Indications 

Afinitor is a prescription medication indicated for treating advanced renal cell carcinoma (RCC) in patients who have not responded to prior treatment with sunitinib or sorafenib. 

Afinitor is also prescribed for treating subependymal giant cell astrocytoma (SEGA) in patients with tuberous sclerosis (TS) who need medical treatment but cannot undergo curative surgical resection. 

Classified as a kinase inhibitor, Afinitor disrupts the growth of cancer cells, thereby impeding their spread throughout the body. 

Uses and Dosage 

Before taking Afinitor, and with each prescription refill, carefully read its medication guide and patient information leaflet. For any questions or clarifications, consult your doctor or pharmacist without hesitation. 

Afinitor’s dosage is individualized based on the patient’s medical condition, treatment response, lab results, and concomitant medications. 

Afinitor should be taken orally once daily at a fixed time, either with or without food, in a consistent manner. Tablets must be ingested whole with a glass of water and should not be crushed or chewed. 

Afinitor tablets are packed in individual blister packs that should be opened with scissors only when ready to be taken. Crushed or broken tablets should not be ingested. 

For patients unable to swallow Afinitor tablets:  

1. Get a glass of water containing around 30 mL. 
2. Put the tablet into the water. 
3. Stir the water gently until the tablet is completely dispersed. 
4. Drink the mixture immediately. 
5. Rinse the glass with the same amount of water. 
6. Drink the rinse to ensure the entire dose is taken. 

Follow your doctor’s instructions precisely when taking Afinitor, and do not take more or less of it or take it more frequently than prescribed. 

Side Effects 

Listed below are the side effects associated with the use of Afinitor. Inform your doctor promptly if any of them persist or worsen. 

Common Side Effects 

• Fever 
• Cough 
• Infections 
• Weakness or fatigue 
• Mouth sores 
• Nausea  
• loss of appetite 
• Swelling in any part of the body 
• Rash 
• Missed menstrual periods 
• Headache 
• Signs of high blood sugar: 
  • Increased thirst or urination 
  • Dry mouth 
  • Fruity breath odor 
• Hair loss may occur temporarily, but hair growth is expected to return once treatment is completed 

 Serious Side Effects 

• Blisters or ulcers in the mouth 
• Red or swollen gums 
• Trouble swallowing 
• Indication of lung problems:  
  • New or worsening cough 
  • Chest pain 
  • Wheezing 
  • Feeling short of breath 
• Signs of infection: 
  • Fever 
  • Chills 
  • Tiredness 
  • Joint pain 
  • Skin rash 
• Signs of kidney problems:  
  • Little or no urination 
  • Swelling in feet or ankles 
• Signs of Liver problems: 
  • Nausea 
  • loss of appetite 
  • Stomach pain (upper right side) 
  • Dark urine 
  • Clay-colored stools 
  • Jaundice (yellowing of the skin or eyes) 
• Indication of low blood cell counts: 
  • Flu-like symptoms 
  • Skin sores 
  • Easy bruising 
  • Unusual bleeding 
  • Pale skin 
  • Cold hands and feet 
  • Feeling light-headed 
• Any wound that will not heal 
• A surgical cut that exhibits redness, warmth, swelling, pain, bleeding, or discharge of pus. 

If you experience any of the severe symptoms listed above, contact your doctor immediately, as they may tell you to delay or permanently discontinue your cancer treatment. 

Allergic Reactions 

Afinitor rarely causes severe allergic reactions. However, seek emergency medical help if you experience the following signs of an allergic reaction: 

• Hives 
• Chest pain 
• Difficult breathing 
• Swelling of your throat, face, lips, or tongue 

These symptoms may be more likely to occur if you are taking an ACE inhibitor medication for your heart or blood pressure. 

This list does not contain all the potential side effects of Afinitor. Notify your doctor promptly if you experience any unlisted effects. 

Cautions 

Before taking Afinitor, tell your doctor or pharmacist if you have any known allergies, especially to: 

• Everolimus 
• Sirolimus 
• Temsirolimus 
• Any medications 
• Any ingredients present in Afinitor tablets 

To ensure Afinitor is safe for you, disclose to your physician your medical background, specifically regarding any history of: 

• Liver disease 
• Any recent or current infections 
• Diabetes 
• High cholesterol or triglyceride levels 
• Radiation treatment 

Some products that may interact with Afinitor include:  

• Natalizumab 
• Rituximab 
• Lisinopril 
• Captopril 

To minimize the possibility of drug interactions, inform your healthcare provider about all the medications you are presently taking, including prescription and non-prescription medicines, as well as dietary supplements and herbal products. 

Certain medications may affect the elimination and efficacy of Afinitor. Examples of such medications are:  

• Azole antifungals (e.g., itraconazole, ketoconazole) 
• Cobicistat 
• Macrolide antibiotics (e.g., clarithromycin, erythromycin) 
• Nefazodone 
• HIV protease inhibitors (e.g., atazanavir, indinavir) 
• Ritonavir 
• St. John’s wort 
• Telithromycin 
• Others 

Avoid receiving or coming into contact with anyone who has received a “live” vaccine while using Afinitor. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles), as there is a risk of virus transmission. 

Refrain from using mouthwashes or medications that contain alcohol, peroxide, iodine, or thyme if you have mouth sores or ulcers. For severe cases, your doctor may prescribe a steroid mouthwash. 

Before undergoing any surgery, inform your doctor that you are taking Afinitor. It may be necessary to stop taking this medication at least one week before the surgery due to the possibility of slower wound healing. Follow your doctor’s instructions regarding when to stop or resume taking this medication. 

Afinitor can be absorbed through the skin and lungs. Pregnant women or those who may become pregnant should not handle this medication or inhale dust from the tablets to avoid harm to an unborn baby. 

Inform your doctor if you are pregnant or planning to conceive while taking Afinitor, as it may harm the fetus. 

Afinitor may impact fertility in men and women. However, effective birth control is still necessary to avoid pregnancy. 

Women who are able to become pregnant must use effective birth control during Afinitor treatment and for 8 weeks after the final dose. Men with female partners who could become pregnant must use effective birth control during Afinitor treatment and for 4 weeks after the final dose. 

Breastfeeding is not recommended while taking Afinitor and for 2 weeks after stopping treatment due to the unknown risk of everolimus passing into breast milk. Consult your doctor before nursing an infant.