National Comprehensive Cancer Network® (NCCN®) preferred
  |   The only preferred regimen for malignant PEComa (locally advanced unresectable or metastatic disease)1*
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  • About
    PEComa
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About PEComa

Mechanism of Action

AMPECT Study
Efficacy Data

Safety

Dosing Schedule
Dose Modifications
Adverse Reaction Management
Drug Interaction Recommendations

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FYARRO is the
FIRST AND ONLY
treatment that can...

GO DEEP

FOR DURABLE RESPONSES

FYARRO is the
FIRST AND ONLY
treatment that can...

GO DEEP

FOR DURABLE RESPONSES

Taking the fight to malignant PEComa with nanoparticle technology, FYARRO penetrates tumors for powerful responses that last

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*ALL NCCN recommendations for malignant PEComa are category 2A.1 NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

PEComa=perivascular epithelioid cell tumor.

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed January 24, 2023. To view the most recent and complete version of the guidelines, go to NCCN.org.

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*ALL NCCN recommendations for malignant PEComa are category 2A.1 NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.

PEComa=perivascular epithelioid cell tumor.

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed January 24, 2023. To view the most recent and complete version of the guidelines, go to NCCN.org.

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This site is intended for U.S. healthcare professionals.

Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Important Safety Information

Contraindication

History of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.

Warnings and Precautions

FYARRO can cause serious adverse reactions. Withhold, resume at reduced dose, or permanently discontinue FYARRO based on severity (See Dosage and Administration of full Prescribing Information).

Stomatitis: Stomatitis, including mouth ulcers and oral mucositis, occurred in 79% of patients, including 18% Grade 3.

Myelosuppression: FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated.

Infections: FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor for signs and symptoms of infection.

Hypokalemia: FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients, including 12% Grade 3 events. Monitor serum potassium prior to starting FYARRO and supplement potassium as medically indicated.

Hyperglycemia: FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor more frequently in diabetic patients.

Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis: FYARRO can cause ILD/non-infectious pneumonitis, which occurred in 18% of patients, all Grades 1 or 2. Monitor for new or worsening respiratory symptoms or radiological changes.

Hemorrhage: FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor for signs and symptoms.

Hypersensitivity Reactions: FYARRO can cause hypersensitivity reactions, including anaphylaxis. Anaphylaxis, angioedema, exfoliative dermatitis and hypersensitivity vasculitis have been observed with use of oral sirolimus. Monitor for hypersensitivity during and following each FYARRO infusion. Monitor for at least 2 hours following completion of the first infusion and as clinically indicated for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue based on severity.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception while using FYARRO and for 12 weeks after the last dose.

Male Infertility: Azoospermia or oligospermia may occur.

Immunizations: Avoid live vaccines.

Adverse Reactions

The most common (≥30%) adverse reactions were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia.

The most common (≥6%) Grade 3 to 4 laboratory abnormalities were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase.

Drug Interactions

Strong CYP3A4 and/or P-gp Inhibitors or Inducers: Avoid concomitant use.

Moderate or Weak CYP3A4 Inhibitors: Reduce FYARRO dose.

Use in Specific Populations

Hepatic Impairment: Reduce the dose of FYARRO in patients with mild or moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

Lactation: Advise not to breastfeed.

Females and Males of Reproductive Potential: May impair fertility in females and males.

Please see full Prescribing Information.

Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

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FYARRO® is a registered trademark of Aadi Bioscience, Inc.

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© 2023 Aadi Bioscience, Inc. All rights reserved. US-FYA-2300007 3/23

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Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Important Safety Information

Contraindication

History of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.

Warnings and Precautions

FYARRO can cause serious adverse reactions. Withhold, resume at reduced dose, or permanently discontinue FYARRO based on severity (See Dosage and Administration of full Prescribing Information).

Stomatitis: Stomatitis, including mouth ulcers and oral mucositis, occurred in 79% of patients, including 18% Grade 3.

Myelosuppression: FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated.

Infections: FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor for signs and symptoms of infection.

Hypokalemia: FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients, including 12% Grade 3 events. Monitor serum potassium prior to starting FYARRO and supplement potassium as medically indicated.

Hyperglycemia: FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor more frequently in diabetic patients.

Interstitial Lung Disease (ILD)/Non-Infectious Pneumonitis: FYARRO can cause ILD/non-infectious pneumonitis, which occurred in 18% of patients, all Grades 1 or 2. Monitor for new or worsening respiratory symptoms or radiological changes.

Hemorrhage: FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor for signs and symptoms.

Hypersensitivity Reactions: FYARRO can cause hypersensitivity reactions, including anaphylaxis. Anaphylaxis, angioedema, exfoliative dermatitis and hypersensitivity vasculitis have been observed with use of oral sirolimus. Monitor for hypersensitivity during and following each FYARRO infusion. Monitor for at least 2 hours following completion of the first infusion and as clinically indicated for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue based on severity.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential hazard to the fetus and to use effective contraception while using FYARRO and for 12 weeks after the last dose.

Male Infertility: Azoospermia or oligospermia may occur.

Immunizations: Avoid live vaccines.

Adverse Reactions

The most common (≥30%) adverse reactions were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia.

The most common (≥6%) Grade 3 to 4 laboratory abnormalities were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase.

Drug Interactions

Strong CYP3A4 and/or P-gp Inhibitors or Inducers: Avoid concomitant use.

Moderate or Weak CYP3A4 Inhibitors: Reduce FYARRO dose.

Use in Specific Populations

Hepatic Impairment: Reduce the dose of FYARRO in patients with mild or moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

Lactation: Advise not to breastfeed.

Females and Males of Reproductive Potential: May impair fertility in females and males.

Please see full Prescribing Information.

Indication

FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).