Risdiplam Dosage

Medically reviewed by Drugs.com. Last updated on Jan 23, 2024.

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 or 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

Less than 2 months: 0.15 mg/kg orally once a day

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
Weight 20 kg or more: 5 mg orally once a day

Comments:

See Other Comments or Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Data not available

Dose Adjustments

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

Precautions

CONTRAINDICATIONS: None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Take orally once a day after a meal at the same time each day. Drink water after administration to ensure the drug has been completely swallowed.
Oral syringe should be used to measure the dose. Dose preparation and administration should be demonstrated to patient or 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 nasogastric or gastrostomy 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, then resume regular dosing 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 to 8C]). Reconstituted drug is stable for 64 days.
If refrigeration is not available, reconstituted drug can be stored at room temperature up to 40C (up to 104F) for up to 5 days.
This drug can be removed from, and returned to, a refrigerator. The total combined time out of refrigeration should not exceed 5 days.

Patient advice:

Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Patients or 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.