infigratinib (Rx)

Brand and Other Names:Truseltiq
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and infigratinib

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            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 (120)

            • 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.

            • clozapine

              clozapine 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.

            • desipramine

              desipramine 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.

            • 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)

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                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%)
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                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
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                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.

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                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])

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                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)

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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.