Active Ingredient: Nusinersen
Nusinersen is indicated for the treatment of 5q Spinal Muscular Atrophy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intraspinal, 12 milligrams nusinersen, 1 one dose, over the duration of 14 days. Afterwards, intraspinal, 12 milligrams nusinersen, 1 one dose, over the duration of 14 days. Afterwards, intraspinal, 12 milligrams nusinersen, 1 one dose, over the duration of 35 days. Afterwards, intraspinal, 12 milligrams nusinersen, once every 4 months.
The recommended dosage is 12 mg 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 or a maintenance dose is delayed or missed, nusinersen should be administered according to the schedule in Table 1 below.
Table 1. Recommendations for delayed or missed dose:
| Delayed or missed dose | Timing of Dosing Administration |
| Loading dose | |
| • Administer the delayed or missed loading dose as soon as possible with at least 14 days between doses; continue with subsequent doses on the prescribed intervals from the last dose. e.g. if the third loading dose is administered 30 days late at Day 58 (instead of the original schedule at Day 28), then the fourth loading dose should be administered 35 days later at Day 93 (instead of the original schedule at Day 63) with a maintenance dose 4 months thereafter. | |
| Maintenance dose | Timing of Dosing Administration |
| > 4 to < 8 months from last dose | • Administer the delayed maintenance dose as soon as possible; then • The next maintenance dose per the original scheduled date, as long as these two doses are administered at least 14 days apart*; |
| ≥ 8 to < 16 months from last dose | • Administer the missed dose as soon as possible and then the next dose 14 days later*; |
| ≥ 16 to < 40 months from last dose | • Administer the missed dose as soon as possible and then the next dose 14 days later, followed by a third dose 14 days later*; |
| ≥ 40 months from last dose | • Administer the entire loading regimen on the prescribed intervals (Days 0, 14, 28 and 63)*; |
* then subsequently to the above recommendations, a maintenance dose 4 months after the last dose should be administered and repeated every 4 months.
Nusinersen is for intrathecal use by lumbar puncture.
Treatment should be administered by health care professionals experienced in performing lumbar punctures.
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.
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