Spinraza

— THERAPEUTIC CATEGORIES —
  • Miscellaneous musculoskeletal disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Storage

    Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

    If no refrigeration is available, Spinraza may be stored in its original carton, protected from light at or below 30°C (86°F) for up to 14 days.

    Prior to administration, unopened vials of Spinraza can be removed from and returned to the refrigerator, if necessary. If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours at a temperature that does not exceed 25°C (77°F).

    Manufacturer

    Biogen

    Generic Availability

    NO

    Mechanism of Action

    Spinraza is designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Using in vitro assays and studies in transgenic animal models of SMA, Spinraza was shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein.

    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

    Absorption

    Median time to peak plasma concentration: 1.7–6.0 hours.

    Distribution

    Distributed within the CNS and peripheral tissues (eg, skeletal muscle, liver, kidney).

    Metabolism

    Metabolized via exonuclease (3’- and 5’)-mediated hydrolysis.

    Elimination

    Renal. Half-life: 135–177 days (in CSF); 63–87 days (in plasma).

    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

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