For UK Healthcare Professionals Only

For UK Healthcare Professionals Only

LYTGOBI▼ offers once-daily oral dosing1

All information on this page is taken from the LYTGOBI Summary of Product Characteristics which can be found here

LYTGOBI is taken:

At a recommended starting dose of 20 mg orally (comprising five 4 mg tablets), once per day.

As tablets, swallowed whole with a glass of water at the same time every day, with or without food.

Without pre-planned treatment breaks until disease progression or unacceptable toxicity.

LYTGOBI therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer.

Presence of FGFR2 gene fusions or rearrangements should be confirmed by an appropriate diagnostic test prior to initiation of LYTGOBI therapy.

Treatment should be continued until disease progression or unacceptable toxicity.

Keep dosing information at your fingertips – download the LYTGOBI Dosing Guide today

Download here

LYTGOBI is packaged to support patient convenience1

Packshot

Day 1 is row 1. Each row of tablets equals one daily dose. 
Each package contains one week's worth of LYTGOBI tablets.

LYTGOBI dose modifications are available to manage adverse reactions1

Starting dose
Dose reduction levels
20 mg taken
orally once daily 		First Second
16 mg taken orally
once daily		 12 mg taken orally
once daily

Dose modifications for hyperphosphataemia1

Adverse reaction
LYTGOBI dose modifications
Serum phosphate
≥5.5 mg/dL to ≤7 mg/dL
  • Initiate phosphate-lowering therapy and monitor serum phosphate weekly
  • LYTGOBI should be continued at current dose
Serum phosphate
>7 mg/dL to ≤10 mg/dL
  • Initiate/intensify phosphate-lowering therapy and monitor serum phosphate weekly AND
  • Dose-reduce LYTGOBI to next lower dose
    • If the serum phosphate resolves to ≤7.0 mg/dL within 2 weeks after dose reduction, continue at this reduced dose
    • If serum phosphate is not ≤7.0 mg/dL within 2 weeks, further reduce LYTGOBI to the next lower dose
    • If serum phosphate is not ≤7.0 mg/dL within 2 weeks after the second dose reduction, withhold LYTGOBI until serum phosphate is ≤7.0 mg/dL and resume at the dose prior to suspending
Serum phosphate
>10 mg/dL
  • Initiate/intensify phosphate-lowering therapy and monitor serum phosphate weekly AND
  • Suspend LYTGOBI until phosphate is ≤7.0 mg/dL and resume LYTGOBI at the next lower dose
  • Permanently discontinue LYTGOBI if serum phosphate is not ≤7.0 mg/dL within 2 weeks following two dose reductions

Dose modifications for serous retinal detachment1

Adverse reaction
LYTGOBI dose modifications
Asymptomatic
  • Continue LYTGOBI at current dose. Monitoring should be performed as described in section 4.4 of the SmPC
Moderate decrease in visual acuity (best corrected visual acuity 20/40 or better or ≤3 lines of decreased vision from baseline); limiting instrumental activities of daily living
  • Withhold LYTGOBI
  • If improved on subsequent examination, LYTGOBI should be resumed at the next lower dose level
  • If symptoms recur or persist, or examination does not improve, permanent discontinuation of LYTGOBI should be considered based on clinical status
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or >3 lines decreased vision from baseline up to 20/200); limiting activities of daily living
  • Withhold LYTGOBI until resolution
  • If improved on subsequent examination, LYTGOBI may be resumed at two dose levels lower
  • If symptoms recur, persist or examination does not improve, permanent discontinuation of LYTGOBI should be considered based on clinical status
Visual acuity worse than 20/200 in affected eye; limiting activities of daily living
  • Permanent discontinuation of LYTGOBI should be considered based on clinical status

Dose modifications for other adverse reactions1

Adverse reaction
LYTGOBI dose modifications
Other adverse reactions

Grade 3*

  • Withhold LYTGOBI until toxicity resolves to Grade 1 or baseline, then resume LYTGOBI:
    • for haematological toxicities resolving within 1 week, at the dose prior to suspending
    • for other adverse reactions, at next lower dose

Grade 4*

  • Permanently discontinue LYTGOBI

*Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03)

If dose modification is required, alternative 28-count (four 5 mg tablets daily) and 21-count (three 5 mg tablets daily) blister packs are available. Permanently discontinue treatment if the patient is unable to tolerate 12 mg of LYTGOBI once daily.

Packshot

Hyperphosphataemia and serous retinal detachment can both be effectively managed through dose modifications1 – download the LYTGOBI Adverse Reaction Guide to find out more  

Download here
Explore the LYTGOBI
efficacy data View the LYTGOBI
safety profile Discover the
LYTGOBI MoA

Please see full Prescribing Information for LYTGOBI (futibatinib) here.

FGFR2, fibroblast growth factor receptor 2; MoA, mechanism of action; SmPC, Summary of Product Characteristics.

References: 1. LYTGOBI Summary of Product Characteristics.