Fyarro Generic Name & Formulations
Sirolimus protein-bound particles [albumin-bound] 100mg; per vial; lyophilized pwd for IV infusion after reconstitution.
mTOR kinase inhibitor.
Locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Fyarro Dosage and Administration
Give by IV infusion over 30mins. 100mg/m2 on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. Mild hepatic impairment (total bilirubin ≤ULN, AST >ULN or total bilirubin >1–1.5×ULN, any AST): reduce to 75mg/m2. Moderate hepatic impairment (total bilirubin >1.5–3.0×ULN, any AST), concomitant moderate or weak CYP3A4 inhibitors: reduce to 56mg/m2. Dosage modifications for adverse reactions: see full labeling.
Hypersensitivity to other rapamycin derivatives or albumin.
Fyarro Boxed Warnings
Have cardiopulmonary resuscitation medication and equipment readily available. Monitor for infusion reactions at least 2hrs after the 1st infusion, during and after each subsequent infusion as clinically needed. Withhold, resume at reduced dose, or permanently discontinue based on severity and type of adverse reaction. Obtain CBCs at baseline, every 2 months for the 1st year of treatment, and every 3 months thereafter, or more frequently if clinically indicated. Monitor K+ levels prior to initiation; give K+ supplementation as medically indicated. Monitor fasting serum glucose prior to initiation, every 3 months during therapy, or as clinically indicated (more frequently in diabetics). Update vaccinations according to current guidelines prior to initiation. Avoid close contact with those who have received live vaccines during treatment. Risk for transmission of infectious agents (eg, viral diseases, Creutzfeldt-Jakob Disease). Severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise to use effective contraception during and for 12 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Concomitant live vaccines: not recommended. Avoid concomitant strong CYP3A4 and/or P-gp inhibitors and inducers, grapefruit, or grapefruit juice. Concomitant moderate or weak CYP3A4 inhibitors: reduce Fyarro dose (see Adult). Antagonized by moderate or weak CYP3A4 inducers.
Fyarro Adverse Reactions
Stomatitis, fatigue, rash, infection (monitor), nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, dysgeusia, lab abnormalities (decreased lymphocytes, increased glucose, decreased K+, decreased phosphate, decreased hemoglobin, increased lipase); myelosuppression, interstitial lung disease (ILD)/non-infectious pneumonitis, hemorrhage (monitor), hypersensitivity reactions, azoospermia, oligospermia.
Fyarro Clinical Trials
Fyarro Patient Counseling