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Afinitor Disperz (Oral)

Generic name: everolimus [ e-ver-OH-li-mus ]
Brand names: Afinitor, Afinitor Disperz, Zortress
Drug classes: MTOR inhibitors, Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on May 24, 2023.

Oral route(Tablet)

Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Immunosuppression increases susceptibility to infection and risk of malignancies, such as lymphoma and skin cancer. Increased risk of kidney arterial and venous thrombosis resulting in graft loss was reported within the first 30 days posttransplantation. To avoid nephrotoxicity, reduce doses of cyclosporine when used in combination with everolimus and monitor cyclosporine and everolimus whole blood trough concentrations. Do not use in heart transplantation; serious infections and increased mortality within the first 3 months posttransplant was observed .

Uses for Afinitor Disperz

Everolimus is used to treat advanced (late-stage) cancers or noncancerous tumors, such as kidney and breast cancer, subependymal giant cell astrocytoma (SEGA, a brain tumor), renal angiomyolipoma (kidney tumor), and partial-onset seizures (epilepsy) with tuberous sclerosis complex (TSC), and neuroendocrine tumors of the pancreas, stomach or bowels, and lungs. It is used for patients who have already received other medicines that did not work well or those who will not be treated with surgery.

Everolimus works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. It belongs to the group of medicines known as antineoplastics (cancer medicines).

Everolimus is also used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney or liver) in patients who have received kidney or liver transplant. This medicine may be used with cyclosporine, steroids, basiliximab, or tacrolimus. When a patient receives an organ transplant, the body's white blood cells may try to get rid of (reject) the transplanted organ. Everolimus works to suppress the immune system and prevents the white blood cells from getting rid of the transplanted organ.

This medicine is available only with your doctor's prescription.

Before using Afinitor Disperz

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of everolimus in children 1 year of age and older to treat SEGA brain tumors and in children 2 years of age and older to treat partial-onset seizures. However, use is not recommended in children younger than 1 year of age to treat SEGA brain tumors and in children younger than 2 years of age to treat partial-onset seizures.

Appropriate studies have not been performed on the relationship of age to the effects of everolimus when used for kidney cancer, neuroendocrine tumors, and kidney or liver transplants in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of everolimus in the elderly. However, elderly patients are more likely to have unwanted side effects, which may require caution and an adjustment in the dose for patients receiving everolimus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper use of Afinitor Disperz

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you have a kidney or liver transplant, you might have to take this medicine for the rest of your life to prevent rejection of the organ. Do not change your dose or stop taking this medicine without checking first with your doctor.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine the same way every day. Take it at the same time and consistently either with or without food.

Swallow the regular tablet whole with a glass of water. Do not crush, break, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

Do not swallow the tablet for suspension. It must be dissolved in water before you take the medicine. If you are preparing the oral suspension for another person, wear disposable gloves.

Do not use the regular tablet and the tablet for suspension together. Use only one dosage form of this medicine.

You may be given a mouthwash (eg, dexamethasone alcohol-free mouthwash) when starting the medicine to prevent mouth sores or ulcers. Do not drink or eat food for at least 1 hour after swishing and spitting the mouthwash.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher levels of everolimus in the body. This could result in more unwanted effects.

If you have a kidney transplant, everolimus will be given together with another medicine called cyclosporine. Take both medicines at the same time.

If you have a liver transplant, everolimus will be given together with another medicine called tacrolimus. Take both medicines at the same time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Afinitor® or Afinitor® Disperz, you may still take it up to 6 hours after the time you normally take the dose. But if more than 6 hours have passed, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original package until you are ready to use it. The oral suspension must be used within 60 minutes after mixing. If it is not used during this time, throw it away and prepare another dose.

Keep Zortress® tablets dry.

Detailed Afinitor Disperz dosage information

Precautions while using Afinitor Disperz

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 8 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment with Afinitor® or Afinitor® Disperz and for 4 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are planning to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

This medicine may cause a serious lung problem called interstitial lung disease or non-infectious pneumonitis. Check with your doctor right away if you have chest pain, chills, cough, fever, or trouble breathing.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.

While you are being treated with everolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Everolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live virus vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Everolimus can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

This medicine may increase your risk for getting skin cancer. When you begin taking this medicine:

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Everolimus may cause a serious allergic reaction called angioedema, which can be life-threatening and requires immediate medical attention. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (eg, captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], ramipril [Altace®]). Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, or chest tightness while you are using this medicine.

If you have a kidney or liver transplant, this medicine may increase your risk for having a blood clot in the new kidney. This usually occurs within the first 30 days after the kidney transplant. Check with your doctor right away if you are making less urine, or if you have pain in your groin, lower back, side, or stomach, dark urine, fever, nausea, or vomiting.

This medicine may also prevent you from healing correctly after an injury. Do not take this medicine at least 1 week before surgery and at least 2 weeks after a surgery. Call your doctor right away if you have blood, fluid, or pus in your incision, your incision opens up, or if it is red, warm, painful, or swollen.

This medicine may also increase your risk of bleeding and cause delay in wound healing. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

Make sure any doctor who treats you knows that you are using this medicine. This medicine may worsen the side effects from radiation treatment.

If you are taking this medicine after a kidney transplant, it may increase your risk for developing rare and serious virus infections, including polyoma virus-associated nephropathy (PVAN), progressive multiple leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels), hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura. Tell your doctor right away if you have a change in mental status, dark or bloody urine, decreased urine output, difficulty speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, severe chest pain, sudden weakness in the arms or legs, unusual bleeding or bruising, or yellow eyes or skin.

Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using this medicine. You may use a special mouthwash (eg, dexamethasone alcohol-free oral solution) or mouth gel to treat these ulcers. Ask your doctor what type of products to use.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor if you notice a change in your blood or urine sugar tests.

Tell your doctor if you are taking a corticosteroid or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, cannabidiol, St. John's Wort) or vitamin supplements.

Side Effects of Afinitor Disperz

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Less common

Rare

Incidence not known

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Afinitor Disperz side effects (more detail)

Commonly used brand name(s)

In the U.S.

Available Dosage Forms:

Therapeutic Class: Immune Suppressant

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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