Afinitor® - TheGIConnection

Class: Biological therapy

Generic Name: Everolimus (ever-OH-li-mus)

Trade Name: Afinitor®

How is this drug used? Afinitor 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); for the treatment of a benign brain tumor—subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis—in children and adults who require treatment but are not candidates for surgical removal of the tumor; for the treatment of progressive, locally advanced or metastatic, pancreatic neuroendocrine tumors (PNET) that cannot be surgically removed; for the treatment of renal angiomyolipoma (a benign kidney tumor) in people with tuberous sclerosis; and in combination with Aromasin® (exemestane) for the treatment of advanced, hormone receptor-positive, HER2-negative breast cancer in postmenopausal women who have already been treated with certain other medications.

What is the mechanism of action? Afinitor belongs to a group of drugs referred to kinase inhibitors. Afinitor 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 Afinitor has demonstrated a reduction in the replication and spread of cancer cells.

How is Afinitor given (administered)? Afinitor is given orally in the form of a tablet. You should not drink grapefruit juice or eat grapefruit during treatment with Afinitor.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Afinitor. 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 most common (occur in 30% or more of patients) side effects of treatment with Afinitor?

Among patients with advanced PNET, breast cancer, or renal cell cancer:

Mouth sores
Infections
Rash
Diarrhea
Fatigue
Edema (swelling)
Abdominal pain
Nausea
Fever
Weakness
Cough
Headache
Decreased appetite

Among patients with SEGA:

Mouth sores
Upper respiratory infections
Sinusitis
Ear infections
Fever

Among patients with renal angiomyolipoma

Mouth sores

What are some of the less common but potentially serious side effects of treatment with Afinitor?

Non-infectious pneumonitis (inflammation of the lungs)
Serious infections
Kidney failure

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.
It is important that patients inform their physician about all medical conditions, including kidney problems, liver problems, diabetes or high blood sugar, high blood cholesterol, infections, and history of hepatitis B.
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. In particular, tell your doctor if you take St. John’s Wort; medicine for infections, seizures, heart conditions or high blood pressure; or medicine that suppresses the immune system
Patients should inform their physician about any recent or planned vaccinations. During treatment with Afinitor you should not receive a live vaccine and should not be around someone who’s recently received a live vaccine.
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?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience any of the following:

Fever
Chills
New or worsening cough
Shortness of breath
Chest pain
Difficulty breathing or wheezing
Pain, redness or ulcers of the mouth or throat
Flu or cold-like symptoms
Excessive or prolonged fatigue or weakness
Symptoms of hepatitis B (fever, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stool or dark urine, yellowing of the skin, pain in upper right side).

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: A, Biological Therapy