VYEPTI Concentrate for solution for infusion Ref.[49510] Active ingredients: Eptinezumab

The treatment should be initiated by a healthcare professional experienced in the diagnosis and treatment of migraine. The infusion of VYEPTI should be initiated and supervised by a healthcare professional.

Posology

The recommended dose is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks (see section 5.1).

The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. When switching dosage, the first dose of the new regimen should be given on the next scheduled dosing date.

Overall benefit and continuation of treatment should be assessed 6 months after initiation of the treatment. Any further decision to continue the treatment should be made on an individual patient basis.

Special Populations

Elderly (aged 65 years and over)

There is limited data available for the use of VYEPTI in patients ≥65 years of age. No dose adjustment is required in the elderly patients as the pharmacokinetics of eptinezumab were not affected by age.

Renal impairment/hepatic impairment

No dose adjustment is required in patients with renal impairment or hepatic impairment (see section 5.2).

Paediatric population

The safety and efficacy of VYEPTI in children aged 6 to 18 years has not yet been established.

Currently no data are available.

There is no relevant use of VYEPTI in children below the age of 6 years for the prophylaxis of migraine.

Method of administration

VYEPTI is for intravenous use only after dilution.

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

Following dilution, infuse VYEPTI, over approximately 30 minutes.

The treating healthcare professional should observe or monitor patients during and after the infusion in accordance with normal clinical practice.

Do not administer VYEPTI as a bolus injection.

Doses up to 1000 mg have been administered intravenously to humans without tolerability issues or clinically significant adverse reactions.

In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.

3 years.

Following dilution, the VYEPTI solution for infusion (VYEPTI and 0.9% sodium chloride for injection) must be infused within 8 hours (see section 6.6).

Store in a refrigerator (2°C-8°C).

Do not freeze or shake.

Keep the vial in the outer carton in order to protect from light.

Following dilution, the VYEPTI solution for infusion (VYEPTI and 0.9% sodium chloride for injection) may be stored at room temperature (below 25°C) or refrigerated at 2°C-8°C.

4 mL type I glass vial with chlorobutyl rubber stopper. The vial stopper is made without natural rubber latex.

Each carton contains one vial.

The medicinal product requires dilution prior to administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution for infusion.

The medicinal product contains no preservative and is intended for single use only and any unused medicinal product should be disposed.

Prior to dilution, the medicinal product (concentrate in the vials) should be inspected visually; do not use if the concentrate contains visible particulate matter or is cloudy or discoloured (other than clear to slightly opalescent, colourless to brownish-yellow).

For both the 100 mg and the 300 mg dose, a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prepare the VYEPTI solution for infusion as described below. No other intravenous diluents or volume may be used to prepare the VYEPTI solution for infusion.

Gently invert the VYEPTI solution for infusion to mix completely. Do not shake.

Following dilution, VYEPTI solution for infusion must be infused within 8 hours. During this time, VYEPTI solution for infusion may be stored at room temperature (below 25°C) or refrigerated at 2°C-8°C. If stored at 2°C-8°C, allow the VYEPTI solution for infusion to warm to room temperature prior to infusion. DO NOT FREEZE.

VYEPTI 100 mg dose:

To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from one single-use vial using a sterile needle and syringe. Inject the 1.0 mL (100 mg) content into a 100 mL bag of 0.9% sodium chloride for injection

VYEPTI 300 mg dose:

To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from 3 single-use vials using a sterile needle and syringe. Inject the resulting 3.0 mL (300 mg) content into a 100 mL bag of 0.9% sodium chloride for injection.

Infusion administration instructions

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored.

Infuse VYEPTI 100 mg dose or VYEPTI 300 mg dose as prescribed, following dilution of the vial content in a 100 mL bag of 0.9% sodium chloride for injection, over approximately 30 minutes. Use an intravenous infusion set with a 0.2 or 0.22 μm in-line or add-on filter. After the infusion is complete, flush the line with 20 mL of 0.9% sodium chloride for injection.

Do not administer VYEPTI as a bolus injection.

No other medications should be administered through the infusion set or mixed with VYEPTI.

Any unused medicinal product or waste material should be disposed in accordance with local requirements.