LYFNUA Film-coated tablet Ref.[51267] Active ingredients: Gefapixant

Posology

The recommended dose of gefapixant is one 45 mg tablet taken orally twice daily with or without food.

Missed dose

Patients should be instructed that if they miss a dose, they should skip the missed dose and go back to the regular schedule. Patients should not double their next dose or take more than the prescribed one.

Special populations

Elderly (≥65 years old)

No dose adjustment is required for elderly patients (see sections 5.1 and 5.2).

Gefapixant is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, the risk of adverse reactions to gefapixant may be greater in these patients. Care should be taken with initial dosing frequency.

Renal impairment

Dose adjustment is required in patients with severe renal impairment (eGFR <30 mL/minute/1.73 m²) not requiring dialysis. The dose should be reduced to one 45 mg tablet taken once daily. No dose adjustment is required in patients with mild or moderate renal impairment (eGFR ≥30 mL/minute/1.73 m²). Insufficient data are available in patients with end-stage renal disease requiring dialysis to make dosing recommendations (see section 5.2).

Hepatic impairment

Patients with hepatic impairment have not been studied. However, given that hepatic metabolism is a minor route of elimination of gefapixant, no dose adjustment is recommended (see section 5.2).

Paediatric population

There is no relevant use of Lyfnua in the paediatric population (under 18 years of age) for the indication of refractory or unexplained chronic cough.

Method of administration

Oral use.

Tablets should be swallowed whole and may be taken with or without food. Patients should be instructed not to break, crush or chew the tablets.

In a clinical study with 8 healthy subjects administered gefapixant 1,800 mg twice daily (40 times the recommended human dose) for up to 14 days, crystals composed of gefapixant were detected in the urine of participants. No evidence of renal or urinary system injury was observed.

In cases of overdose reported during the Phase III studies, no adverse events were reported.

In case of overdose, monitor the patient for adverse reactions and institute appropriate supportive measures. Gefapixant is partially removed by haemodialysis.

3 years.

This medicinal product does not require any special storage conditions.

Opaque white PVC/PE/PVdC blisters with push through aluminium lidding foil. Packs of 28, 56 and 98 film-coated tablets in non-perforated blisters (14 tablets per card) and multipacks containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.

Not all pack sizes may be marketed.

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