Spinraza (Nusinersen)

960.05

Limited availability

For this product the estimated delivery time is usually between 12 and 20 working days. The price is subject to change depending on medicine availability.

DISEASE INDICATIONS

Spinal Muscular Atrophy

MANUFACTURER

Biogen Idec Ltd

USAGE

Intrathecal Injection

MEDICINE APPROVED BY

  • European Medical Agency (EMA)

  • Food and Drug Administration (FDA)

  • Health Canada

  • Therapeutic Goods Administration (TGA)

  • Medsafe (NZ)

    PATIENTS HELPED

    • Over 1.2 million patients reached

    • More than 11,000 patients helped

    • 100% successful deliveries to 88 countries

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What is Spinraza (nusinersen) for?

Spinraza (nusinersen) is indicated for the treatment of pediatric and adult patients with spinal muscular atrophy (SMA)[1,4].

How does Spinraza (nusinersen) work?

SMA is a rare and often fatal hereditary (genetic) disease that causes weakness and muscle wasting due to the loss of motor neurons controlling movement[2].

Spinraza (nusinersen) is an antisense oligonucleotide (ASO) that is designed to treat SMA caused by mutations in the chromosome 5q. This mutation leads to the deficiency of a protein, the survival motor neuron (SMN) protein. Spinraza (nusinersen) alters the synthesis of the deficient protein to increase production of full-length SMN protein and thereby promoting the maintenance of motor neurons[3].

Is Spinraza (nusinersen) approved?

Spinraza (nusinersen) was approved for the treatment of children and adults with spinal muscular atrophy (SMA) by:

  • FDA (USA) on December 23, 2016[2]
  • EMA (EU) on May 30, 2017[5]
  • TGA (Australia) on November 2, 2017[6]
  • Health Canada on August 29, 2017[8]
  • Medsafe (New Zealand) on August 23, 2018[9]

It has also been approved in China (February 2019)[7]. Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How do I take Spinraza (nusinersen)?

Spinraza is an injection administered into the fluid surrounding the spinal cord (intrathecal injection)[2,5]. The standard dosage is:

  • 12 mg / 5 mL per administration

Initiate treatment with 4 loading doses. The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter. Treatment should be continued for as long as the patient benefits from it[1,5].

Complete information about Spinraza (nusinersen) dosage and administration can be found in the references section.

Consult your treating doctor for personalised dosing.

Common side effects of Spinraza (nusinersen)

Side effects include[4]:

  • back pain
  • headache
  • vomiting.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[1,4].

References

  1. Summary of Product Characteristics [FDA]: Spinraza (nusinersen)[PDF]
    Biogen, Dec 2016.
  2. FDA approves first drug for spinal muscular atrophy
      FDA, Dec 2016.
  3. FDA Approves Biogen’s SPINRAZA™ (nusinersen), The First Treatment for Spinal Muscular Atrophy
      Biogen, Dec 2016.
  4. Summary of Product Characteristics [EMA]: Spinraza (nusinersen)[PDF]
    Biogen, June 2017.
  5. Human Medicines: Spinraza (nusinersen)
      Oct 2017.
  6. Australian Public Assessment Report for nusinersen[PDF]
        Aug 2018.
  7. Approval of Spinraza (nusinersen) in China
        Feb 2019.
  8. Product monograph [Health Canada]: Spinraza (nusinersen)[PDF]
    Biogen, Dec 2018.
  9. Product detail [Medsafe]: Spinraza (nusinersen)
    Biogen, Oct 2018.

This content has been reviewed by a Medical Doctor.

SPINRAZA (NUSINERSEN) Package

1 vial of 12 mg/5 mL

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