TRYNGOLZA Solution for injection Ref.[115924] Active ingredients: Olezarsen

Posology

The recommended dose of olezarsen is 80 mg administered by subcutaneous injection once monthly.

Missed dose

If a dose is missed, Tryngolza should be administered as soon as possible. Dosing at monthly intervals should be resumed from the date of the most recently administered dose.

Special populations

Elderly population

No dose adjustment is required in patients ≥65 years of age (see section 5.2).

Renal impairment

No dose adjustment is necessary in patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥30 to <90 mL/min/1.73 m²) (see section 5.2).

Olezarsen has not been studied in patients with severe renal impairment or end-stage renal disease and should only be used in these patients if the anticipated clinical benefit outweighs the risk.

Hepatic impairment

No dose adjustment is necessary in patients with mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] with aspartate aminotransferase [AST] > ULN, or total bilirubin > 1-1.5 × ULN with any AST) (see section 5.2).

Olezarsen has not been studied in patients with moderate or severe hepatic impairment and should only be used in these patients if the anticipated clinical benefit outweighs the risk.

Paediatric population

The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established. No data are available (see section 5.1).

Method of administration

This medicinal product is intended for subcutaneous use only. It should not be administered intramuscularly.

Each pre-filled pen is for single use only.

Patients and/or caregivers should be trained in the administration of this medicinal product in accordance with the comprehensive instructions for use provided at the end of the package leaflet.

This medicinal product should be administered into the abdomen or front of the thigh. The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. It should not be injected into skin that is bruised, tender, red, or hard, into scars or damaged skin; the area around the navel should be avoided.

Some patients might not be responsive to the treatment after 6 months, in such a case the discontinuation of olezarsen should be considered on an individual basis by the prescribing physician.

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

In the case of overdose, patients should be carefully observed and supportive care administered, as appropriate.

4 years.

Store in a refrigerator (2°C–8°C).

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

Tryngolza can be stored in the original package outside the refrigerator (up to 30°C) for up to 6 weeks. If not used within the 6 weeks, it should be discarded.

0.8 mL solution for injection in a type I glass syringe with a stainless steel staked needle, rigid needle shield, and siliconised chlorobutyl elastomer plunger stopper. The syringe is assembled into a disposable single-dose pre-filled pen.

Pack size of one pre-filled pen.

The single dose pre-filled pen should be removed from a refrigerator (2°C to 8°C) at least 30 minutes before use to allow it to reach room temperature (up to 30°C) prior to injection. Other warming methods (e.g. hot water or microwave) should not be used.

The medicinal product should be inspected visually prior to administration. The solution should be a clear and colourless to yellow liquid. It is normal to see air bubbles in the solution. If the solution is cloudy or contains visible particulate matter, the content must not be injected and the medicinal product should be returned to the pharmacy. Do not use if the solution appears frozen.

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