EVRYSDI Powder for oral solution (2022)

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Περιεχόμενα

1. Name of the medicinal product

Evrysdi 0.75 mg/mL powder for oral solution.

2. Qualitative and quantitative composition

Each bottle contains 60 mg risdiplam in 2 g powder for oral solution. Each mL of the constituted solution contains 0.75 mg risdiplam. Excipients with known effects: Each mL contains 0.38 mg of sodium ...

3. Pharmaceutical form

Powder for oral solution. Light yellow, yellow, greyish yellow, greenish yellow, or light green powder.

4.1. Therapeutic indications

Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 ...

4.2. Posology and method of administration

Treatment with Evrysdi should be initiated by a physician with experience in the management of SMA. Posology The recommended once daily dose of Evrysdi is determined by age and body weight (see Table 1). ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Potential embryo-foetal toxicity Embryo-foetal toxicity has been observed in animal studies (see section 5.3). Patients of reproductive potential should be informed of the risks and must use highly effective ...

4.5. Interaction with other medicinal products and other forms of interaction

Risdiplam is primarily metabolized by hepatic enzymes flavin monooxygenase 1 and 3 (FMO1 and 3), and also by cytochrome P450 enzymes (CYPs) 1A1, 2J2, 3A4, and 3A7. Risdiplam is not a substrate of human ...

4.6. Pregnancy and lactation

Patients of reproductive potential Contraception in male and female patients Male and female patients of reproductive potential should adhere to the following contraception requirements: Female patients ...

4.7. Effects on ability to drive and use machines

Evrysdi has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile In infantile-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (54.8%), rash (29.0%) and diarrhoea (19.4%). In later-onset ...

4.9. Overdose

There is no known antidote for overdosage of Evrysdi. In the event of an overdose, the patient should be closely supervised and supportive care instituted.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system ATC code: M09AX10 Mechanism of action Risdiplam is a survival of motor neuron 2 (SMN2) pre-mRNA ...

5.2. Pharmacokinetic properties

Pharmacokinetic parameters have been characterised in healthy adult subjects and in patients with SMA. After administration of treatment as an oral solution, PK of risdiplam were approximately linear between ...

5.3. Preclinical safety data

Impairment of fertility Treatment with risdiplam was associated with male germ cell arrest in rats and monkeys without safety margins based on systemic exposures at the no observed adverse effect level ...

6.1. List of excipients

Mannitol (E421) Isomalt (E953) Strawberry flavour Tartaric acid (E334) Sodium benzoate (E211) Macrogol/polyethylene glycol 6000 Sucralose Ascorbic acid (E300) Disodium edetate dihydrate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Powder for oral solution: 2 years. Constituted oral solution: 64 days stored in a refrigerator (2 to 8°C). If necessary, the patient or their caregiver may store the oral solution at room ...

6.4. Special precautions for storage

Powder for oral solution Keep in the original amber glass bottle to protect from light. Constituted oral solution For storage conditions after constitution of the medicinal product, see section 6.3. Keep ...

6.5. Nature and contents of container

Amber type III glass bottle with a tamper-evident child resistant screw cap. Each carton contains; one bottle, 1 press-in bottle adapter, two re-usable 6 mL and two re-usable 12 mL graduated amber oral ...

6.6. Special precautions for disposal and other handling

Evrysdi powder must be constituted to the oral solution by a HCP (eg. pharmacist) prior to being dispensed. Preparation Caution should be exercised in the handling of Evrysdi powder for oral solution (see ...

8. Marketing authorization number(s)

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 26 March 2021

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