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Spinraza Generic Name & Formulations
Legal Class
Rx
General Description
Nusinersen 12mg/5mL; soln for intrathecal inj; preservative-free.
Pharmacological Class
Antisense oligonucleotide.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Spinraza Indications
Indications
Spinal muscular atrophy (SMA).
Spinraza Dosage and Administration
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.
Spinraza Contraindications
Not Applicable
Spinraza Boxed Warnings
Not Applicable
Spinraza Warnings/Precautions
Warnings/Precautions
Do not administer in areas of infected or inflamed skin. Increased risk of bleeding complications. Obtain 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.
Spinraza Pharmacokinetics
See Literature
Spinraza Interactions
Spinraza Adverse Reactions
Adverse Reactions
Lower respiratory infection, constipation, pyrexia, headache, vomiting, back pain; thrombocytopenia, coagulation abnormalities, renal toxicity.
Spinraza Clinical Trials
See Literature
Spinraza Note
Not Applicable
Spinraza Patient Counseling
See Literature
