Everolimus - TheGIConnection

Class: Chemotherapy

Generic Name: Everolimus (ever-OH-li-mus)
Trade Name: Afinitor®

How is this drug used? Everolimus is FDA-approved for the treatment of advanced renal cell carcinoma (kidney cancer) among patients whose cancer has recurred or progressed following treatment with either Sutent® (sunitinib) or Nexavar® (sorafenib). It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Everolimus belongs to a group of drugs referred to kinase inhibitors. Everolimus inhibits the serine-threonine kinase referred to as the mammalian target of rapamycin (mTOR). MTOR is involved in cellular replication, growth, and metabolism. Inhibition of mTOR with everolimus has demonstrated a reduction in the replication and spread of cancer cells.

How is everolimus given (administered)? Everolimus is given orally in the form of a 5 or 10 mg tablet. The daily dose depends on several factors, including side effects incurred from treatment, the overall health of the patient and other treatment being used. Everolimus may be taken with or without food.
Allergic-type reactions, although rare, may occur following treatment with everolimus. These reactions are characterized by difficulty breathing, low blood pressure, lightheadedness or dizziness. Patients will be monitored for these reactions.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with everolimus. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the liver or kidneys. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the common (occur in 30% or more of patients) side effects of treatment with everolimus?

Ulcers or sores of the mouth or throat
Increased levels of cholesterol and triglycerides
Increased levels of blood glucose
Changes in liver function tests

What are the less common (occur in 10% to 29% of patients) side effects of treatment with everolimus?

Infection
Rash
Anorexia
Headache
Fever
Nose bleeds
Lack of energy
Inflammation of the lining of the lungs
Fluid retention
Diarrhea
Low levels of white blood cells – increases risk of infection
Low levels of red blood cells – increases risk of anemia
Low levels of platelets – increases risk of bleeding

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Pay careful attention to the physician’s instructions and inform the physician of any side effects.
Maintain adequate rest and nutrition.
If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
Wash hands often to reduce the risk of infection.
Eat small, frequent meals in an attempt to relieve nausea.

Are there any special precautions patients should be aware of before starting treatment?

Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future since some drugs may cause fertility problems.
It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
Patients should check with their physician before starting any new drug or nutritional supplement.
Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

Fever
Pain, redness or ulcers of the mouth or throat
Chills
Cough
Flu or cold-like symptoms
Excessive or prolonged fatigue or weakness
Yellowing of skin or eyes
Difficulty in breathing
Excessive or prolonged nausea or vomiting
Severe or prolonged diarrhea
Severe pain
Severe or prolonged nosebleeds or excessive bleeding
Excessive fluid retention

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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Tags: Chemotherapy, E