Spinraza (nusinersen)
How to buy Spinraza (nusinersen): You can order Spinraza (nusinersen) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.
Neurology | Spinal Muscular Atrophy |
Marketing Authorisation Holder | Biogen Idec Ltd |
Mode of Action | Antisense oligonucleotide (ASO) |
Administration | intrathecal injection |
Regulatory agency approval | European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia |
Strength | 2.4 milligram / millilitre |
Package | 1 vial of 12mg/ 5 ml - Vials |
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 movement2.
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 in order to increase production of full-length SMN protein and thereby promoting the maintenance of motor neurons3.
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, 20162
- EMA (EU) on May 30, 20175
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 it1,5.
Complete information about Spinraza (nusinersen) dosage and administration can be found in the resources section.
Consult your treating doctor for personalised dosing.
Common side effects of Spinraza (nusinersen)
- back pain
- headache
- vomiting.
Working ingredient | Nusinersen |
---|---|
Shipping method | Cold chain (temperature controlled) |
Package | 1 vial of 12mg/ 5 ml - |
Therapeutic Area | Neurology |
Neurology | Spinal Muscular Atrophy |
Indication | Spinal Muscular Atrophy (SMA) |
Administration | intrathecal injection |
Mode of Action | Antisense oligonucleotide (ASO) |
Strength | 2.4 |
Regulatory agency approval | European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia |
Marketing Authorisation Holder | Biogen Idec Ltd |
HS Code | N/A |
CAS Number | N/A |
At the final analysis, the percentage of responders (patients achieving the pre-defined motor milestone responder criteria) among the nusinersen group was 51% vs 0% among the patients in the control group. Fewer patients died or received permanent ventilation among the nusinersen treated patients (39%) compared with the control group (68%)4. The portion of patients that achieved improvement in total milestone score (which included the ability to kick, head control, rolling, sitting, crawling, standing or walking) was 67% in the patients treated with nusinersen vs 17% in the sham-control group, while the portion of patients that worsened in the two groups was 1% and 22% respectively4. When measured with the Children’s Hospital of Philadelphia Infant Test for Neuromuscular Disease (CHOP INTEND) score, the proportion of patients achieving a 4-point improvement was 73% with nusinersen and 3 % without, while the proportion of those worsening was 7% with nusinersen and 49% without4.
Positive results were achieved also in a study on patients with later onset SMA (after 6 months of age). The study CS4 (CHERISH) involved 126 patients randomised 2:1 to either nusinersen or sham-control. The main measure considered was the Hammersmith Functional Motor Scale Expanded (HFMSE). Among the patients treated with nusinersen, 57.3% achieved an improvement from baseline of at least 3 points vs. 20.5% of the patients in the control group4.
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)
cited Oct 2017
Shipping Type | Cold Chain |
Shipping method | Cold chain (temperature controlled) |
Dynamic Weight | No |
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