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.[rx,rx]
As a novel inhibitor of FGFR, futibatinib was first approved by the FDA in September 2022 to treat different types of intrahepatic cholangiocarcinoma.[rx]
Mechanism of action
The fibroblast Growth Factor receptor (FGFR) pathway play a key role in cell proliferation, differentiation, migration, and survival. Notably, FGFR genomic aberrations and aberrant FGFR signaling pathways are observed in some cancers,[rx,rx] as constitutive FGFR signaling can support the proliferation and survival of malignant cells.[rx]
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.[rx] Upon binding to FGFR, futibatinib blocks FGFR phosphorylation and downstream signaling pathways,[rx] such as the RAS-dependent mitogen-activated protein kinase (MAPK), phosphatidylinositol 3-kinase (PI3KCA)/Akt/mTOR, phospholipase Cγ (PLCγ), and JAK/STAT.[rx] Futibatinib ultimately decreases cell viability in cancer cell lines with FGFR alterations, including FGFR fusions or rearrangements, amplifications, and mutations.[rx]
Futibatinib is an anticancer agent with demonstrated anti-tumor activity in mouse and rat xenograft models of human tumors with activating FGFR genetic alterations.[rx] Futibatinib is not expected to affect cell lines with no FGFR genomic aberrations.[rx] It suppresses the growth of tumors in a dose-dependent manner.[rx]
Indications
- Treatment of cholangiocarcinoma
- Futibatinib is approved to treat: Intrahepatic cholangiocarcinoma (cancer that forms in the bile ducts inside the liver) that has spread or cannot be removed with surgery. It is used in adults whose cancer has been treated and has an FGFR2gene fusion or other change in the structure of the FGFR2 gene.
- Futibatinib is indicated for the treatment of adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
- Futibatinib is a kinase inhibitor used to treat intrahepatic cholangiocarcinoma in previously treated adults.
- 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.[rx]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).[rx]
- Locally Advanced Intrahepatic Cholangiocarcinoma
- Metastatic Intrahepatic Cholangiocarcinoma
- Unresectable Intrahepatic Cholangiocarcinoma
- Patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Use in Cancer
Fulvestrant is approved to be used alone or with other drugs to treat:
- Breast cancer. It is used:
- Alone in postmenopausal women with hormone receptor-positive (HR+) and HER2-negative advanced cancer that has not been treated with hormone therapy.
- Alone in postmenopausal women with HR+ advanced cancer that got worse after treatment with hormone therapy.
- Palbociclib succinate in postmenopausal women with HR+ and HER2-negative advanced or metastatic cancer. It is used as first-line hormone therapy or after cancer got worse during treatment with hormone therapy.
- Palbociclib or abemaciclib in women with HR+ and HER2-negative advanced or metastatic cancer that got worse after treatment with hormone therapy.
Fulvestrant is also being studied in the treatment of other types of cancer.
Contraindications
- Futibatinib can cause hypersensitivity reactions.[rx] Therefore, it is contraindicated in patients who have experienced hypersensitivity
- sickle cell anemia
- pain crisis in sickle cell disease
- decreased blood platelets
- capillary leak syndrome is a condition where fluid leaks out of small blood vessels
- acute respiratory distress syndrome, a type of lung disorder
- glomerulonephritis, a condition that affects the kidneys
- myelodysplastic syndrome, a bone marrow disorder
- rupture of the spleen
- Pregnancy
- Lactating mother
Dosage
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.
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 of 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 of 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 the 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.
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 | 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 | 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Levoketoconaz | 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 | 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 | 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. |
| Naloxone | The metabolism of Futibatinib can be decreased when combined with Naloxone. |
| 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. |
| 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. |
| 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. |
| 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 | 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 | 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. |
| 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 from animal studies and its mechanism of action, this drug has the potential to cause fetal harm when administered to a pregnant woman. Women of childbearing potential should use effective contraception during treatment and for 1 week after the last dose. Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 1 week after the last dose. Pregnancy status should be verified in females of childbearing potential prior to initiating therapy. Females of childbearing potential should be apprised of the embryofetal risk associated with this drug.
Lactation
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 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.
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 a vision or eye problems, diabetes, anemia, a history of a 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.
References