Fyarro (Sirolimus Albumin-bound) 100mg Injection | PEComa | GLT

Generic Information: Fyarro (Sirolimus Albumin-bound) — Injectable Suspension

Fyarro is the brand name of sirolimus protein-bound particles for injectable suspension (albumin-bound), developed and marketed by Aadi Bioscience, Inc. This page covers the 100 mg single-dose vial, supplied as a sterile lyophilized powder for reconstitution. Fyarro is a distinct intravenous formulation of sirolimus — not the oral tablet used in transplantation — engineered as albumin-bound nanoparticles to deliver the drug directly into the bloodstream. It was approved by the U.S. FDA in November 2021 as the first and only treatment specifically indicated for malignant PEComa, an ultra-rare sarcoma, and has been added to the NCCN Guidelines as the preferred regimen for this disease.

What Is Fyarro (Sirolimus Albumin-bound) Used For?

Fyarro is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Malignant PEComa is an ultra-rare soft-tissue sarcoma that frequently harbors alterations in the TSC1 or TSC2 genes, leading to activation of the mTOR pathway — which makes sirolimus a rational and effective target. Before Fyarro, there was no FDA-approved therapy specific to this disease. The approval was based on the AMPECT trial, which demonstrated meaningful antitumor activity in this previously untreatable population.

How Does Fyarro (Sirolimus Albumin-bound) Work?

Fyarro delivers sirolimus bound to albumin nanoparticles, which are taken up by tumor tissue and release the drug to inhibit mTOR. Malignant PEComa cells frequently carry TSC1 or TSC2 mutations that keep the mTOR pathway switched on, driving uncontrolled cell growth and survival. By inhibiting mTOR, sirolimus shuts down this oncogenic signaling, slowing tumor growth and, in many patients, producing durable tumor shrinkage. The albumin-bound formulation allows intravenous administration and enhances drug delivery compared with the oral formulation.

Indications

Fyarro is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). It is the first and only FDA-approved therapy specific to this ultra-rare sarcoma.

Dosage

The recommended dosage of Fyarro is 100 mg/m² administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, until disease progression or unacceptable toxicity. Patients are monitored for at least 2 hours after the first infusion. Premedication may be given to reduce infusion reactions, and dose reductions are applied for adverse reactions such as stomatitis, myelosuppression, or infections.

Side Effects

The most common adverse reactions (in at least 30% of patients) include stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, and musculoskeletal pain. Stomatitis occurred in a majority of patients and was the most frequent reason for dose modification. Serious risks include myelosuppression, infections, hypokalemia, hyperglycemia, and interstitial lung disease. Blood counts, potassium, and glucose should be monitored before and during treatment.

Storage

Store Fyarro vials refrigerated at 2–8°C in the original carton, protected from light. The lyophilized powder is reconstituted before use, and the reconstituted suspension should be administered promptly according to the prescribing information.

Why Choose the GLT?

Fyarro is an orphan-designated therapy for an ultra-rare cancer, and its United States list price reflects that rarity. For patients and institutions seeking access to this first-in-class treatment for malignant PEComa, sourcing through a Hong Kong-licensed supplier such as GLT provides a verified channel with full batch documentation and transparent availability. Given that malignant PEComa affects only a few hundred patients annually in the United States and has historically lacked any approved therapy, reliable access to Fyarro can be a decisive factor in a patient's treatment plan.

How to Order Fyarro (Sirolimus Albumin-bound)

To order Fyarro, contact our team on WhatsApp at +86 15234153837 or by email at [email protected]. Please share the required quantity and your destination country so we can confirm availability, documentation, and delivery terms.

FAQ

Is Fyarro the same as oral sirolimus? No. Fyarro is a distinct albumin-bound intravenous formulation of sirolimus, developed specifically for malignant PEComa, not the oral tablet used in transplantation.

Who makes Fyarro? Fyarro is developed and marketed by Aadi Bioscience, Inc., a U.S. biopharmaceutical company focused on mTOR-driven cancers.

What is malignant PEComa? Malignant PEComa is an ultra-rare soft-tissue sarcoma that often carries TSC1 or TSC2 mutations, which activate the mTOR pathway and make it sensitive to sirolimus.

How is Fyarro given? It is given by intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.