WARNING

Gazyva (obinutuzumab) is a medication used to treat certain types of blood cancers, particularly chronic lymphocytic leukemia (CLL) and follicular lymphoma. Like any medication, it carries certain risks and side effects. Some of the potential risks associated with taking Gazyva include:

• Infusion reactions: Some patients may experience infusion-related reactions during or shortly after receiving Gazyva. These reactions can range from mild to severe and may include symptoms such as fever, chills, nausea, vomiting, itching, rash, or difficulty breathing.
• Infections: Gazyva can suppress the immune system, increasing the risk of infections. Patients may be more susceptible to bacterial, viral, or fungal infections while undergoing treatment.
• Low blood cell counts: Gazyva can cause a decrease in the production of certain blood cells, including white blood cells, red blood cells, and platelets. This can lead to an increased risk of infections, anemia, and bleeding.
• Tumor lysis syndrome: In some cases, Gazyva treatment may lead to tumor lysis syndrome, a condition characterized by the rapid breakdown of cancer cells, releasing their contents into the bloodstream. This can cause electrolyte imbalances, kidney problems, and other complications.
• Progressive multifocal leukoencephalopathy (PML): Although rare, PML is a serious viral infection of the brain that has been reported in patients receiving Gazyva, particularly those with weakened immune systems.
• Other side effects: Additional side effects of Gazyva may include fatigue, diarrhea, constipation, cough, headache, and muscle or joint pain.

It’s essential for patients receiving Gazyva to be closely monitored by their healthcare provider for any signs of adverse reactions or complications. The benefits and risks of treatment should be carefully weighed, and patients should discuss any concerns with their healthcare team.

Why is this medication prescribed?

Gazyva (obinutuzumab) is a medication that is primarily prescribed for the treatment of certain types of cancer. It is specifically used in combination with other chemotherapy drugs for the treatment of:

• Chronic Lymphocytic Leukemia (CLL): Gazyva is used in combination with chlorambucil for previously untreated CLL, as well as in combination with bendamustine followed by Gazyva alone for relapsed or refractory CLL.
• Follicular Lymphoma: Gazyva is used in combination with chemotherapy (bendamustine followed by Gazyva alone) for previously untreated advanced-stage follicular lymphoma.

Gazyva is a monoclonal antibody that works by targeting and destroying certain cancer cells, thereby helping to slow down the progression of the disease.

How should this medicine be used?

Gazyva (obinutuzumab) is administered as an intravenous (IV) infusion. The dosage and treatment schedule may vary depending on the specific type and stage of cancer being treated, as well as other factors determined by your healthcare provider. Here are some general guidelines for the use of Gazyva:

• Administration: Gazyva is typically administered in a healthcare setting such as a hospital or clinic. A healthcare professional will administer the medication through a vein in your arm.
• Pre-medication: Before receiving Gazyva, your healthcare provider may administer medications to help reduce the risk of infusion-related reactions. These may include antihistamines, corticosteroids, and acetaminophen.
• Treatment Schedule: Gazyva is usually given in cycles, with each cycle consisting of one or more treatment days followed by a rest period. The specific duration and frequency of the treatment cycles will depend on the type of cancer being treated and your healthcare provider’s recommendations.
• Monitoring: During and after the infusion, your healthcare team will closely monitor you for any signs of infusion-related reactions or other side effects. They will also perform regular blood tests to monitor your response to treatment.
• Follow-up: It is important to attend all scheduled appointments and follow the instructions provided by your healthcare provider. They will assess your progress, adjust the treatment plan if necessary, and address any concerns or side effects you may experience.

Other uses for this medicine

Gazyva (obinutuzumab) is primarily approved for the treatment of chronic lymphocytic leukemia (CLL) and follicular lymphoma, as mentioned earlier. However, it is important to note that healthcare providers may sometimes prescribe medications for “off-label” uses, meaning using the medication for a purpose not specifically approved by regulatory authorities. It’s best to consult with your healthcare provider to determine if Gazyva is being considered for any off-label uses.

What special precautions should I follow?

Regarding special precautions, here are some important points to consider:

• Allergies: Inform your healthcare provider if you are allergic to obinutuzumab or any other medications, as well as any other allergies you may have. This is important to prevent any potential allergic reactions.
• Infections: Gazyva can increase the risk of infections. It is important to inform your healthcare provider about any current or past infections, as well as any signs of infection that may develop during treatment (such as fever, cough, or unusual fatigue). Your healthcare provider may monitor your blood cell counts and take precautions to reduce the risk of infections.
• Infusion-related reactions: Gazyva can cause infusion-related reactions during or shortly after administration. These reactions may include fever, chills, nausea, headache, and difficulty breathing. Your healthcare provider will closely monitor you during the infusion and may take steps to minimize the risk of these reactions, such as pre-medicating with antihistamines or corticosteroids.
• Blood disorders: Gazyva can affect your blood cell counts, leading to low levels of red blood cells, white blood cells, and platelets. Your healthcare provider will regularly monitor your blood counts and take appropriate measures if any abnormalities are detected.
• Pregnancy and breastfeeding: Gazyva can harm an unborn baby, so it is important to discuss with your healthcare provider if you are pregnant or planning to become pregnant. It is also not known if Gazyva passes into breast milk, so breastfeeding should be avoided during treatment.
• Other medications and treatments: Inform your healthcare provider about all the medications, supplements, or herbal products you are taking, as well as any recent or planned vaccinations. Some medications and treatments may interact with Gazyva or affect its effectiveness.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Gazyva (obinutuzumab) use. However, it’s always important to maintain a healthy and balanced diet to support your overall well-being during cancer treatment. Your healthcare provider or a registered dietitian can provide personalized dietary recommendations based on your specific needs and any side effects you may experience.

What should I do if I forget a dose?

If you forget a dose of Gazyva, it is crucial to contact your healthcare provider or treatment team as soon as possible. They will provide guidance on the best course of action, as missing a dose can impact the effectiveness of the treatment. It is important not to try to catch up on missed doses or alter the treatment schedule without consulting your healthcare provider first.

What side effects can this medication cause?

Gazyva (obinutuzumab) can cause various side effects. It’s important to note that not all individuals will experience these side effects, and their severity can vary. Your healthcare provider will monitor you closely for side effects and provide appropriate management strategies. Some of the potential side effects of Gazyva may include:

• Infusion-related reactions: These reactions can occur during or shortly after the infusion. They may include fever, chills, nausea, vomiting, headache, fatigue, dizziness, rash, and difficulty breathing. Pre-medications and a slower infusion rate can help reduce the risk and severity of these reactions.
• Infections: Gazyva can increase the risk of infections. Common signs of infection include fever, cough, sore throat, and urinary tract symptoms. It is important to promptly report any signs of infection to your healthcare provider.
• Blood disorders: Gazyva can affect blood cell counts. It may lead to low levels of red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia). This can increase the risk of bleeding, bruising, and infections. Blood tests will be regularly performed to monitor these parameters.
• Hypersensitivity reactions: Some individuals may experience allergic reactions to Gazyva. Symptoms may include rash, itching, swelling, dizziness, and difficulty breathing. Seek immediate medical attention if you experience any signs of a severe allergic reaction.
• Tumor lysis syndrome: In rare cases, Gazyva can cause a condition known as tumor lysis syndrome. This occurs when cancer cells break down rapidly, releasing their contents into the bloodstream. It can lead to electrolyte imbalances and kidney problems. Your healthcare provider will closely monitor you and take measures to prevent or manage this condition.
• Other common side effects: Other common side effects may include fatigue, muscle and joint pain, diarrhea, constipation, headache, cough, and decreased appetite.

It’s important to communicate any side effects or concerns to your healthcare provider promptly. They can provide appropriate guidance, offer supportive care measures, and adjust the treatment plan if needed to minimize side effects and optimize your treatment experience.

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

When it comes to storage and disposal of Gazyva (obinutuzumab), here are some important points to consider:

• Storage: Gazyva is typically stored in a healthcare setting such as a hospital or clinic. It is usually provided in single-use vials and should be stored according to the specific storage instructions provided by the healthcare facility.
• Disposal: Since Gazyva is administered by healthcare professionals, they will handle the proper disposal of any unused or expired medication and materials associated with the treatment. It is important not to dispose of Gazyva or any medical waste at home. Follow the guidelines and protocols established by your healthcare provider or facility for safe disposal.

In case of emergency/overdose

In case of an emergency or overdose situation, it is important to seek immediate medical attention or contact emergency services (such as calling the emergency hotline in your country). Emergency symptoms or situations can include severe allergic reactions, difficulty breathing, chest pain, or any other severe adverse reactions.

To be prepared for emergencies, make sure to keep a list of emergency contact numbers easily accessible. You may also consider informing your close contacts, such as family members or caregivers, about your treatment and what to do in case of an emergency.

What other information should I know?

• Regular Monitoring: Your healthcare provider will regularly monitor your condition, perform blood tests, and conduct other necessary assessments to evaluate the effectiveness of the treatment and manage any side effects.
• Interactions: Inform your healthcare provider about all medications, supplements, or herbal products you are taking, as some medications may interact with Gazyva and affect its effectiveness or increase the risk of side effects.
• Follow-up Care: Attend all scheduled appointments with your healthcare provider and follow their instructions regarding ongoing care, including potential follow-up treatments or surveillance.
• Supportive Care: Your healthcare provider may recommend supportive care measures to help manage side effects and promote your well-being during treatment. This may include medications, lifestyle modifications, or other interventions.

Remember to consult your healthcare provider for comprehensive and personalized information about Gazyva, including storage, disposal, emergency procedures, and any other specific instructions or precautions relevant to your individual circumstances.