WARNING

Rituxan Hycela is a combination medication that includes rituximab and hyaluronidase, and it is used for the treatment of certain types of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. Like any medication, Rituxan Hycela comes with potential risks and side effects. It’s important to note that individual responses to medications can vary, and the following information is not exhaustive. Always consult with a healthcare professional for personalized advice. Here are some potential risks associated with Rituxan Hycela:

• Infusion Reactions: Infusion reactions, including fever, chills, nausea, and headache, can occur during or after the administration of Rituxan Hycela. These reactions are typically more common with the first infusion and may be less severe with subsequent infusions.
• Infections: Rituxan Hycela can increase the risk of infections. Serious infections, including reactivation of hepatitis B, have been reported. Patients should be screened for infections before starting treatment, and precautions should be taken to prevent infections during and after treatment.
• Cardiovascular Effects: Rituxan Hycela may cause serious cardiovascular reactions, including arrhythmias and angina. Patients with pre-existing cardiac conditions may be at higher risk.
• Severe Skin and Mucosal Reactions: Severe skin and mucosal reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome, have been reported with rituximab-containing products.
• Tumor Lysis Syndrome (TLS): TLS is a potentially life-threatening complication that can occur with the rapid breakdown of cancer cells. Close monitoring and appropriate management strategies are needed to prevent and treat TLS.
• Hepatitis B Reactivation: Rituxan Hycela can cause the reactivation of hepatitis B in patients who are chronic carriers of the virus. Hepatitis B screening and monitoring are recommended.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and serious brain infection, has been reported in patients receiving rituximab, particularly in those with weakened immune systems.
• Bone Marrow Suppression: Rituxan Hycela may lead to decreased blood cell counts, including white blood cells, red blood cells, and platelets.

It’s crucial for individuals considering or undergoing Rituxan Hycela treatment to have thorough discussions with their healthcare providers. The benefits and risks of the medication should be carefully weighed, and patients should be monitored closely during and after treatment for any signs of adverse effects.

Why is this medication prescribed?

Rituxan Hycela is a medication that contains two active ingredients: rituximab and hyaluronidase. Rituximab is a monoclonal antibody that targets a specific protein on the surface of certain immune cells called B cells. Hyaluronidase is an enzyme that helps the rituximab to be absorbed more effectively.

Rituxan Hycela is prescribed for the treatment of certain types of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). It is also used in combination with glucocorticoids for the treatment of adults with moderate to severe rheumatoid arthritis.

How should this medicine be used?

The dosing and administration of Rituxan Hycela involve a subcutaneous (under the skin) injection. The healthcare provider will determine the appropriate dose and schedule based on the specific condition being treated. The medication is typically administered by a healthcare professional in a healthcare setting, but some patients may be trained to self-inject under the guidance of their healthcare provider.

It’s important to follow the prescribed dosage and administration schedule provided by the healthcare provider. Rituxan Hycela should not be injected intravenously (into a vein) or intramuscularly (into a muscle).

Before starting Rituxan Hycela, it’s crucial to inform the healthcare provider about any other medications, allergies, or medical conditions you may have. Additionally, patients should be monitored for any potential side effects or adverse reactions during and after the administration of the medication.

As with any prescription medication, it’s essential to discuss any questions or concerns about Rituxan Hycela with your healthcare provider, and not to adjust the dosage or stop the treatment without their guidance.

Other uses for this medicine

Rituxan Hycela is primarily indicated for the treatment of certain types of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Its use is generally limited to these specific conditions. However, healthcare providers may sometimes prescribe medications “off-label” for conditions or uses not explicitly approved by regulatory authorities. Off-label use should only occur when the healthcare provider believes that the potential benefits outweigh the risks based on their clinical judgment and the available evidence.

What special precautions should I follow?

Patients receiving Rituxan Hycela should be closely monitored, and certain precautions should be taken to minimize the risk of potential adverse effects. Here are some special precautions to consider:

• Infusion Reactions: Infusion reactions are a known risk with Rituxan Hycela. Patients may experience symptoms such as fever, chills, nausea, and headaches during or after the infusion. To mitigate this, healthcare providers often administer pre-medications, and patients are monitored closely during the infusion.
• Infections: Rituxan Hycela can increase the risk of infections. Patients should be screened for infections before starting treatment, and caution should be taken to prevent infections during and after treatment. In some cases, antiviral or antibacterial prophylaxis may be recommended.
• Cardiovascular Effects: Rituxan Hycela may cause serious cardiovascular reactions, including arrhythmias and angina. This is particularly relevant for patients with pre-existing cardiac conditions.
• Hepatitis B Reactivation: There is a risk of hepatitis B reactivation with Rituxan Hycela. Patients should be tested for hepatitis B before starting treatment, and antiviral therapy may be indicated for those with a history of hepatitis B infection.
• Tumor Lysis Syndrome (TLS): Monitoring and preventive measures are essential to reduce the risk of TLS, a potentially life-threatening complication associated with the rapid breakdown of cancer cells.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and serious brain infection, has been reported in patients receiving rituximab-containing products. Healthcare providers should be vigilant for any signs of neurological symptoms.
• Bone Marrow Suppression: Rituxan Hycela may lead to decreased blood cell counts, including white blood cells, red blood cells, and platelets. Regular blood tests are necessary to monitor for bone marrow suppression.

Patients should communicate openly with their healthcare providers about their medical history, current medications, and any concerns they may have. It’s crucial to attend all scheduled appointments and follow the recommended monitoring and testing protocols. Rituxan Hycela should only be used under the supervision of a qualified healthcare professional.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Rituxan Hycela. However, maintaining a healthy and well-balanced diet is generally advisable during cancer treatment to support overall health. If you have any dietary concerns or specific dietary restrictions, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

Rituxan Hycela is typically administered by healthcare professionals in a clinical setting, and the schedule is determined by your healthcare provider. It’s unlikely that you will forget a dose on your own. However, if you have concerns about your treatment schedule or miss an appointment, contact your healthcare provider as soon as possible. It’s important not to self-administer or adjust the dosing schedule without consulting your healthcare team.

What side effects can this medication cause?

Rituxan Hycela, like any medication, can cause side effects. It’s important to note that not everyone will experience these side effects, and the severity can vary from person to person. Common side effects may include:

• Infusion Reactions: Symptoms may include fever, chills, nausea, headache, and fatigue. These reactions are more common during the first infusion and tend to be less severe with subsequent infusions.
• Infections: Rituxan Hycela can increase the risk of infections. Common signs of infection include fever, chills, cough, and difficulty breathing. Serious infections, including reactivation of hepatitis B, have been reported.
• Cardiovascular Effects: Rituxan Hycela may cause serious cardiovascular reactions, such as arrhythmias and angina (chest pain). Patients with pre-existing cardiovascular conditions may be at higher risk.
• Tumor Lysis Syndrome (TLS): This is a potentially life-threatening complication associated with the rapid breakdown of cancer cells. Symptoms may include nausea, vomiting, confusion, and kidney problems.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection that has been reported in patients receiving rituximab-containing products. Symptoms may include changes in behavior, difficulty speaking, and vision problems.
• Skin and Mucosal Reactions: Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome, have been reported.
• Bone Marrow Suppression: Rituxan Hycela may lead to decreased blood cell counts, including white blood cells, red blood cells, and platelets. This can increase the risk of infection, anemia, and bleeding.
• Hepatitis B Reactivation: Rituxan Hycela can cause the reactivation of hepatitis B in patients who are chronic carriers of the virus.

It’s important to promptly report any unusual or severe symptoms to your healthcare provider during and after Rituxan Hycela treatment. Your healthcare team will closely monitor you for potential side effects and take appropriate measures to manage them.

This list is not exhaustive, and there may be other side effects associated with Rituxan Hycela. Patients should consult with their healthcare provider for a comprehensive understanding of potential risks and benefits based on their individual health status and medical history.

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

Storage and Disposal of Rituxan Hycela:

• Storage:
  • Rituxan Hycela is typically stored in a healthcare setting, and healthcare professionals are responsible for proper storage.
  • If you are provided with a home-use kit, follow the storage instructions provided by your healthcare provider or pharmacist.
  • Store Rituxan Hycela as directed, and do not freeze the medication.
• Disposal:
  • Rituxan Hycela is typically administered by healthcare professionals in a clinical setting. Therefore, the disposal of any unused or expired medication is the responsibility of the healthcare facility.

In case of emergency/overdose

In case of an emergency or suspected overdose, seek immediate medical attention or contact your local poison control center. Overdose symptoms may include severe infusion reactions, increased risk of infections, and other serious side effects associated with Rituxan Hycela. Do not attempt to self-administer additional doses or adjust your treatment without consulting a healthcare professional.

What other information should I know?

• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The potential risks and benefits of Rituxan Hycela during pregnancy and breastfeeding should be discussed with your healthcare team.
• Immunizations: Inform your healthcare provider of any recent vaccinations or planned vaccinations. Rituxan Hycela can affect the immune system, and live vaccines should generally be avoided during treatment.
• Regular Monitoring: Regular monitoring, including blood tests and medical evaluations, will likely be conducted to assess your response to treatment and monitor for potential side effects.
• Informing Healthcare Providers: Keep your healthcare providers informed about all medications, supplements, and over-the-counter drugs you are taking, as they can potentially interact with Rituxan Hycela.
• Follow-Up Care: Attend all scheduled appointments and follow the recommended treatment plan. If you have any concerns or experience new symptoms, contact your healthcare provider promptly.
• Patient Education: Educate yourself about the potential side effects and warning signs associated with Rituxan Hycela. Be vigilant in reporting any unusual symptoms to your healthcare team.

Always follow the guidance provided by your healthcare provider regarding the use, storage, and disposal of Rituxan Hycela. Individualized instructions may vary, and it’s crucial to consult with your healthcare team for specific information based on your health status and treatment plan.