Taking Afinitor

Before starting treatment with Afinitor

Before you start treatment with Afinitor, it is important to tell your doctor about all prescription and non-prescription medicines, vitamins, and herbal supplements you are taking. This is important because some of these may affect how Afinitor works, or Afinitor may affect how they work. Using Afinitor with other medicines can cause serious side effects.

In particular, tell your doctor if you are taking medicine for:

  • Fungal or bacterial infections
  • Tuberculosis (TB)
  • Seizures
  • HIV/AIDS
  • Heart conditions or high blood pressure

Also be sure to tell your doctor if you are taking:

  • St. John's wort (also known as Hypericum perforatum)
  • Medicines that suppress your immune system

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine. You should also tell your healthcare provider before you start taking any new medicine.

Other things to tell your doctor before taking Afinitor

Talk to your doctor before taking Afinitor if you are allergic to any of the following:

  • Sirolimus (Rapamune®)
  • Temsirolimus (Torisel®)
  • Inactive ingredients in Afinitor, including:
    - Butylated hydroxytoluene

    - Magnesium stearate

    - Lactose monohydrate

    - Hypromellose

    - Crospovidone

    - Lactose anhydrous

Besides telling your doctor about all the medicines you are taking, you should also tell him/her about any medical conditions you have, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high 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. If you are not sure about the type of immunization or vaccine, ask your healthcare provider
  • Other medical conditions
  • Are pregnant, or could become pregnant. It is not known if Afinitor will harm your unborn baby. You should use effective birth control while using Afinitor and for 8 weeks after stopping treatment
  • Are breastfeeding or plan to breastfeed. It is not known if Afinitor passes into your breast milk. You and your doctor should decide if you will take Afinitor or breastfeed. You should not do both

Possible drug interactions with Afinitor

Some kinds of other medicines may lower or raise the amount of Afinitor in your blood. Your doctor may also need to change the dose of these medicines, the dose of Afinitor, or prescribe a different medicine all together. Be sure to tell your doctor if you are taking any other medicines including prescription or nonprescription medicines, vitamins, or herbal supplements. Using Afinitor with other medicines can cause serious side effects.

The following medicines may lower or raise the amount of Afinitor in your blood. This is not a all inclusive list of medication. Check with your doctor for additional medications that might interact with Afinitor.

Medicines for seizures:

  • Carbamazepine
  • Phenobarbital
  • Phenytoin

Medicines for tuberculosis:

  • Rifabutin
  • Rifampin
  • Rifapentine

Medicines for bacterial infections:

  • Clarithromycin
  • Erythromycin
  • Telithromycin

Medicines for nausea and vomiting:

  • Aprepitant

Medicines for fungal infections:

  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Voriconazole

Medicines for HIV/AIDS:

  • Amprenavir
  • Atazanavir
  • Fosamprenavir
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Saquinavir

Medicines for heart conditions and high blood pressure:

  • Diltiazem
  • Verapamil

These names are generic and may differ from branded names. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those listed above.

Foods to avoid:

Be sure not to drink grapefruit juice or eat grapefruit while you are on Afinitor. Grapefruit may make it harder for the body to break down Afinitor. If this process is slowed down, the levels of Afinitor in your body could build up and cause harm.

How to take Afinitor

Afinitor is an oral pill you take once daily, consistently with or consistently without food. You may take Afinitor at home or at any other place that works for you. This may eliminate the need to receive treatment in your doctor's office. Afinitor should be taken at the same time every day.

You should take Afinitor exactly as your doctor tells you to, but here are some general guidelines:

  • Swallow Afinitor tablets whole with a glass of water. Do not crush or chew the tablets.
  • If you cannot swallow AFINITOR tablets whole, you can stir them into a glass of water:
    • Put the prescribed number of tablets into a glass that contains about 2 Tablespoons (30mL) of water
    • Gently stir the contents until the tablets break apart and then drink the mixture right away
    • Add about 2 Tablespoons (30 mL) of water to the glass and drink all of the water. This will help to make sure that you get the full dose of AFINITOR.

Remember, your doctor may change your dose of Afinitor if needed. As your treatment journey continues with Afinitor, it is important that you keep in touch with your healthcare team and follow your doctor's directions so that you can get the most out of your therapy. Call your doctor if you have any questions about taking your medicine. Afinitor will work best if you follow the directions from your doctor carefully.

Important Afinitor dosing information

Afinitor is available in 2.5-milligram, 5-milligram, 7.5-milligram and 10-milligram strength tablets that are white to slightly yellow.

 

Making sure you take Afinitor every day gives you the best chance of slowing the progression of your cancer. If you stop taking it or skip doses you will not get the most benefit from Afinitor.

If you miss a dose of Afinitor, it's okay to take it up to 6 hours after the time you normally take it. If it is more than 6 hours after you normally take Afinitor, skip the dose for that day. The next day, take your usual dose of Afinitor at your usual time. Do not take 2 doses to make up for the one that you missed. Contact your doctor if you have any questions or concerns.

If you take too much Afinitor, contact your doctor or go to the nearest hospital emergency department right away. Take the pack of Afinitor with you.

How to store Afinitor tablets

Afinitor tablets come in foil-wrapped blister packaging. This protects them from moisture and light. To store your tablets:

  • Do not take the tablets out of the package (to put them in a pillbox, for example) until it is time to take them

  • Open the foil package with scissors just before taking your tablets

  • Store Afinitor at 25°C (77°F) somewhere dry and out of the light. Excursions are allowed between 59°F to 86°F (15°C to 30°C).
  • Safely throw away Afinitor that is out of date or no longer needed. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published—ask your local pharmacist if you have questions
  • If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals

Always be sure to call your doctor if you have any questions about taking your medicine. Afinitor will work best if you follow the directions from your doctor carefully. Also, remember to keep Afinitor and all medicines out of the reach and sight of children.

When Afinitor is the
next step of your journey

The treatment of advanced kidney cancer has many steps. Learn more about Afinitor by clicking here.

Afinitor is a prescription medicine used to treat people with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked (ie, Sutent® [sunitinib] or Nexavar® [sorafenib]).

Important Safety Information

Patients should not take AFINITOR if they are allergic to AFINITOR or to any of its ingredients. Patients should tell their healthcare provider before taking AFINITOR if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR can cause serious side effects including lung or breathing problems, infections and kidney failure, which can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR for a while or use a lower dose. Patients should follow their healthcare provider's instructions.

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe, and can even lead to death. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing or wheezing.

Infections: AFINITOR may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe, and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they 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, or pain in the upper right side.

Kidney Failure: AFINITOR may cause kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR.

Mouth Ulcers: AFINITOR can cause mouth ulcers and sores. Patients should tell their healthcare provider if they have pain, discomfort, or open sores in their mouth. Their healthcare provider may tell them to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.

Blood Tests: Patients will have regular blood tests before they start AFINITOR and as needed during their treatment. These will include tests to check the patient's blood cell count, kidney and liver function, and blood sugar levels.

Other Medicines/Food and AFINITOR: AFINITOR may affect the way other medicines work, and other medicines can affect how AFINITOR works. Using AFINITOR with other medicines can cause serious side effects. Patients should tell their healthcare provider about all of the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements such as: St. John's Wort and medicine for fungal infections, bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure, and medicines that suppress their immune system. Patients should not drink grapefruit juice or eat grapefruit during their treatment with AFINITOR as it may make the amount of AFINITOR in their blood increase to a harmful level.

Patients should not take AFINITOR tablets which are broken or crushed. Patients should not chew or crush the tablets.

Liver Problems and Other Medical Conditions: The amount of AFINITOR in the blood was increased in patients who had liver problems. Patients should tell their healthcare provider about all their medical conditions including if they have or have had liver problems, diabetes or high blood sugar, high cholesterol levels, infections, hepatitis B, or other medical conditions.

Vaccinations: Patients should tell their healthcare provider if they are scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with AFINITOR.

Use in Pregnancy: It is not known if AFINITOR will harm an unborn baby. Women should use effective birth control while using AFINITOR and for 8 weeks after stopping treatment.

Common Side Effects: Common side effects of AFINITOR include mouth ulcers; feeling weak or tired; cough and shortness of breath; diarrhea; skin problems (such as rash, dry skin, and itching); nausea and vomiting; fever; loss of appetite; swelling of arms, hands, feet, ankles, face or other parts of the body; abnormal taste; inflammation of lining of the digestive system; headache; nose bleeds; and pain in arms and legs.

Patients should tell their healthcare provider if they have any side effect that bothers them or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information for AFINITOR



Sutent®, Rapamune® and Torisel® are registered trademarks of Pfizer Inc.
Nexavar® is a registered trademark of Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc.