Fyarro(sirolimus) albumin, which was approved by the US Food and Drug Administration in November 2021, can be used to treat malignant perivascular epithelioid cell tumors. As an mTOR inhibitor, what precautions should be taken during treatment?
Precautions for Fyarro(sirolimus) Albumin (Fyarro)?
1. Stomatitis
Patients treated with Fyarro(sirolimus) Albumin (Fyarro) may develop stomatitis, including oral ulcers and oral mucositis. Depending on the severity of the adverse reaction, the medication should be suspended, the dose should be reduced, or Fyarro(sirolimus) albumin should be permanently discontinued.
2. Bone marrow suppression
Fyarro(sirolimus) albumin can cause bone marrow suppression, including anemia, thrombocytopenia, and neutropenia. Check blood cell counts at baseline and every 2 months in the first year of treatment, and every 3 months during subsequent treatment. If clinically indicated, the frequency of examinations can be increased, and depending on the severity of the adverse reaction, the medication should be suspended, the dose should be reduced, or Fyarro(sirolimus) albumin should be permanently discontinued.
3. Infections
Fyarro(sirolimus) albumin can cause infections. Patients should be monitored for infections, including opportunistic infections. Depending on the severity of the adverse reaction, Fyarro(sirolimus) albumin should be suspended, the dose should be reduced, or it should be permanently discontinued.
4. Hypokalemia
(1) Fyarro(sirolimus) albumin can cause hypokalemia. Potassium levels should be monitored before starting use and potassium should be supplemented as medically indicated.
(2) Depending on the severity of the adverse reaction, Fyarro(sirolimus) albumin should be suspended, the dose should be reduced, or it should be permanently discontinued.
5. Hyperglycemia
(1) Fyarro(sirolimus) albumin (Fyarro) can cause hyperglycemia. Fasting blood glucose should be monitored before starting Fyarro(sirolimus) albumin.
(2) During treatment, non-diabetic patients should monitor blood glucose every 3 months or as clinically needed. Diabetic patients should monitor blood glucose more frequently.
(3) Depending on the severity of the adverse reaction, Fyarro(sirolimus) albumin should be suspended, the dose should be reduced, or it should be permanently discontinued.
6. Interstitial lung disease/non-infectious pneumonia
Fyarro(sirolimus) albumin can cause interstitial lung disease (ILD)/non-infectious pneumonia. Depending on the severity of the adverse reaction, Fyarro(sirolimus) albumin should be suspended, the dose should be reduced, or it should be permanently discontinued.
7. Bleeding
Fyarro(sirolimus) albumin (Fyarro) can cause severe, sometimes fatal bleeding. Patients should be monitored for signs and symptoms of bleeding and, depending on the severity of the adverse reaction, Fyarro(sirolimus) albumin should be suspended, the dose should be reduced, or it should be permanently discontinued.
8. Allergic reactions
(1)Fyarro(sirolimus) albumin can cause allergic reactions. Allergic reactions, including anaphylaxis, angioedema, exfoliative dermatitis, and allergic vasculitis, may occur after taking oral Fyarro(sirolimus). Hypersensitivity reactions, including anaphylaxis, have been observed when human albumin is used.
(2) In an environment with cardiopulmonary resuscitation drugs and equipment, closely monitor patients for signs and symptoms of infusion reactions during and after each Fyarro(sirolimus) albumin infusion. Monitor patients for at least 2 hours after the first infusion and monitor each subsequent infusion as clinically necessary.
(3) Depending on the severity, suspend, reduce, or permanently discontinue Fyarro(sirolimus) albumin and administer appropriate medical treatment as needed.
