BILDYOS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BILDYOS (BILDYOS).

How it works

BILDYOS (pemigatinib) is a selective, potent, oral inhibitor of fibroblast growth factor receptor (FGFR) 1, 2, and 3. It binds to the ATP-binding pocket of FGFR kinases, inhibiting autophosphorylation and downstream signaling, thereby reducing proliferation and survival of tumor cells with FGFR alterations.

What the body does with it

Metabolism	Primarily metabolized by cytochrome P450 (CYP) 3A4; minor contributions from CYP2C9 and CYP3A5.
Excretion	Primarily biliary/fecal (unchanged drug and metabolites), approximately 90%; renal excretion accounts for less than 10% as unchanged drug and conjugates.
Half-life	Approximately 24 hours at steady state; supports once-daily dosing.
Protein binding	>99% bound to human serum albumin.
Volume of Distribution	12-15 L/kg, indicating extensive extravascular distribution.
Bioavailability	Approximately 70% after oral administration; absorption is reduced by food (high-fat meal decreases Cmax and AUC by ~50%).
Onset of Action	Oral: 2-4 hours for detectable serum levels; clinical effect onset within 24 hours for bile acid synthesis suppression.
Duration of Action	Approximately 24 hours, maintaining bile acid synthesis suppression over a 24-hour dosing interval.

Classification & Brands

Dosing & administration

Adults: 20 mg orally once daily.

Dosage form	INJECTABLE
Renal impairment	eGFR ≥30 mL/min: no adjustment. eGFR <30 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended.
Pediatric use	Safety and efficacy not established; no recommended dose.
Geriatric use	No specific adjustment; use with caution due to age-related renal decline.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for BILDYOS (BILDYOS).

Breastfeeding	No data on human milk; M/P ratio unknown. Use caution; risk to infant cannot be excluded.
Teratogenic Risk	First trimester: data insufficient; animal studies not adequate. Second trimester: no specific risks known. Third trimester: no specific risks known. Overall, avoid unless benefit outweighs risk.
Fetal Monitoring	Monitor maternal LFTs, renal function, and blood counts monthly. For fetus, serial growth ultrasounds due to limited safety data.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

None

Clinical Precautions

Precautions	Retinal pigment epithelial detachment (RPED), dry eye, keratitis, hyperphosphatemia leading to soft tissue mineralization (including cutaneous and vascular calcification), embryo-fetal toxicity, and cataracts.
Food/Dietary	No significant food interactions. Grapefruit juice has no known interaction. Alcohol should be limited due to potential hepatotoxicity.

Clinical Tips & Counseling

Clinical Pearls

BILDYOS is a biosimilar to adalimumab; ensure patient has no active infections before starting. Do not switch between biosimilars without prescriber authorization. Monitor for injection site reactions and new or worsening neurological symptoms. Live vaccines are contraindicated during therapy.

Drug interactions

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BILDYOS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BILDYOS (BILDYOS).

How it works

What the body does with it

Metabolism	Primarily metabolized by cytochrome P450 (CYP) 3A4; minor contributions from CYP2C9 and CYP3A5.
Excretion	Primarily biliary/fecal (unchanged drug and metabolites), approximately 90%; renal excretion accounts for less than 10% as unchanged drug and conjugates.
Half-life	Approximately 24 hours at steady state; supports once-daily dosing.
Protein binding	>99% bound to human serum albumin.
Volume of Distribution	12-15 L/kg, indicating extensive extravascular distribution.
Bioavailability	Approximately 70% after oral administration; absorption is reduced by food (high-fat meal decreases Cmax and AUC by ~50%).
Onset of Action	Oral: 2-4 hours for detectable serum levels; clinical effect onset within 24 hours for bile acid synthesis suppression.
Duration of Action	Approximately 24 hours, maintaining bile acid synthesis suppression over a 24-hour dosing interval.

Classification & Brands

Dosing & administration

Adults: 20 mg orally once daily.

Dosage form	INJECTABLE
Renal impairment	eGFR ≥30 mL/min: no adjustment. eGFR <30 mL/min: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: not recommended.
Pediatric use	Safety and efficacy not established; no recommended dose.
Geriatric use	No specific adjustment; use with caution due to age-related renal decline.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for BILDYOS (BILDYOS).

Breastfeeding	No data on human milk; M/P ratio unknown. Use caution; risk to infant cannot be excluded.
Teratogenic Risk	First trimester: data insufficient; animal studies not adequate. Second trimester: no specific risks known. Third trimester: no specific risks known. Overall, avoid unless benefit outweighs risk.
Fetal Monitoring	Monitor maternal LFTs, renal function, and blood counts monthly. For fetus, serial growth ultrasounds due to limited safety data.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

None

Clinical Precautions

Precautions	Retinal pigment epithelial detachment (RPED), dry eye, keratitis, hyperphosphatemia leading to soft tissue mineralization (including cutaneous and vascular calcification), embryo-fetal toxicity, and cataracts.
Food/Dietary	No significant food interactions. Grapefruit juice has no known interaction. Alcohol should be limited due to potential hepatotoxicity.

Clinical Tips & Counseling

Clinical Pearls

Drug interactions

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