AMVUTTRA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25MG [SIN17124P]

Product Info

AMVUTTRA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25MG

[SIN17124P]

Indication

4.1 Therapeutic indications

Amvuttra is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN).

Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Dosing

4.2 Posology and method of administration

Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. Treatment should be started as early as possible in the disease course to prevent the accumulation of disability.

Posology

The recommended dose of Amvuttra is 25 mg administered via subcutaneous injection once every 3 months.

Vitamin A supplementation at approximately, but not exceeding, 2 500 international units to 3 000 international units vitamin A per day is advised for patients treated with Amvuttra (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The decision to continue treatment in those patients whose disease progresses to stage 3 polyneuropathy should be taken at the discretion of the physician based on the overall benefit and risk assessment.

There is limited data with vutrisiran in patients with New York Heart Association (NYHA) Class IV and in patients who have both NYHA Class III and National Amyloidosis Centre (NAC) stage III. However, if patients on vutrisiran progress to these stages, these data suggest that patients can remain on treatment.

Missed dose
If a dose is missed, Amvuttra should be administered as soon as possible. Dosing should be resumed every 3 months, from the most recently administered dose.

Special populations

Elderly patients
No dose adjustment is required in patients ≥ 65 years of age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is necessary in patients with mild (total bilirubin ≤ 1 x upper limit of normal (ULN) and aspartate aminotransferase (AST) > 1 x ULN, or total bilirubin > 1.0 to 1.5 x ULN and any AST) or moderate (total bilirubin > 1.5 to 3 × ULN and any AST) hepatic impairment. Vutrisiran has not been studied in patients with severe hepatic impairment and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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). Vutrisiran 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 potential risk (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Amvuttra in children or adolescents < 18 years of age have not been established. No data are available.

Method of administration

Amvuttra is for subcutaneous use only. Amvuttra should be administered by a healthcare professional.

This medicinal product is ready-to-use and for single-use only.

Visually inspect the solution for particulate matter and discolouration. Do not use if discoloured or if particles are present.

Prior to administration, if stored cold, the pre-filled syringe should be allowed to warm by leaving carton at room temperature for about 30 minutes.

• The subcutaneous injection should be administered into one of the following sites: the abdomen, thighs, or upper arms. Amvuttra should not be injected into scar tissue or areas that are reddened, inflamed, or swollen.

• If injecting into the abdomen, the area around the navel should be avoided.

Contraindications

4.3 Contraindications

Severe hypersensitivity (e.g., anaphylaxis) to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.