Name: Lirafugratinib (Lyrfigtu) in Previously treated FGFR2 fusion or rearrangement-positive cholangiocarcinoma: Dosage
Published: 2026-09-27T09:44:05-04:00

Product information and disease description Product description Product information Dosing and administration

Dosage

6 evidence topics · 2 sources

Recommended dosage

“The recommended dosage of LYRFIGTU is 70 mg orally once daily until disease progression or unacceptable toxicity.” (opens the prescribing information at this quote)

“The first part of the trial, or the dose escalation, is complete, and the second part of the trial, or the dose expansion, is ongoing at the 70mg once daily recommended Phase 2 dose.” (opens the source at this quote in a new tab)

Dose reductions for adverse reactions

Dose reduction	Dosage
First	“50 mg once daily”
Second	“40 mg once daily”
Third	“30 mg once daily”
Fourth	“20 mg once daily”

“Permanently discontinue LYRFIGTU if the patient is unable to tolerate 20 mg once daily.” (opens the prescribing information at this quote)

Dose modification for retinal pigment epithelial detachment

“Continue LYRFIGTU at the current dose and continue periodic ophthalmic evaluation” (opens the prescribing information at this quote)
“Withhold LYRFIGTU until resolution, then resume at 1 dose level lower” (opens the prescribing information at this quote)
“Withhold LYRFIGTU until resolution, then resume at 2 dose levels lower” (opens the prescribing information at this quote)

Dose modification for other adverse reactions

Severity	Dosage modification
“Grade 3”	“Withhold LYRFIGTU until toxicity resolves to Grade ≤1 or baseline, then resume LYRFIGTU at 1 dose level lower.”
“Grade 3”	“If Grade 3 toxicity recurs, withhold LYRFIGTU until toxicity resolves to Grade ≤1 or baseline, then resume at 1 dose level lower or permanently discontinue LYRFIGTU.”
“Grade 4”	“Withhold LYRFIGTU until toxicity resolves to Grade ≤2 or baseline, then resume LYRFIGTU at 1 dose level lower or permanently discontinue LYRFIGTU”

Dose modification with strong or moderate CYP3A inhibitors

“Avoid concomitant use. If concomitant use cannot be avoided, reduce LYRFIGTU dosage to 40 mg once daily.” (opens the prescribing information at this quote)
“Avoid concomitant use. If concomitant use cannot be avoided, reduce LYRFIGTU dosage to 50 mg once daily.” (opens the prescribing information at this quote)
“After a CYP3A inhibitor has been discontinued for 3 elimination half-lives, resume LYRFIGTU at the dosage that was used before starting the inhibitor [see Clinical Pharmacology (12.3)].” (opens the prescribing information at this quote)

Dosage in organ impairment

“No dosage modifications are recommended for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.” (opens the prescribing information at this quote)