WARNING

RAD001, also known as everolimus, is a medication that belongs to a class of drugs called mTOR inhibitors. It is used in the treatment of various conditions, including certain types of cancers and conditions that affect the immune system. Like any medication, RAD001 comes with potential risks and side effects. It’s important to note that individuals may react differently to medications, and not everyone will experience these side effects. Here are some potential risks associated with taking RAD001:

• Immunosuppression: RAD001 can suppress the immune system, increasing the risk of infections. Patients taking RAD001 should be closely monitored for signs of infection, and precautions should be taken to avoid exposure to contagious illnesses.
• Metabolic Effects: RAD001 can affect blood glucose levels and lipid profiles. Monitoring blood sugar and cholesterol levels is important, especially in individuals with pre-existing diabetes or lipid disorders.
• Gastrointestinal Issues: Common side effects include nausea, diarrhea, and stomatitis (inflammation of the mouth and lips). These symptoms can affect the patient’s quality of life and may require supportive care.
• Pulmonary Effects: Interstitial lung disease or pneumonitis has been reported in some patients taking RAD001. Patients experiencing symptoms such as cough, difficulty breathing, or chest pain should seek medical attention.
• Renal Toxicity: RAD001 may cause renal (kidney) impairment. Kidney function should be regularly monitored, and dosage adjustments may be necessary.
• Hematologic Effects: RAD001 can affect blood cell counts, leading to anemia, thrombocytopenia, and neutropenia. Regular blood tests are important to monitor for these effects.
• Wound Healing: RAD001 may impair wound healing. Patients scheduled for surgery should inform their healthcare providers, as the drug may need to be temporarily discontinued.
• Hormonal Effects: RAD001 may affect hormone levels, leading to conditions such as hyperglycemia and changes in reproductive hormones.

It’s crucial for individuals prescribed RAD001 to discuss the potential risks and benefits with their healthcare provider. Patients should also promptly report any unusual or severe side effects to their healthcare team. This information is a general overview, and specific risks can vary based on individual health, the condition being treated, and other factors. Always consult with a healthcare professional for personalized medical advice and guidance.

Why is this medication prescribed?

RAD001, also known as everolimus, is a medication that belongs to a class of drugs called mammalian target of rapamycin (mTOR) inhibitors. It is used for various medical conditions, primarily in the treatment of certain types of cancer and in the prevention of organ transplant rejection. Here are some specific uses:

• Cancer Treatment: Everolimus is often prescribed for the treatment of certain types of cancers, including advanced breast cancer, advanced kidney cancer, pancreatic neuroendocrine tumors, and certain types of brain tumors. It works by inhibiting the activity of mTOR, a protein that plays a role in the growth and division of cancer cells.
• Organ Transplantation: RAD001 is also used in transplant medicine to prevent the rejection of transplanted organs, such as kidneys. It helps to suppress the immune system, reducing the risk of the body attacking and rejecting the newly transplanted organ.

How should this medicine be used?

The use of RAD001 (everolimus) is specific to the medical condition being treated, and the dosage and administration should be determined by a healthcare professional. It’s crucial to follow the prescribed instructions provided by your doctor or healthcare team. The following are general guidelines for the use of RAD001, but these may vary based on individual circumstances:

• Dosage: The dosage of RAD001 can vary depending on the specific medical condition being treated. It is typically taken once daily. The exact dosage will be determined by your healthcare provider based on factors such as your weight, overall health, and the type of condition being treated.
• Administration: RAD001 is usually administered orally in the form of tablets. It can be taken with or without food. However, it’s essential to follow the specific instructions provided by your healthcare provider or pharmacist.
• Consistency: Take RAD001 consistently at the same time each day to maintain a steady level of the medication in your system.
• Swallowing Tablets: Swallow the RAD001 tablet whole with a glass of water. Do not crush, chew, or break the tablet unless directed otherwise by your healthcare provider.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
• Interactions: Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, and supplements. RAD001 can interact with other medications, and adjustments may be necessary.
• Monitoring: Your healthcare provider may monitor certain laboratory values, such as blood counts and kidney function, during the course of RAD001 treatment. Regular check-ups and blood tests may be scheduled to assess your response to the medication and detect any potential side effects.
• Side Effects: Be aware of potential side effects and report any unusual or severe symptoms to your healthcare provider promptly.

Always consult your healthcare provider or pharmacist if you have any questions or concerns about the use of RAD001. It’s important to adhere to the prescribed regimen and maintain open communication with your healthcare team throughout the course of treatment.

Other uses for this medicine

In addition to its primary uses in cancer treatment and immunosuppression, RAD001 (everolimus) has been investigated for its potential benefits in various other medical conditions. Clinical trials and research have explored its efficacy in conditions such as tuberous sclerosis complex, seizures associated with tuberous sclerosis complex, angiomyolipoma (a type of benign kidney tumor), and certain types of neurological disorders. However, the use of RAD001 for these conditions may not be as widely established or approved as its use in cancer and immunosuppression, and it is important to consult with a healthcare professional for the most up-to-date information.

What special precautions should I follow?

Regarding special precautions for the use of RAD001, it’s crucial to follow your healthcare provider’s guidance and adhere to the prescribed regimen. Here are some general precautions to be aware of:

• Pregnancy and Breastfeeding: RAD001 may harm the developing fetus, so it is important to inform your healthcare provider if you are pregnant or planning to become pregnant. Breastfeeding while taking RAD001 is not recommended, as it may pass into breast milk and could harm the nursing infant.
• Liver and Kidney Function: RAD001 is metabolized by the liver, so individuals with liver impairment may require dose adjustments. Your healthcare provider will assess your liver function and adjust the dosage accordingly. Kidney function should also be monitored, and dosage adjustments may be necessary in individuals with impaired kidney function.
• Infections: RAD001 may suppress the immune system, increasing the risk of infections. It is important to report any signs of infection, such as fever or persistent cough, to your healthcare provider promptly.
• Lipid Levels: RAD001 may increase cholesterol and triglyceride levels. Regular monitoring of lipid levels and appropriate management may be necessary.
• Lung Issues: Interstitial lung disease (ILD) has been reported in patients taking RAD001. Notify your healthcare provider if you experience new or worsening respiratory symptoms, such as cough or difficulty breathing.
• Blood Counts: Regular monitoring of blood counts, including white blood cell count and platelet count, may be conducted during treatment.
• Other Medications: Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, and supplements, as RAD001 may interact with other drugs.

It’s essential to attend all scheduled medical appointments, communicate openly with your healthcare team, and report any side effects or concerns promptly. Your healthcare provider will assess your individual health status and tailor the treatment plan to meet your specific needs while minimizing potential risks.

What special dietary instructions should I follow?

Special Dietary Instructions for RAD001:

• Food Intake: RAD001 can be taken with or without food. Follow your healthcare provider’s instructions regarding whether to take it with a meal or on an empty stomach.
• Grapefruit and Grapefruit Juice: Avoid consuming grapefruit or grapefruit juice while taking RAD001, as it may interact with the medication and affect its absorption.
• Dietary Changes for Lipid Levels: If RAD001 affects your lipid levels, your healthcare provider may recommend dietary changes. This could include a low-cholesterol and low-fat diet.

What should I do if I forget a dose?

If you forget to take a dose of RAD001, follow these general guidelines:

• Missed Dose: Take the missed dose as soon as you remember, unless it is almost time for your next scheduled dose.
• Double Dose: Do not take a double dose to make up for a missed one. If it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule.
• Consult Your Healthcare Provider: If you have questions or concerns about a missed dose, contact your healthcare provider for guidance.

What side effects can this medication cause?

RAD001 (everolimus) can cause a range of side effects, and their severity can vary from person to person. It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. If you are prescribed RAD001, your healthcare provider will monitor you for potential side effects and provide guidance on managing them. Common side effects of RAD001 include:

• Infections: RAD001 can suppress the immune system, increasing the risk of infections. Common signs of infection include fever, chills, and persistent cough.
• Mouth Sores: Some individuals may develop mouth sores or ulcers.
• Rash: Skin rash is a common side effect of RAD001. It’s important to inform your healthcare provider if you experience any rash.
• Diarrhea: RAD001 can cause diarrhea. Staying hydrated and notifying your healthcare provider if diarrhea is severe or persistent is important.
• Fatigue: Feeling tired or fatigued is a common side effect of RAD001.
• Anemia: A decrease in red blood cell count (anemia) can occur.
• Changes in Blood Glucose Levels: RAD001 may affect blood glucose levels. Individuals with diabetes should monitor their blood sugar levels closely.
• Increased Cholesterol and Triglyceride Levels: RAD001 can elevate cholesterol and triglyceride levels. Regular monitoring and management may be required.
• Lung Issues: Interstitial lung disease (ILD) has been reported in some patients. Notify your healthcare provider if you experience new or worsening respiratory symptoms, such as cough or difficulty breathing.
• Hypertension (High Blood Pressure): RAD001 may cause an increase in blood pressure.
• Stomatitis (Inflammation of the Mouth): In addition to mouth sores, stomatitis, or inflammation of the mouth, can occur.
• Nausea and Vomiting: Some individuals may experience nausea and vomiting.
• Peripheral Edema: Swelling of the extremities (peripheral edema) can occur.

It’s important to report any side effects or changes in your health to your healthcare provider promptly. Your healthcare team can provide guidance on managing side effects and may adjust your treatment plan if necessary. Additionally, the benefits of the medication in treating the underlying condition will be carefully weighed against the potential risks and side effects. If you have concerns about the side effects of RAD001, discuss them with your healthcare provider for personalized guidance.

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

Storage and Disposal of RAD001 (Everolimus):

• Storage:
  • Store RAD001 at room temperature, away from light and moisture.
  • Keep the medication in its original packaging and out of reach of children.
  • Do not store RAD001 in the bathroom, as the humidity may affect its stability.
• Disposal:
  • Follow specific disposal instructions provided by your healthcare provider, pharmacist, or local waste disposal regulations.
  • Do not flush RAD001 down the toilet or pour it down the drain unless instructed to do so.

In case of emergency/overdose

In case of an emergency or overdose, seek immediate medical attention or contact your local poison control center. Symptoms of an overdose may include severe dizziness, fainting, or difficulty breathing.

What other information should I know?

• Follow Healthcare Provider’s Instructions: Take RAD001 exactly as prescribed by your healthcare provider. Do not alter the dosage or stop taking the medication without consulting your healthcare team.
• Regular Monitoring: Your healthcare provider may conduct regular blood tests and monitor your overall health during RAD001 treatment. Attend all scheduled appointments.
• Drug Interactions: Inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medications, and supplements, as RAD001 may interact with other drugs.
• Avoid Grapefruit: Avoid consuming grapefruit or grapefruit juice while taking RAD001, as it may interact with the medication.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant or planning to become pregnant. RAD001 may harm the fetus. Breastfeeding is not recommended while taking RAD001.
• Notify Healthcare Provider: Report any new or unusual symptoms, side effects, or changes in your health to your healthcare provider promptly.
• Allergies: Inform your healthcare provider of any known allergies to medications or other substances.
• Medical Alert ID: Consider wearing a medical alert ID bracelet or necklace indicating that you are taking RAD001. In case of an emergency, this information can be crucial.

Always consult with your healthcare provider or pharmacist for specific guidance and information tailored to your individual health needs. They can provide detailed instructions on the safe use, storage, and disposal of RAD001 based on your medical history and condition.