WARNING

Truxima (rituximab-abbs) is a medication used to treat various conditions such as non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Like any medication, Truxima carries potential risks and side effects. Some of the common risks associated with Truxima include:

• Infusion Reactions: Immediate reactions such as fever, chills, itching, rash, or difficulty breathing can occur during or shortly after the infusion. These reactions are typically managed by slowing down the infusion rate or administering medications like antihistamines.
• Infections: Truxima suppresses the immune system, increasing the risk of infections. Serious infections, including bacterial, viral, and fungal infections, can occur. Patients are advised to report any signs of infection promptly.
• Decreased Blood Cell Counts: Truxima can cause a decrease in white blood cells, which are crucial for fighting infections, as well as red blood cells and platelets, leading to anemia and increased susceptibility to bleeding.
• Cardiovascular Side Effects: There is a risk of serious cardiovascular events, including arrhythmias, angina, myocardial infarction, and heart failure, particularly in patients with a history of cardiovascular disease.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and potentially fatal brain infection, has been reported in patients treated with rituximab, particularly in those with weakened immune systems.
• Tumor Lysis Syndrome (TLS): In patients with a high tumor burden, rapid destruction of cancer cells can lead to metabolic abnormalities such as kidney failure, heart arrhythmias, and seizures.
• Hepatitis B Reactivation: Truxima can reactivate hepatitis B virus in patients who are carriers of the virus, leading to severe liver damage or failure.
• Pulmonary Toxicity: Rare cases of severe respiratory problems, including interstitial pneumonitis and pulmonary fibrosis, have been reported with rituximab use.
• Tumor Flare Reaction: In some cases, there may be an initial worsening of symptoms or the appearance of new symptoms shortly after starting Truxima treatment, known as a tumor flare reaction.

It’s essential for patients receiving Truxima to be closely monitored by their healthcare provider for any signs of adverse reactions or complications. Patients should also discuss the potential risks and benefits of Truxima treatment with their healthcare provider before starting therapy.

Why is this medication prescribed?

Truxima (rituximab-abbs) is prescribed for several medical conditions, primarily those involving the immune system or certain types of cancer. Here are some common indications for which Truxima may be prescribed:

• Non-Hodgkin’s Lymphoma (NHL): Truxima is often used in combination with chemotherapy to treat certain types of NHL, including follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma.
• Chronic Lymphocytic Leukemia (CLL): Truxima, in combination with chemotherapy or other targeted therapies, may be prescribed for the treatment of CLL.
• Rheumatoid Arthritis (RA): Truxima is approved for use in combination with methotrexate for the treatment of moderate to severe RA in adult patients who have not responded adequately to other therapies.
• Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA): Truxima, in combination with glucocorticoids, is indicated for the treatment of GPA and MPA in adult patients.
• Other Autoimmune Diseases: Truxima may also be used off-label for other autoimmune conditions such as lupus nephritis or pemphigus vulgaris, particularly when other treatments have been ineffective.

The specific condition being treated, as well as individual patient factors, will determine the appropriate use of Truxima. It’s essential for patients to discuss their medical history and treatment options thoroughly with their healthcare provider to determine whether Truxima is the right choice for them.

How should this medicine be used?

Regarding special precautions for Truxima (rituximab-abbs), patients and healthcare providers should be aware of the following:

• Infusion Reactions: Patients should be closely monitored during and after Truxima infusions for signs of infusion reactions, including fever, chills, rash, and difficulty breathing. Premedication with corticosteroids, antihistamines, and/or acetaminophen may be administered to reduce the risk of infusion reactions.
• Infections: Truxima suppresses the immune system, increasing the risk of infections. Patients should be monitored for signs of infection, and appropriate prophylactic antibiotics may be prescribed in certain situations.
• Hepatitis B Reactivation: Patients should be screened for hepatitis B virus (HBV) infection before starting Truxima therapy, as reactivation of HBV can occur, leading to severe liver damage or failure. HBV carriers may require antiviral prophylaxis during and after treatment with Truxima.
• Cardiovascular Effects: Truxima may increase the risk of serious cardiovascular events, particularly in patients with pre-existing cardiovascular disease. Patients should be monitored for signs of heart failure, arrhythmias, and angina.
• Pregnancy and Breastfeeding: Truxima may cause harm to a developing fetus, and women of childbearing potential should use effective contraception during treatment and for a certain period afterward. It is not known whether Truxima is excreted in breast milk, so breastfeeding is not recommended during treatment.
• Malignancies: There is a risk of developing malignancies, including lymphoma and other cancers, with Truxima therapy. Patients should undergo regular monitoring for the development of new malignancies.

Patients should discuss any concerns or questions about Truxima therapy with their healthcare provider, and they should be informed about the potential risks and benefits of treatment. Close monitoring and adherence to recommended precautions can help minimize the risks associated with Truxima therapy.

Other uses for this medicine

Some potential off-label uses of Truxima may include:

• Off-label cancer treatments: Truxima may be used for certain cancers beyond its approved indications, based on emerging research and clinical trials.
• Off-label autoimmune conditions: Truxima might be used for autoimmune diseases not officially approved for treatment but where it has shown efficacy in clinical studies.

What special precautions should I follow?

Regarding special precautions for Truxima (rituximab-abbs), patients and healthcare providers should be aware of the following:

• Infusion Reactions: Patients should be closely monitored during and after Truxima infusions for signs of infusion reactions, including fever, chills, rash, and difficulty breathing. Premedication with corticosteroids, antihistamines, and/or acetaminophen may be administered to reduce the risk of infusion reactions.
• Infections: Truxima suppresses the immune system, increasing the risk of infections. Patients should be monitored for signs of infection, and appropriate prophylactic antibiotics may be prescribed in certain situations.
• Hepatitis B Reactivation: Patients should be screened for hepatitis B virus (HBV) infection before starting Truxima therapy, as reactivation of HBV can occur, leading to severe liver damage or failure. HBV carriers may require antiviral prophylaxis during and after treatment with Truxima.
• Cardiovascular Effects: Truxima may increase the risk of serious cardiovascular events, particularly in patients with pre-existing cardiovascular disease. Patients should be monitored for signs of heart failure, arrhythmias, and angina.
• Pregnancy and Breastfeeding: Truxima may cause harm to a developing fetus, and women of childbearing potential should use effective contraception during treatment and for a certain period afterward. It is not known whether Truxima is excreted in breast milk, so breastfeeding is not recommended during treatment.
• Malignancies: There is a risk of developing malignancies, including lymphoma and other cancers, with Truxima therapy. Patients should undergo regular monitoring for the development of new malignancies.

Patients should discuss any concerns or questions about Truxima therapy with their healthcare provider, and they should be informed about the potential risks and benefits of treatment. Close monitoring and adherence to recommended precautions can help minimize the risks associated with Truxima therapy.

What special dietary instructions should I follow?

Regarding special dietary instructions for Truxima (rituximab-abbs), there are no specific dietary restrictions associated with its use. However, maintaining a balanced and nutritious diet can support your overall health and may help you better tolerate treatment. It’s essential to stay hydrated before and after Truxima infusions, as adequate hydration can help reduce the risk of infusion-related reactions.

What should I do if I forget a dose?

If you forget a dose of Truxima, it’s essential to contact your healthcare provider or infusion center as soon as possible to reschedule your appointment. Missing a dose may affect the effectiveness of your treatment regimen, so it’s crucial to follow the recommended schedule provided by your healthcare provider. Do not attempt to administer Truxima on your own or make changes to your treatment plan without consulting your healthcare provider.

What side effects can this medication cause?

Truxima (rituximab-abbs) can cause various side effects, ranging from mild to severe. It’s essential to discuss potential side effects with your healthcare provider before starting treatment. Some common side effects of Truxima include:

• Infusion Reactions: Immediate reactions such as fever, chills, nausea, headache, rash, itching, and difficulty breathing can occur during or shortly after the infusion. These reactions are typically managed by slowing down the infusion rate or administering medications like antihistamines or corticosteroids.
• Infections: Truxima suppresses the immune system, increasing the risk of infections. Common infections may include upper respiratory tract infections, urinary tract infections, sinusitis, and pneumonia. Serious infections, including bacterial, viral, and fungal infections, can also occur.
• Decreased Blood Cell Counts: Truxima can cause a decrease in white blood cells (leukopenia), which are crucial for fighting infections, as well as red blood cells (anemia) and platelets (thrombocytopenia), leading to increased susceptibility to infections and bleeding.
• Fatigue: Feeling tired or fatigued is a common side effect of Truxima treatment.
• Nausea and Vomiting: Some patients may experience nausea and vomiting during or after Truxima infusions.
• Fever: Low-grade fever is a common side effect of Truxima treatment.
• Headache: Headaches are another common side effect reported by some patients receiving Truxima.
• Muscle and Joint Pain: Some patients may experience muscle or joint pain as a side effect of Truxima treatment.
• Allergic Reactions: Rarely, severe allergic reactions such as anaphylaxis may occur in response to Truxima treatment.
• Hepatitis B Reactivation: Truxima can reactivate hepatitis B virus in patients who are carriers of the virus, leading to severe liver damage or failure.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and potentially fatal brain infection, has been reported in patients treated with rituximab, particularly in those with weakened immune systems.
• Tumor Lysis Syndrome (TLS): In patients with a high tumor burden, rapid destruction of cancer cells can lead to metabolic abnormalities such as kidney failure, heart arrhythmias, and seizures.
• Pulmonary Toxicity: Rare cases of severe respiratory problems, including interstitial pneumonitis and pulmonary fibrosis, have been reported with rituximab use.

It’s essential for patients receiving Truxima to be closely monitored by their healthcare provider for any signs of adverse reactions or complications. Patients should also report any new or worsening symptoms to their healthcare provider promptly.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Truxima should be stored in its original packaging at the recommended temperature indicated on the product label. Typically, it is stored under refrigeration between 2°C to 8°C (36°F to 46°F). Protect it from light.
• Handling: Truxima should be handled carefully and should not be shaken vigorously. It should be visually inspected for particulate matter and discoloration before administration. Do not use if the solution is cloudy, discolored, or contains particles.
• Disposal: Any unused portion of Truxima or materials used during the preparation and administration of the medication should be disposed of properly according to local regulations and healthcare facility policies. Consult your healthcare provider or pharmacist for guidance on the proper disposal methods.

In case of emergency/overdose

In case of emergency or overdose of Truxima:

• Emergency: In case of any severe allergic reactions, such as difficulty breathing, swelling of the face, lips, throat, or tongue, or severe infusion reactions like chest pain or severe dizziness, seek immediate medical attention. Emergency medical services should be contacted if necessary.
• Overdose: There is limited information available regarding specific overdose symptoms of Truxima. However, if an overdose is suspected due to accidental administration of a higher dose than prescribed, immediate medical attention should be sought. Healthcare professionals will manage any overdose situation based on the patient’s symptoms and provide supportive care as needed.

What other information should I know?

• Monitoring: During and after Truxima infusions, patients should be monitored closely for signs of infusion reactions, infections, and other potential side effects. Regular monitoring of blood cell counts and liver function tests may also be necessary during treatment.
• Precautions: Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting Truxima treatment. Certain medications or medical conditions may interact with Truxima or increase the risk of adverse effects.
• Pregnancy and Breastfeeding: Truxima may harm a developing fetus, so women of childbearing potential should use effective contraception during treatment and for a certain period afterward. It is not known whether Truxima is excreted in breast milk, so breastfeeding is not recommended during treatment.
• Follow-up: Patients should attend all scheduled appointments and follow their healthcare provider’s instructions regarding Truxima treatment. Regular follow-up visits allow for monitoring of treatment response, side effects, and overall health status.

Patients should discuss any questions or concerns about Truxima treatment with their healthcare provider or pharmacist to ensure safe and effective use of the medication.