Risdiplam Oral Solution For Spinal Muscular Atrophy

Risdiplam Oral Solution Application Scope

Risdiplam, the new and special drug, is used for the treatment of spinal muscular atrophy (SMA) in patients aged 2 months and older.

Risdiplam Oral Solution Characteristics

• Ingredients:
  Risdiplam (active ingredient) along with excipients, is necessary to formulate an oral solution.
• Properties:
  Risdiplam is a survival motor neuron 2 (SMN2) splicing modifier that increases the production of functional SMN protein, which is deficient in spinal muscular atrophy (SMA).
• Specification:
  Each bottle contains 60 mg of risdiplam powder, which must be reconstituted into an oral solution by a healthcare professional.
• Packaging Specification:
  One bottle of 60 mg powder for oral solution, accompanied by oral syringes for accurate dosage administration.
• Storage:
  After reconstitution, the solution should be stored refrigerated (2°C to 8°C) and must not be frozen.
• Expiry Date:
  The prepared oral solution must be used within 64 days.
• Executive Standard:
  Approved by the U.S. Food and Drug Administration (FDA).
• Approval Number:
  NDA 213535.
• Date of Revision:
  August 2022.
• Manufacturer:
  Genentech, Inc.

Guidelines For The Use Of Risdiplam Oral Solution

Dosage and Administration: Administer once daily, orally, with food. The dosage is determined based on the patient’s age and weight.

Adverse Reactions: Common side effects include,

Medication Limitations

Contraindications:

Patients who are allergic to risdiplam or any of its components should not use this medication.

Precautions:

Pregnant women or those planning to become pregnant should consult their doctor before use, as the drug may harm the fetus.

Risdiplam Oral Solution Interactions

Avoid using medications that are substrates of multidrug and toxin extrusion proteins (MATE), such as metformin, as it may increase plasma concentrations of these drugs.

 

Note: If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYueMed. It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.