Afinitor Disperz

The tablets for oral suspension are intended to be used to treat SEGA associated with TSC, and seizures associated with TSC only. If you are using the tablets for oral suspension, the tablets must be mixed with water to prepare a suspension (particles of drug mixed into a liquid) before taking the medication. Use tap water or non-sparkling water only. Do not use juice or any other liquids. You may choose to use an oral syringe to mix the tablets and water, or mix the tablets with water in a small amount of water in a glass.

To use an oral syringe, place the prescribed number of Afinitor Disperz (Everolimus) tablets for suspension into the oral syringe. Draw 5 mL of water and 4 mL of air into the syringe. Let the syringe rest for 3 minutes, until the tablets have mixed with the water and formed a suspension. Gently invert the syringe 5 times immediately before taking the dose. After taking the dose, draw another 5 mL of water into the syringe and gently swirl the water in the syringe to wash any remaining medication off the sides of the syringe. Swallow the contents of the syringe.

To use a small glass, place the prescribed number of Afinitor Disperz (Everolimus) tablets for oral suspension into the glass containing approximately 25 mL of water and let the tablets and water stand for 3 minutes. Stir the contents gently with a spoon and drink the contents immediately. After taking the dose, add a small amount of water to the glass and gently swirl the contents of the glass or rinse any remaining medication off the sides of the glass. Swallow the contents of the glass.

These tablets for suspension should not be swallowed whole, broken or crushed. Once the suspension has been prepared, it should be taken immediately. If it is not administered within 60 minutes, safely discard the suspension and start over. Wash your hands before and after preparing the suspension.

Avoid drinking grapefruit juice or eating grapefruit, star fruit, or Seville oranges. These foods can slow down how the body gets rid of the medication and may result in too much medication in the body.

It is important that Afinitor Disperz (Everolimus) be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is more than 6 hours after the time you normally take the medication, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Afinitor Disperz (Everolimus) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

2 mg
Each round, flat, white-to-slightly yellowish tablet with a bevelled edge and no score, engraved with "D2" on one side and "NVR" on the other, contains 2 mg of Afinitor Disperz (Everolimus). Nonmedicinal ingredients: butylated hydroxytoluene, cellulose microcrystalline, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and silica colloidal anhydrous.

3 mg
Each round, flat, white-to-slightly yellowish tablet with a bevelled edge and no score, engraved with "D3" on one side and "NVR" on the other, contains 3 mg of Afinitor Disperz (Everolimus). Nonmedicinal ingredients: butylated hydroxytoluene, cellulose microcrystalline, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and silica colloidal anhydrous.

5 mg
Each round, flat, white-to-slightly yellowish tablet with a bevelled edge and no score, engraved with "D5" on one side and "NVR" on the other, contains 5 mg of Afinitor Disperz (Everolimus). Nonmedicinal ingredients: butylated hydroxytoluene, cellulose microcrystalline, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and silica colloidal anhydrous.

Do not take Afinitor Disperz (Everolimus) if you:

• are allergic to Afinitor Disperz (Everolimus) or any ingredients of the medication
• are allergic to Sirolimus or Temsirolimus

There may be an interaction between Afinitor Disperz (Everolimus) and any of the following:

• Abiraterone acetate
• Amiodarone
• angiotensin-converting enzyme inhibitors (ACEIs; e.g., Captopril, Lisinopril, Ramipril)
• Aprepitant
• Atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG vaccine
• Bicalutamide
• Bosentan
• calcium channel blockers (e.g., Diltiazem, nicardipine, Verapamil)
• Carbamazepine
• Carvedilol
• Cimetidine
• Clozapine
• Cobicistat
• conivaptan
• Cyclosporine
• Deferasirox
• Deferiprone
• Denosumab
• Desipramine
• Dexamethasone
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Rosiglitazone)
• Dipyridamole
• dipyrone
• Doxorubicin
• Dronedarone
• echinacea
• Enzalutamide
• Fenofibrate
• Fingolimod
• hepatitis protease inhibitors (e.g., boceprevir, simeprevir)
• fosphenytoin
• grapefruit juice
• Haloperidol
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• Leflunomide
• Lomitapide
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Mefloquine
• Metronidazole
• mifepristone
• Mirabegron
• Mitotane
• Modafinil
• nefazodone
• Norfloxacin
• Oxcarbazepine
• pentobarbital
• Phenobarbital
• Phenytoin
• Pimecrolimus
• Prazosin
• primidone
• Progesterone
• Propranolol
• protein kinase inhibitors (e.g., Crizotinib, Dabrafenib, imatinib, Lapatinib, Nilotinib)
• quinidine
• quinine
• rifabutin
• rifampin
• Roflumilast
• St. John's wort
• siltuximab
• Stiripentol
• Tacrolimus
• Tamoxifen
• Tocilizumab
• Trastuzumab
• Trazodone
• Ulipristal
• vaccines
• Vinblastine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Afinitor Disperz (Everolimus). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Afinitor Disperz (Everolimus).

Anemia: Afinitor Disperz (Everolimus) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Afinitor Disperz (Everolimus) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you have a medical condition or are taking medication that affects blood clotting, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed.

If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, vomiting coffee-ground like substances, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Clotting: Afinitor Disperz (Everolimus) has been linked to clots in the leg and lungs. If you develop sudden pain with redness and swelling in one of your legs (usually in the calf), sudden difficulty breathing, or coughing up blood, contact your doctor immediately.

Breathing problems: Afinitor Disperz (Everolimus) has been linked to inflammation and damage to the lungs. If you develop shortness of breath or a persistent cough, contact your doctor.

Cholesterol and triglycerides: Afinitor Disperz (Everolimus) may cause an increase in the amount of cholesterol or triglycerides in the blood. If you have High Cholesterol or are at risk for heart disease, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed.

Diabetes: Afinitor Disperz (Everolimus) may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Afinitor Disperz (Everolimus).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed.

If you experience signs of high blood sugar, such as increased thirst and urination, excessive hunger, unexplained weight loss or a fruity odour to your breath, contact your doctor as soon as possible.

Fertility: Afinitor Disperz (Everolimus) can cause changes to sperm in men and may cause ovulation and menstrual bleeding to stop during treatment in women. These changes may continue after stopping the medication.

Fluid and electrolyte balance: Afinitor Disperz (Everolimus) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Afinitor Disperz (Everolimus). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Afinitor Disperz (Everolimus).

Grapefruit juice: Drinking grapefruit juice, or eating grapefruit, star fruit, or Seville oranges while you are taking Afinitor Disperz (Everolimus) can affect how the medication is removed from the body and may cause too much of the medication to build up in the body. This can cause possibly harmful side effects. You should avoid these foods while taking Afinitor Disperz (Everolimus).

Hepatitis B: There have been reports of flare-ups of hepatitis B occurring when people take Afinitor Disperz (Everolimus). If you have a history of hepatitis B, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed.

Infection: As well as killing tumour cells, Afinitor Disperz (Everolimus) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections and public areas with lots of people. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Afinitor Disperz (Everolimus) can cause harm to the kidneys. While you are taking Afinitor Disperz (Everolimus), your doctor should test your kidney function regularly with blood tests. If you have kidney problems, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Afinitor Disperz (Everolimus).

Liver function: Liver disease or reduced liver function may cause Afinitor Disperz (Everolimus) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Afinitor Disperz (Everolimus) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Afinitor Disperz (Everolimus), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Afinitor Disperz (Everolimus).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Mouth ulcers: Afinitor Disperz (Everolimus) commonly causes inflammation of the mucous membrane in your mouth resulting in mouth ulcers. Avoid using any alcohol, hydrogen peroxide, iodine, or thyme-containing mouthwashes as they can worsen the ulcers. Discuss proper treatment for mouth ulcers with your doctor.

Surgery: Afinitor Disperz (Everolimus) causes changes to the blood and wound healing. Make sure anyone involved in your medical care knows you are taking Afinitor Disperz (Everolimus).

Pregnancy: Afinitor Disperz (Everolimus) may cause harm to an unborn baby. Women who may become pregnant while taking Afinitor Disperz (Everolimus) must use an effective form of birth control, even if they have not had their first menstrual period. Effective birth control must be used during treatment with Afinitor Disperz (Everolimus), and for at least eight weeks following the discontinuation of treatment. If you become pregnant while taking Afinitor Disperz (Everolimus), contact your doctor immediately.

Breast-feeding: It is not known if Afinitor Disperz (Everolimus) passes into breast milk. If you are a breast-feeding mother and are taking Afinitor Disperz (Everolimus), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Afinitor Disperz (Everolimus) is not recommended for children with cancer who are less than 18 years of age. The safety and effectiveness of using Afinitor Disperz (Everolimus) have not been studied for children with SEGA who are less than 1 year of age and there is limited information about the use of Afinitor Disperz (Everolimus) for children less than 3 years of age.

Seniors: People over 65 years of age are more likely to experience side effects while taking Afinitor Disperz (Everolimus). Your doctor may adjust your dose based on side effects and how well the medication is tolerated.