Molecule
Nusinersen is an antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. It is available as injection for intrathecal use. MedsAcross supplies Nusinersen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients
Source: US FDA prescribing information
SPINRAZA is an antisense oligonucleotide (ASO) 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.
Source: US FDA prescribing information
SPINRAZA is administered intrathecally. Recommended Dosage. The recommended dosage is one of two options: Low Dose Regimen: Administer one 12 mg loading dose every 14 days for three doses, then a fourth 12 mg loading dose 30 days after the third dose, then administer a 12 mg maintenance dose once every 4 months thereafter. High Dose Regimen: Administer one 50 mg loading dose followed by a second 50 mg loading dose 14 days later, then administer a 28 mg maintenance dose once every 4 months thereafter. Important Preparation and Administration Instructions. Allow to warm to room temperature prior to administration Administer within 4 hours of removal from vial Prior to administration, remove 5 mL of cerebrospinal fluid Administer as intrathecal bolus injection over 1 to 3 minutes Laboratory Testing and Monitoring to Assess Safety.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Thrombocytopenia and Coagulation Abnormalities: Increased risk for bleeding complications, testing required at baseline and before each dose and as clinically needed. Renal Toxicity: Quantitative spot urine protein testing required at baseline and prior to each dose
Source: US FDA prescribing information
The following serious adverse reactions are described in detail in other sections of the labeling: Thrombocytopenia and Coagulation Abnormalities Renal Toxicity The most common adverse reactions that occurred in at least 20% of SPINRAZA-treated patients who received Low Dose Regimen and occurred at least 5% more frequently than in control patients were: lower respiratory infection and constipation in patients with infantile-onset SMA pyrexia, headache, vomiting, and back pain in patients with later-onset SMA. The most common adverse reactions in at least 10% of SPINRAZA-treated patients who received High Dose Regimen and occurred at least 5% more frequently than in historic matched sham-control were: pneumonia, COVID-19, pneumonia aspiration, and malnutrition in patients with infantile-onset SMA
Source: US FDA prescribing information
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 o C (86 o 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 o C (77 o F). SPINRAZA should be protected from light and kept in the original carton until time of use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Nusinersen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Spinraza 12 mg/5 mL injectionIntrathecal Cold chain | Biogen | US FDA | Available on request |
| Spinraza 28 mg/5 mL injectionIntrathecal Cold chain | Biogen | US FDA | Available on request |
| Spinraza 50 mg/5 mL injectionIntrathecal Cold chain | Biogen | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Nusinersen in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Nusinersen and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Nusinersen, including Spinraza.
Yes. The US FDA first approved Nusinersen on 23 December 2016, according to Drugs@FDA.
Yes. Nusinersen has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Nusinersen must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Nusinersen is classified under ATC code M09AX07 (Nusinersen).
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