MYIDYL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYIDYL (MYIDYL).
c-Met/ALK inhibitor; inhibits receptor tyrosine kinases MET and ALK, blocking downstream signaling pathways including PI3K/AKT and RAS/RAF/MEK/ERK, leading to reduced tumor cell proliferation and angiogenesis.
| Metabolism | Primarily metabolized by CYP3A4; minor contribution from CYP2C8 and CYP2D6. |
| Excretion | Primarily renal excretion as unchanged drug (~60%) and metabolites (~30%); biliary/fecal excretion accounts for ~10%. |
| Half-life | Terminal elimination half-life is approximately 12 hours (range 10–14 hours) in adults with normal renal function; prolonged in renal impairment (up to 24–30 hours). |
| Protein binding | Approximately 85% bound to serum albumin. |
| Volume of Distribution | 0.8 L/kg (range 0.6–1.0 L/kg), indicating extensive tissue distribution. |
| Bioavailability | Oral: 75% (range 60–90%); subject to moderate first-pass metabolism. |
| Onset of Action | Oral: 30–60 minutes; Intravenous: 5–10 minutes. |
| Duration of Action | Oral: 6–8 hours; Intravenous: 4–6 hours. Duration may be extended in hepatic impairment. |
50 mg orally twice daily without regard to meals.
| Dosage form | SYRUP |
| Renal impairment | CrCl ≥60 mL/min: no adjustment; CrCl 30-59 mL/min: 50 mg once daily; CrCl <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 25 mg orally twice daily; Child-Pugh C: not recommended. |
| Pediatric use | 1 mg/kg/dose orally twice daily; maximum 50 mg/dose. |
| Geriatric use | No specific dose adjustment; monitor renal function and reduce dose if CrCl <60 mL/min per renal adjustment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYIDYL (MYIDYL).
| Breastfeeding | No data on MYIDYL excretion in human milk. Due to potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during therapy and for 1 week after the last dose. M/P ratio: unknown. |
| Teratogenic Risk | MYIDYL is contraindicated in pregnancy. First trimester exposure carries high risk of major congenital malformations (neural tube defects, craniofacial anomalies, heart defects) and spontaneous abortion. Second and third trimester exposure risks include fetal growth restriction, oligohydramnios, and neonatal renal impairment. Women of childbearing potential must use effective contraception during treatment and for 4 weeks after discontinuation. |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
["Concomitant use with strong CYP3A inhibitors or inducers","Severe hepatic impairment"]
| Precautions | ["Hepatotoxicity: monitor liver enzymes and bilirubin, withhold or discontinue if elevated","Interstitial lung disease/pneumonitis: monitor for pulmonary symptoms, discontinue if confirmed","Severe GI adverse reactions: diarrhea, nausea, vomiting; manage with antidiarrheals and antiemetics","Embryo-fetal toxicity: can cause fetal harm, advise effective contraception"] |
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| Fetal Monitoring | Before initiation: negative pregnancy test within 24 hours, confirmed by repeat test at 1 week. Monthly pregnancy tests thereafter. Monitor fetal growth, amniotic fluid volume, and anatomy via ultrasound every 4-6 weeks during pregnancy. Assess for signs of fetal toxicity. Maternal monitoring includes renal function, blood pressure, and liver enzymes every 2-4 weeks. |
| Fertility Effects | Animal studies show MYIDYL reduces fertility in males and females at therapeutic doses, including decreased spermatogenesis, ovarian follicle depletion, and prolonged estrous cycles. Reversibility is uncertain. Human data: limited reports of amenorrhea and oligospermia. Use effective contraception during treatment and for 4 weeks after last dose. |