Spinraza

— THERAPEUTIC CATEGORIES —
  • Miscellaneous musculoskeletal disorders

Spinraza Generic Name & Formulations

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

Not Applicable

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