Afinitor (everolimus)

What is Afinitor?

Afinitor is a brand-name prescription medication that’s used to treat certain types of cancers, tumors, and seizures. It contains the drug everolimus.

Afinitor is a type of drug called a mammalian target of rapamycin (mTOR) inhibitor. mTORs are targeted therapies that work by “targeting” and attacking cancer cells. Afinitor is not considered chemotherapy, which acts on all cells in the body that are growing quickly, not just cancer cells.

Afinitor is available in two forms:

• Afinitor. This comes as a tablet that you swallow.
• Afinitor Disperz. This comes as a tablet for oral suspension. You dissolve the tablet in water, which you then swallow.

What it does

Afinitor is approved to treat several types of cancers and tumors:

• Advanced hormone receptor-positive, HER2-negative breast cancer in females* who have gone through menopause and have already tried letrozole (Femara) or anastrozole (Arimidex). Afinitor for breast cancer is to be used with the anticancer drug exemestane (Aromasin).
• Advanced renal cell carcinoma (kidney cancer) in adults who have already tried the anticancer drugs sunitinib (Sutent) or sorafenib (Nexavar).
• Neuroendocrine tumors in the pancreas, lungs, or stomach and gut in adults that cannot be treated by surgery.
• Renal angiomyolipoma,a type of benign (not cancerous) kidney tumor, in adults with the genetic disorder tuberous sclerosis.

Afinitor Disperz is approved to treat:

• partial seizures (also called focal onset seizures)in adults and children ages 2 years and older with tuberous sclerosis who are taking antiseizure drugs

Both Afinitor and Afinitor Disperz are approved to treat:

• subependymal giant cell astrocytoma (SEGA), a type of benign (not cancerous) brain tumor in adults and children ages 1 year and older with tuberous sclerosis

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Afinitor generic

Afinitor is a brand-name medication that contains the active drug everolimus. This active drug is also available as a generic medication.

A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug. Generics tend to cost less than brand-name drugs.

If you’re interested in using the generic form of Afinitor, talk with your doctor. They can tell you if it comes in forms and strengths that can be used for your condition.

Note: Everolimus is also available as the brand-name drug Zortress, which is used to prevent organ rejection after an organ transplant.

Afinitor side effects

Afinitor can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Afinitor. This list does not include all possible side effects.

For more information on possible side effects of Afinitor, talk with your doctor or pharmacist. They can also give you tips on how to deal with a bothersome side effect.

More common side effects

The more common side effects of Afinitor can include:

• stomatitis (sores or swelling in your mouth)
• increased risk of infections
• rash
• diarrhea
• swelling of your hands, arms, feet, ankles, or legs
• pain in your abdomen (belly)
• nausea
• vomiting
• fever
• weakness or lack of energy
• cough
• headache
• loss of appetite
• weight loss
• metabolic syndrome

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Afinitor can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects can include the following:

• allergic reaction
• pneumonitis (swelling in your lungs) that’s not caused by an infection
• infections
• angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
• kidney failure
• myelosuppression (a condition in which bone marrow makes fewer blood cells than usual)

See the “Side effect details” section below for symptoms of these conditions.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Afinitor. In clinical trials, 3% of people who took Afinitor had an allergic reaction. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare, but possible. In clinical trials, up to 1% of people taking Afinitor had a severe allergic reaction. Symptoms of a severe allergic reaction can include:

• angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic reaction to Afinitor. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Rash

Rash is one of the most common side effects of Afinitor. In clinical studies, rash occurred in up to 59% of people using Afinitor. You may be having an allergic reaction to Afinitor if:

• you have a rash that doesn’t go away after a couple days, or
• you have chest pains or trouble breathing or swallowing

Call your doctor right away if you have a severe allergic reaction to Afinitor. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Pneumonitis

Afinitor is a type of drug called a mammalian target of rapamycin (mTOR) inhibitor. A possible side effect of this type of drug is noninfectious pneumonitis. This is inflammation (swelling) of the lungs that’s not caused by an infection. In clinical studies, up to 19% of people who took Afinitor had noninfectious pneumonitis.

Symptoms of pneumonitis can include:

• shortness of breath
• cough
• fatigue

If you start having symptoms of pneumonitis, call your doctor right away. Your doctor may change your dose of Afinitor or have you stop taking it.

Hair loss

Hair loss typically doesn’t occur with use of Afinitor alone. However, it can occur when Afinitor is used with a drug called exemestane.

Hair loss is common in people who take exemestane. In one clinical study, 15% of people who took exemestane alone had hair loss.

In another study, 10% of people treated with Afinitor and exemestane for breast cancer had hair loss.

It’s important to note that hair loss was only seen when Afinitor was given with exemestane. People who took Afinitor alone didn’t experience hair loss.

Typically, hair loss from use of exemestane isn’t permanent. Your hair should start to grow back weeks after your treatment ends. If you’re concerned about hair loss, talk with your doctor.

Infections

Drugs that treat cancer, such as Afinitor, can weaken your body’s immune system. This can put you at increased risk for infections. In clinical studies, up to 58% of people who took Afinitor had an infection, and up to 10% had a severe infection.

Symptoms of severe infections can include:

• high fever
• shivering
• rapid heart rate
• confusion
• shortness of breath
• pain or discomfort
• sweating

If you start having symptoms of an infection while taking Afinitor, talk with your doctor. They may change your dosage or have you stop taking the medication. They may need to prescribe medication to treat your infection. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Kidney failure

There have been reports of kidney failure in people treated with Afinitor. In clinical studies, up to 2% of people had high levels of serum creatinine, which measures your kidney health. Also, 1% had proteinuria (high levels of protein in urine), which may be a sign of kidney damage.

Also in these studies, 3% of people with kidney cancer developed kidney failure. And nearly 3% of people with pancreatic cancer had severe kidney failure.

Before and during your treatment with Afinitor, your doctor will track how well your kidneys are working. This is very important if you’re at risk for kidney disease.

Symptoms of kidney failure can include:

• urinating less
• swelling in your legs, ankles, or feet
• shortness of breath
• confusion
• fatigue
• nausea
• chest pain or pressure
• irregular heartbeat
• seizures

Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

If you have a history of kidney problems, talk with your doctor before taking Afinitor.

Myelosuppression

Myelosuppression is a common side effect of taking Afinitor. With this condition, bone marrow makes fewer blood cells than usual. This can decrease the number of your red blood cells, white blood cells, and platelets.

In clinical studies, as many as 92% of people who took Afinitor had anemia (a low red blood cell count). Severe anemia, which requires medical treatment such as a blood transfusion, occurred in up to 15% of people who took Afinitor.

Symptoms of anemia can include:

• fatigue
• weakness
• pale or yellowish skin
• irregular heartbeat
• shortness of breath
• dizziness or lightheadedness
• chest pain

In clinical studies, up to 54% of people who took Afinitor had thrombocytopenia (a low platelet count). Up to 3% of those cases were severe. Severely low platelet counts put you at increased risk for having a bleed that requires medical treatment.

Symptoms of a low platelet count can include:

• easy bruising
• longer wound heal time
• bleeding from your gums or nose
• blood in your urine or stool

If you have leukopenia (a low white blood cell count), you may also develop infections. This is especially true if you have a low count of a certain type of white blood cell (neutropenia). In clinical trials, up to 46% of people who took Afinitor developed neutropenia. Up to 9% of cases were severe. Your risk of developing a serious infection is greater if your neutropenia is severe.

Symptoms of an infection can include:

• fever
• chills
• cough
• swelling

If you have symptoms of an infection while taking Afinitor, talk with your doctor. They may want to change your dose or have you stop taking the medication. They may also prescribe medication to treat the infection. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Metabolic syndrome

Metabolic syndrome is a common side effect of taking Afinitor. With this condition, your blood sugar, cholesterol, and triglyceride levels can increase while you’re taking the drug.

In clinical studies, hyperglycemia (high blood sugar) was reported in up to 75% of people who took Afinitor. High cholesterol levels were reported in up to 86% of people. And high triglyceride levels were reported in up to 73% of people.

High cholesterol and high triglyceride levels don’t normally cause symptoms. But they can increase your risk for chronic (long-term) diseases, such as heart disease, over time.

Symptoms of high blood sugar can include:

• feeling more thirsty than normal
• urinating more often than normal
• urinating more often at night
• blurry vision
• sores that won’t heal
• fatigue

Your doctor should monitor your blood sugar, cholesterol, and triglyceride levels before and during your Afinitor treatment. If you have diabetes, you’ll need to check your blood sugar levels more often.

Side effects in children

Infections, including serious infections, may be more common in people of all ages during Afinitor treatment. Two clinical studies looked at children who took Afinitor. Children younger than age 6 years had higher rates of infection than children older than age 6 years.

One study looked at Afinitor use in children with a certain condition. This condition was the genetic disorder tuberous sclerosis with a type of benign (not cancerous) brain tumor called subependymal giant cell astrocytoma (SEGA).

In this study, infections occurred in:

• 96% of children younger than age 6 years
• 67% of children ages 6 years and older

And serious infections occurred in:

• 35% of children younger than age 6 years
• 7% of children ages 6 years and older

In another study, children with tuberous sclerosis-related partial seizures took Afinitor in addition to other antiseizure drugs.

• In this study, infections occurred in:
  • 77% of children younger than age 6 years
  • 53% of children ages 6 years and older
• And serious infections occurred in:
  • 16% of children younger than age 6 years
  • 4% of children ages 6 years and older

Afinitor cost

As with all medications, the cost of Afinitor can vary. The cost may differ between forms and strengths of the drug too. For instance, the price of 5-mg tablets may differ from the price of 10-mg tablets. The actual price you’ll pay depends on your insurance coverage and the pharmacy you use.

Financial and insurance assistance

If you need financial support for Afinitor or help understanding your insurance coverage, assistance is available.

Novartis, the manufacturer of Afinitor, offers a program called the Novartis Oncology Universal Co-Pay Program. For more information and to find out if you’re eligible for support, call 877-577-7756. Or you can visit the program website.

Afinitor uses

The Food and Drug Administration (FDA) approves prescription drugs such as Afinitor to treat certain conditions. Afinitor is FDA-approved to treat a range of cancers, tumors, and seizures.

Afinitor for breast cancer

Afinitor may be prescribed for advanced hormone receptor-positive, HER2-negative breast cancer in females* who have gone through menopause and who have already tried treatment with the drugs letrozole (Femara) or anastrozole (Arimidex). Afinitor for breast cancer is to be used with the anticancer drug exemestane (Aromasin).

In a clinical study, females who took Afinitor and exemestane had a response rate of 12.6%. A response rate is the percentage of people whose cancer decreases or disappears with treatment. Response rate is another term for success rate. Females who took only exemestane had a 1.7% response rate.

The study also found that taking Afinitor and exemestane more than doubled the time people lived without their breast cancer getting worse. This was compared to people who took only exemestane.

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Afinitor for kidney cancer

Afinitor may be prescribed for advanced renal cell carcinoma (kidney cancer) in adults. It’s given to those who have already tried the anticancer drugs sunitinib (Sutent) or sorafenib (Nexavar).

In a clinical study, people with kidney cancer who took Afinitor had a response rate of 2%. That’s the percentage of people whose cancer decreased or disappeared with treatment. This was compared to a 0% response rate in people who received only supportive care (no cancer medication).

The study also found that taking Afinitor more than doubled the amount of time people lived without their kidney cancer getting worse. This was compared to people who received only supportive care (no cancer treatment).

Afinitor for neuroendocrine tumors

Afinitor may be prescribed for certain types of neuroendocrine tumors in adults. It’s given for neuroendocrine tumors that have progressed and that can’t be treated by surgery.

Neuroendocrine tumors can be cancerous or benign (not cancerous). They may release hormones into your blood that affect a number of your body’s functions. Therefore, symptoms of these tumors can vary depending on where the tumor is located and what hormones are being released. Afinitor is specifically approved for neuroendocrine tumors in the pancreas, lung, or stomach and gut.

In two clinical studies of people with neuroendocrine tumors, taking Afinitor more than doubled the amount of time people lived without their tumors getting worse. This was compared to people who received only supportive care (no cancer medication).

People with neuroendocrine tumors in the lung or stomach and gut had a response rate of 2%. That’s the percentage of people whose cancer decreased or disappeared with treatment. This was compared to people who received only supportive care, who had a response rate of 1%.

Afinitor isn’t FDA-approved to treat neuroendocrine tumors called functional carcinoid tumors. This type of tumor actively makes hormones.

Afinitor for benign kidney tumor caused by TS

Afinitor may be prescribed to treat renal angiomyolipoma in adults with the genetic disorder tuberous sclerosis (TS). Renal angiomyolipoma is a type of benign (not cancerous) kidney tumor.

In a clinical study of adults with kidney tumors, 41.8% of people had the size of their tumors reduced by at least 50%. This was compared to a 0% response rate in people who received only supportive care (no cancer medication).

Afinitor and Afinitor Disperz for brain tumor caused by TS

Both Afinitor and Afinitor Disperz are approved to treat subependymal giant cell astrocytoma (SEGA), a benign (not cancerous) brain tumor. They’re approved for this use in:

• adults with the genetic disorder tuberous sclerosis (TS)
• children ages 1 year and older with TS

In a clinical study in adults with SEGA, 35% of people who took Afinitor had the size of their tumor reduced by at least 50%. In comparison, there was a 0% response rate in people who received only supportive care (no cancer medication).

In another study, at six months, 32% of people who took Afinitor had the size of their tumor reduced by at least 50%.

Afinitor Disperz for seizures caused by TS

Afinitor Disperz is approved for use with antiseizure drugs to treat partial seizures(also called focal onset seizures) in:

• adults with the genetic disorder tuberous sclerosis (TS)
• children ages 2 years and older with TS

In a clinical study of people with tuberous sclerosis (TS) and partial seizures, Afinitor Disperz was taken along with antiseizure drugs. This drug combination reduced the number of seizures that people had by at least 50% for 28.2% to 40% of the people. Half of the people who took Afinitor Disperz had their number of seizures reduced by at least 29.3% to 39.6%.

Afinitor and children

Afinitor and Afinitor Disperz are approved to treat subependymal giant cell astrocytoma (SEGA), a benign (not cancerous) brain tumor in children ages 1 year and older who have tuberous sclerosis. Tuberous sclerosis is a genetic disorder.

Afinitor Disperz is also approved for use with antiseizure drugs to treat partial seizures(also called focal onset seizures) in children ages 2 years and older who have tuberous sclerosis.

Afinitor dosage

The Afinitor dosage your doctor prescribes will depend on several factors. These may include:

• the type of condition you’re taking Afinitor to treat
• your age
• your body weight
• other medical conditions you may have
• other drugs you may be taking
• how severe your side effects are

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Afinitor comes in two forms:

• Afinitor. This comes as a tablet that you swallow. It’s available in four strengths:
  • 2.5 mg
  • 5 mg
  • 7.5 mg
  • 10 mg
• Afinitor Disperz. This comes as a tablet that you dissolve in water, and then swallow. It’s available in three strengths:
  • 2 mg
  • 3 mg
  • 5 mg

Afinitor dosage for breast cancer

For advanced hormone receptor-positive, HER2-negative breast cancer, the recommended starting dosage of Afinitor is 10 mg per day. If side effects become severe or your condition worsens, your doctor may change your dosage.

Afinitor dosage for kidney cancer

For advanced renal cell carcinoma (kidney cancer), the recommended starting dosage of Afinitor is 10 mg per day. If side effects become severe or your condition worsens, your doctor may change your dosage.

Afinitor dosage for neuroendocrine tumors of the pancreas, lung, or stomach/gut

For neuroendocrine tumors of the pancreas, lung, or stomach/gut, the recommended starting dosage of Afinitor is 10 mg per day. If side effects become severe or your condition worsens, your doctor may change the dosage.

Afinitor dosage for kidney tumors

For renal angiomyolipoma, a type of benign (not cancerous) kidney tumor, the recommended starting dosage of Afinitor is 10 mg per day. If side effects become severe or your condition worsens, your doctor may change the dosage.

Afinitor or Afinitor Disperz dosage for brain tumors

For subependymal giant cell astrocytoma (SEGA), a type of benign (not cancerous) brain tumor, the recommended daily starting dose of Afinitor is 4.5 mg per square meterof body surface area (BSA).

Your doctor will calculate your BSA and determine your dosage. They’ll round it to the nearest dose to match a strength the drug comes in.

If side effects become severe or your condition worsens, your doctor may change the dosage.

Afinitor Disperz dosage for seizures

For partial seizures(also called focal onset seizures), the recommended daily starting dose of Afinitor Disperz is 5 mg per square meterof BSA.

Your doctor will calculate your BSA and determine your dosage. They’ll round it to the nearest dose to match a strength the drug comes in.

If side effects become severe or your condition worsens, your doctor may change the dosage.

Pediatric dosage

For either SEGA or partial seizures in children, the recommended dosage of Afinitor or Afinitor Disperz is based on BSA. Your doctor will calculate your child’s BSA and determine the dosage. They’ll round it to the nearest dose to match a strength the drug comes in.

• For SEGA in children, the recommended dose of Afinitor or Afinitor Disperz is 4.5 mg per square meter.
• For partial seizures in children, the recommended dose of Afinitor Disperz in 5 mg per square meter.

If side effects become severe or your child’s condition worsens, your doctor may change the dosage.

What if I miss a dose?

If you miss a dose of Afinitor, you can take it if it is within six hours of your normal scheduled dose. If more than six hours have passed, skip the dose and take the next dose at its normal time. Do not take two doses to make up for a missed dose. If you have questions about missing a dose, talk with your doctor or pharmacist about what to do.

Will I need to use this drug long term?

Afinitor is meant to be used as a long-term treatment. If you and your doctor determine that Afinitor is safe and effective for you, you’ll likely take it long term. If the side effects become severe or if your condition worsens, your doctor may have you stop taking Afinitor.

Common questions about Afinitor

Here are answers to some frequently asked questions about Afinitor.

Is Afinitor chemotherapy?

No, Afinitor isn’t a type of chemotherapy. Afinitor is a type of drug called a mammalian target of rapamycin (mTOR) inhibitor, which is considered a targeted therapy. Targeted therapy works by “targeting” and attacking cancer cells.

Chemotherapy medications are different than targeted therapies. Chemotherapy drugs act on all cells in the body that are growing quickly, not just cancer cells. Chemotherapy medications usually kill the growing cells and affect more cells in the body than targeted therapy does.

What can I do to prevent mouth sores from Afinitor?

To help keep your mouth healthy and free from sores, practice good dental hygiene. Brush your teeth twice a day and floss once a day. Also, eat a healthy diet and look for any changes in your mouth. If you notice any mouth problems, tell your doctor.

You can also try using an alcohol-free mouthwash while being treated with Afinitor. This may help reduce your risk for mouth sores.

According to a 2017 review, researchers are looking at several ways to help prevent mouth sores in people using Afinitor or other drugs from the same class. Studies haven’t yet proven that these methods are effective, but possible options include:

• brushing and gargling with salt water
• rinsing with and swallowing a glutamine solution (available in drug stores as a powder or a premade solution called Healios)
• using a hydrocortisone mouthwash or a prednisolone rinse (available by prescription only)
• using an alcohol-free mouthwash that contains dexamethasone (available by prescription only)
• taking prednisone (available by prescription only)

If you want to help prevent mouth sores, talk with your doctor. They can suggest the best options for you.

Can I use this drug if I haven’t reached menopause?

Maybe. The Food and Drug Administration (FDA) has approved Afinitor to treat advanced hormone receptor-positive, HER2-negative breast cancer in females* who have gone through menopause.

In theory, Afinitor could be used to treat this cancer in females who haven’t yet gone through menopause. Although Afinitor isn’t currently approved for this use, a clinical study is looking at this treatment option.

If you haven’t yet reached menopause and want to learn more about Afinitor, talk with your doctor.

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Is Afinitor the same as Zortress?

Afinitor and Zortress are both prescription medications that contain the drug everolimus. However, they’re used for different purposes and prescribed at different doses.

Afinitor is approved to treat many types of cancers and tumors, and is prescribed at higher doses. Zortress is approved at much lower doses to help prevent organ rejection in people who have had a kidney or liver transplant.

Is Afinitor used to treat carcinoid tumors?

Yes and no. Afinitor is approved to treat nonfunctional types of carcinoid tumors of the pancreas, lungs, and stomach or gut. Nonfunctional tumors don’t produce hormones. (Another name for carcinoid tumors is neuroendocrine tumors. These are tumors that grow in and around nerve cells and cells that make hormones.)

Afinitor isn’t approved to treat functional carcinoid tumors. These are tumors that actively release hormones.

Afinitor use with other drugs

Afinitor can be used alone or with certain other drugs.

Afinitor with other cancer drugs

For most cancers, Afinitor is typically used by itself. But for advanced hormone receptor-positive, HER2-negative breast cancer, Afinitor is prescribed with the anticancer drug exemestane (Aromasin). Both Afinitor and Aromasin have been approved for this use by the Food and Drug Administration (FDA).

Some drugs may be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Examples of other cancer drugs that are used off-label with Afinitor include:

• fulvestrant (Faslodex) to treat breast cancer
• tamoxifen (Soltamox) to treat breast cancer
• lenvatinib (Lenvima) to treat kidney cancer

Combining drugs, and adding more drugs to your treatment plan, can increase the number and severity of side effects you have.

For example, kidney failure is a possible serious side effect of both Afinitor and lenvatinib. Both of these drugs also have warnings for people undergoing surgery because the drugs can delay surgery healing time. Using Afinitor and lenvatinib together is likely to increase your risk for kidney failure or trouble healing after surgery.

If you’re concerned about how certain drug combinations might affect you, talk with your doctor.

Afinitor with other antiseizure medications

Afinitor Disperz is approved to be used along with antiseizure medications to treat partial seizures(also called focal onset seizures) associated with the genetic disorder tuberous sclerosis (TS).

Examples of antiseizure drugs that may be used with Afinitor include:

• levetiracetam (Keppra)
• lamotrigine (Lamictal)
• topiramate (Topamax)
• valproic acid (Depakote)
• carbamazepine (Tegretol)
• phenytoin (Dilantin)

Using Afinitor Disperz with certain antiseizure drugs, such as phenytoin, can decrease how well Afinitor Disperz works. The antiseizure drugs can make Afinitor Disperz break down more than usual in your body. This lessens the amount of Afinitor Disperz in your system.

If you’re taking an antiseizure drug, tell your doctor. They may need to increase your Afinitor dose or recommend other treatment options.

Afinitor and alcohol

There are no known interactions between Afinitor and alcohol. However, alcohol may interact with certain other chemotherapy medications.

Talk with your doctor about the risks of drinking alcohol with Afinitor.

Afinitor interactions

Afinitor can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can increase the risk of side effects.

Afinitor and other medications

Below are lists of medications that can interact with Afinitor. These lists do not contain all drugs that may interact with Afinitor.

Before taking Afinitor, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential drug interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that increase or decrease how well Afinitor works

Some medications interact with how Afinitor is broken down within your body. This can increase or decrease the level of Afinitor, affecting how well it works. If you take any of these medications, tell your doctor. They may need to change your dosage.

Examples of these drugs include:

• rifampin (Rifadin, Rimactane)
• phenytoin (Dilantin)
• phenobarbital
• ritonavir (Norvir)
• amiodarone (Nexterone, Pacerone)
• ketoconazole
• verapamil (Calan SR)

ACE inhibitors

Angiotensin-converting enzyme (ACE) inhibitors are blood pressure medications. Their side effects include angioedema (a type of swelling caused by an allergic reaction). Angioedema is also a possible side effect of taking Afinitor. Taking an ACE inhibitor with Afinitor may increase your risk of developing angioedema.

Symptoms of angioedema can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling in your throat
• skin redness
• large, thick bumps on your skin

Angioedema may be severe, especially if swelling occurs in your throat. If you have any symptoms of angioedema, call your doctor right away. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Examples of ACE inhibitor drugs include:

• benazepril (Lotensin)
• enalapril (Vasotec)
• lisinopril (Prinivil, Zestril)
• perindopril
• quinapril (Accupril)
• ramipril (Altace)
• trandolapril

If you develop angioedema, your doctor will probably have you stop taking both Afinitor and any ACE inhibitors.

Afinitor and vaccinations

Live vaccines haven’t been studied in people being treated with Afinitor. Due to the increased risk of infection, avoid getting live vaccines while taking Afinitor. Also avoid close contact with people who recently received a live vaccine.

If you have questions about Afinitor and vaccinations, talk with your doctor.

Afinitor and herbs and supplements

Taking St. John’s wort with Afinitor may make Afinitor work less well. If you take the supplement, talk with your doctor. They may want you to stop taking the supplement and will recommend another treatment option.

Afinitor and foods

Avoid eating grapefruit or drinking grapefruit juice while taking Afinitor. The fruit or juice can increase the amount of the drug in your body to dangerous levels. Talk with your doctor if you have any concerns.

Alternatives to Afinitor

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Afinitor, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for breast cancer

Other drugs besides Afinitor that may be used to treat the same type of breast cancer in females* who have gone through menopause include:

• abemaciclib (Verzenio)
• fulvestrant (Faslodex)
• palbociclib (Ibrance)

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Alternatives for kidney cancer

Other drugs besides Afinitor that may be used to treat advanced renal cell carcinoma (kidney cancer) include:

• axitinib (Inlyta)
• temsirolimus (Torisel)

Alternatives for neuroendocrine tumors of the pancreas, lung, or stomach/gut

Other drugs besides Afinitor that may be used to treat neuroendocrine tumors include:

• lutetium Lu 177 (Lutathera)
• sunitinib (Sutent)
• streptozocin (Zanosar)

Alternatives for kidney tumors

The Food and Drug Administration (FDA) hasn’t approved other medications besides Afinitor to treat renal angiomyolipoma in people with tuberous sclerosis. Renal angiomyolipomas are benign (not cancerous) kidney tumors.

Sirolimus may be used off-label to treat benign (not cancerous) kidney tumors in people with tuberous sclerosis. Sirolimus is in the same class of drugs as Afinitor. Sirolimus has been studied in people with kidney tumors and tuberous sclerosis. However, the studies were small in size, and more studies are needed to confirm how well the drug works.

Alternatives for brain tumors

The FDA hasn’t approved other medications besides Afinitor and Afinitor Disperz to treat subependymal giant cell astrocytoma (SEGA). This is a benign (not cancerous) brain tumor in people with tuberous sclerosis.

Alternatives for seizures

The FDA hasn’t approved other medications besides Afinitor Disperz to treat partial seizures(also called focal onset seizures) related to tuberous sclerosis in adults and children ages 2 years and older.

Afinitor vs. Ibrance

You may wonder how Afinitor compares to other medications that are prescribed for similar uses. Here we look at how Afinitor and Ibrance are alike and different.

Ingredients

Afinitor contains the drug everolimus. It’s a type of drug called a mammalian target of rapamycin (mTOR) inhibitor.

Ibrance contains the drug palbociclib. It’s a type of drug called a cyclin-dependent kinase (CDK) 4 and 6 inhibitor.

Both Afinitor and Ibrance are targeted therapies, which work by “targeting” and attacking certain parts of cancer cells. However, the two drugs affect different enzymes (proteins that aid chemical changes in your body). Afinitor targets mTOR enzymes, while Ibrance targets CDK 4 and 6 enzymes. By blocking these enzymes, the two drugs prevent cancer cells from growing and spreading.

Uses

Afinitor and Ibrance are both similar and different in how they treat cancer, tumors, and seizures.

Breast cancer

The Food and Drug Administration (FDA) has approved both Afinitor and Ibrance to treat advanced hormone receptor-positive, HER2-negative breast cancer in females.* However, the two drugs differ in some ways regarding their use in treating breast cancer.

Afinitor is approved for use with the anticancer drug exemestane (Aromasin) in females after menopause. The females must have already tried letrozole (Femara) or anastrozole (Arimidex), both anticancer drugs.

Ibrance is also approved to treat metastatic (advanced) breast cancer. This is breast cancer that has spread to other parts of the body. Ibrance is to be used with fulvestrant (Faslodex) in females whose cancer got worse after they tried endocrine (hormone) therapies including:

• letrozole (Femara)
• anastrozole (Arimidex)
• exemestane (Aromasin)

Ibrance is also approved as the starting therapy for advanced or metastatic breast cancer in either females who have gone through menopause or males.* Ibrance is to be used with an aromatase inhibitor (AI). AIs are a type of hormone therapy that blocks the production of estrogen.

* Use of the terms “female” and “male” within this article refers to a person’s sex assigned at birth.

Other cancers and tumors

While Ibrance is only approved to treat breast cancer, Afinitor is approved to treat other cancers and tumors including:

• advanced renal cell carcinoma (kidney cancer) in adults who have already tried the anticancer drugs sunitinib (Sutent) or sorafenib (Nexavar)
• neuroendocrine tumors in the pancreas, lung, or stomach/gut in adults that can’t be treated with surgery
• renal angiomyolipoma, a type of benign (not cancerous) kidney tumor in adults with the genetic disorder tuberous sclerosis
• subependymal giant cell astrocytoma (SEGA), a type of benign (not cancerous) brain tumor in adults or children ages 1 year and older with tuberous sclerosis (Afinitor Disperz is also approved to treat these brain tumors.)

Partial seizures

Afinitor Disperz is approved for use with antiseizure drugs to treat partial seizures(also called focal onset seizures) in:

• adults and children ages 2 years and older with tuberous sclerosis

Drug forms and administration

Afinitor is available in two forms:

• Afinitor. This comes as a tablet that you swallow. Be sure to take Afinitor tablets whole. Don’t chew, split, or crush them. The tablets come in four strengths:
  • 2.5 mg
  • 5 mg
  • 7.5 mg
  • 10 mg
• Afinitor Disperz. This comes asa tablet that you must prepare as an oral suspension. This means you’ll dissolve it in water, which you then swallow. The tablets come in three strengths:
  • 2 mg
  • 3 mg
  • 5 mg

Ibrance comes as capsules and tablets that you swallow. It’s available in three strengths:

• 75 mg
• 100 mg
• 125 mg

Side effects and risks

Afinitor and Ibrance can cause similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Afinitor, with Ibrance, or with both drugs (when taken individually).

• Can occur with Afinitor:
  • weight loss
  • cough
  • swelling of your hands, arms, feet, ankles, or legs
  • pain in your abdomen (belly)
• Can occur with Ibrance:
  • hair loss
  • nose bleeds
  • altered taste
• Can occur with both Afinitor and Ibrance:
  • diarrhea
  • nausea
  • vomiting
  • stomatitis (sores or swelling in your mouth)
  • increased risk of infection
  • rash
  • weakness or lack of energy
  • fatigue
  • loss of appetite
  • fever

Serious side effects

These lists contain examples of serious side effects that can occur with Afinitor, with Ibrance, or with both drugs (when taken individually).

• Can occur with Afinitor:
  • angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
  • kidney failure
• Can occur with Ibrance:
  • few unique serious side effects
• Can occur with both Afinitor and Ibrance:
  • severe allergic reactions
  • myelosuppression (when bone marrow makes fewer blood cells)
  • pneumonitis (swelling in the lungs)

Effectiveness

These drugs haven’t been directly compared in head-to-head clinical studies. But researchers have found both Afinitor and Ibrance to be effective in treating advanced hormone receptor-positive, HER2-negative breast cancer in females* who have:

• gone through menopause
• already tried treatment with the drugs letrozole (Femara) or anastrozole (Arimidex)

* Use of the term “female” within this article refers to a person’s sex assigned at birth.

Costs

Afinitor and Ibrance are both brand-name drugs.

Afinitor and Afinitor Disperz both come in generic forms. But Ibrance doesn’t come in a generic version. Brand-name medications usually cost more than generics.

Afinitor is more expensive than Ibrance. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

How to take Afinitor

Take Afinitor as your doctor or another healthcare professional instructs.

Taking Afinitor

Swallow Afinitor tablets whole. Don’t chew, split, or crush them.

Taking Afinitor Disperz

For a helpful video on how to take Afinitor Disperz, visit the drug’s website.

You must prepare Afinitor Disperz tablets as an oral suspension. This means you’ll dissolve them in water, which you will then swallow.

Preparing the suspension in a syringe

If you have trouble drinking from a glass, you may want to use an oral syringe to take Afinitor.

Preparing the suspension

To prepare the suspension in a syringe, follow these steps:

1. Wash and dry your hands.
2. Put on disposable gloves. Avoid touching the medication if you’re giving it to someone else.
3. Take the plunger out of a 10-mL oral syringe.
4. Place a tablet or tablets of the prescribed dose into the barrel of the syringe. Don’t break or crush the tablets. You’ll need another syringe for doses higher than 10 mg.
5. Put the plunger back in the barrel of the syringe and push until it touches the tablets.
6. Add water to a drinking glass.
7. Put the syringe tip in the glass. Pull back the plunger until there’s about 5 mL of water in the syringe.
8. Turn the syringe so the tip is pointing up. Pull the plunger to add 4 mL of air into the syringe.
9. Empty the glass and place the syringe in it, tip up.
10. Wait three minutes until the tablets dissolve.

Taking the dose

Now that you’ve prepared the suspension, you’re ready to take the dose. Follow these steps:

1. Gently turn the syringe end to end five times.
2. Hold the syringe tip up and press the plunger to remove extra air.
3. Place the syringe tip in your mouth and press the plunger. Be sure to take the dose within 60 minutes. If you don’t, safely dispose of the suspension.
4. Draw up another 5 mL of water and 4 mL of air into the same syringe.
5. Swirl as before to get the remaining drugs into the suspension. Then take the rest of the dose right away.
6. Wash and dry your hands.

Preparing the suspension in a small drinking glass

You don’t have to use an oral syringe to take Afinitor. You can also prepare the suspension in a small glass. Follow these steps:

1. Wash and dry your hands.
2. Put on disposable gloves and avoid touching the medication if you’re giving it to someone else.
3. Place the prescribed dose into a small drinking glass with about 25 mL of water. Don’t break or crush the tablets. If your dose is higher than 10 mg, you’ll need to split the dose. That means repeating these steps to take the rest of the dose. There should be a maximum dose of 10 mg per glass.
4. Wait three minutes until the tablets dissolve.
5. Stir the suspension gently with a spoon.
6. Drink the suspension. Be sure to do so within 60 minutes of preparing it.
7. Add another 25 mL of water to the glass. Stir with the same spoon to get the remaining drugs into the suspension. Then drink the rest of the suspension right away.
8. Wash and dry your hands.

Timing

Take Afinitor once a day at the same time each day.

Duration of treatment

People may take Afinitor for different lengths of time. This is based on how well their body tolerates the drug. It’s also based on whether the disease progresses, and when that progression occurs.

Taking Afinitor with food

You can take Afinitor with or without food. However, you should consistently take it the same way, either always with food or always without food.

Can Afinitor be crushed, split, or chewed?

No. You shouldn’t crush, split, or chew Afinitor or Afinitor Disperz tablets.

How Afinitor works

Afinitor is used to treat many types of cancer and tumors. It’s also used to treat partial seizures(also called focal onset seizures) for people with the genetic disorder tuberous sclerosis.

Afinitor is a type of drug called a mammalian target of rapamycin (mTOR) inhibitor. An mTOR is a protein (enzyme) that helps cells grow and divide. mTOR inhibitors work by inhibiting (stopping) cancer cells from getting bigger and spreading.

Afinitor also helps treat tuberous sclerosis-related seizures, but how it does this isn’t completely understood. Tuberous sclerosis seizures are thought to be caused in part by inflammation from tumors. One theory is that blocking mTOR reduces inflammation between nerve cells in the brain, which could help reduce seizures.

How long does it take to work?

The effectiveness of cancer drugs is usually measured by a response rate. Response rates can be monitored by different types of tests. You and your doctor will create a plan to monitor your treatment and response. If the drug works, it may take a few weeks or longer to notice a response to the drug.

Afinitor and pregnancy

You shouldn’t take Afinitor if you’re planning on becoming pregnant or are currently pregnant. In animal studies, Afinitor was harmful to fetuses when pregnant females were given the drug.

Birth control needs

Females* should use contraception (birth control) during Afinitor treatment and for eight weeks after their last dose. Males* should also use birth control during treatment and for four weeks after their last dose.

* Use of the terms “female” and “male” within this article refers to a person’s sex assigned at birth.

Afinitor and breastfeeding

It isn’t known if Afinitor passes into human breast milk. Animal studies have shown that Afinitor passes into breast milk at a high level. However, animal studies don’t always predict what will occur in humans.

Because the effects are not known, it is recommended that people do not breastfeed during treatment with Afinitor and for two weeks after their last dose.

If you have any concerns about breastfeeding and taking Afinitor, talk with your doctor.

Afinitor warnings

Before taking Afinitor, talk with your doctor about your health history. In some cases, Afinitor may not be right for you based on your health history. Talk with your doctor if any of the following applies to you:

• Surgical healing. Afinitor may delay your recovery time after surgery. It may also increase your risk for wound-related complications, including reopening and infections of the wound. Talk with your doctor if you’ve recently had surgery or are planning to have it soon. If you’ll be having a planned surgery, your doctor will likely recommend that you don’t take Afinitor for the week before your surgery. They’ll also likely have you wait at least two weeks after your surgery to restart the drug.
• Older age. In the breast cancer clinical study, people ages 65 years and older had a higher rate of stopping Afinitor and death. This was compared to people in younger age groups. If you’re ages 65 years or older, your doctor should carefully monitor your Afinitor dose. Then they should adjust it to help you avoid side effects.
• Metabolic disorders. Afinitor has been reported in clinical studies to cause high levels of blood sugar, cholesterol, and triglycerides. If you have diabetes or another metabolic disorder, your doctor will carefully monitor your levels before and during your Afinitor treatment.
• Liver problems. According to clinical studies, if you’ve had hepatitis B, taking Afinitor may cause the infection to return. Also, your doctor may need to adjust your dosage of Afinitor if you have liver problems. Before you take Afinitor, tell your doctor if you have liver problems or have ever had hepatitis B.
• Radiation therapy. Afinitor may cause your body to be more sensitive to radiation therapy or react to radiation therapy. This can happen if you have radiation treatment before, during, or after taking Afinitor. Talk with your doctor about your risk for these complications. Your doctor will closely monitor you if needed.

Afinitor overdose

Using more than the recommended dose of Afinitor can lead to serious and life threatening side effects.

Overdose symptoms

Symptoms of taking too much Afinitor can include:

• stomatitis (sores or swelling in your mouth)
• infections
• pneumonitis (swelling in the lungs that’s not caused by an infection)
• kidney failure
• myelosuppression (when bone marrow makes fewer blood cells)

What to do if you take too much

If you think you’ve taken too much of Afinitor, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Afinitor expiration, storage, and disposal

When you get Afinitor from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Store Afinitor tablets at room temperature in their original container. Be sure to protect them from light and moisture.

Disposal

If you no longer need to take Afinitor and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.