AMVUTTRA Solution for injection Ref.[50230] Active ingredients: Vutrisiran

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, 2500 IU to 3000 IU vitamin A per day is advised for patients treated with Amvuttra (see section 4.4).

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.

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).

Hepatic impairment

No dose adjustment is necessary in patients with mild hepatic impairment (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). Vutrisiran 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 potential risk (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). 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).

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.

In case of overdose, it is recommended that the patient be monitored as medically indicated for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted.

2 years.

Do not store above 30°C. Do not freeze.

Pre-filled syringe (Type I glass) with stainless steel 29-gauge needle with a needle shield.

Amvuttra is available in packs containing one single-use pre-filled syringe.

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