Welcome to a website of Aadi Bioscience, Inc. (“Aadi”). By using the site, you agree to be bound by the following terms and all applicable laws and regulations. If you do not agree to these Terms of Use, you are not permitted to use the site. The information provided on this website is presented in summary form, is general in nature, and is provided for informational purposes only. The information on this site is intended only for the purpose of helping patients and family members better understand certain health conditions and treatment options. The content is not intended in any way to be a substitute for professional medical advice and should not be interpreted as treatment recommendations. Only a physician who has had an opportunity to interact with the patient in person, with access to the patient’s records and the opportunity to conduct appropriate follow-up, can provide recommendations for treatment.
Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Neither the content nor any other service offered by or through this website is intended to be relied on for medical diagnosis or treatment, without a physician’s interaction and involvement. Never disregard medical advice or delay in seeking it because of something you have read on this website.
THIS SITE AND THE CONTENT ARE PROVIDED “AS IS”. AADI, ITS LICENSORS, AND ITS SUPPLIERS, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD PARTIES’ RIGHTS, AND FITNESS FOR PARTICULAR PURPOSE. SPECIFICALLY, AADI, ITS LICENSORS, AND ITS SUPPLIERS MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS, CURRENTNESS, SUITABILITY OR TIMELINESS OF THE CONTENT, SOFTWARE, TEXT, GRAPHICS, TOOLS, LINKS, OR COMMUNICATIONS PROVIDED ON OR THROUGH THE USE OF THE WEBSITE OR AADI, OR ON ANY SITE OR SITES “LINKED” TO THIS SITE. AADI MAKES NO WARRANTY THAT THE SITE WILL BE AVAILABLE, UNINTERRUPTED, ERROR FREE, OR FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL AADI, ITS LICENSORS, ITS SUPPLIERS, OR ANY THIRD PARTIES MENTIONED ON THE WEBSITE BE LIABLE FOR ANY DAMAGES (INCLUDING, WITHOUT LIMITATION, INCIDENTAL AND CONSEQUENTIAL DAMAGES, PERSONAL INJURY/WRONGFUL DEATH, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION) RESULTING FROM THE USE OR INABILITY TO USE THE WEBSITE OR THE CONTENT OR ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, EFFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, LINE SYSTEM FAILURE, LOSS OF DATA, OR LOSS OF USE RELATED TO THE SITE OR ANY WEB SITE OPERATED BY ANY THIRD PARTY, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT AADI IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IF YOU ARE DISSATISFIED WITH US, ANY OF OUR SERVICES OR THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USE OF THE SITE.
Any claims arising in connection with your use of the site or any content must be brought within one (1) year of the date of the event giving rise to such action occurred.
As a resource to our visitors, this site provides links to other web sites. However, because we do not control the content of the other websites we may link to, and due to their constantly changing nature, we cannot be responsible for the content, practices or standards of third-party sites. Aadi does not endorse the content on any third-party websites. Aadi is not responsible for the content of linked third-party sites, sites framed within the site, or third-party advertisements, and does not make any representations regarding their content or accuracy. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.
Everything that you read or see on the site is copyrighted or otherwise protected and owned by the Aadi or a third party who licensed or granted to Aadi the right to use such material. Unless otherwise expressly noted, nothing that you read or see on the site may be copied or used except as provided in these Terms of Use or with the prior written approval of Aadi.
We grant you permission to print individual pages from the site, unless otherwise expressly noted, for your own personal, non-commercial use in learning about the services or products offered by Aadi or for your non-commercial use in connection with health care or education. If you are a health care professional or provider, you may print individual pages from the site, unless otherwise expressly noted, and share the information and materials with others. No other permission is granted to you to print, copy, reproduce, distribute, license, transfer, sale, transmit, upload, download, store, display in public, alter, modify or create derivative works of these materials. This grant of permission is not a transfer of title, and under this permission you may not:
We make no warranties or representations to you that your use of any materials displayed on the site will not infringe the rights of third parties.
Unless otherwise indicated, all logos, names, designs, and marks on the site are trademarks or service marks owned or used under license by Aadi. The use or misuse of any of these marks or other information is strictly prohibited. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of Aadi or any third party.
Except as expressly provided above nothing contained herein shall be construed as conferring any license or right under any Aadi copyright. Except as expressly set forth on the site, if you submit any information to us, including any comments, remarks, suggestions, ideas, notes, drawings, graphics, concepts, or other information, you are giving that information, and all your rights in it, to Aadi free of charge and such information shall be deemed to be non-confidential and Aadi shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose and distribute the information to others without limitation, without your consent or any compensation to you or anyone else. Aadi shall be free to use any know-how or techniques contained in such information for any purpose whatsoever including but not limited to developing, manufacturing and marketing products incorporating such information. This is true whether you submit such information to us by email, through a form on the site, on a bulletin board, or in any other manner. Aadi may from time to time monitor, review and, in its sole discretion, modify or delete any postings you make on the site however, Aadi is not obligated to do so.
You agree not to submit or transmit any material that is unlawful, threatening, libelous, defamatory, obscene, pornographic, profane, or might in any other way violate any law, regulation, or rule. You are solely responsible for any material you submit to the site. You further agree not to upload, email, post or transmit to, or distribute or otherwise publish through the site any material which disrupts the normal operation of the site, including posting or otherwise transmitting material that is not related to the subject at issue or otherwise restricts or inhibits any other user from using the site. Through your usage of the site, you may submit and/or Aadi may gather certain limited information about you and your web site usage. We are free to use such information for any purpose we deem appropriate, including marketing purposes.
To obtain full access to the site, you may be required to complete a registration. You are responsible for maintaining the confidentiality of your account and password and for restricting access to your computer. You accept responsibility for all activities that occur under your account or password and such use shall be deemed to be use by you. You will ensure that all use of your account fully complies with these Terms of Use. Transfer of the account by you to any other person or entity is prohibited.
When using the site, information will be transmitted over a medium that is beyond the control and jurisdiction of Aadi and its suppliers. Accordingly, Aadi assumes no liability for or relating to the delay, failure, interruption, or corruption of any data or other information transmitted in connection with use of this site.
Aadi is located in Pacific Palisades, California, in the United States of America (USA). This site is intended for the exclusive use of residents of the USA. Aadi makes no representation that the materials on the site are appropriate or available for use in other locations. Access to the content may not be legal by certain persons or in certain countries outside of the USA. If you access this site from outside the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction.
These Terms of Use are governed by the internal substantive laws of the State of California, without resort to its conflict of laws principles. If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use. You expressly agree that exclusive jurisdiction for any dispute with Aadi, or in any way relating to your use of this site, resides in the courts of the State of California. Aadi may modify these Terms of Use at any time without notice to you. Aadi may terminate this agreement, terminate your access to all or part of the site, or suspend any user’s access to all or part of the site, at any time, without notice to you, if it believes, in its sole judgment, that you have breached or may breach any term or condition of this agreement, or for its convenience. You may terminate this agreement at any time by destroying all materials received from the site and ceasing to use the site.
Except as expressly provided in a particular “legal notice” on this site, these Terms of Use constitute the entire agreement between you and Aadi with respect to the use of this site, and content. Your use of this site is also subject to the Privacy Statement on this website.
FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Contraindications
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.
FYARRO® is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
This site is intended for U.S. audiences.
FYARRO® is a registered trademark of Aadi Bioscience, Inc.
All other trademarks are property of their respective owners.
© 2024 Aadi Bioscience, Inc. All rights reserved. US-FYA-2300127 1/24