WARNING

Taking Afinitor (everolimus) carries several risks that are important to be aware of:

• Infections: Afinitor suppresses the immune system, increasing the risk of bacterial, viral, and fungal infections. Patients may experience symptoms like fever, chills, or sore throat and should seek prompt medical attention if these occur.
• Liver Problems: Afinitor can affect liver function, potentially leading to liver damage. Symptoms of liver issues include jaundice (yellowing of the skin or eyes), dark urine, and abdominal pain. Regular liver function tests are required to monitor for these effects.
• Kidney Issues: The medication may impair kidney function. Symptoms to watch for include decreased urine output, swelling in the legs or ankles, and sudden weight gain. Kidney function should be monitored regularly.
• Blood Sugar Elevation: Afinitor can cause elevated blood sugar levels, which can be problematic for patients with diabetes or those at risk of diabetes. Monitoring blood glucose levels is important, and adjustments to diabetes management may be needed.
• Gastrointestinal Problems: Common side effects include nausea, vomiting, diarrhea, and mouth ulcers. These can be bothersome and may require symptomatic treatment.
• Allergic Reactions: Severe allergic reactions, such as rash, itching, swelling, or difficulty breathing, can occur. Immediate medical attention is required for these symptoms.
• Respiratory Issues: Some patients may experience difficulty breathing or other respiratory problems. It’s important to report any new or worsening respiratory symptoms to a healthcare provider.
• Bleeding and Bruising: Afinitor can affect blood clotting, leading to unusual bleeding or bruising. Any signs of bleeding, such as easy bruising, prolonged bleeding from cuts, or blood in urine or stool, should be reported immediately.

Regular monitoring and consultation with a healthcare provider can help manage these risks and ensure the medication is used safely.

Why is this medication prescribed?

Afinitor (everolimus) is prescribed for several conditions, primarily in the context of cancer and certain other diseases. It’s used to:

• Treat Certain Cancers: It can be prescribed for advanced or metastatic breast cancer, neuroendocrine tumors, and kidney cancer. It works by inhibiting mTOR (mammalian target of rapamycin), a protein that helps regulate cell growth and division.
• Manage Renal Transplant: Afinitor is used to prevent organ rejection in kidney transplant patients, helping to suppress the immune system.
• Treat Tuberous Sclerosis Complex (TSC): In patients with TSC, Afinitor can help manage symptoms like renal angiomyolipomas (tumors in the kidneys) and subependymal giant cell astrocytomas (a type of brain tumor).
• Control Other Tumors: It may be used for other specific types of tumors based on individual patient needs and the condition’s response to treatment.

The medication is typically used when other treatments haven’t been effective or aren’t suitable.

How should this medicine be used?

Afinitor (everolimus) should be used exactly as prescribed by your healthcare provider. Here are some general guidelines for its use:

• Dosage and Administration: Afinitor is taken by mouth, usually in the form of tablets. The tablets should be swallowed whole with a glass of water. They should not be crushed, chewed, or broken.
• Timing: It’s important to take Afinitor at the same time each day to help maintain a consistent level of the medication in your body.
• With or Without Food: Afinitor can be taken with or without food. However, it’s best to avoid high-fat meals, as they can affect the absorption of the medication.
• Dosage Adjustments: Your dosage may be adjusted based on your response to the medication, side effects, and other factors. Your healthcare provider will monitor you regularly and make adjustments as needed.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it’s almost time for your next dose. In that case, skip the missed dose and continue with your regular schedule. Do not double up on doses.
• Monitoring: Regular blood tests and monitoring by your healthcare provider are important to check for side effects and ensure the medication is working effectively.
• Interactions and Precautions: Inform your healthcare provider of all other medications you are taking, including over-the-counter drugs and supplements, as they can interact with Afinitor.

Always follow your healthcare provider’s instructions and consult them if you have any questions or concerns about how to take Afinitor.

Other uses for this medicine

In addition to its primary uses for cancer and transplant management, Afinitor (everolimus) may be prescribed for other conditions based on individual patient needs and responses. For example, it can be used to manage specific symptoms of tuberous sclerosis complex (TSC), such as subependymal giant cell astrocytomas (SEGA) or renal angiomyolipomas.

What special precautions should I follow?

Special Precautions for Afinitor:

• Allergic Reactions: Inform your doctor if you have any history of allergies or unusual reactions to Afinitor or similar medications.
• Infections: Afinitor can suppress the immune system, increasing the risk of infections. Report any signs of infection, such as fever, sore throat, or persistent cough.
• Liver Function: Since Afinitor is metabolized by the liver, liver function tests are necessary to ensure that your liver is working properly. Tell your doctor if you have liver disease.
• Kidney Function: Regular monitoring of kidney function is important, especially if you have pre-existing kidney issues.
• Drug Interactions: Inform your healthcare provider of all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, as Afinitor can interact with various drugs.
• Blood Sugar Levels: Afinitor may affect blood sugar levels. If you have diabetes or other blood sugar issues, monitor your blood sugar levels closely and inform your doctor of any changes.
• Pregnancy and Breastfeeding: Afinitor can harm an unborn baby, so it’s important to avoid pregnancy while taking this medication. Use effective contraception and inform your doctor if you become pregnant. Avoid breastfeeding while on Afinitor, as it can pass into breast milk and potentially harm a nursing infant.
• Side Effects: Be aware of potential side effects, including mouth ulcers, nausea, diarrhea, and rash. Report severe or persistent side effects to your healthcare provider.
• Vaccinations: Avoid live vaccines while taking Afinitor, as the medication can weaken the immune response.

Always follow your healthcare provider’s advice and consult them with any concerns or questions regarding the use of Afinitor and its precautions.

What special dietary instructions should I follow?

• Food Interactions: Afinitor can be taken with or without food, but it’s advisable to avoid high-fat meals. High-fat foods can affect the absorption of the medication.
• Hydration: Drink plenty of fluids to help prevent dehydration, especially if you experience side effects like diarrhea.
• Grapefruit: Avoid grapefruit and grapefruit juice, as they can interact with Afinitor and affect its effectiveness.

What should I do if I forget a dose?

• Timing: If you miss a dose, take it as soon as you remember unless it’s almost time for your next dose.
• Do Not Double Up: If it’s nearly time for your next dose, skip the missed dose. Do not take two doses at once to make up for the missed dose.
• Consult Your Healthcare Provider: If you’re unsure about what to do after missing a dose, contact your healthcare provider for specific instructions.

What side effects can this medication cause?

Afinitor (everolimus) can cause various side effects, ranging from mild to severe. Common and less severe side effects include:

• Mouth Ulcers: Painful sores or ulcers in the mouth.
• Nausea and Vomiting: Feeling sick to your stomach or vomiting.
• Diarrhea: Frequent, loose, or watery stools.
• Rash: Skin rash or itching.
• Fatigue: Feeling unusually tired or weak.
• Loss of Appetite: Decreased interest in eating.
• Headache: General pain or discomfort in the head.
• Fever: Elevated body temperature.
• Swelling: Edema or swelling of hands, feet, or other parts of the body.

Serious side effects that require immediate medical attention include:

• Infections: Symptoms such as fever, chills, or persistent sore throat could indicate an infection.
• Liver Problems: Yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right side of the abdomen.
• Kidney Problems: Decreased urine output, swelling of the ankles or legs, or weight gain.
• Severe Allergic Reactions: Difficulty breathing, swelling of the face or throat, severe rash, or itching.
• Bleeding or Bruising: Unusual bleeding or bruising, which could indicate a problem with blood clotting.
• Difficulty Breathing: Shortness of breath or other respiratory issues.
• Severe Gastrointestinal Issues: Persistent nausea, vomiting, or diarrhea that doesn’t improve.

It’s important to monitor for any side effects and discuss them with your healthcare provider, especially if they are severe or persistent. Your provider can offer guidance on managing side effects and determine if any adjustments to your treatment plan are necessary.

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

Storage and Disposal of Afinitor:

Storage:

• Temperature: Store Afinitor at room temperature, typically between 68°F to 77°F (20°C to 25°C). Avoid exposure to excessive heat, moisture, or direct sunlight.
• Container:Keep Afinitor in its original container with the lid tightly closed to protect it from moisture and light.
• Children and Pets: Store Afinitor out of reach of children and pets to prevent accidental ingestion.

Disposal:

• Expired or Unused Medication: Dispose of unused or expired Afinitor properly. Do not flush it down the toilet or pour it into a drain unless specifically instructed to do so.
• Drug Take-Back Programs: Utilize drug take-back programs or disposal sites in your community if available. Your pharmacist or local waste disposal authority can provide information on safe disposal options.
• Household Disposal: If no take-back programs are available, mix Afinitor with an undesirable substance (such as used coffee grounds or kitty litter) and place it in a sealed plastic bag or container before disposing of it in your household trash.

In case of emergency/overdose

• Contact Emergency Services: If you experience severe symptoms such as difficulty breathing, chest pain, or signs of a severe allergic reaction (swelling, rash, etc.), seek immediate medical attention or call emergency services.
• Poison Control: Contact your local poison control center for guidance if you suspect an overdose.
• Symptoms: Overdose symptoms may include severe nausea, vomiting, diarrhea, or unusual bleeding/bruising. Report these symptoms to your healthcare provider immediately.
• Medical Attention: Go to the nearest emergency room or contact your healthcare provider for urgent medical attention if an overdose is suspected.

What other information should I know?

• Regular Monitoring: Regular blood tests and follow-up visits with your healthcare provider are essential to monitor for side effects and ensure the medication is working as intended.
• Communication: Keep an open line of communication with your healthcare provider about any side effects, concerns, or changes in your health.
• Medication List: Maintain an updated list of all medications you are taking and share this information with all your healthcare providers to avoid potential drug interactions.
• Pregnancy and Breastfeeding: Avoid pregnancy and breastfeeding while on Afinitor. Discuss any plans for pregnancy or breastfeeding with your healthcare provider.

Always follow your healthcare provider’s instructions and consult them with any questions or concerns about Afinitor.