Adult: 5 mg once daily. To ensure complete administration, patients are advised to drink water after doses. In patients who are unable to swallow, doses may be given via nasogastric tube, flush with water after doses. Child: 2 months to <2 years 0.20 mg/kg; ≥2 years weighing <20 kg: 0.25 mg/kg; ≥20 kg: Same as adult dose. All doses are given once daily. In infants who are breastfed, administer doses after breastfeeding. Refer to specific product guidelines for the calculation of dosing volumes.
Administration
Should be taken with food. Take after a meal at approx the same time each day w/ water. Do not mix w/ food/liqd/formula/milk. For breastfeeding infants, take after breastfeeding. For patients w/ difficulty swallowing, may be administered via nasogastric or gastrostomy tube then flush tube w/ water afterwards.
Reconstitution
Reconstitute with 79 mL of purified water to yield a final concentration of 0.75 mg/mL. Shake well for 15 seconds and wait for 10 minutes; if resulting solution is not clear, shake well again for another 15 seconds.
Contraindications
Hypersensitivity.
Special Precautions
Children. Pregnancy and lactation.
Adverse Reactions
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, mouth ulcers, aphthous ulcers, constipation. General disorders and administration site conditions: Pyrexia. Infections and infestations: Pneumonia. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infections. Skin and subcutaneous tissue disorders: Rash.
Patient Counseling Information
Avoid inhalation and direct contact with skin or mucous membranes with the dry powder or the reconstituted solution. If contact occurs, wash thoroughly with soap and water; rinse eyes with water.
Monitoring Parameters
Evaluate pregnancy status prior to use in females with reproductive potential. Monitor respiratory and hydration status of infants and neonates prior to administration. Assess skin frequently during therapy.
Drug Interactions
May increase midazolam exposure. May increase the plasma concentration of metformin and fexofenadine.
Food Interaction
Do not mix with milk or formula milk.
Action
Description: Risdiplam is a survival of motor neuron (SMN) 2 pre-mRNA splicing modifier which shifts the balance from exon 7 exclusion to exon 7 inclusion into the mRNA transcript, thereby causing an increased production of functional and stable SMN protein. It treats spinal muscular atrophy by increasing and maintaining functional SMN protein levels in the brain. Pharmacokinetics: Absorption: Time to peak plasma concentration: 1-4 hours. Distribution: Evenly distributed to all parts of the body. Crosses the blood brain barrier. Plasma protein binding: Approx 89%, primarily to albumin. Metabolism: Metabolised in the liver by flavin monooxygenase 1 and 3 (FMO1, FMO3) and by CYP1A1, 2J2, 3A4, and 3A7 into M1 (inactive metabolite). Excretion: Via faeces (approx 53%; 14% as unchanged drug); urine (28%; 8% as unchanged drug). Elimination half-life: Approx 50 hours.
Chemical Structure
Risdiplam Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 118513932, Risdiplam. https://pubchem.ncbi.nlm.nih.gov/compound/Risdiplam. Accessed Nov. 25, 2021.
Storage
Store between 20-25°C. Reconstituted solutions are stable between 2-8°C for 64 days. Do not freeze. Protect from light. If prepared dose is not taken within 5 minutes, discard dose. Follow applicable procedures for receiving handling, administration, and disposal.
M09AX10 - risdiplam ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
References
Anon. Risdiplam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/10/2021.Buckingham R (ed). Risdiplam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/10/2021.Evrysdi 0.75 mg/mL (Roche [Malaysia] SDN. BHD.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/10/2021.Evrysdi 0.75 mg/mL Powder for Oral Solution (Roche Registration GmbH). European Medicines Agency [online]. Accessed 11/10/2021.Evrysdi Powder, for Solution (Genetech Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 11/10/2021.Joint Formulary Committee. Risdiplam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/10/2021.
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