Spinraza 5.6 mg/mL
Nusinersen · INJECTION, SOLUTION · Biogen Inc.
Spinraza (nusinersen) is an injection given directly into the fluid around the spinal cord to treat spinal muscular atrophy by working with survival motor neuron genes. It is designed to help improve muscle strength and function in patients with this genetic nerve disorder.
Key Facts
- Brand Name
- Spinraza
- Generic Name
- Nusinersen
- NDC Code (Product)
64406-036- Manufacturer
- Biogen Inc.
- Strength
- 5.6 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Marketing Status
- Application #
- NDA209531
- Drug Class
- Survival Motor Neuron-2-directed RNA Interaction [EPC]; Antisense Oligonucleotide [EPC]
- Marketing Start
- 03/27/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION SPINRAZA is administered intrathecally ( 2.1 ) Recommended Dosage ( 2.1 ) 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 ( 2.3 ) 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 ( 2.4 ) At baseline and prior to each dose, obtain a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing 2.1 Recommended Dosage SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures. Two d…
Contraindications
4 CONTRAINDICATIONS None. None.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in detail in other sections of the labeling: Thrombocytopenia and Coagulation Abnormalities [see Warnings and Precautions ( 5.1 )] Renal Toxicity [see Warnings and Precautions ( 5.2 )] 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 ( 6.1 ) pyrexia, headache, vomiting, and back pain in patients with later-onset SMA ( 6.1 ) 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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-844-477-4672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical …
Frequently Asked Questions
What is Spinraza used for?
Spinraza (nusinersen) is an injection given directly into the fluid around the spinal cord to treat spinal muscular atrophy by working with survival motor neuron genes. It is designed to help improve muscle strength and function in patients with this genetic nerve disorder.
Is Spinraza a controlled substance?
Spinraza is not classified as a controlled substance by the DEA.
What is the generic name for Spinraza?
The generic name for Spinraza is Nusinersen. There are no other listed brand versions of Nusinersen.
What is the NDC code for Spinraza 5.6 mg/mL?
The NDC (National Drug Code) for Spinraza 5.6 mg/mL is 64406-036, listed by Biogen Inc..
Other Spinraza Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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