Dosing & Uses
Dosage Forms & Strengths
capsule
- 25mg
- 100mg
Cholangiocarcinoma
Indicated for treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
Each cycle is 28 days
125 mg PO qDay for 21 consecutive days followed by 7 days off therapy
Continue until disease progression or unacceptable toxicity
Dosage Modifications
Dose reductions for adverse reactions
- First dose reduction: 100 mg qDay
- Second dose reduction: 75 mg qDay
- Third dose reduction: 50 mg qDay
Retinal pigment epithelial detachment (RPED)
- Continue at current dose and periodic ophthalmic evaluation
- If resolving within 14 days, continue current dose
- If not resolving within 14 days, withhold until resolving; then resume at previous or a lower dose
Hyperphosphatemia
-
Serum phosphate >5.5 to ≤7.5 mg/dL
- Continue at the current dose and initiate or dose adjust phosphate binder accordingly
- Monitor serum phosphate weekly
- Hold phosphate binder dosing during the week off in each cycle (Days 22-28) and during dose interruptions for nonhyperphosphatemia adverse events
-
Serum phosphate >7.5 mg/dL or single serum phosphate >9 mg/dL
- Regardless of duration or dose of phosphate-lowering therapy
- Withhold until level returns to serum phosphate ≤5.5 mg/dL
-
Resume as below, with maximal phosphate binder dosing:
- Serum phosphate >7.5 mg/dL occurred for <7 days: Restart at the same dose
- Serum phosphate >7.5 mg/dL for >7 days or if patient had a one-time serum phosphate of >9 mg/dL: Resume at the next lower dose level
-
Serum phosphate with life-threatening consequences
- Urgent interventions indication (eg, dialysis)
- Permanently discontinue
Other adverse reactions
- Grade 3: Withhold dose until resolved to Grade ≤1, then resume at the next lower dose level; if not resolved within ≤14 days, permanently discontinue
- Grade 4: Permanently discontinue
Coadministration with gastric acid-reducing agents
- Avoid coadministration with proton pump inhibitors (PPIs), a H2-receptor antagonist, or a locallyacting antacid
-
If use is unavoidable
- H2-antagonists: Separate administration by at least 2 hr before or 10 hr after
- Locally acting antacids: Separate administration by at least 2 hr before or after
Renal impairment
- Mild-to-moderate (CrCl 30-89 mL/min): Reduce to 100 mg qDay
- Severe (CrCl <30 mL/min) or end-stage renal disease receiving intermittent hemodialysis: Recommended dose not established
Hepatic impairment
- Mild (total bilirubin [TB] >ULN to 1.5x ULN or AST >ULN): 100 mg qDay
- Moderate (TB >1.5 to 3x ULN with any AST): 75 mg qDay
- Severe (TB >3x with any AST): Recommended dose not established
Dosing Considerations
Verify pregnancy status of females of reproductive potential before initiating
Patient selection
- Select patients based on presence of an FGFR2 fusion or rearrangement
- Information on FDA-approved tests is available at: https://www.fda.gov/CompanionDiagnostics
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- idelalisib
idelalisib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
- isoniazid
isoniazid will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.
Serious - Use Alternative (119)
- abametapir
abametapir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- aluminum hydroxide
aluminum hydroxide will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- aluminum hydroxide/magnesium carbonate
aluminum hydroxide/magnesium carbonate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- aluminum hydroxide/magnesium trisilicate
aluminum hydroxide/magnesium trisilicate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- amiodarone
amiodarone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- amobarbital
amobarbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- apalutamide
apalutamide will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- aprepitant
aprepitant will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- armodafinil
armodafinil will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- aspirin/citric acid/sodium bicarbonate
aspirin/citric acid/sodium bicarbonate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- atazanavir
atazanavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- bexarotene
bexarotene will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- bicalutamide
bicalutamide will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- bosentan
bosentan will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- brigatinib
brigatinib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- butabarbital
butabarbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- butalbital
butalbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- calcium carbonate
calcium carbonate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- carbamazepine
carbamazepine will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ceritinib
ceritinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- chloramphenicol
chloramphenicol will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cimetidine
cimetidine will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before or 10 hr after administration of a H2-antagonist.
- citric acid/sodium bicarbonate
citric acid/sodium bicarbonate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- clarithromycin
clarithromycin will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- clobazam
clobazam will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- clotrimazole
clotrimazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cobicistat
cobicistat will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- conivaptan
conivaptan will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- crizotinib
crizotinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dabrafenib
dabrafenib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- darunavir
darunavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dexlansoprazole
dexlansoprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- diltiazem
diltiazem will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- doxycycline
doxycycline will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- dronedarone
dronedarone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- efavirenz
efavirenz will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- elagolix
elagolix will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- elvitegravir
elvitegravir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- encorafenib
encorafenib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- entacapone
entacapone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin base
erythromycin base will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- erythromycin stearate
erythromycin stearate will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- esomeprazole
esomeprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- etravirine
etravirine will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- famotidine
famotidine will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before or 10 hr after administration of a H2-antagonist.
- fedratinib
fedratinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fluconazole
fluconazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fluvoxamine
fluvoxamine will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosamprenavir
fosamprenavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosaprepitant
fosaprepitant will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fosphenytoin
fosphenytoin will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- fostamatinib
fostamatinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- grapefruit
grapefruit will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- haloperidol
haloperidol will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- iloperidone
iloperidone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- imatinib
imatinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- indinavir
indinavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ivacaftor
ivacaftor will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ivosidenib
ivosidenib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ketoconazole
ketoconazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lansoprazole
lansoprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- lapatinib
lapatinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- larotrectinib
larotrectinib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lefamulin
lefamulin will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- letermovir
letermovir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- levoketoconazole
levoketoconazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lonafarnib
lonafarnib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lopinavir
lopinavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lorlatinib
lorlatinib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- magaldrate
magaldrate will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- magnesium hydroxide
magnesium hydroxide will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- magnesium oxide
magnesium oxide will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- metronidazole
metronidazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- mifepristone
mifepristone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- mitotane
mitotane will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nafcillin
nafcillin will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nefazodone
nefazodone will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nelfinavir
nelfinavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- netupitant/palonosetron
netupitant/palonosetron will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- nizatidine
nizatidine will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before or 10 hr after administration of a H2-antagonist.
- ombitasvir/paritaprevir/ritonavir
ombitasvir/paritaprevir/ritonavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- omeprazole
omeprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- pantoprazole
pantoprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- pentobarbital
pentobarbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- pexidartinib
pexidartinib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenobarbital
phenobarbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- phenytoin
phenytoin will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- posaconazole
posaconazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- primidone
primidone will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rabeprazole
rabeprazole will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- ranitidine
ranitidine will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before or 10 hr after administration of a H2-antagonist.
- ribociclib
ribociclib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifabutin
rifabutin will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifampin
rifampin will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rifapentine
rifapentine will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- ritonavir
ritonavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- rucaparib
rucaparib will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- saquinavir
saquinavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- schisandra
schisandra will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- secobarbital
secobarbital will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- sertraline
sertraline will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- simethicone
simethicone will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before and after administration of a locally-acting antacid.
- sotorasib
sotorasib will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- St John's Wort
St John's Wort will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- stiripentol
stiripentol will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- telotristat ethyl
telotristat ethyl will decrease the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tetracycline
tetracycline will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- tipranavir
tipranavir will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- verapamil
verapamil will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voriconazole
voriconazole will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- voxelotor
voxelotor will increase the level or effect of infigratinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
Monitor Closely (0)
Minor (0)
Adverse Effects
>10%
All grades
- Increased creatinine (93%)
- Increased phosphate (90%)
- Decreased phosphate (64%)
- Nail toxicity (57%)
- Stomatitis (56%)
- Increased alkaline phosphatase (54%)
- Decreased hemoglobin (53%)
- Increased ALT (51%)
- Fatigue (44%)
- Dry eye (44%)
- Increased lipase (44%)
- Increased calcium (43%)
- Decreased lymphocytes (43%)
- Decreased sodium (41%)
- Alopecia (38%)
- Increased triglycerides (38%)
- Increased AST (38%)
- Increased urate (37%)
- Decreased platelets (37%)
- Palmoplantar erythrodysesthesia syndrome (33%)
- Arthralgia (32%)
- Dysgeusia (32%)
- Constipation (30%)
- Abdominal pain (26%)
- Decreased leukocytes (26%)
- Dry mouth (25%)
- Eyelash changes (25%)
- Diarrhea (24%)
- Decreased albumin (24%)
- Increased bilirubin (24%)
- Dry skin (23%)
- Decreased appetite (22%)
- Vomiting (21%)
- Vision blurred (21%)
- Decreased potassium (21%)
- Nausea (19%)
- Epistaxis (18%)
- Increased cholesterol (18%)
- Dyspepsia (17%)
- Edema (17%)
- Pain in extremity (17%)
- Headache (17%)
- Increased potassium (17%)
- Pyrexia (15%)
- Weight decreased (15%)
- Decreased neutrophils (14%)
Grade 3 or 4
- Increased urate (37%)
- Decreased phosphate (31%)
- Decreased (20%)
- Stomatitis (15%)
- Increased phosphate (13%)
1-10%
All grades
- Decreased calcium (10%)
Grade 3 or 4
- Increased alkaline phosphatase (8%)
- Increased lipase (7%)
- Increased calcium (7%)
- Increased creatinine (7%)
- Increased bilirubin (6%)
- Increased ALT (6%)
- Decreased hemoglobin (5%)
- Abdominal (5%)
- Increased AST (4%)
- Fatigue (4%)
- Increased potassium (3%)
- Decreased potassium (3%)
- Increased triglycerides (3%)
- Decreased leukocytes (3%)
- Diarrhea (3%)
- Weight decreased (2%)
- Decreased neutrophils (2%)
- Decreased calcium (2%)
- Pain in extremity (2%)
- Increased cholesterol (1%)
- Decreased albumin (1%)
- Decreased appetite (1%)
- Headache (1%)
- Pyrexia (1%)
- Edema (1%)
- Nausea (1%)
- Vomiting (1%)
- Constipation (1%)
Warnings
Contraindications
None
Cautions
Fetal harm may occur
RPED
- May cause RPED, which may cause symptoms such as blurred vision
- Perform a comprehensive ophthalmic examination including optical coherence tomography before initiation, at 1 month, at 3 months, and then every 3 months thereafter during treatment
- Refer patients for ophthalmic evaluation urgently for onset of visual symptoms, and follow up every 3 weeks until resolution or discontinuation
Hyperphosphatemia
- Hyperphosphatemia reported, leading to soft-tissue mineralization, cutaneous calcinosis, nonuremic calciphylaxis, vascular calcification, and myocardial calcification
- Median onset time for hyperphosphatemia was 8 days
- Monitor for hyperphosphatemia throughout treatment
Drug interaction overview
-
Strong or moderate CYP3A inhibitors
- Avoid coadministration
- Strong or moderate CYP3A4 inhibitor may increase infigratinib plasma concentrations and risk of adverse reactions
-
Strong or moderate CYP3A inducers
- Avoid coadministration
- Strong or moderate CYP3A4 inducers may decrease infigratinib plasma concentrations and its efficacy
-
Gastric acid–reducing agents
- Avoid coadministration
- Gastric acid–reducing agents may decrease infigratinib plasma concentrations and its efficacy
- If use is unavoidable, stagger administration of infigratinib from H2-antagonists or locally acting antacids
Pregnancy & Lactation
Pregnancy
Based on findings in animal studies and its mechanism of action, fetal harm or loss of pregnancy may occur
There are no available data on use during pregnancy
Verify pregnancy status of females of reproductive potential before initiation
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 1 month after final dose
- Males with female partners of reproductive potential: Use effective contraception during treatment and for 1 month after final dose
Animal data
- Oral administration of infigratinib to pregnant animals during organogenesis at maternal exposures below the human exposure at the clinical dose of 125 mg resulted in malformations, fetal growth restriction, and embryofetal death
Lactation
There are no data on presence of infigratinib or its metabolites in human milk, or effects on the breastfed children, or effects on milk production
Advise females not to breastfeed during treatment and for 1 month after the final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Orally bioavailable inhibitor of the FGFR types 1, 2, and 3 (FGFR1/2/3)
Inhibits FGFR 1/2/3 phosphorylation and signaling, and decreases cell viability in cancer cell lines with activating FGFR amplifications and fusions
Absorption
Steady-state reached at 15 days
Peak plasma time: 6 hr
Peak plasma concentration
- Infigratinib: 282.5 ng/mL
- BHS697: 42.1 ng/mL
- CQM157: 15.7 ng/mL
AUC
- Infigratinib: 3780 ng·hr/mL
- BHS697: 717 ng·hr/mL
- CQM157: 428 ng·hr/mL
Effect of food
-
Following administration with a high-fat and high-calorie meal
- AUC: Increased by 80-120%
- Peak plasma concentrations: Increased by 60-80%
- Peak plasma time: Shifted from 4 to 6 hr
-
Following administration with a low-fat low-calorie meal
- AUC: Increased by 70%
- Peak plasma concentration: Increased by 90%
- Peak plasm time: No change
Distribution
- Vd: 1,600 L
- Protein bound: 96.8% (primarily lipoprotein)
Metabolism
Predominantly metabolized by CYP3A4 (~94%) and to a lesser extent by FMO3 (6%) in vitro
Major drug-related moiety in plasma was unchanged infigratinib (38% of dose) followed by two active metabolites, BHS697 and CQM157 (each at >10% of dose)
BHS697 is mainly metabolized by CYP3A4 and CQM157 is metabolized through both Phase I and Phase II biotransformation pathway
BHS697 and CQM157 contribute about 16% to 33% and 9% to 12% of overall pharmacologic activity
Elimination
Clearance: 33.1 L/hr
Half-life: 33.5 hr
Excretion: Feces (77% [3.4% unchanged]); urine (7.2% [1.9% unchanged])
Administration
Oral Administration
Take on an empty stomach at least 1 hr before or 2 hr after food, at approximately the same time each day
Swallow capsules whole with a glass of water; do not crush, chew, or dissolve
Missed dose by ≥4 hr or vomited dose: Resume regular daily dose schedule the next day
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
Formulary
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