NHL 
  Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.

Recommended Dose for Chronic Lymphocytic Leukemia (CLL):

The recommended dose is:

• 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2-6 (every 28 days).

Recommended Dose as a Component of Zevalin for treatment of NHL:

• Infuse Truxima 250 mg/m2 within 4 hours prior to the administration of Indium-111-(In-111-) Zevalin and within 4 hours prior to the administration of Yttrium-90-(Y-90-) Zevalin.
• Administer Truxima and In-111-Zevalin 7-9 days prior to Truxima and Y-90-Zevalin.
• Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.

Recommended Dose for Premedication and Prophylactic Medications:

Premedicate with acetaminophen and an antihistamine before each infusion of Truxima. For patients administered Truxima according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion.

Provide prophylaxis treatment for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

If Truxima 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.

• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Truxima.

WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Infusion Reactions

Administration of rituximab products, including Truxima, can result in serious, including fatal, infusion reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Truxima infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.

Severe Mucocutaneous Reactions

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

Hepatitis B Virus (HBV) Reactivation

HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Truxima. Discontinue Truxima and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products.