WARNING

The risks of taking Arzerra (Generic Ofatumumab) for chronic lymphocytic leukemia (CLL) include:

• Infusion-Related Reactions: Symptoms such as fever, chills, rash, and difficulty breathing during or after the infusion.
• Infection Risk: Increased susceptibility to infections due to immune system suppression.
• Hepatitis B Reactivation: Possible reactivation of hepatitis B in patients with a history of the infection.
• Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection that can cause neurological symptoms.
• Low Blood Cell Counts: Can lead to anemia, bleeding problems, or increased infection risk.
• Allergic Reactions: Severe allergic reactions may occur, including potential anaphylaxis.
• Cardiac Issues: Rare cases of heart-related problems may occur.

Regular monitoring and communication with your healthcare provider are crucial to manage these risks effectively.

Why is this medication prescribed?

Arzerra (generic name Ofatumumab) is primarily prescribed for the treatment of chronic lymphocytic leukemia (CLL) in patients who have received prior therapy. It is used to target and kill cancer cells by binding to a specific protein (CD20) found on the surface of B cells, which are involved in the disease. Here are a few key points about Arzerra:

• Chronic Lymphocytic Leukemia (CLL): It is used for patients with CLL who have not responded well to other treatments or have specific genetic markers that make them suitable for this therapy.
• Mechanism of Action: Ofatumumab is a monoclonal antibody that targets the CD20 protein on B cells. By binding to this protein, it helps the immune system recognize and destroy the cancerous B cells.
• Combination Therapy: Often, it is used in combination with other medications, such as chemotherapy or targeted therapies, to enhance its effectiveness.
• Administration: It is administered via intravenous infusion, typically in a healthcare setting.

The choice to use Arzerra would be based on a thorough evaluation of the patient’s specific condition and medical history by their healthcare provider.

How should this medicine be used?

Arzerra (Ofatumumab) is administered by intravenous infusion, and here’s how it’s generally used:

• Preparation: Arzerra must be prepared and diluted by a healthcare professional. It’s not something patients handle themselves.
• Infusion Schedule: The first dose is usually given as a slow infusion, which helps reduce the risk of infusion-related reactions. The initial infusion can take several hours. After the initial dose, subsequent infusions are typically given at regular intervals, such as every 4 weeks. The exact schedule depends on the treatment plan prescribed by the healthcare provider.
• Monitoring: During the infusion, patients are closely monitored for any adverse reactions or infusion-related reactions. This can include symptoms like fever, chills, nausea, or rash.
• Pre-Medication: Patients might receive medications to help prevent or manage infusion-related reactions, such as antihistamines, corticosteroids, or acetaminophen.
• Dosage Adjustments: The dosage and frequency of infusions can be adjusted based on the patient’s response to treatment and any side effects experienced.
• Post-Infusion Care: After the infusion, patients might be observed for a short period to ensure there are no immediate reactions.

Always follow the specific instructions provided by the healthcare provider and the medication’s prescribing information. If you have any concerns or experience side effects, it’s important to contact your healthcare team promptly.

Other uses for this medicine

While Arzerra is primarily approved for chronic lymphocytic leukemia (CLL), it is also being investigated and used for other conditions, including:

• Relapsed or Refractory Non-Hodgkin Lymphoma (NHL): Research is ongoing into its efficacy for other types of B-cell lymphomas.
• Autoimmune Disorders: Ofatumumab is also being studied for its potential use in autoimmune diseases due to its effects on B cells.

What special precautions should I follow?

Special Precautions to Follow for Arzerra:

• Infusion-Related Reactions: Be aware of the potential for infusion-related reactions, especially during the initial infusion. Report any symptoms such as fever, chills, rash, or difficulty breathing immediately.
• Infection Risk: Ofatumumab can weaken the immune system, increasing the risk of infections. Ensure you are up-to-date with vaccinations and avoid contact with individuals who have infections.
• Hepatitis B: Prior to starting treatment, you should be screened for hepatitis B. Reactivation of hepatitis B has been reported in patients receiving Ofatumumab.
• Cytomegalovirus (CMV) Monitoring: CMV reactivation can occur, so monitoring may be necessary.
• Cardiac Monitoring: In patients with pre-existing heart conditions, monitoring might be required, as Ofatumumab can potentially affect heart function.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. Ofatumumab is not recommended during pregnancy and breastfeeding due to potential harm to the fetus or infant.
• Pre-Medications: Follow instructions on pre-medications to reduce the risk of infusion-related reactions.
• Allergic Reactions: If you have a history of severe allergic reactions or hypersensitivity, inform your healthcare provider, as adjustments to the infusion protocol may be necessary.

Always follow the guidance of your healthcare provider and report any unusual symptoms or side effects promptly.

What special dietary instructions should I follow?

There are no specific dietary restrictions or instructions for Arzerra. However, maintaining a balanced diet and staying hydrated is generally beneficial. Always follow any specific advice provided by your healthcare provider regarding your overall health and nutrition.

What should I do if I forget a dose?

• Contact Your Healthcare Provider: If you miss a dose, contact your healthcare provider immediately to reschedule the missed infusion. They will provide instructions based on your treatment plan.
• Do Not Double Up: Do not attempt to make up for a missed dose by receiving two doses at once. Your healthcare provider will determine the appropriate steps to take.
• Follow-Up: Adhere to your rescheduled infusion appointments to ensure the effectiveness of your treatment.

What side effects can this medication cause?

Arzerra (Ofatumumab) can cause a range of side effects. Some of these are common and manageable, while others may be more serious. Here’s an overview:

Common Side Effects:

• Infusion-Related Reactions: Fever, chills, nausea, vomiting, rash, headache, and fatigue.
• Infections: Increased risk of infections such as upper respiratory infections, urinary tract infections, or fungal infections.
• Low Blood Cell Counts: Can lead to anemia, increased risk of bleeding (thrombocytopenia), or a higher risk of infections (neutropenia).

Serious Side Effects:

• Severe Infusion Reactions: Difficulty breathing, severe rash, or significant drops in blood pressure.
• Hepatitis B Reactivation: Can lead to liver inflammation and potential liver damage.
• Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection that can cause severe neurological symptoms.
• Tumor Lysis Syndrome: A condition that can occur when cancer cells break down rapidly, leading to metabolic imbalances and kidney problems.
• Cardiac Events: Such as heart failure or arrhythmias.
• Autoimmune Conditions: New or worsening autoimmune disorders.
• Regular Monitoring: Your healthcare provider will monitor for these side effects during treatment and may perform regular blood tests to check your blood cell counts and liver function.
• Pre-Medication: To reduce the risk of infusion-related reactions, pre-medications like antihistamines or corticosteroids may be administered.

If you experience any severe or unusual symptoms, contact your healthcare provider immediately. They will be able to provide guidance on managing side effects and making any necessary adjustments to your treatment plan.

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

Storage and Disposal of Arzerra (Ofatumumab):

Storage:

• Arzerra should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Once reconstituted and diluted, the solution should be used immediately. If it must be stored before use, it should be kept at room temperature (up to 25°C or 77°F) and used within 24 hours.

Disposal:

• Any unused or expired Arzerra should be disposed of according to local regulations and guidelines. Do not dispose of it in household trash or flush it down the toilet.
• Your healthcare provider or pharmacist can provide guidance on proper disposal methods or take the medication for safe disposal.

In case of emergency/overdose

• Symptoms of Overdose: While overdose of Arzerra is rare, symptoms could include severe infusion reactions or more intense side effects.
• Seek Immediate Medical Attention: Contact emergency services or go to the nearest emergency room if you suspect an overdose or experience severe side effects.
• Healthcare Provider: Notify your healthcare provider immediately for further instructions if you experience severe side effects or an overdose.

What other information should I know?

• Regular Monitoring: Frequent monitoring by your healthcare provider is crucial to track effectiveness and manage side effects. This may include blood tests and other evaluations.
• Medication Interactions: Inform your healthcare provider about all other medications you are taking, including over-the-counter drugs and supplements, as they may interact with Arzerra.
• Vaccinations: Ensure you are up-to-date with vaccinations, as live vaccines should generally be avoided during treatment with Arzerra.
• Pre-Medication Protocol: Follow any pre-medication instructions provided by your healthcare provider to minimize infusion-related reactions.

Always follow the specific guidelines provided by your healthcare provider and the medication’s prescribing information. If you have any concerns or experience new symptoms, contact your healthcare provider promptly.