What should I know before starting FYARRO?

 

Before you begin treatment with FYARRO, it is important to know about the possible side effects and precautions so that you can be prepared to address them with your doctor if they occur. Contact your doctor immediately if you have any side effects.

PEComa patient portrayal PEComa patient portrayal

During your treatment journey, you may experience the following:

Stomatitis

Stomatitis (mouth ulcers and sores) are common during treatment with FYARRO and can be severe. Your doctor may also prescribe an alcohol-free mouthwash to help treat mouth sores

Thrombocytopenia

Thrombocytopenia (low blood platelets) and low blood cell counts including anemia (low red blood cell count) and neutropenia (low white blood cell count) may occur. Your doctor will perform periodic blood tests to check for potential side effects of FYARRO

Infection

Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well

Hypokalemia

Hypokalemia (low levels of potassium) and hyperglycemia (too much sugar in the blood) are possible during treatment with FYARRO

Lung

Inflammation of the lungs. Report any new or worsening respiratory symptoms to your doctor right away, such as trouble breathing

Hemorrhage

Hemorrhage (severe bleeding). If you experience bleeding, call your doctor right away

Allergy

Allergic reaction (hypersensitivity). Contact your doctor or seek emergency care for any signs of an allergic reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness

Pregnancy

Pregnancy should be avoided during treatment with FYARRO due to the risk of fetal harm. Women and men should use contraception during treatment with FYARRO and for 12 weeks after the last dose. Tell your doctor if you suspect or know you've become pregnant. Women should not breastfeed while receiving FYARRO. Fertility issues including difficulty getting pregnant for both females and males may occur

Vaccine

Vaccines may not work as well if you are receiving FYARRO. The use of live vaccines or close contact with other people who have received a live vaccine should be avoided

What are the potential side effects of FYARRO?

doctor

Be sure to tell a doctor right away about any side effects you may be experiencing with FYARRO. In some cases, side effects may be serious—in the AMPECT study, 41% of patients experienced serious adverse reactions. Serious side effects are those that are life-threatening, require or extend a hospitalization, or result in disability, permanent damage, or a birth defect.

The most common side effects with FYARRO were:

Most common side effects

Stomatitis (mouth ulcers and sores)

Most common side effects

Fatigue (tiredness)

Most common side effects

Rash

Most common side effects

Infection

Most common side effects

Nausea

Most common side effects

Edema (swelling)

Most common side effects

Diarrhea

Most common side effects

Musculoskeletal pain

Most common side effects

Decreased weight

Most common side effects

Decreased appetite

Most common side effects

Cough

Most common side effects

Vomiting

Most common side effects

Dysgeusia (altered taste)

These are not all of the potential side effects of FYARRO. Talk to your doctor for more information and advice.

Managing side effects

Good to know

Managing side effects

Some side effects may require your doctor to decrease the dose of FYARRO or skip one or more doses until the side effect goes away. You and your doctor may also choose to stop treatment with FYARRO if you are having side effects and/or are not seeing results with FYARRO

*FYARRO is not for everyone. Talk to your doctor to see if FYARRO may be right for you.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.

IMPORTANT SAFETY INFORMATION

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or other medications that work similarly to sirolimus (eg, everolimus, temsirolimus), or human albumin.

FYARRO can cause the following serious side effects; depending on the severity, your doctor may decide to decrease your dose or stop treatment with FYARRO:

  • Mouth ulcers and sores are common during treatment with FYARRO and can be severe. If you develop pain, discomfort, or open sores in your mouth, tell your doctor.
  • Decreased blood cell counts (red blood cells, platelets, and white blood cells). Your doctor should do blood tests before you start and during treatment with FYARRO.
  • Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well.
  • Low potassium, which can affect your heart rhythm if severe. Your doctor should do blood tests to check your potassium levels before you start and during treatment with FYARRO.
  • Increased blood sugar levels in blood. Your doctor should do blood tests before you start and during treatment with FYARRO. Diabetic patients should monitor their blood sugar more frequently.
  • Lung inflammation. If you develop a persistent cough, chest pain, or shortness of breath, tell your doctor right away.
  • Bleeding, which can lead to death. If you develop bleeding, tell your doctor right away.
  • Allergic reactions, which can be severe and life-threatening. Tell your doctor or get medical help right away if you develop swelling of your face, lips, tongue, or throat; a rash, itching, or flushing of your skin; hives; difficulty breathing or swallowing; chest pain; or dizziness.
  • Harm to an unborn baby. Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with FYARRO. Exposure to FYARRO during pregnancy or within 12 weeks before becoming pregnant can cause harm to your baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with FYARRO. Birth control should be used while receiving FYARRO 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 the last dose of FYARRO.
  • Infertility in woman and men. FYARRO may affect your ability to become pregnant if you are female, or your ability to father a child if you are male.
  • Vaccinations may be less effective while being treated with FYARRO. In addition, you should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO.

Before taking FYARRO, tell your doctor if you are breast feeding. It is not known if FYARRO could pass into breast milk and harm your baby. You should not breast feed during treatment with FYARRO and for 2 weeks after the last dose. Tell your doctor about all your medical conditions and the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Tell your doctor before you start taking any new medicine. 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.

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 and appetite; cough; vomiting; and altered taste.

These are not all the possible side effects of FYARRO. Tell your doctor if you have any side effect that bothers you 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.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.

INDICATION
IMPORTANT SAFETY INFORMATION

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or other medications that work similarly to sirolimus (eg, everolimus, temsirolimus), or human albumin.

FYARRO can cause the following serious side effects; depending on the severity, your doctor may decide to decrease your dose or stop treatment with FYARRO:

  • Mouth ulcers and sores are common during treatment with FYARRO and can be severe. If you develop pain, discomfort, or open sores in your mouth, tell your doctor.
  • Decreased blood cell counts (red blood cells, platelets, and white blood cells). Your doctor should do blood tests before you start and during treatment with FYARRO.
  • Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well.
  • Low potassium, which can affect your heart rhythm if severe. Your doctor should do blood tests to check your potassium levels before you start and during treatment with FYARRO.
  • Increased blood sugar levels in blood. Your doctor should do blood tests before you start and during treatment with FYARRO. Diabetic patients should monitor their blood sugar more frequently.
  • Lung inflammation. If you develop a persistent cough, chest pain, or shortness of breath, tell your doctor right away.
  • Bleeding, which can lead to death. If you develop bleeding, tell your doctor right away.
  • Allergic reactions, which can be severe and life-threatening. Tell your doctor or get medical help right away if you develop swelling of your face, lips, tongue, or throat; a rash, itching, or flushing of your skin; hives; difficulty breathing or swallowing; chest pain; or dizziness.
  • Harm to an unborn baby. Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with FYARRO. Exposure to FYARRO during pregnancy or within 12 weeks before becoming pregnant can cause harm to your baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with FYARRO. Birth control should be used while receiving FYARRO 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 the last dose of FYARRO.
  • Infertility in woman and men. FYARRO may affect your ability to become pregnant if you are female, or your ability to father a child if you are male.
  • Vaccinations may be less effective while being treated with FYARRO. In addition, you should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO.

Before taking FYARRO, tell your doctor if you are breast feeding. It is not known if FYARRO could pass into breast milk and harm your baby. You should not breast feed during treatment with FYARRO and for 2 weeks after the last dose. Tell your doctor about all your medical conditions and the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Tell your doctor before you start taking any new medicine. 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.

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 and appetite; cough; vomiting; and altered taste.

These are not all the possible side effects of FYARRO. Tell your doctor if you have any side effect that bothers you 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.

INDICATION

FYARRO® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is a prescription medicine used to treat adults with malignant perivascular epithelioid cell tumors (PEComa) that have spread to other parts of the body (metastatic) or cannot be removed by surgery (locally advanced, unresectable). It is not known if FYARRO is safe and effective in people with severe liver problems or in children.