Afinitor

DRUG DESCRIPTION

AFINITOR (everolimus), an inhibitor of mTOR, is an antineoplastic agent.

The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20pentaone.

The molecular formula is C53H83NO14 and the molecular weight is 958.2. The structural formula is:

AFINITOR (everolimus) Structural Formula Illustration

AFINITOR is supplied as tablets for oral administration containing 2.5 mg, 5 mg, or 10 mg of everolimus together with butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, and lactose anhydrous as inactive ingredients.

What are the possible side effects of everolimus (Afinitor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath;
  • white patches or sores inside your mouth or on your lips; or
  • other signs of infection such as sore throat, flu symptoms, easy bruising or bleeding (nosebleeds,...

Read All Potential Side Effects and See Pictures of Afinitor

What are the precautions when taking everolimus tablets (Afinitor)?

Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, any recent/current infections, diabetes, high cholesterol/triglyceride levels.

Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult...

Read All Potential Precautions of Afinitor


Afinitor Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea/vomiting, decreased appetite, changes in taste, nosebleeds, dry skin, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol or peroxide, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling hands/ankles/feet, increased thirst/urination.

Tell your doctor immediately if this rare but very serious side effect occurs: change in the amount of urine.

Everolimus can lower the body's ability to fight an infection. It can also cause very serious (rarely fatal) lung problems. Tell your doctor immediately if you develop symptoms of infection or lung problems, including fever, chills, persistent sore throat, cough, shortness of breath, chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, any recent/current infections, diabetes, high cholesterol/triglyceride levels.

Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication and for 8 weeks after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Afinitor Patient Information Including Side Effects

Brand Names: Afinitor

Generic Name: everolimus (Pronunciation: E ver OH li mus)

  • What is everolimus (Afinitor)?
  • What are the possible side effects of everolimus (Afinitor)?
  • What is the most important information I should know about everolimus (Afinitor)?
  • What should I discuss with my health care provider before taking everolimus (Afinitor)?
  • How should I take everolimus (Afinitor)?
  • What happens if I miss a dose (Afinitor)?
  • What happens if I overdose (Afinitor)?
  • What should I avoid while taking everolimus (Afinitor)?
  • What other drugs will affect everolimus (Afinitor)?
  • Where can I get more information?

What is everolimus (Afinitor)?

Everolimus is used to treat advanced kidney cancer.

Everolimus is usually given after sorafenib (Nexavar) or sunitinib (Sutent) have been tried without successful treatment of symptoms.

Everolimus may also be used for other purposes not listed in this medication guide.

What are the possible side effects of everolimus (Afinitor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath;
  • white patches or sores inside your mouth or on your lips; or
  • other signs of infection such as sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.

Less serious side effects may include:

  • tired feeling;
  • headache;
  • stomach pain, diarrhea;
  • swelling, weight gain;
  • dry skin; or
  • sleep problems (insomnia);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about everolimus (Afinitor)?

You should not use this medication if you are allergic to everolimus or sirolimus (Rapamune).

Do not use everolimus without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before taking everolimus, tell your doctor if you have a breathing disorder, such as asthma or COPD, liver disease, diabetes, or high cholesterol.

Do not receive a "live" vaccine while you are being treated with everolimus, and avoid coming into contact with anyone who has recently received a live vaccine (including measles, mumps, rubella, oral polio, chickenpox, BCG, and nasal flu vaccine).

There are many other medicines that can interact with everolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have a serious side effect such as stabbing chest pain, feeling short of breath, fever, chills, cough, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.

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