WARNING

Taking Zydelig (idelalisib) is associated with certain risks, and it’s important for individuals considering or using this medication to be aware of these potential risks. Some key risks of taking Zydelig include:

• Infections: Zydelig can increase the risk of serious and potentially fatal infections. Patients should be monitored for signs of infection, and any infections should be treated promptly.
• Hepatitis B Virus (HBV) Reactivation: Individuals with a history of HBV may experience reactivation of the virus during Zydelig treatment. Screening for HBV and appropriate monitoring are essential.
• Diarrhea and Colitis: Zydelig commonly causes diarrhea, and severe cases of colitis (inflammation of the colon) have been reported. Patients should report persistent or severe gastrointestinal symptoms.
• Pneumonitis: Inflammation of the lungs (pneumonitis) is a serious potential side effect. Any new or worsening respiratory symptoms should be evaluated promptly.
• Hepatic Toxicity: Zydelig may cause liver enzyme elevations, and regular monitoring of liver function is necessary. Dose adjustments may be required if hepatic toxicity occurs.
• Renal Toxicity: Zydelig may cause kidney problems, and regular monitoring of renal function is recommended.
• Hypertension: Blood pressure should be monitored during treatment, and antihypertensive therapy may be required.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and serious brain infection, has been reported with Zydelig. Patients should be monitored for any new or worsening neurological symptoms.

It’s important for individuals to discuss these risks with their healthcare provider before starting Zydelig. Additionally, close communication with the healthcare team during treatment is crucial for the early detection and management of any potential complications. The decision to use Zydelig is typically made based on an assessment of the potential benefits and risks in the context of the individual’s specific medical condition. If you have concerns or experience any unusual symptoms while taking Zydelig, it’s important to seek prompt medical attention.

Why is this medication prescribed?

Zydelig (idelalisib) is a prescription medication used to treat certain types of blood cancers. Specifically, it is indicated for the treatment of:

• Chronic Lymphocytic Leukemia (CLL): Zydelig is used in combination with rituximab in patients with relapsed CLL.
• Follicular B-Cell Non-Hodgkin Lymphoma (FL): Zydelig is used as a monotherapy for patients with relapsed FL that is refractory to at least two prior systemic therapies.
• Small Lymphocytic Lymphoma (SLL): Zydelig is also indicated for the treatment of relapsed SLL in combination with rituximab.

Zydelig works by inhibiting a specific enzyme called phosphoinositide 3-kinase (PI3K), which plays a role in the growth and survival of certain cancer cells.

How should this medicine be used?

Zydelig is available in oral tablet form, and the dosage and administration can vary based on the specific type of cancer being treated. It is important to follow the prescribing doctor’s instructions and the medication guide provided with the drug. Here are some general guidelines:

• Dosage: The recommended dosage may differ depending on the specific condition being treated. The prescribing healthcare provider will determine the appropriate dose for the individual patient.
• Administration: Zydelig is typically taken orally with food. The tablets should be swallowed whole and not crushed, broken, or chewed.
• Frequency: The dosing frequency can vary, and it is important to take Zydelig exactly as prescribed by the doctor. Do not skip doses or alter the dosage without consulting the healthcare provider.
• Monitoring: Patients taking Zydelig may require regular monitoring, including blood tests, to assess the response to treatment and monitor for potential side effects.
• Adverse Reactions: It’s important to be aware of potential side effects and report any unusual or severe symptoms to the healthcare provider promptly.
• Special Instructions: Patients should inform their healthcare provider of any other medications, supplements, or herbal products they are taking, as Zydelig may interact with other drugs.

As with any prescription medication, the use of Zydelig should be closely supervised by a healthcare professional to ensure its safety and efficacy for the specific patient. Always consult with a healthcare provider for personalized medical advice and guidance.

Other uses for this medicine

The primary approved uses for Zydelig (idelalisib) were in the treatment of Chronic Lymphocytic Leukemia (CLL), Follicular B-Cell Non-Hodgkin Lymphoma (FL), and Small Lymphocytic Lymphoma (SLL). It’s important to note that new uses or indications for medications can emerge over time, so it’s advisable to consult the most recent medical literature or a healthcare professional for the latest information.

What special precautions should I follow?

Special Precautions for Zydelig:

• Infections: Zydelig can increase the risk of serious and potentially fatal infections. Before starting treatment, patients should be screened for infections, and any existing infections should be treated prior to initiating Zydelig. During treatment, patients should be monitored for signs of infection, and appropriate measures should be taken to manage infections.
• Hepatitis B Virus Reactivation: Hepatitis B virus (HBV) reactivation can occur in patients with a history of HBV infection during treatment with Zydelig. Patients should be screened for HBV before starting treatment. Monitoring for signs of HBV reactivation is crucial, and antiviral therapy may be necessary.
• Diarrhea/Colitis: Zydelig has been associated with severe diarrhea and colitis (inflammation of the colon). Patients should be monitored for the development of diarrhea, and appropriate management, including interruption or discontinuation of Zydelig, may be necessary.
• Pneumonitis: Pneumonitis (inflammation of the lungs) has been reported with Zydelig. Patients experiencing new or worsening respiratory symptoms should be evaluated promptly.
• Hepatic Toxicity: Zydelig may cause liver enzyme elevations. Liver function should be monitored, and dose adjustments may be necessary if hepatic toxicity occurs.
• Renal Toxicity: Zydelig may cause kidney problems. Monitoring of renal function is recommended, and dose adjustments may be needed in patients with renal impairment.
• Hypertension: Blood pressure should be monitored during treatment, and antihypertensive therapy may be required.
• Risk of Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and serious brain infection, has been reported with Zydelig. Patients should be monitored for any new or worsening neurological symptoms.

It’s important for patients to communicate openly with their healthcare providers about their medical history and any existing conditions before starting Zydelig. Additionally, regular follow-up visits and monitoring are essential to detect and manage any potential side effects. Patients should not modify their dosage or discontinue Zydelig without consulting their healthcare provider.

Please note that the information provided here is based on the knowledge, and there may have been developments or changes since then. Always consult with a healthcare professional for the most current and personalized medical advice.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Zydelig. However, taking Zydelig with food may help reduce the risk of gastrointestinal side effects such as diarrhea. Follow your healthcare provider’s advice regarding the timing of Zydelig in relation to meals.

What should I do if I forget a dose?

If you forget to take a dose of Zydelig, take it as soon as you remember on the same day. If it is already the next day, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed one. If you are unsure about what to do, contact your healthcare provider for guidance.

What side effects can this medication cause?

Zydelig (idelalisib) can cause a range of side effects, and it’s important for patients to be aware of them and promptly report any unusual or severe symptoms to their healthcare provider. The most common side effects associated with Zydelig include:

• Diarrhea: Diarrhea is a frequent side effect of Zydelig. It’s important to stay well-hydrated, and your healthcare provider may prescribe medications to manage diarrhea.
• Pyrexia (Fever): Elevated body temperature may occur.
• Fatigue: Some patients may experience fatigue or weakness.
• Nausea: Zydelig can cause nausea. If it is persistent or severe, notify your healthcare provider.
• Cough: Coughing may occur as a side effect.
• Pneumonitis: Inflammation of the lungs (pneumonitis) is a serious potential side effect. If you experience new or worsening respiratory symptoms, such as difficulty breathing or persistent cough, seek medical attention.
• Rash: Skin rash is another reported side effect. Inform your healthcare provider if you develop a rash.
• Abdominal Pain: Some individuals may experience abdominal pain.
• Increased Liver Enzymes: Zydelig can cause elevated liver enzymes. Regular monitoring is necessary, and your healthcare provider will assess the need for dose adjustments.
• Neutropenia: A decrease in the number of neutrophils (a type of white blood cell) may occur.
• Elevated Blood Pressure: Some patients may experience increased blood pressure.
• Colitis: Inflammation of the colon (colitis) has been reported. Severe cases may require discontinuation of Zydelig.
• Infections: Zydelig can increase the risk of infections. Contact your healthcare provider if you develop signs of infection, such as fever, chills, or persistent cough.
• Hepatitis B Virus (HBV) Reactivation: In patients with a history of HBV, reactivation can occur. Monitoring and, if necessary, antiviral therapy are important.
• Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and serious brain infection, has been reported with Zydelig. Notify your healthcare provider if you experience neurological symptoms such as confusion, difficulty speaking, or changes in vision.

It’s important to note that the above list is not exhaustive, and individuals may experience side effects to varying degrees. Always communicate openly with your healthcare provider about any symptoms or concerns you may have during Zydelig treatment. They can provide guidance on managing side effects and may adjust your treatment plan if necessary. Additionally, individual responses to medications can vary, and your healthcare provider will consider your overall health and medical history when prescribing Zydelig.

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

Storage and disposal information for Zydelig:

Storage:

• Temperature: Store Zydelig at room temperature between 68°F to 77°F (20°C to 25°C). Keep it in its original container to protect it from light and moisture.
• Container: Keep Zydelig in its original packaging to protect it from light. Ensure that the container is tightly closed when not in use.
• Location: Store Zydelig in a safe and secure place, out of reach of children and pets.

Disposal:

• Follow Instructions: Dispose of Zydelig according to the specific instructions provided by your healthcare provider or pharmacist.
• Community Programs: Check for local take-back programs or community disposal options for unused medications.
• FDA Guidelines: Follow any disposal guidelines provided by the U.S. Food and Drug Administration (FDA) or your country’s regulatory agency.

In case of emergency/overdose

In the case of a suspected overdose or emergency, contact your local emergency services (such as 911 in the United States) or go to the nearest emergency room immediately. Overdose symptoms may include severe diarrhea, abdominal pain, respiratory distress, or other severe adverse reactions. It is important to seek medical attention promptly.

What other information should I know?

• Follow-up Appointments: Attend all scheduled follow-up appointments with your healthcare provider to monitor your response to Zydelig and manage any potential side effects.
• Lab Tests: Regular blood tests and other laboratory monitoring may be required during Zydelig treatment. Follow your healthcare provider’s recommendations for monitoring.
• Medical Alerts: Wear a medical alert bracelet or carry a medical alert card to inform healthcare providers about your Zydelig treatment in case of emergencies.
• Inform Healthcare Providers: Inform all healthcare providers, including dentists and emergency medical personnel, about your use of Zydelig.
• Other Medications: Inform your healthcare provider of all other medications, supplements, or herbal products you are taking, as Zydelig may interact with other drugs.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The use of Zydelig during pregnancy or breastfeeding should be discussed with your healthcare provider.

This information is intended to provide general guidance, and specific recommendations may vary. Always follow the instructions provided by your healthcare provider and pharmacist. If you have questions or concerns, consult with your healthcare professional for personalized advice.