Risdiplam

Generic name
Risdiplam
Brand name
ATC Code
M09AX10
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

5q spinal muscle atrophy (SMA)
  • Oral
    • 2 months up to 2 years
      • 0.2 mg/kg/day in 1 dose
      • Directions for administration:

        Administer after meals. Do not mix with formula or breastfeeding. 

    • ≥ 2 years
      • 0.25 mg/kg/day in 1 dose. Max: 5 mg/dose.
      • Directions for administration:

        Administer after meals.

    • < 2 months
      • 0.15 mg/kg/day in 1 dose
      • Directions for administration:

        Administer after meals. Do not mix with formula or breastfeeding. 

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Infantile SMA (type 1):

Very common (>10%): Diarrhea, rash, maculopapular rash, erythema, dermatitis, allergic dermatitis, papular rash, folliculitis, pyrexia (including hyperpyrexia)

Common (1-10%): Oral and aphthous ulcers, urinary tract infections (including cystitis)

Frequently (1-10%).

In addition, in late-onset SMA (types 2 and 3):

Very common (>10%): Headache

Common (1-10%): nausea, arthralgia

 

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Other drugs for disorders of the musculo-skeletal system
M09AX03
M09AX07
M09AX09
M09AX09

References

  1. Roche Registration GmbH, SmPC Evrysdi 0.75 mg/mL powder for oral solution, (EU/1/21/1531/001) Rev 9, 2-10-2024, www.ema.europa.eu
  2. Roche Registration GmbH, SmPC Evrysdi 0.75 mg/mL powder for oral solution, (EU/1/21/1531/001) Rev 9, 2-10-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose