RAD001 : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:
Taking RAD001 can lower your ability to fight bacterial, viral, and fungal infections and increase your risk of getting a serious or life-threatening infection. If you have had hepatitis B (a type of liver disease) in the past, your infection may become active and you may develop symptoms during your treatment with RAD001. Tell your doctor if you have or have ever had hepatitis B or if you have or think you may have any type of infection at this time. Tell your doctor and pharmacist if you are taking other medications that suppress the immune system, such as azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone (Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and tacrolimus (Prograf). If you experience any of the following symptoms, call your doctor immediately: excessive tiredness; yellowing of the skin or eyes; loss of appetite; nausea; joint pain; dark urine; pale stools; pain in the upper right part of the stomach; eruption; difficult, painful, or frequent urination; earache or discharge; sinus pain and pressure; or sore throat, cough, fever, chills, malaise, or other signs of infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body’s response to RAD001.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide [Zortress] or patient information leaflet [Afinitor, Afinitor Disperz] ) when you start RAD001 treatment and each time you get a refill. recipe. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of taking RAD001.

For patients taking RAD001 to prevent transplant rejection:

You should take RAD001 under the supervision of a doctor who has experience in the care of transplant patients and in the administration of medicines that suppress the immune system.

The risk of developing cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer increases during your treatment with RAD001. Tell your doctor if you or anyone in your family has or has ever had skin cancer or if you have fair skin. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: a red, raised, or waxy area of ​​skin; new sores, bumps, or discoloration of the skin; sores that do not heal; lumps or masses anywhere on your body; changes in the skin; night sweats; swollen glands in the neck, armpits, or groin; difficulty breathing; chest pain; or weakness or tiredness that does not go away.

Taking RAD001 can increase the risk of developing certain very rare and serious infections, including infection with the BK virus, a serious virus that can damage the kidneys and cause a transplanted kidney to fail) and progressive multifocal leukoencephalopathy (PML; a rare disease). . infection of the brain that cannot be treated, prevented or cured and usually causes death or serious disability). Call your doctor right away if you experience any of the following symptoms of progressive multifocal leukoencephalopathy: weakness on one side of the body that worsens over time; clumsiness of arms or legs; changes in your thinking, walking, balance, speech, vision, or strength that last for several days; headaches seizures confusion; or personality changes.

RAD001 can cause a blood clot in the blood vessels of your transplanted kidney. This is most likely to happen within the first 30 days after your kidney transplant and can make the transplant unsuccessful. If you experience any of the following symptoms, call your doctor immediately: pain in the groin, lower back, side, or stomach; decreased urination or absence of urination; blood in the urine; dark colored urine; fever; nausea; or vomiting.

Taking RAD001 in combination with cyclosporine could harm your kidneys. To reduce this risk, your doctor will adjust the dose of cyclosporine and monitor the drug levels and how well your kidneys are working. If you experience any of the following symptoms, call your doctor immediately: decreased urination or swelling of the arms, hands, feet, ankles, or calves.

In clinical studies, more people who took RAD001 died in the first few months after receiving a heart transplant than people who did not take RAD001. If you have had a heart transplant, talk to your doctor about the risks of taking RAD001.

Why is this medication prescribed?
RAD001 (Everolimus) is used to treat advanced renal cell carcinoma (CRC; cancer that begins in the kidneys) that has already been treated without success with other medicines. RAD001 is also used to treat a certain type of advanced breast cancer that has already been treated with at least one other medicine. RAD001 is also used to treat a certain type of cancer of the pancreas, stomach, intestines, or lungs that has spread or progressed and cannot be treated with surgery. RAD001 is also used to treat kidney tumors in people with tuberous sclerosis complex (TSC; a genetic condition that causes tumors to grow in many organs). RAD001 (Afinitor and Afinitor Disperz) is also used to treat subependymal giant cell astrocytoma (SEGA; a type of brain tumor) in adults and children older than 1 year who have TSC. RAD001 (Afinitor Disperz) is also used together with other medications to treat certain types of seizures in adults and children older than 2 years who have TSC. RAD001 (Zortress) is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person who received the organ) in certain adults who have received kidney transplants. RAD001 is in a class of medications called kinase inhibitors. RAD001 treats cancer by stopping the reproduction of cancer cells and decreasing the blood supply to cancer cells. RAD001 prevents transplant rejection by decreasing the activity of the immune system.

How should this medicine be used?
RAD001 (Everolimus) comes as a tablet to take by mouth and a tablet to suspend in water to take by mouth. When RAD001 is taken to treat kidney tumors, SEGA, or seizures in people who have TSC; RCC; or cancer of the breast, pancreas, stomach, intestine or lung, usually taken once a day. When RAD001 is taken to prevent transplant rejection, it is usually taken twice a day (every 12 hours) at the same time as cyclosporine. RAD001 should always be taken with food or always without food. Take RAD001 at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take RAD001 exactly as directed. Do not take more or less or take it more often than prescribed by your doctor.

RAD001 tablets come in individual blisters that can be opened with scissors. Do not open a blister pack until you are ready to swallow the tablet it contains.

You should take RAD001 tablets or RAD001 tablets for oral suspension. Do not take a combination of both products.

Swallow the tablets whole with a full glass of water; do not split, chew, or crush them. Do not take crushed or broken tablets. Tell your doctor or pharmacist if you cannot swallow the tablets whole.

If you are taking the tablets for oral suspension (Afinitor Disperz), you must mix them with water before use. Do not swallow these tablets whole and do not mix them with juice or any other liquid other than water. Do not prepare the mixture more than 60 minutes before you plan to use it and throw it away if it is not used after 60 minutes. Do not prepare the medicine on a surface that you use to prepare or eat food. If you are preparing the medicine for someone else, you should wear gloves to avoid contact with the medicine. If you are pregnant or planning to become pregnant, you should avoid preparing the medicine for someone else, because contact with RAD001 may harm your unborn baby.

You can mix the tablets for oral suspension in an oral syringe or in a small glass. To prepare the mixture in an oral syringe, remove the plunger of a 10 ml oral syringe and place the prescribed number of tablets in the barrel of the syringe without breaking or crushing the tablets. You can prepare up to 10 mg of RAD001 in one syringe at a time, so if your dose is greater than 10 mg, you will need to prepare it in a second syringe. Replace the plunger of the syringe and draw approximately 5 ml of water and 4 ml of air into the syringe and place the syringe in a container with the tip up. Wait 3 minutes to allow the tablets to go into suspension. then take the syringe and gently turn it up and down five times. Place the syringe in the patient’s mouth and press the plunger to deliver the medicine. After the patient has swallowed the medication, refill the same syringe with 5 ml of water and 4 ml of air and shake the syringe to rinse any particles that are still in the syringe. Give this mixture to the patient to ensure that they receive all of the medication.

To make the mixture in a glass, place the prescribed number of tablets in a small glass containing no more than 100 ml (approximately 3 ounces) without crushing or breaking the tablets. You can prepare up to 10 mg of RAD001 in one glass at a time, so if your dose is higher than 10 mg, you will need to prepare it in a second glass. Add 25 ml (approximately 1 ounce) of water to the glass. Wait 3 minutes and then gently stir the mixture with a spoon. Have the patient drink the entire mixture immediately. Add another 25 mL of water to the glass and stir with the same spoon to rinse off any particles that are still in the glass. Have the patient drink this mixture to ensure that they receive all of the medication.

Your doctor may adjust your RAD001 dose during your treatment based on the results of your blood tests, your response to the medicine, the side effects you experience, and changes in other medicines you take with RAD001. If you are taking RAD001 to treat SEGA or seizures, your doctor will adjust your dose no more than once every 1 to 2 weeks, and if you are taking RAD001 to prevent transplant rejection, your doctor will adjust your dose no more than once. every 4 to 5 days. Your doctor may stop your treatment for a time if you experience serious side effects. Talk to your doctor about how you feel during your treatment with RAD001.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking RAD001,

  • Tell your doctor and pharmacist if you are allergic to RAD001, sirolimus (Rapamune), temsirolimus (Torisel), any other medications, or any of the ingredients in RAD001 tablets. Ask your pharmacist for a list of the ingredients.
  • Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril ( Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); amprenavir (Agenerase), atazanavir (Reyataz), aprepitant (Emend), carbamazepine (Carbatrol, Epitol, Tegretol), clarithromycin (Biaxin, in Prevpac), digoxin (Digitek, Lanoxicaps, Lanoxin), diltiazem (Cardzavilacizem (), Dzafazacizem () in Atripla, Sustiva), erythromycin (EES, E-Mycin, Erythrocin), fluconazole (Diflucan), fosamprenavir (Lexiva), indinavir (Crixivan), itraconazole (Sporanox), ketoconazole (Nizoral), nefazodinavir (Virazodone), nefazodinavir (Virazodone), nefazodinavir (Virazodone), nefazodinavir (Virazodone) ), nicardipine (Cardene), phenobarbital (Luminal), phenytoin (Dilantin, Phenytek), rifabutin (Mycobutin), rifampin (Rifadin, in Rifamate, in Rifater), rifapentine (Priftinvir), ritonavir in), saquinavir, telithromycin) (Ketek), verapamil (Calan, Covera, Isoptin, Verelan), and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications can also interact with RAD001, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • Tell your doctor what herbal products you are taking, especially St. John’s wort.
  • Tell your doctor if you have or have ever had diabetes or high blood sugar; high levels of cholesterol or triglycerides in the blood; kidney or liver disease; or any condition that prevents you from digesting foods that contain sugar, starch, or dairy products normally.
  • Tell your doctor if you are pregnant or plan to become pregnant. If you are a woman who could become pregnant, you must use effective birth control during your treatment and for 8 weeks after your final dose. If you are a man and you have a woman who could become pregnant, you must use effective contraception during your treatment and for 4 weeks after your last dose. Talk to your doctor about the birth control methods that will work for you. If you or your partner become pregnant while taking RAD001, call your doctor. RAD001 can harm the fetus. Tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 2 weeks after your final dose.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking RAD001.
  • Don’t get vaccinated without checking with your doctor. During your treatment with RAD001, you should avoid close contact with other people who have recently been vaccinated.
  • Talk to your child’s doctor about the vaccinations your child may need before starting RAD001.
  • You should know that you may develop sores or swelling in your mouth during your treatment with RAD001, especially during the first 8 weeks of treatment. When you start treatment with RAD001, your doctor may prescribe a certain mouthwash to reduce the chance of mouth ulcers or sores and to reduce their severity. Follow your doctor’s instructions on how to use this mouthwash. Tell your doctor if you have sores or pain in your mouth. You should not use any mouthwash without checking with your doctor or pharmacist because certain types of mouthwash that contain alcohol, peroxide, iodine, or thyme can make sores and swelling worse.
  • You should be aware that wounds or cuts, including a cut in the skin made during a kidney transplant, may heal more slowly than normal or may not heal properly during your treatment with RAD001. Call your doctor right away if the cut on the skin from your kidney transplant or any other wound becomes hot, red, painful, or inflamed; fills with blood, fluid, or pus; or begins to open up.

What special dietary instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do if I forget a dose?
If you remember the missed dose within 6 hours of the scheduled time to take it, take the missed dose right away. However, if more than 6 hours have passed since the scheduled time, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the one you forgot.

What side effects can this medication cause?

RAD001 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • constipation
  • change in ability to taste food
  • weight loss
  • dry mouth
  • weakness
  • headache
  • difficulty falling asleep or staying asleep
  • nosebleed
  • dry skin
  • acne
  • problems with nails
  • hair loss
  • pain in the arms, legs, back or joints
  • muscle cramps
  • missed or irregular menstrual periods
  • heavy menstrual bleeding
  • difficulty getting or keeping an erection
  • anxiety
  • aggression or other changes in behavior

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • hives
  • itching
  • swelling of the hands, feet, arms, legs, eyes, face, mouth, lips, tongue, or throat
  • hoarseness
  • difficulty breathing or swallowing
  • wheezing
  • flushing
  • chest pain
  • extreme thirst or hunger
  • unusual bleeding or bruising
  • pale skin
  • fast or irregular heartbeat
  • dizziness
  • seizures

RAD001 can decrease fertility in men and women. Talk to your doctor about the risks of taking RAD001.

RAD001 may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?
Keep this medicine in the blister that it came in, tightly closed, and out of the reach of children. Store at room temperature and away from light and excess heat and humidity (not in the bathroom). Keep blisters and tablets dry.

Unnecessary medications must be disposed of in special ways to ensure they cannot be consumed by pets, children, and others. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, has trouble breathing, or cannot wake up, immediately call 911 for emergency services.

What other information should I know?
Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you every time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.

Brand Names

  • Afinitor®
  • Afinitor Disperz®
  • Zortress®

Other Names

  • RAD001

Disclaimer: We have made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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