Multikinase inhibitors
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Lytgobi Dosage

Drug Detail:Lytgobi (Futibatinib [ fue-ti-ba-ti-nib ])

Generic Name: FUTIBATINIB 4mg

Dosage Form: tablet

Drug Class: Multikinase inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for the treatment of unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with LYTGOBI based on the presence of an FGFR2 gene fusion or rearrangement [see Clinical Studies (14.1)]. 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.

Recommended Dosage

The recommended dosage of LYTGOBI is 20 mg (five 4 mg tablets) taken orally once daily until disease progression or unacceptable toxicity occurs.

Take LYTGOBI with or without food at approximately the same time each day [see Clinical Pharmacology (12.3)].

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.

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
*
Permanently discontinue LYTGOBI if unable to tolerate 12 mg orally once daily.
First dose reduction 16 mg (four 4 mg tablets) orally once daily
Second dose reduction* 12 mg (three 4 mg tablets) orally once daily

Recommended dosage modifications for adverse reactions are provided in Table 2.

Table 2: Recommended Dosage Modifications for LYTGOBI Adverse Reactions
Adverse Reaction Severity LYTGOBI Dosage Modifications
a Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
Retinal Pigment Epithelial Detachment (RPED) [see Warnings and Precautions (5.1)] 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.
Hyperphosphatemia [see Warnings and Precautions (5.2)] Serum phosphate ≥5.5 - ≤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.
    -
    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 3a
  • 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 4a Permanently discontinue LYTGOBI
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