LIBTAYO dosing protocol 1

Treatment may be continued until symptomatic
disease progression or unacceptable toxicity.

In patients with a low body weight, a dose of 3 mg/kg every two weeks administered as an IV infusion over 30 minutes may be considered.

No dose reductions are recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability.

Please see the Product Monograph for completing dosing and administration recommendations.

IV: intravenous.

Preparation of LIBTAYO1

1. Visually inspect the drug product for particulate matter and discolouration prior to administration.

  • Libtayo is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles
  • Discard the vial if the solution is cloudy, discolored or contains extraneous particulate matter other than trace amounts of translucent-to-white particles
  • Do not shake the vial

2. Withdraw the required volume from the vial(s) of LIBTAYO and transfer into an intravenous (IV) infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

3. Mix the diluted solution by gentle inversion.

  • Do not shake the solution
  • The final concentration of the diluted solution should be between 1 mg/mL to 20 mg/mL

LIBTAYO is for single use only. Dispose of any unused medicinal product or waste material in accordance with local requirements.

No compatibility studies have been performed. Do not mix with other medicinal products.

Administration of LIBTAYO 1

LIBTAYO must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile in-line or add-on filter (0.2-micron to 5-micron pore size)

  • Do not co-administer with other drugs through the same infusion line

Storage of LIBTAYO1

Once prepared, administer the diluted solution immediately. If diluted solution is not administered immediately, it may be stored temporarily either:

  • At room temperature up to 25°C for no more than 8 hours from the time of preparation. This includes room temperature storage of the infusion solution in the IV container and time for administration of the infusion.
  • or
  • Under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation. Allow the diluted solution to come to room temperature prior to administration.

  • Do not freeze
  • Do not shake

SAFETY PROFILE

Learn about the safety and tolerability profile of LIBTAYO in patients with advanced CSCC.

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EFFICACY PROFILE

Explore the efficacy profile of LIBTAYO, including cases seen from the trials.

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STUDY DESIGN

Learn the details behind Study 1423 and Study 1540, two clinical trials used to evaluate the efficacy and safety profile of LIBTAYO.

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