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Drug overview for LYTGOBI (futibatinib):
Generic name: futibatinib (FUE-ti-BA-ti-nib)
Drug class: Antineoplastic-Fibroblast Growth Factor Receptor (FGFR) Inh.
Therapeutic class: Antineoplastics
Futibatinib is an antineoplastic agent and small molecule kinase inhibitor of fibroblast growth factor receptor (FGFR) 1, 2, 3, and 4.
No enhanced Uses information available for this drug.
Generic name: futibatinib (FUE-ti-BA-ti-nib)
Drug class: Antineoplastic-Fibroblast Growth Factor Receptor (FGFR) Inh.
Therapeutic class: Antineoplastics
Futibatinib is an antineoplastic agent and small molecule kinase inhibitor of fibroblast growth factor receptor (FGFR) 1, 2, 3, and 4.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for LYTGOBI (futibatinib) have been approved by the FDA:
Indications:
Cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
Professional Synonyms:
CCA with FGFR2 gene fusion or rearrangement
Indications:
Cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
Professional Synonyms:
CCA with FGFR2 gene fusion or rearrangement
The following dosing information is available for LYTGOBI (futibatinib):
If adverse reactions occur during futibatinib therapy, temporary interruption, dosage reduction, and/or permanent discontinuance of the drug may be necessary. If dosage modification is required, reduce the dosage of futibatinib as described in Table 1.
Administer orally once daily. Administer futibatinib tablets with or without food at approximately the same time each day. Swallow tablets whole; do not crush, chew, split, or dissolve the tablets.
If a dose is missed by >=12 hours, or if vomiting occurs after the dose is taken, resume dosing with the next scheduled dose. Store tablets at 20-25degreesC (excursions permitted between 15-30degreesC).
If a dose is missed by >=12 hours, or if vomiting occurs after the dose is taken, resume dosing with the next scheduled dose. Store tablets at 20-25degreesC (excursions permitted between 15-30degreesC).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LYTGOBI 12 MG DOSE (3X 4MG TB) | Maintenance | Adults take by oral route once daily per package directions |
| LYTGOBI 16 MG DOSE (4X 4MG TB) | Maintenance | Adults take by oral route once daily per package directions |
| LYTGOBI 20 MG DOSE (5X 4MG TB) | Maintenance | Adults take by oral route once daily per package directions |
No generic dosing information available.
The following drug interaction information is available for LYTGOBI (futibatinib):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Futibatinib/Dual P-gp & Strong 3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Futibatinib is primarily metabolized by CYP3A4. P-glycoprotein (P-gp) and BCRP (breast cancer resistance protein) transport proteins participate in the elimination of futibatinib.(1) Agents that induce both P-gp and CYP3A4 may reduce the plasma levels of futibatinib.(1) CLINICAL EFFECTS: Concurrent or recent use of dual P-gp and strong CYP3A4 inducers may result in decreased levels and effectiveness of futibatinib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The manufacturer of futibatinib states concurrent use with dual P-gp and strong CYP3A4 inducers should be avoided.(1) DISCUSSION: Coadministration with rifampin (P-gp and strong CYP3A4 inducer) decreased the maximum concentration (Cmax) and area-under-curve (AUC) of futibatinib by 53% and 64%, respectively.(1) Dual P-gp and CYP3A4 inducers linked to this monograph include: apalutamide, carbamazepine, fosphenytoin, phenytoin, rifampin, rifapentine, and St. John's wort.(2,3) |
CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, EPITOL, EQUETRO, ERLEADA, FOSPHENYTOIN SODIUM, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, RIFADIN, RIFAMPIN, TEGRETOL, TEGRETOL XR |
| Futibatinib/Dual Strong CYP3A4 & P-gp Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Futibatinib is primarily metabolized by CYP3A4. P-glycoprotein (P-gp) and BCRP (breast cancer resistance protein) transport proteins participate in the elimination of futibatinib.(1) Dual inhibitors of CYP3A4 and P-gp may inhibit metabolic and transporter-based elimination of futibatinib.(1) CLINICAL EFFECTS: Concurrent use with dual inhibitors of CYP3A4 and P-gp may result in elevated systemic levels and toxicity from futibatinib.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of futibatinib states concurrent use with dual P-gp and strong CYP3A4 inhibitors should be avoided.(1) DISCUSSION: In an interaction study, multiple doses of itraconazole (an inhibitor of CYP3A4 and P-gp) increased the mean maximum concentration (Cmax) and area-under-curve (AUC) of futibatinib by 51% and 41%, respectively.(1) Dual P-gp and CYP3A4 inhibitors linked to this monograph include: adagrasib, clarithromycin, cobicistat, indinavir, itraconazole, josamycin, ketoconazole, levoketoconazole, lonafarnib, lopinavir, mibefradil, mifepristone, nefazodone, nirmatrelvir, paritaprevir, posaconazole, saquinavir, telaprevir, telithromycin, tipranavir, and tucatinib.(2,3) |
APTIVUS, CLARITHROMYCIN, CLARITHROMYCIN ER, EVOTAZ, GENVOYA, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, KALETRA, KETOCONAZOLE, KORLYM, KRAZATI, LANSOPRAZOL-AMOXICIL-CLARITHRO, LOPINAVIR-RITONAVIR, MIFEPREX, MIFEPRISTONE, NEFAZODONE HCL, NOXAFIL, OMECLAMOX-PAK, PAXLOVID, POSACONAZOLE, PREZCOBIX, RECORLEV, SPORANOX, STRIBILD, SYMTUZA, TOLSURA, TUKYSA, TYBOST, VOQUEZNA TRIPLE PAK, ZOKINVY |
There are 0 moderate interactions.
The following contraindication information is available for LYTGOBI (futibatinib):
Drug contraindication overview.
*None.
*None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hyperphosphatemia |
The following adverse reaction information is available for LYTGOBI (futibatinib):
Adverse reaction overview.
Adverse effects reported in >=20% of patients receiving futibatinib were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting. Laboratory abnormalities reported in >=20% of patients receiving futibatinib were increased phosphate, increased creatinine, decreased hemoglobin, increased/decreased glucose, increased calcium, decreased sodium, decreased phosphate, increased ALT/AST, increased alkaline phosphatase, decreased lymphocytes, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, increased prothrombin international normalized ratio, and decreased potassium.
Adverse effects reported in >=20% of patients receiving futibatinib were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting. Laboratory abnormalities reported in >=20% of patients receiving futibatinib were increased phosphate, increased creatinine, decreased hemoglobin, increased/decreased glucose, increased calcium, decreased sodium, decreased phosphate, increased ALT/AST, increased alkaline phosphatase, decreased lymphocytes, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, increased prothrombin international normalized ratio, and decreased potassium.
There are 17 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Hypercalcemia Hyperphosphatemia Hyponatremia Lymphopenia |
Ascites Biliary obstruction Gastrointestinal hemorrhage Hypophosphatemia Increased alanine transaminase Increased aspartate transaminase Neutropenic disorder Retinal pigment epithelial detachment Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
|
Calcification of vascular system Calcinosis cutis Calciphylaxis |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Alopecia Anorexia Arthralgia Constipation Diarrhea Dry eye Dry skin Dysgeusia Fatigue Hyperglycemia Musculoskeletal pain Nail disorders Nausea Palmar-plantar erythrodysesthesia Stomatitis Urinary tract infection Vomiting Xerostomia |
Fever |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for LYTGOBI (futibatinib):
Safety and efficacy of futibatinib in pediatric patients have not been established. In animal toxicity studies (duration of 4 or 13 weeks in rats and dogs, respectively), futibatinib was associated with increased inorganic phosphorus and calcium in plasma, ectopic mineralization in different organs and tissues, lesions in bone/cartilage, and corneal lesions when given at exposures lower than those achieved in humans at the recommended dosage of 20 mg.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Futibatinib use during pregnancy can cause fetal harm based on findings in an animal study and the mechanism of action of the drug. Human data on futibatinib use during pregnancy are not available. Administration of oral futibatinib to pregnant rats during the period of organogenesis resulted in fetal malformations, fetal growth retardation, and embryofetal death at maternal exposures lower than the human exposure at the clinical dose of 20 mg based on AUC.
Confirm pregnancy status prior to initiating futibatinib in females of reproductive potential. Apprise patients of the potential hazard to the fetus if futibatinib is used during pregnancy.
Confirm pregnancy status prior to initiating futibatinib in females of reproductive potential. Apprise patients of the potential hazard to the fetus if futibatinib is used during pregnancy.
It is unknown whether futibatinib or its metabolites are distributed into human milk; effects on milk production or the breast-fed infant are also unknown. Because of the potential for serious adverse reactions in breast-fed infants, advise women to not breast-feed during treatment with futibatinib and for 1 week after the last dose.
The manufacturer makes no specific dosage recommendations for geriatric patients. Clinical studies of futibatinib included patients >=65 years of age. There were no overall differences in the safety or efficacy of futibatinib between geriatric and younger patients. No clinically important differences in futibatinib systemic exposures were observed based on age (range, 18-82 years).
The following prioritized warning is available for LYTGOBI (futibatinib):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for LYTGOBI (futibatinib)'s list of indications:
| Cholangiocarcinoma with FGFr2 fusion or rearrangement | |
| C22.1 | Intrahepatic bile duct carcinoma |
| C24.0 | Malignant neoplasm of extrahepatic bile duct |
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