Skip to Content

Risdiplam Dosage

Medically reviewed by Drugs.com. Last updated on Aug 17, 2020.

Applies to the following strengths: 0.75 mg/mL

Usual Adult Dose for Spinal Muscular Atrophy

5 mg orally once a day

Comments:
-See Other Comments/Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy.

Usual Pediatric Dose for Spinal Muscular Atrophy

2 months to less than 2 years: 0.2 mg/kg orally once a day

2 years and older weight less than 20 kg: 0.25 mg/kg orally once a day

2 years and older weight 20 kg or more: 5 mg orally once a day

Comments:
-See Other Comments/Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy in patients 2 months of age and older.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Not recommended

Dose Adjustments

Elderly: Clinical studies did not include patients aged 65 years and over to determine if the respond differently; use caution

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take orally once a day at approximately the same time each day; swallow water after administration to ensure the drug has been completely swallowed
-Oral syringe should be used to measure dose; dose preparation and administration should be demonstrated to patient/caregiver prior to first dose
-Once dose is prepared, it must be administered within 5 minutes; if dose is not taken within 5 minutes, discard dose from the oral syringe and prepare a new dose

INFANTS:
-For infants who are breastfed, administer dose after breastfeeding
-This drug should not be mixed with formula or milk

Nasogastric Tube or Gastrostomy Tube:
-This drug may be administered via NG or G-tube; the tube should be flushed with water after medication has been administered

MISSED DOSE: If a dose is missed, administer as soon as possible if still within 6 hours of the missed dose, and resume regular dosing schedule the next day; otherwise, skip the missed dose and resume regular dosing the next day

VOMITED DOSE or NOT FULLY SWALLOWED: If the full dose is vomited or not fully swallowed, the patient should be instructed to wait until the next day to take their next dose at the regularly scheduled time; do not take another dose to make up for the lost dose

PREPARATION OF ORAL SOLUTION BY PHARMACIST:
-Use caution when handling product; see manufacturer product information for specific reconstitution instructions
-Product should be reconstituted prior to dispensing to patient

Storage requirements:
-Prior to use: Store dry powder in original carton at room temperature (59F to 86F [15C to 30C])
-Once reconstituted: Store in original amber bottle in the refrigerator (36F to 46F [2C too 8C]); stable for 64 days once reconstituted

GENERAL:
-Because this drug is predominantly metabolized in the liver and safety and efficacy have not been assessed in patients with liver impairment, this drug is not recommended in patients with liver impairment.

Patient advice:
-Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-Patients/caregivers should receive this drug as a liquid solution from the pharmacy; if the bottle is a powder, they should contact their pharmacy for a replacement.
-Women of childbearing potential should be advised on the use of effective contraception during treatment and for 1 month after stopping; women should immediately notify their healthcare provider if they are pregnant or are planning to become pregnant.
-Male patients should understand that their fertility may be compromised while on treatment.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.