Everolimus (Generic Name)

Other Names: Afinitor®, Zortress®

About This Drug

This drug is used to treat cancer. It is given by mouth (orally).

Possible Side Effects (More Common)

• Bone marrow depression; This is a decrease in the number of white blood cells, red blood cells, and platelets. It may increase your risk for infection, fatigue, and bleeding.
• Soreness of the mouth and throat. You may have red areas, white patches, or sores that are painful.
• Skin changes, such as a rash (which may look like acne), redness, itchiness, dry skin, cracked skin, peeling skin, or signs of possible infection. This drug may affect the skin around your nails (cuticles).
• Changes in liver and kidney function. Blood tests will be used to check your liver enzymes and serum creatinine as needed.
• Increased cholesterol and triglyceride levels
• Electrolyte changes. Blood tests will be used to check your electrolytes as needed.
• Respiratory problems may occur.  You may  idevelop an  infection or inflammation of your sinuses and lungs, nasal congestion, cough and shortness of breath. 

Possible Side Effects (Less Common)

• Increased blood pressure.  Your blood pressure will be monitored as needed.
• Changes in your heart function.  Your doctor will monitor your heart function as needed.
• Abdominal pain
• Changes in bowel movements.  Some patients experience diarrhea, while other patients experience constipation.
• Nausea and vomiting
• Fever
• Taste changes
• Decrease in appetite
• Increase or a decrease in blood sugar  levels. You may become diabetic.
• Fatigue and weakness
• Tremors
• Headache
• Seizures
• Personality change
• Insomnia
• Dizziness
• Back, arm, and leg pain.
• Swelling (fluid retention) in the legs, ankles, or feet
• Skin changes.  Your skin may have discolor or lose some color.
• Hair  changes.  Hair may lose some color. There may be hair thinning or moderate hair loss.
• Hand-and-foot syndrome.  The palms of your hands or soles of your feet may tingle or become numb, painful, swollen, or red. Rarely, blistering and severe skin reactions occur.
• Blood clots (rare); A blood clot in your leg may cause your leg to swell, appear red and warm, and/or cause pain. A blood clot in your lungs may cause shortness of breath, pain when breathing, and/or chest pain.
• Increased risk of skin cancer.

Sexual Problems and Reproductive Concerns

Sexual problems and reproduction concerns may occur.  In men and women both, this drug may temporarily or permanently affect your ability to have children.  This cannot be determined before your therapy.  In men, this drug may interfere with your ability to make sperm, but it should not change your ability to have sexual relations.  In women, menstrual bleeding may become irregular or stop while you are receiving this drug.  Do not assume that you cannot become pregnant if you do not have a menstrual period.  Speak with your doctor or nurse if  you plan to have children.  Ask for information on sperm or egg banking.

Pregnancy Warning:  This drug may have harmful effects on the unborn child, so effective methods of birth control should be used by both men and women during your cancer treatment. and for at least 8 weeks after treatment.

Genetic counseling is available to you to discuss the effects of thisdoctor or nurse doctor or  drug therapy on future pregnancies.  In addition, a genetic counselor can review the potential risks of problems in the fetus due to this medication if an exposure during pregnancy has occurred.

Breast Feeding Warning:  It is not known if this drug passes into breast milk.  For this reason, women are advised to discuss with their doctor the risks and benefits of breast feeding during treatment with this drug because this drug may enter the breast milk and seriously harm a breast feeding infant.

Women may experience signs of menopause like vaginal dryness or itching. Vaginal lubricants can be used to lessen vaginal dryness, itching, and pain during sexual relations.

Treating Side Effects

• Drink 6 – 8 cups of fluids every day unless your doctor has told you to restrict your fluid intake due to another medical condition.  A cup is 8 ounces of fluid.  If you vomit or have diarrhea, you should drink more fluids so that you do not become dehydrated.
• To protect your skin from sun exposrue, wear sunscreen with SPF of 30 or greater.  Wear protective clothing and sun glasses.  Do not use sunlamps of tanning beds.
• Ask your docor or nurse about medication to help prevent or lessen nausea, vomiting, diarrhea, constipation, headaches, and pain.
• Mouth care is very important.  Your mouth care should consist of regular, gentle cleaning of your teeth and dentures and rinsing your mouth with a mixture of ½ teaspoon of salt in 8 ounces of water or ½ teaspoon of sodium bicarbonate (baking soda) in 8 ounces of water.  This should be done at least after every meal and at bedtime.
• If you have mouth sores, avoid mouthwash that contains alcohol.  Avoid alcohol and smoking because they can irritate your mouth and throat.
• Do not put anything on your rash or reddened skin unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash is bothersome.

Food and Drug Interactions

• Avoid grapefruit and grapefruit juice as it may increase the levels and side effects of temsirolimus
• Avoid the use of St. John’s Wort while taking temsirolimus as this may decrease the levels of the drug making it less effective.  Check with your doctor before starting any other herbal medication, as there may be serious drug interactions.
• Check with your doctor or pharmacist about all other prescription medications and dietary supplements you are taking before starting this medication as there are a lot of known drug interactions with temsirolimus.  In addition, if any new prescription, over-the-counter medication, or dietary supplement is started, check with your doctor or pharmacist to make sure that there are no known interactions

While you are receiving this drug by IV, tell your doctor or nurse immediately If you have any of the following symptoms of an allergic reaction:

• Shortness of breath
• Rash or itching
• Dizziness or lightheadedness
• Feeling your heart beat rapidly (palpitations)

When to Call Your Doctor

Call your doctor or nurse immediately if you have any of the following symptoms:

• Fever of 100.5 F (38 C) or above
• Chills
• Unusual bleeding or bruising
• Wheezing or difficulty breathing
• Cough
• Seizures
• Severe headache
• Trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, or loss of balance or cooordination
• Uncontrolled nausea or vomiting that prevents you from eating or drinking
• Vomiting more than three times a day
• Abdominal pain
• Severe rash or itching
• Diarrhea of 5-6 stools a day  or diarrhea with weakness
• Chest pain or tightness.
• Skin wound that will not heal

• Palms or soles of feet  tingle, numb, painfu, swollen or develop blisters 
• Sores, rash, reddened areas, or itchiness that is unrelieved by prescribed medication
• Swelling in the legs, ankles or feet
• Let that is swollen, red, warm, and/or painful
• Pain, nausea, vomiting, diarrhea, and constipation that is not releived by prescribed medication
• Painful mouth or throat or if you are unable to eat or drink
• Persistent loss of appetite or fast weight loss (such as 5 pounds in 1 week)
• Extreme fatigue or weakness that interferes with daily activities.

New December 2011