Sirolimus Albumin (Fyarro) is a novel antineoplastic agent specifically indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Indications of Sirolimus Albumin (Fyarro)

Primary Indication

Sirolimus Albumin (Fyarro) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Applicable Tumor Types

Specifically targets malignant perivascular epithelioid cell tumor (PEComa).

Applicable to cases confirmed by histological diagnosis.

Disease Stage Requirements

Locally advanced unresectable type.

Metastatic lesions.

Patient Population

Limited to adult patients (18 years of age and older).

It is necessary to assess whether the patient is suitable for receiving systemic treatment.

Specifications and Properties of Sirolimus Albumin (Fyarro)

Dosage Form and Packaging

Dosage Form: Sterile lyophilized powder, which needs to be reconstituted before intravenous injection.

Specification: Single-dose vial, each containing 100 mg of sirolimus and approximately 850 mg of human albumin (including sodium caprylate and sodium acetyltryptophanate).

Appearance: White to yellow powder; after reconstitution, it forms a milky white homogeneous suspension with no visible particles.

Storage Conditions

Unopened Vials: Store under refrigeration (2°C–8°C), protected from light, and keep in the original packaging.

After Reconstitution:Can be stored under refrigeration (2°C–8°C) in the vial for 6 hours (the total cumulative refrigerated storage time shall not exceed 15 hours);

When placed in an infusion bag, it can be stored at room temperature (approximately 25°C) for 4 hours and must be protected from light.

Administration and Dosage of Sirolimus Albumin (Fyarro)

Recommended Dosing Regimen

Dose: 100 mg/m², administered as an intravenous infusion over 30 minutes on Day 1 and Day 8 of each 21-day cycle, until disease progression or unacceptable toxicity occurs.

Dose Adjustment

Adverse Reactions: Temporarily suspend, reduce the dose, or permanently discontinue administration based on the severity of adverse reactions (e.g., first dose reduction to 75 mg/m², second dose reduction to 56 mg/m²).

Patients with Hepatic Impairment: Dose reduction is required for patients with mild or moderate hepatic impairment (75 mg/m² or 56 mg/m², respectively); administration is contraindicated in patients with severe hepatic impairment.

Reconstitution and Administration Steps

Reconstitution: Slowly inject 20 mL of 0.9% Sodium Chloride Injection into the vial along the vial wall (avoid direct impact on the powder). Allow to stand for 5 minutes, then gently swirl until completely dissolved.

Infusion Preparation: Transfer the calculated dose to a PVC or polyolefin infusion bag; no dilution is required, and the infusion should be used immediately.

Precautions

Avoid using medical devices containing silicone oil to prevent the formation of protein fibers.

Inspect the suspension before infusion; discard it if particles, discoloration, or precipitation are observed.