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LYTGOBI is a brand name for Futibatinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1) ] . This…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Confirm the presence of an FGFR2 gene fusion or other rearrangement prior to initiation of treatment with LYTGOBI. 1 ) Recommended dose is 20 mg orally (five 4 mg tablets or one 16 mg tablet and one 4 mg tablet) once daily until disease progression or unacceptable toxicity occurs.
2 ) Swallow tablet whole, with or without food. 1) ]. An FDA-approved test for detection of FGFR2 gene fusions or other rearrangements in patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma for selecting patients for treatment with LYTGOBI is not available.
2 Recommended Dosage The recommended dosage of LYTGOBI is 20 mg (five 4 mg tablets or one 16 mg and one 4 mg tablet) taken orally once daily until disease progression or unacceptable toxicity occurs. 3) ] . Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.
If the patient misses a dose of LYTGOBI for more than 12 hours or if vomiting occurs, resume dosing with the next scheduled dose. 3 Dosage Modification for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1 .
Table 1:
Recommended Dose Reductions for LYTGOBI for Adverse Reactions Dose Reduction Recommended Dosage First dose reduction 16 mg (four 4 mg tablets or one 16 mg tablet) orally once daily Second dose reduction Permanently discontinue LYTGOBI if unable to tolerate 12 mg orally once daily.
12 mg (three 4 mg tablets) orally once daily Recommended dosage modifications for adverse reactions are provided in Table 2 . 03). 1) ] Not applicable Continue LYTGOBI at the current dose and continue periodic ophthalmic evaluation: If resolving within 14 days, continue LYTGOBI at the current dose.
If not resolving within 14 days, withhold LYTGOBI until resolving; then resume LYTGOBI at previous or a lower dose. 5 - ≤7 mg/dL Continue LYTGOBI at the current dose and initiate phosphate lowering therapy. Monitor serum phosphate weekly.
Serum phosphate >7 - ≤10 mg/dL Initiate or adjust phosphate lowering therapy. Monitor serum phosphate weekly and Dose reduce LYTGOBI to next lower dose - If the serum phosphate resolves to ≤7 mg/dL within 2 weeks after dose reduction, continue at this reduced dose.
2) ] Most common (≥20%) adverse reactions 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.
1 ) Most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taiho Oncology Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to LYTGOBI as a single agent at 20 mg orally once daily in 318 patients including 145 patients with cholangiocarcinoma and 173 patients with other advanced solid tumors.
Among 318 patients who received LYTGOBI, 37% were exposed for 6 months or longer and 13% were exposed for greater than 12 months. 1) ] . Patients were treated with LYTGOBI 20 mg orally once daily until disease progression or unacceptable toxicity.
5 - 25 months). Serious adverse reactions occurred in 39% of patients receiving LYTGOBI. 9%). 9% of patients who received LYTGOBI. Adverse reactions requiring permanent discontinuation of LYTGOBI in one patient each were esophagitis, oral dysesthesia, bile duct obstruction, dizziness, and anemia.
5 WARNINGS AND PRECAUTIONS Ocular Toxicity: LYTGOBI can cause retinal pigment epithelial detachment (RPED). Perform a comprehensive ophthalmological examination including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter and urgently at any time for visual symptoms.
1 ) Hyperphosphatemia and Soft Tissue Mineralization: Increases in phosphate levels can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis and vascular calcification. Monitor for hyperphosphatemia and withhold, reduce the dose, or permanently discontinue based on duration and severity of hyperphosphatemia.
2 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and to use effective contraception. 1 Ocular Toxicity Retinal Pigment Epithelial Detachment (RPED) LYTGOBI can cause RPED, which may cause symptoms such as blurred vision.
1) ] where ophthalmologic monitoring did not routinely include optical coherence tomography (OCT), RPED occurred in 9% of patients. The median time to first onset of RPED was 40 days. 3% of patients. Perform a comprehensive ophthalmological examination, including OCT of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter.
For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. 3) ]. 1) ] , dry eye occurred in 15% of patients. Treat patients with ocular demulcents as needed.
2 Hyperphosphatemia and Soft Tissue Mineralization LYTGOBI can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. 2) ] . 1) ] , hyperphosphatemia was reported in 88% of patients based on laboratory values above the upper limit of normal.
4 CONTRAINDICATIONS None. None ( 4 )
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- If serum phosphate is not ≤7 mg/dL within 2 weeks, further reduce LYTGOBI to the next lower dose. - If serum phosphate is not ≤7 mg/dL within 2 weeks after the second dose reduction, withhold LYTGOBI until serum phosphate is ≤7 mg/dL and resume at the dose prior to suspending.
Serum phosphate >10 mg/dL Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly and Withhold LYTGOBI until phosphate is ≤7 mg/dL and resume LYTGOBI at the next lower dose. - Permanently discontinue LYTGOBI if serum phosphate is not ≤7 mg/dL within 2 weeks following 2 dose interruptions and reductions.
Other Adverse Reactions Grade 3 a Withhold LYTGOBI until toxicity resolves to Grade 1 or baseline, then resume LYTGOBI - for hematological toxicities resolving within 1 week, at the dose prior to suspending. - for other adverse reactions, at next lower dose.
Grade 4 a Permanently discontinue LYTGOBI
Dosage interruptions due to an adverse reaction occurred in 66% of patients who received LYTGOBI. Adverse reactions requiring dosage interruption in ≥5% of patients included hyperphosphatemia, palmar-plantar erythrodysesthesia syndrome, increased alanine aminotransferase, increased aspartate aminotransferase, and fatigue.
Dose reductions due to an adverse reaction occurred in 58% of patients who received LYTGOBI. Adverse reactions requiring dosage reductions in ≥2% of patients who received LYTGOBI included hyperphosphatemia, palmar-plantar erythrodysesthesia syndrome, fatigue, increased alanine aminotransferase, increased aspartate aminotransferase, nail toxicity, and stomatitis.
The most common (≥20%) adverse reactions 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.
The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocyte, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.
Table 3 summarizes the adverse reactions in TAS-120-101. Table 4 summarizes laboratory abnormalities in TAS-120-101. 03. b Includes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail infection, nail pigmentation, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.
c Includes diarrhea, colitis, and gastroenteritis. d Includes stomatitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation, and tongue ulceration. e Includes abdominal pain, abdominal discomfort, abdominal pain upper, gastrointestinal pain, and hepatic pain.
f Includes vomiting and hematemesis. g Includes fatigue and asthenia. h Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain.
i Includes arthralgia and arthritis. j Includes dry eye, keratitis, lacrimation increased, photokeratitis, punctate keratitis, and ulcerative keratitis. k Includes dysgeusia, ageusia, and taste disorder. l Includes urinary tract infection, cystitis, and dysuria.
8%). 03. b Percentages are based on patients with data at both baseline and at least one post-baseline data value. 03 does not define grades for increased phosphate. Laboratory value shift table categories were used to assess increased phosphorus levels (Grades ≥3 defined as >7 mg/dL).
d Graded based on comparison to upper limit of normal. 1 Increased potassium 16 2 Coagulation Increased activated partial thromboplastin time 36 8 Increased prothrombin international normalized ratio 25 0
The median time to onset of hyperphosphatemia was 5 days (range 3-117). Phosphate binders were received by 77% of patients who received LYTGOBI. Monitor for hyperphosphatemia throughout treatment. 5 mg/dL. 3) ] . 3 Embryo-Fetal Toxicity Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administered to a pregnant woman.
Oral administration of futibatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure at the clinical dose of 20 mg based on area under the curve (AUC).
Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with LYTGOBI and for 1 week after the last dose of LYTGOBI. 3) ] .