LIBTAYO Concentrate for solution for infusion Ref.[8754] Active ingredients: Cemiplimab

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.

Posology

Recommended dose

The recommended dose is 350 mg cemiplimab, every 3 weeks, administered as an intravenous infusion over 30 minutes.

Treatment may be continued until disease progression or unacceptable toxicity.

Dose modifications

No dose reductions are recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Recommended modifications to manage adverse reactions are provided in Table 1.

Detailed guidelines for the management of immune-related adverse reactions are described in Table 1.

Table 1. Recommended treatment modifications:

Patient Alert Card

All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immune-related adverse reactions and infusion-related reactions. The physician will provide the Patient Alert Card to each patient.

Special populations

Paediatric population

The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established. No data are available.

Elderly

No dose adjustment is recommended for elderly patients. Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).

Renal impairment

No dose adjustment of LIBTAYO is recommended for patients with renal impairment. There are limited data for LIBTAYO in patients with severe renal impairment CLcr <30 ml/min (see section 5.2).

Hepatic impairment

No dose adjustment is recommended for patients with mild hepatic impairment. LIBTAYO has not been studied in patients with moderate or severe hepatic impairment. There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations (see section 5.2).

Method of administration

LIBTAYO is for intravenous use. It must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).

Other medicinal products should not be co-administered through the same infusion line.

For instructions on dilution of the medicinal product before administration, see section 6.6.

In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.

Shelf life

Unopened vial: 30 months.

After opening: Once opened, the medicinal product should be diluted and infused immediately.

After preparation of infusion:

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 intravenous 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. Do not freeze. Allow the diluted solution to come to room temperature prior to administration.

Unopened vial: Store in a refrigerator (2°C to 8°C).

Do not freeze.

Store in the original carton in order to protect from light.

For storage conditions after first opening or dilution of the medicinal product, see section 6.3.

LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.

Each carton contains 1 vial.

Preparation and administration:

• Visually inspect medicinal product for particulate matter and discoloration prior to administration. LIBTAYO is a clear to slightly opalescent, colourless to pale yellow solution that may contain trace amounts of translucent to white particles
• Discard the vial if the solution is cloudy, discoloured or contains extraneous particulate matter other than a few translucent-to-white particles.
• Do not shake the vial.
• Withdraw 7 ml (350 mg) from the vial of LIBTAYO and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. 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 must be administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
• Do not co-administer other medicinal products through the same infusion line.

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