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Afinitor Disperz (Generic Everolimus)

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WARNING

The use of everolimus may reduce your body’s capacity to fight against bacterial, viral, and fungal infections and raise your chance of contracting a serious or fatal infection. If you have had hepatitis B, a form of liver disease, your infection may become active and you may experience symptoms while using everolimus. If you currently have or have ever had hepatitis B, any form of infection, or suspect that you may, let your doctor know. In particular, mention azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone (Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and tacrolimus to your doctor and (Prograf). Call your doctor right away if you have any of the following symptoms: Excessive fatigue, yellowing of the skin or eyes, loss of appetite, nausea, pain in the upper right part of the stomach, joint pain, dark urine, pale stools, rash, painful or frequent urination, ear pain or drainage, sinus pain and pressure, or sore throat, cough, fever, chills, feeling unwell or other infection-related symptoms.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to everolimus, your doctor will prescribe a number of tests.

When you start everolimus medication and each time you renew your prescription, your doctor or pharmacist will give you the patient information sheet from the manufacturer (Medication Guide [Zortress] or patient information booklet [Afinitor, Afinitor Disperz]). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

You should discuss the dangers of using everolimus with your doctor.

Patients receiving everolimus to avoid transplant rejection should:

Everolimus must be taken under the care of a physician who is skilled in managing transplant patients and prescribing immunosuppressive drugs.

During your everolimus treatment, your risk of developing cancer, particularly lymphoma (cancer of a portion of the immune system) or skin cancer, increases. Inform your doctor if you have fair skin, have ever had skin cancer, or if anybody in your family has. Plan to avoid unnecessary or extended exposure to sunlight or UV light (tanning beds and sunlamps), and use protective clothes, sunglasses, and sunscreen while receiving therapy to lower your chance of developing skin cancer. Call your doctor right away if you have any of the following symptoms: a new sore, bump, or discoloration on the skin; sores that do not heal; lumps or masses elsewhere on the body; changes to the skin; night sweats; enlarged glands in the neck, armpits, or groyne; difficulty breathing; chest pain; or weakness or fatigue that does not go away.

The risk of developing certain extremely rare and serious infections, such as the BK virus infection (a serious virus that may harm the kidneys and cause a transplanted kidney to fail), and progressive multifocal leukoencephalopathy may increase if you take everolimus (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). If you develop any of the following PML symptoms, call your doctor right away: clumsiness in the arms or legs; changes in your thinking, walking, balance, speech, eyesight, or strength that last many days; headaches; seizures; disorientation; or personality changes. Weakness on one side of the body that gets worse over time.

A blood clot in the blood arteries of your transplanted kidney may be brought on by everolimus. This is more likely to occur in the first 30 days following your kidney transplant and could result in the transplant’s failure. Call your doctor right away if you have any of the following symptoms: You may experience pain in your lower back, side, or stomach, as well as decreased or no urination, blood in your urine, dark urine, a fever, nausea, or vomiting.

Your kidneys could become damaged if you take cyclosporine and everolimus together. Your doctor will modify your cyclosporine dosage, keep an eye on your drug levels, and assess how well your kidneys are functioning in order to lower this risk. Give your doctor a call right away if you develop any of the following signs or symptoms: reduced urination or edoema in the lower legs, feet, ankles, arms, or hands.

In clinical tests, those who took everolimus within the first several months following a heart transplant died more frequently than those who did not. Discuss the dangers of taking everolimus with your doctor if you have had a heart transplant.

Why is this medication prescribed?

Advanced renal cell carcinoma (RCC; cancer that starts in the kidneys) that has been unsuccessfully treated with various drugs is treated with the drug everolimus (Afinitor). A specific form of advanced breast cancer that has already received treatment with at least one other drug is also treatable with everolimus (Afinitor). A specific type of pancreatic, stomach, intestines, or lung cancer that has spread or advanced and cannot be surgically treated is also treated with everolimus (Afinitor). In addition, kidney tumours in patients with tuberous sclerosis complex are treated with everolimus (Afinitor) (TSC; a genetic condition that causes tumours to grow in many organs). Everolimus (Afinitor and Afinitor Disperz) is also used to treat TSC in adults and children 1 year of age and older who have subependymal giant cell astrocytoma (SEGA), a kind of brain tumour. Everolimus (Afinitor Disperz) is also used to treat specific types of seizures in adults and children with TSC 2 years of age and older when combined with other drugs. In some adults who have received kidney transplants, everolimus (Zortress) is used with additional drugs to avoid transplant rejection (the immune system of the recipient attacks the donated organ). Everolimus belongs to the group of drugs known as kinase inhibitors. Everolimus cures cancer by preventing cancer cells from procreating and by reducing their blood supply. Everolimus reduces immune system activity to prevent transplant rejection.

How should this medicine be used?

Everolimus is available in both oral tablet form and a tablet form that must be submerged in water before being swallowed. Everolimus is typically administered once day to patients with TSC, RCC, breast, pancreas, stomach, intestinal, or lung cancer who have kidney tumours, SEGA, or seizures. Everolimus is typically administered twice daily (every 12 hours) with cyclosporine in order to prevent transplant rejection. Either never take everolimus with food or never take it without food. Every day, take everolimus around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you do not understand, and carefully follow their instructions. Exactly as prescribed, take everolimus. Never take it in larger or less amounts or more frequently than directed by your doctor.

Everolimus tablets are packaged in discrete, scissor-openable blister packs. When you are prepared to swallow the tablet it contains, don’t open a blister pack.

Either everolimus tablets or everolimus tablets for oral suspension should be taken. Do not use both of these medications at once.

With a full glass of water, swallow the pills whole; do not split, chew, or crush them. Taken broken or crushed tablets should not be taken. If you have trouble swallowing the tablets whole, let your doctor or pharmacist know.

The pills for oral suspension (Afinitor Disperz) must be dissolved in water prior to use. These pills shouldn’t be taken whole, and they shouldn’t be combined with juice or any other liquid save water. Don’t make the combination more than 60 minutes in advance of using it, and throw it away if it goes unused after that time. On a surface that you use to cook or eat food, do not make the drug. Wear gloves if you’re going to be preparing the medication for someone else to avoid touching it. Preparing the drug for someone else should be avoided if you are pregnant or intend to become pregnant since everolimus interaction could harm your unborn child.

The pills for oral suspension can be combined in an oral syringe or a small glass. Remove the plunger from a 10-mL oral syringe to prepare the mixture in it. Then, without breaking or crushing the tablets, place the recommended number of tablets in the barrel of the syringe. Everolimus can only be prepared in a syringe up to a maximum dose of 10 mg, thus if your dose is higher, you will need to make it in a second syringe. Replace the syringe’s plunger, add roughly 5 mL of water and 4 mL of air to it, and then insert the syringe’s tip up into a container. Allow the tablets to dissolve in suspension by waiting three minutes. then pick up the syringe and gently rotate it five times up and down. To deliver the drug, insert the syringe into the patient’s mouth and press the plunger. The same syringe should be refilled with 5 mL of water and 4 mL of air and swirled to rinse out any remaining medicine particles after the patient has ingested it. To ensure that the patient gets all of the medication, administer this mixture to them.

Place the recommended number of tablets, without breaking or crushing them, into a tiny glass that can hold no more than 100 mL (approximately 3 ounces), to make the combination in a glass. If your dose is higher than 10 mg, you will need to prepare it in a separate glass because you can only prepare up to 10 mg of everolimus in one glass at a time. To the glass, add 25 mL (about 1 ounce) of water. After three minutes, carefully stir the liquid with a spoon. The patient should consume the full combination right away. To rinse out any remaining particles, add another 25 mL of water to the glass and mix with the same spoon. To ensure that the patient gets all of the medication, have them drink this concoction.

During treatment, your doctor may change your everolimus dosage based on the outcomes of blood tests, your reaction to the drug, adverse effects you encounter, and alterations in other medications you take concurrently with everolimus. Your doctor will modify your dose no more frequently than once every 1 to 2 weeks if you are using everolimus to treat SEGA or seizures, and no more frequently than once every 4 to 5 days if you are taking it to avoid transplant rejection. In the event that you encounter serious adverse effects, your doctor might temporarily cease your medication. Discuss your feelings regarding your everolimus treatment with your doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking everolimus,

  • If you have an allergy to everolimus, sirolimus (Rapamune), temsirolimus (Torisel), any other medications, or any of the ingredients in everolimus tablets, let your doctor and pharmacist know right once. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: drugs that block the action of the angiotensin-converting enzyme (ACE), such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Acc (Agenerase), clarithromycin (Biaxin, in Prevpac), digoxin (Digitek, Lanoxicaps, Lanoxin), diltiazem (Cardizem, Dilacor, Tiazac), efavirenz (in Atripla, Sustiva), erythromycin, atazanavir (Reyataz), prepitant (Emend), carbamazepine (Carbatrol, Epitol, Tegreto (E.E.S., E-Mycin, Erythrocin), Itraconazole (Sporanox), ketoconazole (Nizoral), nelfinavir (Viracept), nefazodone, nevirapine (Viramune), nicardipine (Cardene), fosamprenavir (Lexiva), indinavir (Crixivan), phenytoin, and fosamprenavir (Dilantin, Phenytek), rifampin (Rifadin, in Rifamate, in Rifater), rifabutin (Mycobutin), rifapentine (Priftin), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), telithromycin (Ketek), verapamil (Calan, Covera, Isoptin, Verelan), and voriconazole are some of the (Vfend). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all of the medications you are taking, including any not on this list, as many other drugs may also interact with everolimus.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have diabetes, high blood sugar, high cholesterol or triglyceride levels, renal or liver illness, or any other condition that interferes with your ability to regularly digest foods containing sugar, starch, or dairy products.
  • Inform your physician if you are expecting or intend to get pregnant. You must use reliable birth control during therapy and for 8 weeks following your last dose if you are a woman who is able to get pregnant. Use reliable birth control during treatment and for 4 weeks after your last dosage if you’re a guy with a female partner who might become pregnant. Consult your doctor about birth control options that are right for you. Call your doctor if you or your partner become pregnant while taking everolimus. The foetus may suffer from everolimus. Describe to your doctor if you are nursing a baby. During your therapy and for two weeks following your last dose, stop nursing.
  • Inform your doctor or dentist that you are taking everolimus if you are having surgery, including dental surgery.
  • Avoid getting any shots without first consulting your doctor. You should stay away from close contact with other recently immunised individuals when using everolimus.
  • Before starting everolimus medication, discuss your child’s potential vaccine requirements with your child’s doctor.
  • You should be aware that during your everolimus medication, especially the first 8 weeks, you may experience oral sores or swelling. Your doctor may recommend a specific mouthwash when you begin therapy with everolimus to lessen the likelihood that you may develop mouth sores or ulcers as well as their severity. Use this mouthwash according to your doctor’s instructions. If you experience oral pain or sores, let your doctor know. Because some mouthwashes that contain alcohol, peroxide, iodine, or thyme can exacerbate the sores and swelling, you shouldn’t use any mouthwash without first consulting your doctor or pharmacist.
  • You should be aware that during your treatment with everolimus, wounds or cuts, including the skin cut caused during a kidney transplant, may heal more slowly than usual or may not heal properly. If any wound, including the one from your kidney transplant, becomes warm, red, painful, or swollen, fills with blood, fluid, or pus, or starts to open, call your doctor right once.

What special dietary instructions should I follow?

While using this medication, avoid grapefruit and grapefruit juice.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it if it has been more than six hours since your usual dose. Nevertheless, omit the missed dose and carry on with your regular dosing plan if more than 6 hours have passed since the scheduled time. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Everolimus could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Constipation
  • Changes in food flavour
  • Loss of weight
  • Mouth aridity Weakness
  • Headache
  • Having trouble falling or staying asleep
  • Nosebleed
  • Arid skin
  • Acne
  • Difficulties with nails
  • Nair fall
  • Back, joints, arms, or legs hurt
  • Muscle pain
  • Irregular or missed menstrual cycles
  • Extreme menstrual bleeding
  • Having trouble gaining or maintaining an erection
  • Anxiety
  • Aggression or other behavioural changes

Some adverse effects can be very harmful. Call your doctor right away if you have any of these signs or any of those in the IMPORTANT WARNING section:

  • Hives
  • Itching
  • Swelling of the throat, eyes, face, lips, mouth, hands, feet, arms, or legs
  • Hoarseness
  • Breathing or swallowing challenges
  • Wheezing
  • Flushing
  • Chest discomfort
  • Extreme hunger or thirst
  • Uncommon bruising or bleeding
  • Fast or erratic heartbeat
  • Pale skin
  • Dizziness
  • Seizures

Everolimus may reduce both male and female fertility. You should discuss the dangers of using everolimus with your doctor.

Everolimus may have other negative consequences. If you have any strange side effects while taking this medicine, contact your doctor right once.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly wrapped in the blister pack it came in and out of the reach of children. Store it away from light, excessive heat, and moisture at room temperature (not in the bathroom). Keep the tablets and blister packs dry.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Afinitor®
  • Afinitor Disperz®
  • Zortress®
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