Active Ingredient: Nusinersen
Nusinersen is indicated for the treatment of 5q Spinal Muscular Atrophy.
For this indication, competent medicine agencies globally authorize below treatments:
Intraspinal
12 - 12 mg
From 12 To 12 mg once every 14 day(s)
The recommended dosage is 12 mg (5 ml) per administration. Nusinersen treatment should be initiated as early as possible after diagnosis with 4 loading doses on Days 0, 14, 28 and 63. A maintenance dose should be administered once every 4 months thereafter.
Information on long term efficacy of this medicinal product is not available. The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient’s clinical presentation and response to the therapy.
If a loading dose is delayed or missed nusinersen should be administered as soon as possible, with at least 14 days between doses, and continue dosing at the prescribed frequency. If a maintenance dose is delayed or missed, nusinersen should be administered as soon as possible and dosing continued every 4 months.
Nusinersen is administered as an intrathecal bolus injection over 1 to 3 minutes, using a spinal anaesthesia needle. The injection must not be administered in areas of the skin where there are signs of infection or inflammation. It is recommended that the volume of cerebral spinal fluid (CSF), equivalent to the volume of nusinersen to be injected, is removed prior to administration of nusinersen.
Sedation may be required to administer nusinersen, as indicated by the clinical condition of the patient. Ultrasound (or other imaging techniques) may be considered to guide intrathecal administration of nusinersen, particularly in younger patients and in patients with scoliosis. Aseptic technique should be used when preparing and administering nusinersen.
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