Futibatinib – Uses, Dosage, Side Effects, Interaction Futibatinib is an FGF receptor 2 kinase inhibitor that is used in the treatment of unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. Futibatinib is associated with transient and usually mild elevations in serum aminotransferase during therapy but has not been convincingly linked to cases of clinically apparent liver injury. Futibatinib is an orally bioavailable inhibitor of the fibroblast growth factor receptor (FGFR) with potential antineoplastic activity. Futibatinib selectively and irreversibly binds to and inhibits FGFR, which may result in the inhibition of both the FGFR-mediated signal transduction pathway and tumor cell proliferation, and increased cell death in FGFR-overexpressing tumor cells. FGFR is a receptor tyrosine kinase essential to tumor cell proliferation, differentiation, and survival, and its expression is upregulated in many tumor cell types. Futibatinib is an inhibitor of the Fibroblast Growth Factor receptor (FGFR), which comprises a group of receptor tyrosine kinases that play a key role in cell proliferation, differentiation, migration, and survival. FGFR was investigated in oncology as a therapeutic target, as FGFR genomic aberrations and dysregulated FGFR signaling pathways are observed in some cancers such as cholangiocarcinoma and urothelial malignancies. As a novel inhibitor of FGFR, futibatinib was first approved by the FDA in September 2022 to treat different types of intrahepatic cholangiocarcinoma. As a novel inhibitor of FGFR, futibatinib was first approved by the FDA in September 2022 to treat different types of intrahepatic cholangiocarcinoma. Mechanism of Action The Fibroblast Growth Factor receptor (FGFR) pathway plays a key role in cell proliferation, differentiation, migration, and survival. Notably, FGFR genomic aberrations and aberrant FGFR signaling pathways are observed in some cancers, as constitutive FGFR signaling can support the proliferation and survival of malignant cells. Futibatinib is a selective, irreversible inhibitor of FGFR 1, 2, 3, and 4 with IC50 values of less than 4 nM. It binds to the FGFR kinase domain by forming a covalent bond with cysteine in the ATP-binding pocket. Upon binding to FGFR, futibatinib blocks FGFR phosphorylation and downstream signaling pathways, such as the RAS-dependent mitogen-activated protein kinase (MAPK), phosphatidylinositol 3-kinase (PI3KCA)/Akt/mTOR, phospholipase Cγ (PLCγ), and JAK/STAT. Futibatinib ultimately decreases cell viability in cancer cell lines with FGFR alterations, including FGFR fusions or rearrangements, amplifications, and mutations. Futibatinib is an anticancer agent with demonstrated anti-tumour activity in mouse and rat xenograft models of human tumors with activating FGFR genetic alterations. Futibatinib is not expected to affect cell lines with no FGFR genomic aberrations. It suppresses the growth of tumors in a dose-dependent manner. Indications Futibatinib is indicated to treat adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Treatment of cholangiocarcinoma Futibatinib is an FGF receptor 2 kinase inhibitor that is used in the treatment of unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma. Locally Advanced Intrahepatic Cholangiocarcinoma Metastatic Intrahepatic Cholangiocarcinoma Unresectable Intrahepatic Cholangiocarcinoma Use in Cancer Futibatinib is approved to treat: Intrahepatic cholangiocarcinoma (cancer that forms in the bile ducts inside the liver) has spread or cannot be removed with surgery. It is used in adults whose cancer has been treated and has an FGFR2 gene fusion or other change in the structure of the FGFR2 gene. Futibatinib is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that it provides a clinical benefit in these patients. Futibatinib is also being studied in the treatment of other types of cancer. Contraindications Pregnancy and lactation Low Amount Of Phosphate In The Blood Decreased Blood Platelets Low Levels Of A Type Of White Blood Cell Called Neutrophils A High Alanine Transaminase Level A High Aspartate Transaminase Level Detachment Of Retinal Pigment Epithelium Severe renal failure patient Low Amount Of Sodium In The Blood Anemia A Decreased Number Of Lymphocytes In The Blood Dosage Strengths: 4mg, 5mg, 20mg Cholangiocarcinoma of the biliary tract Usual dose: 20 mg (five 4 mg tablets) taken orally once daily Confirm the presence of an FGFR2 gene fusion or another rearrangement prior to initiation of treatment. Treatment is to be continued until disease progression or unacceptable toxicity occurs. Patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Dose Adjustments DOSE MODIFICATION FOR ADVERSE REACTIONS: First dose reduction: 16 mg (four 4 mg tablets) orally once daily Second dose reduction: 12 mg (three 4 mg tablets) orally once daily Permanently discontinue this drug if unable to tolerate 12 mg orally once daily. DOSE MODIFICATION FOR RETINAL PIGMENT EPITHELIAL DETACHMENT (RPED): Continue this drug at the current dose and continue periodic ophthalmic evaluation: If resolved within 14 days, continue this drug at the current dose. If not resolved within 14 days, withhold this drug until resolved; then resume at the previous or a lower dose. DOSE MODIFICATION FOR HYPERPHOSPHATEMIA: Serum phosphate 5.5 to 7 mg/dL: Continue this drug at the current dose and start with phosphate-lowering therapy. Monitor serum phosphate weekly. Serum phosphate more than 7 to 10 mg/dL: Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly. If the serum phosphate resolves to 7 mg/dL or less within 2 weeks after dose reduction, continue at this reduced dose. If serum phosphate is not 7 mg/dL or below within 2 weeks, further reduce to the next lower dose. If serum phosphate is not 7 mg/dL or below within 2 weeks after the second dose reduction, withhold this drug until serum phosphate is 7 mg/dL or below and resume at the dose prior to suspending. Serum phosphate more than 10 mg/dL: Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly. Withhold this drug until phosphate is 7 mg/dL or below and resume at the next lower dose. Permanently discontinue this drug if serum phosphate is not equal to or less than 7 mg/dL within 2 weeks following 2 dose interruptions and reductions. DOSE MODIFICATION FOR OTHER ADVERSE REACTIONS: Grade 3: Withhold this drug until toxicity resolves to Grade 1 or baseline, then resume. For hematological toxicities that get resolved within 1 week, continue at the dose prior to suspending. For other adverse reactions, continue at the next lower dose. Grade 4: Permanently discontinue this drug. Administration advice: Administer this drug with or without food at approximately the same time each day. Swallow tablets whole. Do not crush, chew, split, or dissolve tablets. If a dose is missed for more than 12 hours or if vomiting occurs, resume dosing the next day as scheduled. Patients should be advised to read FDA-approved patient labeling (Patient Information). Patients should be informed about potential adverse reactions of this drug which include ocular toxicity, hyperphosphatemia, and soft tissue mineralization and immediately reach out to a health care professional if any symptoms related to these events develop. Patients should use artificial tears or hydrating or lubricating eye gels to prevent or treat dry eyes. Inform patients that this drug may cause nail disorders. Notify the health care provider if the patient is pregnant or becomes pregnant during treatment. Patients should be cognizant of the risk to a fetus and the potential loss of a pregnancy during the treatment with this drug. Male and female patients should use an effective method of contraception throughout treatment with this drug and for 1 week after the last dose of this drug. Do not breastfeed during treatment with this drug and for 1 week after the last dose. Do not consume grapefruit products during treatment with this drug. Patients are advised to inform health care professional about all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products. Side Effects The Most Common change in appearance or color of nails muscle pain constipation diarrhea or loose stools feeling tired or weak dry mouth hair loss mouth sore stomach area pain dry skin joint pain changes in taste dry eye nausea or vomiting decrease in appetite difficulty or painful urination, lower back pain, or fever redness, swelling, pain or tenderness on the hands or feet dry or inflamed eyes, increased tears, blurred vision, flashes of light, or seeing black spots muscle cramps or numbness or tingling around your mouth More common Bladder pain bloody or cloudy urine bone or joint pain confusion constipation cracked lips diarrhea difficult, burning, or painful urination difficulty in breathing difficulty in swallowing dry eyes dry mouth fever frequent urge to urinate irregular heartbeats loss of appetite lower back or side pain mood or mental changes muscle cramps in the hands, arms, feet, legs, or face nausea numbness and tingling around the mouth, fingertips, or feet painful irritation of the clear front part of the eye redness, swelling, or pain of the skin scaling of the skin on the hands and feet sores, ulcers, or white spots on the lips, tongue, or inside the mouth stomach cramps, tenderness, or pain swelling, irritation, soreness, or inflammation of the mouth tingling of the hands and feet ulceration of the skin vomiting vomiting of blood or material that looks like coffee grounds watering of the eyes watery or bloody diarrhea weakness Rare Black, tarry stools bloody stools pale skin unusual bleeding or bruising unusual tiredness or weakness Bluish-brownish hands change in taste difficulty in moving lack or loss of strength loss of taste muscle aches, cramps, pains, or stiffness redness or soreness around the fingernails or loosening of the fingernails Drug Interactions DRUG INTERACTION Abametapir The serum concentration of Futibatinib can be increased when it is combined with Abametapir. Abemaciclib The serum concentration of Abemaciclib can be increased when it is combined with Futibatinib. Abrocitinib The serum concentration of Futibatinib can be increased when it is combined with Abrocitinib. Afatinib The serum concentration of Futibatinib can be increased when it is combined with Afatinib. Ambrisentan The serum concentration of Futibatinib can be increased when it is combined with Ambrisentan. Amiodarone The metabolism of Futibatinib can be decreased when combined with Amiodarone. Amprenavir The metabolism of Futibatinib can be decreased when combined with Amprenavir. Apalutamide The metabolism of Futibatinib can be increased when combined with Apalutamide. Apixaban The serum concentration of Futibatinib can be increased when it is combined with Apixaban. Aprepitant The metabolism of Futibatinib can be decreased when combined with Aprepitant. Arsenic trioxide The serum concentration of Futibatinib can be increased when it is combined with Arsenic trioxide. Articaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Articaine. Asciminib The serum concentration of Futibatinib can be increased when it is combined with Asciminib. Asunaprevir The serum concentration of Futibatinib can be increased when it is combined with Asunaprevir. Atazanavir The metabolism of Futibatinib can be decreased when combined with Atazanavir. Avanafil The serum concentration of Avanafil can be increased when it is combined with Futibatinib. Avatrombopag The serum concentration of Futibatinib can be increased when it is combined with Avatrombopag. Axitinib The serum concentration of Axitinib can be increased when it is combined with Futibatinib. Belantamab The serum concentration of Belantamab mafodotin can be increased when it is combined with Futibatinib. Belinostat The serum concentration of Futibatinib can be increased when it is combined with Belinostat. Belumosudil The serum concentration of Futibatinib can be increased when it is combined with Belumosudil. Bendamustine The serum concentration of Bendamustine can be increased when it is combined with Futibatinib. Benzocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Benzyl alcohol. Berotralstat The metabolism of Futibatinib can be decreased when combined with Berotralstat. Betrixaban The serum concentration of Futibatinib can be increased when it is combined with Betrixaban. Binimetinib The serum concentration of Binimetinib can be increased when it is combined with Futibatinib. Bisoprolol The serum concentration of Futibatinib can be increased when it is combined with Bisoprolol. Boceprevir The metabolism of Futibatinib can be decreased when combined with Boceprevir. Bortezomib The serum concentration of Bortezomib can be increased when it is combined with Futibatinib. Bosutinib The serum concentration of Bosutinib can be increased when it is combined with Futibatinib. Brentuximab ve The serum concentration of Brentuximab vedotin can be increased when it is combined with Futibatinib. Bupivacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Bupivacaine. Butacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Butamben. Cabazitaxel The serum concentration of Cabazitaxel can be increased when it is combined with Futibatinib. Cabergoline The serum concentration of Cabergoline can be increased when it is combined with Futibatinib. Canagliflozin The serum concentration of Futibatinib can be increased when it is combined with Canagliflozin. Capmatinib The serum concentration of Futibatinib can be increased when it is combined with Capmatinib. Capsaicin The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Capsaicin. Carbamazepine The metabolism of Futibatinib can be increased when combined with Carbamazepine. Carfilzomib The serum concentration of Futibatinib can be increased when it is combined with Carfilzomib. Carvedilol The serum concentration of Futibatinib can be increased when it is combined with Carvedilol. Cenobamate The serum concentration of Futibatinib can be decreased when it is combined with Cenobamate. Ceritinib The serum concentration of Ceritinib can be increased when it is combined with Futibatinib. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Chloroprocaine. Cinchocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Cinchocaine. Ciprofloxacin The metabolism of Futibatinib can be decreased when combined with Ciprofloxacin. Clarithromycin The metabolism of Futibatinib can be decreased when combined with Clarithromycin. Clobazam The serum concentration of Futibatinib can be increased when it is combined with Clobazam. Clofazimine The serum concentration of Futibatinib can be increased when it is combined with Clofazimine. Clomifene The serum concentration of Futibatinib can be increased when it is combined with Clomifene. Clozapine The metabolism of Futibatinib can be decreased when combined with Clozapine. Cobicistat The metabolism of Futibatinib can be decreased when combined with Cobicistat. Cobimetinib The serum concentration of Cobimetinib can be increased when it is combined with Futibatinib. Cocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Cocaine. Colchicine The serum concentration of Futibatinib can be increased when it is combined with Colchicine. Conivaptan The metabolism of Futibatinib can be decreased when combined with Conivaptan. Copanlisib The serum concentration of Copanlisib can be increased when it is combined with Futibatinib. Crizotinib The serum concentration of Futibatinib can be increased when it is combined with Crizotinib. Curcumin The metabolism of Futibatinib can be decreased when combined with Curcumin. Cyclosporine The serum concentration of Futibatinib can be increased when it is combined with Cyclosporine. Dabigatran etex The serum concentration of Futibatinib can be increased when it is combined with Dabigatran etexilate. Dabrafenib The serum concentration of Futibatinib can be decreased when it is combined with Dabrafenib. Daclatasvir The serum concentration of Futibatinib can be increased when it is combined with Daclatasvir. Dacomitinib The serum concentration of Futibatinib can be increased when it is combined with Dacomitinib. Dactinomycin The serum concentration of Dactinomycin can be increased when it is combined with Futibatinib. Danazol The metabolism of Futibatinib can be decreased when combined with Danazol. Daptomycin The serum concentration of Futibatinib can be increased when it is combined with Daptomycin. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Futibatinib. Darolutamide The serum concentration of Futibatinib can be increased when it is combined with Darolutamide. Darunavir The metabolism of Futibatinib can be decreased when combined with Darunavir. Dasabuvir The serum concentration of Futibatinib can be increased when it is combined with Dasabuvir. Dasatinib The serum concentration of Dasatinib can be increased when it is combined with Futibatinib. Delavirdine The metabolism of Futibatinib can be decreased when combined with Delavirdine. Desvenlafaxine The metabolism of Futibatinib can be decreased when combined with Desvenlafaxine. Dexamethasone The metabolism of Futibatinib can be increased when combined with Dexamethasone. Dexamethasone a The serum concentration of Futibatinib can be decreased when it is combined with Dexamethasone acetate. Digitoxin The serum concentration of Digitoxin can be increased when it is combined with Futibatinib. Digoxin The serum concentration of Digoxin can be increased when it is combined with Futibatinib. Diltiazem The metabolism of Futibatinib can be decreased when combined with Diltiazem. Diosmin The serum concentration of Futibatinib can be increased when it is combined with Diosmin. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Diphenhydramine. Dolutegravir The serum concentration of Futibatinib can be increased when it is combined with Dolutegravir. Dronedarone The serum concentration of Futibatinib can be increased when it is combined with Dronedarone. Duvelisib The serum concentration of Futibatinib can be increased when it is combined with Duvelisib. Dyclonine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Dyclonine. Econazole The metabolism of Futibatinib can be decreased when combined with Econazole. Edoxaban The serum concentration of Futibatinib can be increased when it is combined with Edoxaban. Efavirenz The metabolism of Futibatinib can be decreased when combined with Efavirenz. Elacestrant The serum concentration of Futibatinib can be increased when it is combined with Elacestrant. Elagolix The serum concentration of Futibatinib can be increased when it is combined with Elagolix. Elbasvir The serum concentration of Futibatinib can be increased when it is combined with Elbasvir. Eliglustat The serum concentration of Futibatinib can be increased when it is combined with Eliglustat. Elvitegravir The metabolism of Futibatinib can be decreased when combined with Elvitegravir. Enasidenib The serum concentration of Futibatinib can be increased when it is combined with Enasidenib. Enfortumab vedotin The serum concentration of Futibatinib can be increased when it is combined with Enfortumab vedotin. Entrectinib The serum concentration of Futibatinib can be increased when it is combined with Entrectinib. Enzalutamide The metabolism of Futibatinib can be increased when combined with Enzalutamide. Erdafitinib The serum concentration of Futibatinib can be increased when it is combined with Erdafitinib. You Might Also Read Indomethacin Contraindications, Pregnancy Category Ergotamine The metabolism of Futibatinib can be decreased when combined with Ergotamine. Ertugliflozin The serum concentration of Futibatinib can be increased when it is combined with Ertugliflozin. Erythromycin The serum concentration of Futibatinib can be increased when it is combined with Erythromycin. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Futibatinib. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Etidocaine. Etoposide The serum concentration of Etoposide can be increased when it is combined with Futibatinib. Everolimus The serum concentration of Futibatinib can be increased when it is combined with Everolimus. Favipiravir The serum concentration of Futibatinib can be increased when it is combined with Favipiravir. Fedratinib The serum concentration of Futibatinib can be increased when it is combined with Fedratinib. Fexofenadine The serum concentration of Futibatinib can be increased when it is combined with Fexofenadine. Flibanserin The serum concentration of Futibatinib can be increased when it is combined with Flibanserin. Fluconazole The serum concentration of Futibatinib can be increased when it is combined with Fluconazole. Fluvoxamine The metabolism of Futibatinib can be decreased when combined with Fluvoxamine. Fosnetupitant The metabolism of Futibatinib can be decreased when combined with Fosnetupitant. Fosphenytoin The metabolism of Futibatinib can be increased when combined with Fosphenytoin. Fostemsavir The serum concentration of Futibatinib can be increased when it is combined with Fostemsavir. Fusidic acid The metabolism of Futibatinib can be decreased when combined with Fusidic acid. Gemcitabine The serum concentration of Gemcitabine can be increased when it is combined with Futibatinib. Gilteritinib The serum concentration of Futibatinib can be increased when it is combined with Gilteritinib. Glasdegib The serum concentration of Futibatinib can be increased when it is combined with Glasdegib. Glecaprevir The serum concentration of Futibatinib can be increased when it is combined with Glecaprevir. Grazoprevir The serum concentration of Futibatinib can be increased when it is combined with Grazoprevir. Haloperidol The serum concentration of Haloperidol can be increased when it is combined with Futibatinib. Idelalisib The serum concentration of Futibatinib can be increased when it is combined with Idelalisib. Imipramine The serum concentration of Imipramine can be increased when it is combined with Futibatinib. Indacaterol The serum concentration of Futibatinib can be increased when it is combined with Indacaterol. Indinavir The metabolism of Futibatinib can be decreased when combined with Indinavir. Inotuzumab oz The serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Futibatinib. Isavuconazole The serum concentration of Futibatinib can be increased when it is combined with Isavuconazole. Isavuconazonium The serum concentration of Futibatinib can be increased when it is combined with Isavuconazonium. Isoniazid The metabolism of Futibatinib can be decreased when combined with Isoniazid. Isradipine The metabolism of Futibatinib can be decreased when combined with Isradipine. Istradefylline The serum concentration of Futibatinib can be increased when it is combined with Istradefylline. Itraconazole The metabolism of Futibatinib can be decreased when combined with Itraconazole. Ivacaftor The serum concentration of Futibatinib can be increased when it is combined with Ivacaftor. Ivosidenib The metabolism of Futibatinib can be increased when combined with Ivosidenib. Ixabepilone The serum concentration of Futibatinib can be increased when it is combined with Ixabepilone. Ketoconazole The metabolism of Futibatinib can be decreased when combined with Ketoconazole. Lapatinib The serum concentration of Futibatinib can be increased when it is combined with Lapatinib. Larotrectinib The serum concentration of Futibatinib can be increased when it is combined with Larotrectinib. Lasmiditan The serum concentration of Futibatinib can be increased when it is combined with Lasmiditan. Ledipasvir The serum concentration of Futibatinib can be increased when it is combined with Ledipasvir. Lefamulin The serum concentration of Futibatinib can be increased when it is combined with Lefamulin. Lemborexant The serum concentration of Futibatinib can be increased when it is combined with Lemborexant. Lenvatinib The serum concentration of Futibatinib can be increased when it is combined with Lenvatinib. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Levobupivacaine. Levoketoconazole The metabolism of Futibatinib can be decreased when combined with Levoketoconazole. Levothyroxine The serum concentration of Futibatinib can be decreased when it is combined with Levothyroxine. Lidocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Lidocaine. Linagliptin The serum concentration of Futibatinib can be increased when it is combined with Linagliptin. Lomitapide The serum concentration of Futibatinib can be increased when it is combined with Lomitapide. Lonafarnib The metabolism of Futibatinib can be decreased when combined with Lonafarnib. Loncastuximab te The serum concentration of Loncastuximab tesirine can be increased when it is combined with Futibatinib. Loperamide The serum concentration of Futibatinib can be increased when it is combined with Loperamide. Lopinavir The metabolism of Futibatinib can be decreased when combined with Lopinavir. Lorlatinib The serum concentration of Futibatinib can be decreased when it is combined with Lorlatinib. Lovastatin The metabolism of Futibatinib can be decreased when combined with Lovastatin. Loxapine The serum concentration of Futibatinib can be increased when it is combined with Loxapine. Lumacaftor The metabolism of Futibatinib can be increased when combined with Lumacaftor. Lusutrombopag The serum concentration of Futibatinib can be increased when it is combined with Lusutrombopag. Mannitol The serum concentration of Futibatinib can be increased when it is combined with Mannitol. Maribavir The serum concentration of Futibatinib can be increased when it is combined with Maribavir. Mavacamten The serum concentration of Futibatinib can be decreased when it is combined with Mavacamten. Mefloquine The serum concentration of Futibatinib can be increased when it is combined with Mefloquine. Meloxicam The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Mepivacaine. Methimazole The metabolism of Futibatinib can be decreased when combined with Methimazole. Methoxy pol The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Futibatinib. Methylene blue The serum concentration of Futibatinib can be increased when it is combined with Methylene blue. Metreleptin The metabolism of Futibatinib can be increased when combined with Metreleptin. Miconazole The metabolism of Futibatinib can be decreased when combined with Miconazole. Midostaurin The metabolism of Futibatinib can be decreased when combined with Midostaurin. Mifepristone The serum concentration of Futibatinib can be increased when it is combined with Mifepristone. Milnacipran The metabolism of Futibatinib can be decreased when combined with Milnacipran. Mirabegron The serum concentration of Futibatinib can be increased when it is combined with Mirabegron. Mitapivat The serum concentration of Futibatinib can be increased when it is combined with Mitapivat. Mitotane The metabolism of Futibatinib can be increased when combined with Mitotane. Morphine The serum concentration of Futibatinib can be increased when it is combined with Morphine. Nefazodone The metabolism of Futibatinib can be decreased when combined with Nefazodone. Nelfinavir The metabolism of Futibatinib can be decreased when combined with Nelfinavir. Neratinib The serum concentration of Futibatinib can be increased when it is combined with Neratinib. Netupitant The serum concentration of Futibatinib can be increased when it is combined with Netupitant. Nicardipine The metabolism of Futibatinib can be decreased when combined with Nicardipine. Nilotinib The metabolism of Futibatinib can be decreased when combined with Nilotinib. Nilvadipine The metabolism of Futibatinib can be decreased when combined with Nilvadipine. Nintedanib The serum concentration of Futibatinib can be increased when it is combined with Nintedanib. Norgestimate The serum concentration of Futibatinib can be increased when it is combined with Norgestimate. Nortriptyline The serum concentration of Nortriptyline can be increased when it is combined with Futibatinib. Omadacycline The serum concentration of Futibatinib can be increased when it is combined with Omadacycline. Ombitasvir The serum concentration of Futibatinib can be increased when it is combined with Ombitasvir. Osimertinib The serum concentration of Osimertinib can be increased when it is combined with Futibatinib. Oxetacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Oxybuprocaine. Pacritinib The serum concentration of Futibatinib can be increased when it is combined with Pacritinib. Palbociclib The serum concentration of Futibatinib can be increased when it is combined with Palbociclib. Paliperidone The serum concentration of Futibatinib can be increased when it is combined with Paliperidone. Panobinostat The serum concentration of Panobinostat can be increased when it is combined with Futibatinib. Paritaprevir The serum concentration of Futibatinib can be increased when it is combined with Paritaprevir. Pazopanib The serum concentration of Pazopanib can be increased when it is combined with Futibatinib. You Might Also Read Antidiabetes Drugs; Indications, Side Effects, Drug Interactions Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Futibatinib. Pentobarbital The metabolism of Futibatinib can be increased when combined with Pentobarbital. Phenobarbital The metabolism of Futibatinib can be increased when combined with Phenobarbital. Phenol The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Phenol. Phenytoin The metabolism of Futibatinib can be increased when combined with Phenytoin. Pibrentasvir The serum concentration of Futibatinib can be increased when it is combined with Pibrentasvir. Pirtobrutinib The serum concentration of Futibatinib can be increased when it is combined with Pirtobrutinib. Pitolisant The serum concentration of Futibatinib can be decreased when it is combined with Pitolisant. Pomalidomide The serum concentration of Pomalidomide can be increased when it is combined with Futibatinib. Ponatinib The serum concentration of Futibatinib can be increased when it is combined with Ponatinib. Posaconazole The metabolism of Futibatinib can be decreased when combined with Posaconazole. Pralsetinib The serum concentration of Futibatinib can be increased when it is combined with Pralsetinib. Pramocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Pramocaine. Pravastatin The serum concentration of Futibatinib can be increased when it is combined with Pravastatin. Prednisolone The serum concentration of Futibatinib can be decreased when it is combined with Prednisolone phosphate. Pretomanid The serum concentration of Futibatinib can be increased when it is combined with Pretomanid. Prilocaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Prilocaine. Primaquine The metabolism of Futibatinib can be decreased when combined with Primaquine. Primidone The metabolism of Futibatinib can be increased when combined with Primidone. Procaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Procaine. Propafenone The serum concentration of Futibatinib can be increased when it is combined with Propafenone. Proparacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Propoxycaine. Quinidine The serum concentration of Futibatinib can be increased when it is combined with Quinidine. Quinine The serum concentration of Futibatinib can be increased when it is combined with Quinine. Ranolazine The serum concentration of Futibatinib can be increased when it is combined with Ranolazine. Regorafenib The serum concentration of Futibatinib can be increased when it is combined with Regorafenib. Relugolix The serum concentration of Futibatinib can be increased when it is combined with Relugolix. Reserpine The serum concentration of Futibatinib can be increased when it is combined with Reserpine. Revefenacin The serum concentration of Futibatinib can be increased when it is combined with Revefenacin. Ribociclib The metabolism of Futibatinib can be decreased when combined with Ribociclib. Rifampicin The metabolism of Futibatinib can be increased when combined with Rifampicin. Rifamycin The metabolism of Futibatinib can be increased when combined with Rifamycin. Rifapentine The metabolism of Futibatinib can be increased when combined with Rifapentine. Rimegepant The serum concentration of Futibatinib can be increased when it is combined with Rimegepant. Rimexolone The metabolism of Futibatinib can be increased when combined with Rimexolone. Riociguat The serum concentration of Futibatinib can be increased when it is combined with Riociguat. Ripretinib The serum concentration of Futibatinib can be increased when it is combined with Ripretinib. Ritonavir The metabolism of Futibatinib can be decreased when combined with Ritonavir. Rivaroxaban The serum concentration of Futibatinib can be increased when it is combined with Rivaroxaban. Rolapitant The serum concentration of Futibatinib can be increased when it is combined with Rolapitant. Romidepsin The serum concentration of Romidepsin can be increased when it is combined with Futibatinib. Ropivacaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Ropivacaine. Sapropterin The serum concentration of Futibatinib can be increased when it is combined with Sapropterin. Saquinavir The metabolism of Futibatinib can be decreased when combined with Saquinavir. Sarecycline The serum concentration of Futibatinib can be increased when it is combined with Sarecycline. Satralizumab The serum concentration of Futibatinib can be decreased when it is combined with Satralizumab. Selexipag The serum concentration of Futibatinib can be increased when it is combined with Selexipag. Selumetinib The serum concentration of Futibatinib can be increased when it is combined with Selumetinib. Sildenafil The serum concentration of Futibatinib can be increased when it is combined with Sildenafil. Silodosin The serum concentration of Futibatinib can be increased when it is combined with Silodosin. Simeprevir The serum concentration of Futibatinib can be increased when it is combined with Simeprevir. Simvastatin The serum concentration of Futibatinib can be increased when it is combined with Simvastatin. Sirolimus The serum concentration of Sirolimus can be increased when it is combined with Futibatinib. Sitagliptin The serum concentration of Futibatinib can be increased when it is combined with Sitagliptin. Sofosbuvir The serum concentration of Futibatinib can be increased when it is combined with Sofosbuvir. Somatrogon The metabolism of Futibatinib can be increased when combined with Somatrogon. Sorafenib The serum concentration of Futibatinib can be increased when it is combined with Sorafenib. Sotagliflozin The serum concentration of Futibatinib can be increased when it is combined with Sotagliflozin. Sotorasib The serum concentration of Futibatinib can be decreased when it is combined with Sotorasib. St. John’s Wort The metabolism of Futibatinib can be increased when combined with St. John’s Wort. Stiripentol The metabolism of Futibatinib can be decreased when combined with Stiripentol. Suvorexant The serum concentration of Futibatinib can be increased when it is combined with Suvorexant. Tacrolimus The serum concentration of Futibatinib can be increased when it is combined with Tacrolimus. Talazoparib The serum concentration of Talazoparib can be increased when it is combined with Futibatinib. Tamoxifen The serum concentration of Futibatinib can be increased when it is combined with Tamoxifen. Tazemetostat The serum concentration of Futibatinib can be increased when it is combined with Tazemetostat. Technetium The serum concentration of Futibatinib can be increased when it is combined with Technetium Tc-99m sestamibi. Tegaserod The serum concentration of Futibatinib can be increased when it is combined with Tegaserod. Telaprevir The metabolism of Futibatinib can be decreased when combined with Telaprevir. Telithromycin The metabolism of Futibatinib can be decreased when combined with Telithromycin. Telotristat ethyl The serum concentration of Futibatinib can be decreased when it is combined with Telotristat ethyl. Temsirolimus The serum concentration of Futibatinib can be increased when it is combined with Temsirolimus. Tenofovir disop The serum concentration of Futibatinib can be increased when it is combined with Tenofovir disoproxil. Tepotinib The serum concentration of Futibatinib can be increased when it is combined with Tepotinib. Terfenadine The metabolism of Futibatinib can be decreased when combined with Terfenadine. Tetracaine The risk or severity of methemoglobinemia can be increased when Futibatinib is combined with Tetracaine. Tezacaftor The serum concentration of Futibatinib can be increased when it is combined with Tezacaftor. Ticagrelor The serum concentration of Futibatinib can be increased when it is combined with Ticagrelor. Tipranavir The metabolism of Futibatinib can be decreased when combined with Tipranavir. Tivozanib The serum concentration of Futibatinib can be increased when it is combined with Tivozanib. Tolvaptan The serum concentration of Tolvaptan can be increased when it is combined with Futibatinib. Topotecan The serum concentration of Topotecan can be increased when it is combined with Futibatinib. Toremifene The serum concentration of Futibatinib can be increased when it is combined with Toremifene. Trastuzumab em The serum concentration of Trastuzumab emtansine can be increased when it is combined with Futibatinib. Trazodone The serum concentration of Futibatinib can be decreased when it is combined with Trazodone. Trilaciclib The serum concentration of Trilaciclib can be increased when it is combined with Futibatinib. Trimipramine The serum concentration of Trimipramine can be increased when it is combined with Futibatinib. Troleandomycin The metabolism of Futibatinib can be decreased when combined with Troleandomycin. Tucatinib Tucatinib may decrease the excretion rate of Futibatinib which could result in a higher serum level. Ubrogepant The serum concentration of Ubrogepant can be increased when it is combined with Futibatinib. Umbralisib The serum concentration of Futibatinib can be increased when it is combined with Umbralisib. Umeclidinium The serum concentration of Futibatinib can be increased when it is combined with Umeclidinium. Vandetanib The serum concentration of Futibatinib can be increased when it is combined with Vandetanib. Vardenafil The serum concentration of Futibatinib can be increased when it is combined with Vardenafil. Velpatasvir The serum concentration of Futibatinib can be increased when it is combined with Velpatasvir. Vemurafenib The serum concentration of Futibatinib can be increased when it is combined with Vemurafenib. Venetoclax The serum concentration of Futibatinib can be increased when it is combined with Venetoclax. Verapamil The serum concentration of Futibatinib can be increased when it is combined with Verapamil. Viloxazine The metabolism of Futibatinib can be decreased when combined with Viloxazine. You Might Also Read Rifaximin Tablets - Indications, Contraindications Vinblastine The serum concentration of Vinblastine can be increased when it is combined with Futibatinib. Vincristine The serum concentration of Vincristine can be increased when it is combined with Futibatinib. Vinflunine The serum concentration of Vinflunine can be increased when it is combined with Futibatinib. Voclosporin The serum concentration of Futibatinib can be increased when it is combined with Voclosporin. Vorapaxar The serum concentration of Futibatinib can be increased when it is combined with Vorapaxar. Voriconazole The metabolism of Futibatinib can be decreased when combined with Voriconazole. Voxilaprevir The serum concentration of Futibatinib can be increased when it is combined with Voxilaprevir. Zimelidine The metabolism of Futibatinib can be decreased when combined with Zimelidine. Ziprasidone The metabolism of Futibatinib can be decreased when combined with Ziprasidone. Zonisamide The serum concentration of Futibatinib can be increased when it is combined with Zonisamide. Pregnancy and Lactation US FDA pregnancy category: Not assigned Pregnancy Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of LYTGOBI in pregnant women. Oral administration of futibatinib to pregnant rats during the period of organogenesis at maternal plasma exposures below the human exposure at the clinical dose of 20 mg resulted in fetal malformations, fetal growth retardation, and embryo-fetal death (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Lactation There are no data on the presence of futibatinib or its metabolites in human milk or their effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions from LYTGOBI in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose. Why is this medication prescribed? Futibatinib is used in adults who have received previous therapy to treat a certain type of cholangiocarcinoma (bile duct cancer) that has spread to nearby tissues or other parts of the body and cannot be removed by surgery. Futibatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. How should this medicine be used? Futibatinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take futibatinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take futibatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the tablets whole; do not split, chew, or crush them. If you vomit after taking futibatinib, do not take another dose. Continue your regular dosing schedule. Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with futibatinib. Futibatinib may cause irritation and dry eyes. You should use artificial tears or lubricant eye drops while on treatment with futibatinib to prevent or treat the dry eyes. Your doctor will order an eye exam before and during treatment with futibatinib to watch for more severe eye problems. Make sure you keep all eye exam appointments. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. What special precautions should I follow? Before taking futibatinib, tell your doctor and pharmacist if you are allergic to futibatinib, any other medications, or any of the ingredients in futibatinib tablets. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking futibatinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have vision or eye problems, diabetes, anemia, history of bleeding disorder, or if you have or ever had kidney or liver problems. tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose. If you are a male, you and your partner should use birth control during your treatment and for 1 month after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking futibatinib, call your doctor immediately. Futibatinib may harm the fetus. tell your doctor if you are breastfeeding. You should not breastfeed while you are taking futibatinib and for 1 week after your final dose. What special dietary instructions should I follow? Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication. Unless your doctor tells you otherwise, continue your normal diet. What should I do if I forget a dose? Take the missed dose as soon as you remember it. However, if it has been more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213736s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214622Orig1s000MultidisciplineR.pdf https://pubchem.ncbi.nlm.nih.gov/compound/Futibatinib https://pubchem.ncbi.nlm.nih.gov/substance/354702259 https://www.cancer.gov/about-cancer/treatment/drugs/futibatinib https://go.drugbank.com/drugs/DB15149 https://www.drugs.com/dosage/futibatinib.html https://en.wikipedia.org/wiki/Futibatinib https://www.mayoclinic.org/drugs-supplements/futibatinib-oral-route/side-effects/drg-20539902 https://www.webmd.com/drugs/2/drug-185121/futibatinib-oral/details ChEMBL http://www.ebi.ac.uk/Information/termsofuse.html https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3701238/ https://www.ebi.ac.uk/chembl/g/#browse/targets IUPHAR/BPS Guide to PHARMACOLOGY https://www.guidetopharmacology.org/about.jsp#license https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=9786 https://www.guidetopharmacology.org/targets.jsp Therapeutic Target Database (TTD) https://idrblab.net/ttd/data/drug/details/D01ZLU ChemIDplus https://www.nlm.nih.gov/copyright.html https://pubchem.ncbi.nlm.nih.gov/substance/?source=chemidplus&sourceid=1448169718 https://pubchem.ncbi.nlm.nih.gov/source/ChemIDplus DrugBank https://www.drugbank.ca/legal/terms_of_use https://www.drugbank.ca/drugs/DB15149 FDA Global Substance Registration System (GSRS) https://www.fda.gov/about-fda/about-website/website-policies#linking https://gsrs.ncats.nih.gov/ginas/app/beta/substances/4B93MGE4AL ClinicalTrials.gov https://clinicaltrials.gov/ct2/about-site/terms-conditions#Use https://clinicaltrials.gov/ LiverTox https://www.nlm.nih.gov/copyright.html https://www.ncbi.nlm.nih.gov/books/n/livertox/Futibatinib/ NCI Thesaurus (NCIt) https://www.cancer.gov/policies/copyright-reuse https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&ns=ncit&code=C114283 https://ncit.nci.nih.gov European Medicines Agency (EMA) https://www.ema.europa.eu/en/about-us/legal-notice https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-002647-pip01-19 EU Clinical Trials Register https://www.clinicaltrialsregister.eu/ FDA Orange Book https://www.fda.gov/about-fda/about-website/website-policies#linking https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book Metabolomics Workbench https://www.metabolomicsworkbench.org/data/StructureData.php?RegNo=155310 NCI Cancer Drugs https://www.cancer.gov/policies/copyright-reuse https://www.cancer.gov/about-cancer/treatment/drugs/futibatinib NIPH Clinical Trials Search of Japan https://rctportal.niph.go.jp/en/ Protein Data Bank in Europe (PDBe) http://www.ebi.ac.uk/pdbe-srv/pdbechem/chemicalCompound/show/TZ0 RCSB Protein Data Bank (RCSB PDB) https://www.rcsb.org/pages/policies https://www.rcsb.org/ Springer Nature https://pubchem.ncbi.nlm.nih.gov/substance/?source=15745&sourceid=31051926-507612094 WHO Anatomical Therapeutic Chemical (ATC) Classification https://www.whocc.no/copyright_disclaimer/ https://www.whocc.no/atc/ https://www.whocc.no/atc_ddd_index/ Wikidata https://creativecommons.org/publicdomain/zero/1.0/ https://www.wikidata.org/wiki/Q76791462 https://pubchem.ncbi.nlm.nih.gov Medical Subject Headings (MeSH) https://www.nlm.nih.gov/copyright.html https://www.ncbi.nlm.nih.gov/mesh/2099593 http://www.nlm.nih.gov/mesh/meshhome.html https://www.ncbi.nlm.nih.gov/mesh/68000970 KEGG https://www.kegg.jp/kegg/legal.html http://www.genome.jp/kegg-bin/get_htext?br08303.keg http://www.genome.jp/kegg-bin/get_htext?br08310.keg http://www.genome.jp/kegg-bin/get_htext?br08330.keg PATENTSCOPE (WIPO) https://pubchem.ncbi.nlm.nih.gov/substance/393976448 References