Generic Name and Formulations:
Nusinersen 12mg/5mL; soln for intrathecal inj; preservative-free.
Indications for SPINRAZA:
Spinal muscular atrophy.
Adults and Children:
Consider sedation and ultrasound or other imaging techniques as guidance. Remove 5mL of cerebrospinal fluid prior to inj. Give as intrathecal bolus inj over 1–3 mins. 12mg (5mL) per dose. Initially: give 3 loading doses at 14-day intervals then give 4th loading dose 30 days after. Maintenance: give dose once every 4 months thereafter.
Do not administer in areas of infected or inflamed skin. Increased risk of bleeding complications. Perform platelet count, prothrombin time, aPTT, quantitative spot urine protein testing at baseline, prior to each dose, and as clinically needed; consider repeat testing if urine protein >0.2g/L. Pregnancy. Nursing mothers.
Lower/upper respiratory infection, constipation, teething; thrombocytopenia, coagulation abnormalities, renal toxicity.