Sirolimus Protein-Bound Particles Injection

Sirolimus protein-bound particles (marketed as Fyarro), from Aadi Bioscience, are indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Sirolimus is an mTOR (mechanistic target of rapamycin) inhibitor. In PEComa, which is frequently driven by TSC1/TSC2 gene alterations leading to mTOR pathway activation, sirolimus blocks this pathway, slowing or stopping tumor cell growth. The nanoparticle albumin-bound (nab) formulation improves drug delivery to tumor tissue.

• Serious infections, including opportunistic infections, may occur due to immunosuppressive effects.
• Non-infectious pneumonitis has been reported; monitor for new or worsening respiratory symptoms.
• Impaired wound healing has been observed with mTOR inhibitors.
• Oral ulceration/stomatitis is commonly reported.
• Embryo-fetal toxicity — effective contraception is advised during and after treatment.

What documents are required to import Sirolimus protein-bound to India?

It may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered oncologist
• Diagnostic/pathology report confirming malignant PEComa diagnosis
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is it available in India?

Sirolimus protein-bound (Fyarro) is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source Fyarro (sirolimus protein-bound) from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA (as Fyarro) — November 2021.

What is Sirolimus protein-bound used for?

It treats locally advanced unresectable or metastatic malignant PEComa in adults.

Who manufactures it?

It is developed by Aadi Bioscience and marketed as Fyarro.

How is it administered?

By intravenous infusion, dosed per the treating oncologist’s protocol.

How much does it cost in India?

Cost depends on treatment cycles and sourcing logistics — share your prescription with IPN for a quote.