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Treatment Name: Everolimus (Afinitor®)

Everolimus (Afinitor®) is a Chemotherapy Regimen for Renal Cell Carcinoma - Kidney Cancer

How does everolimus work?
Everolimus is designed to slow the growth of cancer cells by inhibiting several mechanisms that the cell uses to grow and survive.

Goals of therapy:
Everolimus is given to shrink tumors and alleviate symptoms of renal cell carcinoma (RCC). Everolimus is not commonly given with the goal of cure.

Schedule

  • Usual starting dose: Everolimus 10 mg oral capsule by mouth daily

Everolimus is usually taken at home. Typically, therapy with everolimus is continued until the drug no longer works or unacceptable toxicity is experienced.

Side Effects

In clinical studies, the most commonly reported side effects with everolimus are shown here. Side effects sometimes have percentage ranges (example 40 – 53%) because they differed between in clinical studies:

  • High blood cholesterol (76%)
  • High blood triglycerides (71%)
  • Mouth sores (40 - 53%)
  • Anemia [low red blood cells] (28 - 91%)
  • Fluid in legs (28%)
  • Low white blood cells (26%)
  • Rash (25 - 37%)
  • Weight loss (21%)
  • Fatigue (20 - 45%)
  • Increased bleeding risk [low platelets] (20%)
  • Headache (19%)
  • Constipation (19%)
  • Muscle weakness (18 - 21%)
  • Diarrhea (17 - 38%)
  • High blood sugar (16 - 50%)
  • Loss of appetite (16 - 29%)
  • Nausea (15 - 34%)
  • Cough (12 - 38%)
  • Vomiting (12 - 21%)
  • Dry skin (11%)
  • Infections (10%)
  • Lung toxicity (8%)
  • Trouble breathing (8 - 25%)

Approximately 10% of patients discontinue everolimus due to unacceptable side effects

Side effect videos Side Effect Videos
AnemiaAnemiaPainPainFatigue Fatigue BleedingBleedingConstipationConstipationDiarrheaDiarrheaNausea and VomitingNausea and Vomiting

Monitoring

How often monitoring needed?
Labs (blood tests) may be checked before treatment and every 14 days for the first 3 months, then every month thereafter. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood cholesterol, blood triglycerides, plus any others your doctor may order

How often is imaging needed?

Imaging may be checked before treatment and every 8 weeks during treatment. Imaging may include: computerized tomography (CT) scans, magnetic resonance imaging (MRI), and bone scans

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue everolimus as planned, or delay or switch therapy

ChemoExperts Tips

  • Everolimus can possibly impair your body’s ability to heal various wounds. Talk to your oncologist about any planned surgeries and let your surgeon know that you are receiving everolimus
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for renal cell carcinoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Everolimus (Afinitor®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Everolimus (Afinitor®). Depending upon your income, they may be able to help cover the cost of:

  • Everolimus

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Everolimus (Afinitor®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Everolimus (Afinitor®)

Individual Drug Label Information

Everolimus (Afinitor®)

  • Everolimus is an oral tablet 
  • Everolimus can be taken on an empty stomach or with food; however, every dose should be taken the same way in regard to food Tablets should be taken with a full glass of water. 
  • Tablets should be swallowed whole and never chewed, broken, or crushed 
  • If you miss a dose, take the dose as soon as possible ONLY if it is within 6 hours since the dose should have been taken, then return to the normal schedule. If it is already been past 6 hours since the dose should have been taken, do not take the dose. Wait until your next dose is due 
  • Everolimus should be stored at room temperature in a cool, dry place and away from light Only remove the tablet from the blister pack right before taking your dose 
  • Dosage adjustments may be required for liver dysfunction, lung toxicity, mouth sores, high blood sugar or cholesterol, and low blood counts 
  • May interact with certain antifungal, blood pressure, and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions 
  • May interact with grapefruit and grapefruit juice causing increased blood levels of everolimus. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid therapy with St. Johns Wort as it will decrease blood levels of everolimus. This could decrease the effectiveness of everolimus 
General Everolimus Side Effects  
  • Commonly causes mouth sores. Avoid alcohol containing mouthwashes 
  • May lower your body’s ability to fight infections 
  • Can cause high blood sugar levels. Medications that help lower blood sugar may need to be started or adjusted 
  • Can raise blood cholesterol levels. Medications that help lower blood cholesterol levels may need to be started or adjusted 
  • Severe lung toxicity can occur. Let your doctor know if you experience new or worsening breathing problems 
  • Can cause an opening in the wall of your stomach or intestines. Seek help immediately if you experience severe abdominal pain with fever, nausea, or vomiting 
  • Click on the everolimus (Afinitor) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1. Motzer RJ, Escudier B, Oudard B, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449-456.

2. Motzer RJ, Barrioe CH, Kim TM, et al. Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol 2014;32:2765-2772.

Created: August 18, 2015 Updated: September 5, 2018

What is Renal Cell Carcinoma - Kidney Cancer?

A malignant disease of the cells found in the kidney. Renal cell carcinoma (RCC) is a rare condition and is the most commonly diagnosed type of kidney cancer. Known causes of RCC include smoking, obesity, hypertension, family history of RCC, and a genetic disease known as Von Hippel-Lindau disease. The stage of RCC can vary at diagnosis and throughout treatment. RCC uses the TNM (Tumor, Node, Metastasis) staging system and is grouped into stages I, II, III, and IV. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Motzer RJ, Escudier B, Oudard B, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449-456.

2. Motzer RJ, Barrioe CH, Kim TM, et al. Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol 2014;32:2765-2772.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.