REZDIFFRA Film-coated tablet Ref.[116002] Active ingredients: Resmetirom

Posology

The posology is based on the patient's body weight (see section 5.2):

• For patients weighing <100 kg, the recommended dose is 80 mg taken orally once daily.
• For patients weighing ≥100 kg, the recommended dose is 100 mg taken orally once daily.

Missed or delayed doses

If a dose of resmetirom is missed, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.

CYP2C8 inhibitors

Concomitant use of resmetirom with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. If resmetirom is used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel, deferasirox, teriflunomide), the dose of resmetirom should be reduced from 100 mg to 80 mg for patients weighing ≥100 kg and from 80 mg to 60 mg for patients weighing <100 kg (see section 4.5).

Special populations

Hepatic impairment

Mild hepatic impairment:

No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh A). Safety and efficacy have not been demonstrated in Child-Pugh A cirrhosis (see section 5.2).

Moderate or severe hepatic impairment:

Increased exposure (C_max and AUC) of resmetirom has been observed in patients with moderate or severe hepatic impairment. Resmetirom should not be used in patients with moderate or severe (Child-Pugh B or C) hepatic impairment (see section 5.2).

Renal impairment

Mild renal impairment (eGFR 60 to 89 mL/min), moderate renal impairment (eGFR 30 to 59 mL/min) and severe renal impairment (eGFR 15 to 29 mL/min):

No dose adjustment of resmetirom is recommended in patients with mild, moderate or severe renal impairment. In moderate or severe renal impairment the increase in exposure is within the expected variability of exposure (see section 5.2).

Elderly

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

Paediatric population

The safety and efficacy of resmetirom in children and adolescents less than 18 years old have not yet been established. No data are available.

Method of administration

Oral use.

Resmetirom may be taken with or without food (see section 5.2).

In clinical studies in healthy subjects, the highest dose of resmetirom tested was 200 mg once daily for up to 14 days, without reports of any additional adverse reactions.

If overdose occurs the patient should be monitored for signs or symptoms of adverse reactions (see section 4.8), and supportive care should be provided as needed.

The medicinal product is unlikely to be removed by haemodialysis due to high protein binding (see section 5.2).

3 years.

Store below 30°C.

Rezdiffra film-coated tablets are supplied in PVC/PCTFE blisters with aluminium foil lidding.

Pack size of 28 film-coated tablets.

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