Healthy cell PEComa cell Healthy cell Healthy cell

What is PEComa?

Advanced malignant PEComa is a certain type of cancer known as a soft tissue sarcoma.

The “PEC” in PEComa refers to perivascular epithelioid cells, which are the type of cells that make up the tumor. Sarcomas are a rare type of cancer that form in the bones and soft tissues, including fat, blood vessels, muscles, and nerves.

Malignant PEComas are tumors that are very aggressive and cause cancer that can spread throughout the body.

If a malignant PEComa is found in the early stages, it may be surgically removed with no further treatment.

Locally advanced or metastatic malignant PEComa refers to PEComa that cannot be removed by surgery and/or has spread (metastasized) to other parts of the body.

PEComa
cell
Healthy
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Healthy cell

Malignant PEComas are tumors that are very aggressive and cause cancer that can spread throughout the body.

If a malignant PEComa is found in the early stages, it may be surgically removed with no further treatment.

Locally advanced or metastatic malignant PEComa refers to PEComa that cannot be removed by surgery and/or has spread (metastasized) to other parts of the body.

PEComa is rare

A very rare type of cancer

There is only about 1 case per year out of every million people. Malignant PEComas may be hard to diagnose because they are so rare, occur anywhere in the body, and often look like other types of cancer.


Who PEComa affects

PEComa affects both women and men

However, it is somewhat more common in women because it frequently starts in female reproductive organs such as the uterus.

Treatment goals

Treatment goals

There is no cure for advanced malignant PEComa, but it is treatable. In most cases, the main goal of treatment is to help shrink and control cancer growth as long as possible.

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PEComa=perivascular epithelioid cell tumor.

Indication

FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors in adult patients.

Important Safety Information

How is FYARRO taken?
FYARRO is administered by intravenous infusion into your vein over 30 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.

Who should not receive FYARRO?

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or human albumin. You should tell your health care provider before receiving FYARRO if you are allergic to sirolimus (Rapamune®), everolimus (Afinitor®), temsirolimus (Torisel®) or Human Albumin.

What are the possible side effects of FYARRO?

FYARRO can cause serious side effects, including the following:

Mouth ulcers and sores

Mouth ulcers and sores are common during treatment with FYARRO and can be severe. When you start treatment with FYARRO, your health care provider may also prescribe an alcohol-free mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your health care provider. Your health care provider may tell you to restart this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.

Decreased blood cell counts

FYARRO can cause you to have decreased red blood cells, platelets, and white blood cells. Your health care provider should do blood tests to check your blood cell counts before you start and during treatment with FYARRO.

Infections

Infections such as pneumonia, or a bacterial, fungal, or viral infection may develop while on treatment with FYARRO. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children), these infections may be severe and can lead to death. If infections occur, urgent treatment may be required. Tell your health care provider right away if you have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and swelling, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Low potassium

FYARRO can cause your blood potassium levels to fall. Low blood potassium levels can make you feel weak and can affect your heart rhythm if severe. Your health care provider should do blood tests to check your potassium levels before you start and during treatment with FYARRO.

Increased blood sugar and fat (cholesterol and triglyceride) levels in blood

Your health care provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment with FYARRO. Diabetic patients should monitor their fasting serum glucose more frequently.

Lung inflammation

FYARRO can cause inflammation of the lung. If you develop a persistent cough, chest pain, or shortness of breath, let your doctor know right away.

Bleeding

FYARRO can cause serious and sometimes fatal bleeding. If you develop bleeding, let your doctor know right away.

Severe allergic reactions

Call your health care provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness.

Harm to an unborn child

FYARRO can cause harm to your unborn baby. For women who are able to become pregnant, your health care provider will give you a pregnancy test before you start treatment with FYARRO. You should use effective birth control during treatment and for 12 weeks after your last dose of FYARRO. Men with a female partner should use effective birth control during treatment and for 12 weeks after your last dose of FYARRO.

Infertility

FYARRO may affect fertility in woman and men and may affect your ability to become pregnant if you are female, or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you.

Breastfeeding

Do not breastfeed during treatment and for 2 weeks after your last dose.

Vaccinations

You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO. If you are not sure about the type of vaccine, ask your health care provider.

Human albumin

Human serum albumin (HSA), an ingredient in FYARRO, is made from human blood. The blood donors for HSA are checked for infections and the HSA is processed to get rid of germs in the product. Because of these steps, HSA carries only an extremely small risk for transmission of viral diseases and “mad cow” disease, also called variant Creutzfeldt-Jakob disease (vCJD). No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin.

The most common side effects with FYARRO include the following:

  • Mouth ulcers or sores
  • Feeling weak or tired
  • Rash
  • Infection
  • Nausea
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Diarrhea
  • Body pain
  • Decreased weight
  • Decreased appetite
  • Cough
  • Vomiting
  • Altered taste

Other possible side effects that may occur with FYARRO:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual period. Tell your health care provider if this happens

What should I tell my health care provider before taking FYARRO?

Before taking FYARRO, tell your health care provider about all 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

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take the following:

• St John’s wort (Hypericum perforatum)
• Medicine for:
  — Fungal infections
  — Bacterial infections
  — Tuberculosis
  — Seizures
  — HIV-AIDS
  — Heart conditions or high blood pressure

  • Medicines that weaken the immune system (your body’s ability to fight infections and other diseases)

Ask your health care 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 health care provider might need to prescribe a different medicine or your dose of FYARRO may need to be changed. Tell your health care provider before you start taking any new medicine.

What should I do if I receive FYARRO from my health care provider?

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

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

These are not all the possible side effects of FYARRO. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

The risk information provided here is not comprehensive. To learn more, talk about FYARRO with your health care provider or pharmacist. The FDA-approved product labeling can be found at www.FYARRO.com or 1-888-BIO-AADI.

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.

Indication

FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors in adult patients.

Indication
Important Safety Information

How is FYARRO taken?
FYARRO is administered by intravenous infusion into your vein over 30 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.

Who should not receive FYARRO?

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or human albumin. You should tell your health care provider before receiving FYARRO if you are allergic to sirolimus (Rapamune®), everolimus (Afinitor®), temsirolimus (Torisel®) or Human Albumin.

What are the possible side effects of FYARRO?

FYARRO can cause serious side effects, including the following:

Mouth ulcers and sores

Mouth ulcers and sores are common during treatment with FYARRO and can be severe. When you start treatment with FYARRO, your health care provider may also prescribe an alcohol-free mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your health care provider. Your health care provider may tell you to restart this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.

Decreased blood cell counts

FYARRO can cause you to have decreased red blood cells, platelets, and white blood cells. Your health care provider should do blood tests to check your blood cell counts before you start and during treatment with FYARRO.

Infections

Infections such as pneumonia, or a bacterial, fungal, or viral infection may develop while on treatment with FYARRO. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children), these infections may be severe and can lead to death. If infections occur, urgent treatment may be required. Tell your health care provider right away if you have a temperature of 100.5°F or above, have chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and swelling, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Low potassium

FYARRO can cause your blood potassium levels to fall. Low blood potassium levels can make you feel weak and can affect your heart rhythm if severe. Your health care provider should do blood tests to check your potassium levels before you start and during treatment with FYARRO.

Increased blood sugar and fat (cholesterol and triglyceride) levels in blood

Your health care provider should do blood tests to check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment with FYARRO. Diabetic patients should monitor their fasting serum glucose more frequently.

Lung inflammation

FYARRO can cause inflammation of the lung. If you develop a persistent cough, chest pain, or shortness of breath, let your doctor know right away.

Bleeding

FYARRO can cause serious and sometimes fatal bleeding. If you develop bleeding, let your doctor know right away.

Severe allergic reactions

Call your health care provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness.

Harm to an unborn child

FYARRO can cause harm to your unborn baby. For women who are able to become pregnant, your health care provider will give you a pregnancy test before you start treatment with FYARRO. You should use effective birth control during treatment and for 12 weeks after your last dose of FYARRO. Men with a female partner should use effective birth control during treatment and for 12 weeks after your last dose of FYARRO.

Infertility

FYARRO may affect fertility in woman and men and may affect your ability to become pregnant if you are female, or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you.

Breastfeeding

Do not breastfeed during treatment and for 2 weeks after your last dose.

Vaccinations

You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO. If you are not sure about the type of vaccine, ask your health care provider.

Human albumin

Human serum albumin (HSA), an ingredient in FYARRO, is made from human blood. The blood donors for HSA are checked for infections and the HSA is processed to get rid of germs in the product. Because of these steps, HSA carries only an extremely small risk for transmission of viral diseases and “mad cow” disease, also called variant Creutzfeldt-Jakob disease (vCJD). No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin.

The most common side effects with FYARRO include the following:

  • Mouth ulcers or sores
  • Feeling weak or tired
  • Rash
  • Infection
  • Nausea
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Diarrhea
  • Body pain
  • Decreased weight
  • Decreased appetite
  • Cough
  • Vomiting
  • Altered taste

Other possible side effects that may occur with FYARRO:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual period. Tell your health care provider if this happens

What should I tell my health care provider before taking FYARRO?

Before taking FYARRO, tell your health care provider about all 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

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take the following:

  • St John’s wort (Hypericum perforatum)
  • Medicine for:
      — Fungal infections
      — Bacterial infections
      — Tuberculosis
      — Seizures
      — HIV-AIDS
      — Heart conditions or high blood pressure
  • Medicines that weaken the immune system (your body’s ability to fight infections and other diseases)

Ask your health care 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 health care provider might need to prescribe a different medicine or your dose of FYARRO may need to be changed. Tell your health care provider before you start taking any new medicine.

What should I do if I receive FYARRO from my health care provider?

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

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

These are not all the possible side effects of FYARRO. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

The risk information provided here is not comprehensive. To learn more, talk about FYARRO with your health care provider or pharmacist. The FDA-approved product labeling can be found at www.FYARRO.com or 1-888-BIO-AADI.

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.

Indication

FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumors in adult patients.