Afinitor Information and Uses

Afinitor

Afinitor Overview

Afinitor (generic: everolimus) is a prescription medication used to treat certain types of cancer in the pancreas, kidney, brain, and breast. Afinitor belongs to a group of drugs called kinase inhibitors. It works by stopping cancer cells from reproducing and by decreasing blood supply to cancer cells.

Afinitor comes in tablet form and as a tablet to dissolve in water (Afinitor Disperz). It is usually taken once at the same time every day, with or without food.

Common side effects of Afinitor include mouth ulcers, nausea, vomiting, diarrhea, and headache.

Uses of Afinitor

Afinitor is a prescription medicine used to treat:

postmenopausal women with a type of breast cancer known as advanced hormone receptor-positive, HER2-negative breast cancer, along with Aromasin (exemestane) after treatment with other medication has not worked.
adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and can not be treated with surgery.
adults with a type of advanced kidney cancer known as renal cell carcinoma (RCC) when treatment with other medications has not worked.
people with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):

adults with a type of kidney tumor called renal angiomyolipoma, when the tumor does not need surgery right away.
adults and children with a type of brain tumor called subependymal giant cell astrocytoma (SEGA), when the tumor cannot be removed with surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Afinitor

Afinitor can cause serious side effects.

See “Drug Precautions”.

Common side effects of Afinitor in people with advanced pancreatic neuroendocrine tumors and patients with advanced kidney cancer include:

Mouth ulcers. Afinitor can cause mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.
Feeling weak or tired
Cough, shortness of breath
Diarrhea
Rash, dry skin, and itching
Nausea and vomiting
Fever
Loss of appetite
Swelling of arms, hands, feet, ankles, face or other parts of the body
Abnormal taste
Inflammation of lining of the digestive system
Headache
Nose bleeds
Pain in arms and legs

Common side effects of Afinitor in people who have angiomyolipoma with TSC include:

Mouth ulcers. Afinitor can cause mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.
Acne or eczema
Nausea and vomiting
Headache
Cough
Diarrhea
Joint pain
Swelling of your hands, arms, legs, and feet
Stomach-area (abdomen) pain
Respiratory tract infection
Increased blood cholesterol level and certain other blood tests
Decreased blood phosphate level
Low red blood cells and white blood cells
Increased blood sugar levels
Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your doctor if this happens.

Common side effects of Afinitor in people with SEGA include:

Infections of the respiratory tract, sinuses and ears
Mouth ulcers. Afinitor can cause mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.
Diarrhea and constipation
Vomiting
Stomach pain
Fever
Seizure
Headache
Dizziness
Skin problems (such as rash, acne, dry skin, or scratching of the skin)
Cough
Stuffy or runny nose
Change in personality
Low white blood cells (a type of blood cell that fights infection; your doctor will periodically check you for this problem)
High levels of fats in the blood (raised triglycerides)

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Afinitor. For more information, ask your doctor or pharmacist.

Afinitor Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

St. John’s Wort (Hypericum perforatum)
Medicine for:
      ○  Fungal infections
      ○  Bacterial infections
      ○  Tuberculosis
      ○  Seizures
      ○  HIV-AIDS
      ○  Heart conditions or high blood pressure
Medicines that suppress your immune system

This is not a complete list of Afinitor drug interactions. Ask your doctor or pharmacist for more information.

Afinitor Precautions

Afinitor can cause serious side effects. These serious side effects include:

1.  You may develop lung or breathing problems that may be severe, and can even lead to death. Tell your doctor right away if you have any of these symptoms:
      •   New or worsening cough
      •   Shortness of breath
      •   Chest pain
      •   Difficulty breathing or wheezing

2. You may be at an increased risk of developing an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people these infections may be severe, and can even lead to death. You may need to be treated as soon as possible.

Tell your doctor right away if you have a temperature of 100.5˚F or above, chills, or do not feel well.

Symptoms of hepatitis B or infection may include the following:

Fever
Skin rash
Joint pain and inflammation
Tiredness
Loss of appetite
Nausea
Pale stool or dark urine
Yellowing of the skin
Pain in your upper right side

3. You may develop kidney failure which may be severe and can even lead to death. Your doctor will likely do tests to check your kidney function before and during your treatment with Afinitor.

If you have any of the serious side effects listed above, you may need to stop taking Afinitor for a while or use a lower dose. Follow your doctor’s instructions.

Do not take Afinitor if you are allergic to Afinitor or to any of its ingredients. Talk to your doctor before taking this medicine if you are allergic to:

sirolimus (Rapamune)
temsirolimus (Torisel)

Afinitor Food Interactions

You should not drink grapefruit juice or eat grapefruit during your treatment with Afinitor. It may make the amount of Afinitor in your blood increase to a harmful level.

Inform MD

Before taking Afinitor, tell your healthcare provider about all of your medical conditions, including if you:

Have or have had kidney problems
Have or have had liver problems
Have diabetes or high blood sugar
Have high blood cholesterol levels
Have any infections
Previously had hepatitis B
Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with Afinitor. If you are not sure about the type of immunization or vaccine, ask your healthcare provider.

Tell your doctor if you are pregnant or breastfeeding.

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Afinitor and Pregnancy

Tell your doctor if you are pregnant, or could become pregnant. It is not known if Afinitor will harm your unborn baby. You should use effective birth control while using Afinitor and for 8 weeks after stopping treatment.

Afinitor and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Afinitor passes into your breast milk. You and your healthcare provider should decide if you will take Afinitor or breastfeed. You should not do both.

Afinitor Usage

Your healthcare provider will prescribe the dose of Afinitor that is right for you.
Take Afinitor exactly as your healthcare provider tells you. Your healthcare provider may change your dose of Afinitor if needed.
Swallow Afinitor tablets whole with a glass of water.
If you cannot swallow Afinitor tablets whole, you can stir them into a glass of water:
- Put the prescribed number of tablets into a glass that contains about 2 Tablespoons (30 mL) of water
- Gently stir the contents until the tablets break apart and then drink the mixture right away
- Add about 2 Tablespoons (30 mL) of water to the glass and drink all of the water. This will help to make sure that you get the full dose of Afinitor.
Take Afinitor one time every day, at about the same time every day.
Take Afinitor the same way each time, either with food or without food.
You may use scissors to open the blister to avoid spillage.
If you take too much Afinitor contact your healthcare provider or go to the nearest hospital emergency department right away. Take the pack of Afinitor with you.
If you miss a dose of Afinitor, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your Afinitor, skip the dose for that day. The next day, take Afinitor at your usual time. Do not take 2 doses to make up for the one that you missed. If you are not sure about what to do, call your healthcare provider.
You should have regular blood tests before you start Afinitor and as needed during your treatment. These will include tests to check your blood cell count, kidney and liver function, cholesterol, and blood sugar levels.
If you take Afinitor to treat SEGA, you will need to have regular blood tests to measure how much Afinitor is in your blood. This will help your healthcare provider decide how much Afinitor you need to take.

Afinitor Dosage

Take Afinitor exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose of Afinitor is highly individualized based on several factors including: