Afinitor Disperz

Afinitor Disperz is a prescription medication used to treat certain types of brain tumors seen with a genetic condition called tuberous sclerosis complex (TSC). This medication is also approved to be given in combination (as an add-on treatment) with other seizure medications in those with certain types of seizures and who have been diagnosed with TSC. 

Afinitor Disperz belongs to a group of drugs called kinase inhibitors. It works by stopping cancer cells from reproducing and by decreasing blood supply to cancer cells.

Afinitor Disperz comes in tablet form for oral suspension and is usually taken once daily, with or without food.

• If you take it with food, then take it with food all of the time.
• If you do not take it with food, then do not take it with food all of the time.

Common side effects include constipation, mouth ulcers, nausea, vomiting, diarrhea, and headache.

Afinitor Disperz is a prescription medicine used to treat certain types of brain tumors seen with a genetic condition called tuberous sclerosis complex (TSC).

This medication is used to treat both adults and children 1 year of age and older when the tumor cannot be removed completely by surgery.

This medication is also approved to be given in combination (as an added treatment) to other seizure medicines in adults and children 2 years of age and older with a genetic condition called tuberous sclerosis complex (TSC) who have certain types of seizures (epilepsy). 

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Afinitor Disperz can cause serious side effects. See “Drug Precautions”.

Common side effects of Afinitor Disperz include:

• Mouth ulcers. Afinitor Disperz can cause mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel to reduce the likelihood of developing mouth ulcers or sores as well as to reduce their severity. 
• Infections
• Nausea and vomiting
• Diarrhea and constipation
• Swelling of arms, hands, legs, and feet
• Joint pain
• Cough
• Skin problems (rash, acne, or dry skin)
• Fever
• Feeling tired
• Anxiety, aggression, and other abnormal behaviors
• Absence of menstrual periods (menstruation). You may miss one or more menstrual periods. Tell your doctor if this happens.
• Low red blood cells, white blood cells or platelets
• Increased blood cholesterol level and certain other blood tests
• Decreased blood phosphate level
• Increased blood sugar levels

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Afinitor Disperz. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• St. John’s wort 
• Medicine for: 
        ○  Fungal infections 
        ○  Bacterial infections 
        ○  Tuberculosis
        ○  Seizures 
        ○  HIV-AIDS 
        ○  Heart conditions or high blood pressure
• Medicines that suppress your immune system

This is not a complete list of Afinitor Disperz drug interactions. Ask your doctor or pharmacist for more information.

Afinitor Disperz can cause serious side effects including: 

Lung or breathing problems that may be severe, and can even lead to death. Tell your doctor right away if you have any of these symptoms:

• New or worsening cough
• Shortness of breath
• Chest pain
• Difficulty breathing or wheezing

Increased risk of developing an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people, these infections may be severe, and can even lead to death. You may need to be treated as soon as possible. Tell your doctor right away if you have a temperature of 100.5˚F or above, chills, or do not feel well.

Symptoms of hepatitis B or infection may include the following:

• Fever
• Skin rash
• Joint pain and inflammation
• Tiredness
• Loss of appetite
• Nausea
• Pale stool or dark urine
• Yellowing of the skin
• Pain in your upper right side

Severe allergic reactions. Notify your healthcare provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness.

Kidney failure which may be severe and can even lead to death. Your doctor will likely do tests to check your kidney function before and during your treatment with Afinitor Disperz.

Swelling under your skin especially around your mouth, eyes and in your throat (angioedema). Your chance of having swelling under your skin is higher if you take Afinitor Disperz along with certain other medicines. Tell your doctor right away or go to the nearest emergency room if you have any of these symptoms of angioedema:

• sudden swelling of your face, mouth, throat, tongue or hands
• hives or welts
• itchy or painful swollen skin
• trouble breathing

Harm to your unborn baby. It is recommended women avoid becoming pregnant while taking this medication and for 8 weeks after the last dose. 

Delayed wound healing. Afinitor Disperz can cause your incision to heal slowly or not heal well. Call your doctor right away if you have any of the following symptoms:

• your incision is red, warm or painful
• blood, fluid, or pus in your incision
• your incision opens up
• swelling of your incision

Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your healthcare provider should do blood tests to check levels in the blood before you start and during treatment. 

Decreased blood cell counts such as red blood cells, white blood cells, and platelets. Your healthcare provider should do blood tests to check your blood cell counts before you start and during treatment.

Do not take Afinitor Disperz if you are allergic to Afinitor Disperz or to any of its ingredients. Talk to your doctor before taking this medicine if you are allergic to:

• sirolimus (Rapamune)
• temsirolimus (Torisel)

You should not drink grapefruit juice or eat grapefruit during your treatment with Afinitor Disperz. It may make the amount of Afinitor Disperz in your blood increase to a harmful level.

Before taking Afinitor Disperz, tell your healthcare provider about all of your medical conditions, including if you:

• Have or have had kidney problems
• Have or have had liver problems
• Have diabetes or high blood sugar
• Have high blood cholesterol levels
• Have any infections
• Previously had hepatitis B
• Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with Afinitor Disperz. If you are not sure about the type of immunization or vaccine, ask your healthcare provider
• are pregnant or planning on becoming pregnant
• are breastfeeding or planning on breastfeeding

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

Afinitor Disperz can cause harm to your unborn baby. It is recommended women avoid becoming pregnant while taking this medication. In fact, it is recommended to use effective birth control while using this medication and for 8 weeks after stopping treatment. Talk to your healthcare provider about birth control options while using Afinitor Disperz.

In regards to male patients with female partners of reproductive potential, it is recommended males use effective contraception during treatment and for 4 weeks after the last dose. 

It is not known if Afinitor Disperz crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You should not do both. 

Your healthcare provider will prescribe the dose of Afinitor Disperz that is right for you.

Take Afinitor Disperz exactly as your healthcare provider tells you. Your healthcare provider may change your dose of Afinitor Disperz or tell you to temporarily interrupt dosing, if needed. Take only Afinitor or Afinitor Disperz. Do not mix Afinitor and Afinitor Disperz together.

If your healthcare provider prescribes Afinitor Disperz for you, see the “Instructions for Use” that come with your medicine for instructions on how to prepare and take your dose.

• Each dose of Afinitor Disperz must be prepared as a suspension before it is given.
• Afinitor Disperz can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant.
• Wear gloves to avoid possible contact with Afinitor Disperz when preparing suspensions of Afinitor Disperz for another person.

Take Afinitor Disperz 1 time each day at about the same time.

Take Afinitor Disperz the same way each time, either with food or without food.

If you miss a dose of Afinitor Disperz, you may still take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your Afinitor Disperz, skip the dose for that day. The next day, take Afinitor Disperz at your usual time. Do not take 2 doses to make up for a missed dose. If you are not sure about what to do, call your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function
• your weight
• your height
• your age

The recommended dose of Afinitor Disperz when used to treat brain tumor called subependymal giant cell astrocytoma (SEGA) is 4.5 mg/m2 once daily.

When treating TSC-Associated Partial-Onset Seizures, the recommended dose is 5 mg/m2 orally once daily. 

Your doctor will adjust your dose to reach a specific level of medication in your blood. In addition, your doctor will reduce your dose if you have poor liver function and if you are taking certain medications. 

If you take too much Afinitor Disperz, call your local Poison Control Center or seek emergency medical attention right away. Take Afinitor Disperz with you. 

• Store Afinitor Disperz at room temperature, between 68°F to 77°F (20°C to 25°C). 
• Keep Afinitor Disperz in the package it comes in.
• Open the blister package just before taking Afinitor Disperz.
• Keep the Afinitor Disperz dry.
• Keep Afinitor Disperz out of light.
• Do not use Afinitor Disperz that is out of date or no longer needed. 

Keep Afinitor Disperz and all medicines out of the reach of children.

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION

Malignancies and Serious Infections

• Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. 
• Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression. 

Kidney Graft Thrombosis

• An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation. 

Nephrotoxicity

• Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with everolimus. Therefore reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction. It is important to monitor the cyclosporine and everolimus whole blood trough concentrations.

Mortality in Heart Transplantation

• Increased mortality, often associated with serious infections, within the first three months post-transplantation was observed in a clinical trial of de novoheart transplant patients receiving immunosuppressive regimens with or without induction therapy. Use in heart transplantation is not recommended.