.

Some individuals featured may be participating in Biogen clinical trials.

Consider SPINRAZA for your patients at any age or stage of their SMA journey
Learn More Safety Starting SPINRAZA

Discover an SMA treatment that’s delivered directly to the central nervous system to target an underlying cause of motor neuron loss in SMA1,2

How does SPINRAZA work?

SPINRAZA is a modified antisense oligonucleotide designed to target an underlying cause of motor neuron loss
in SMA1  

Explore the MOA
Data and Safety Profile

SPINRAZA has been studied in the longest SMA clinical trial program to date3

Discover the Data Safety Profile
Dedicated Patient Support

If patients or caregivers are experiencing nonmedical barriers to accessing treatment–such as the cost of SPINRAZA–Biogen may be able to help

Learn More

Extensive real-world experience across a broad range of ages*

have been treated with
SPINRAZA worldwide1*

there’s someone from almost every
age group who has taken SPINRAZA1,3

have been treated with
SPINRAZA worldwide3,*

*Based on commercial patients, early access patients, and clinical trial participants through May 2022.
†Clinical studies of SPINRAZA included patients from 3 days to 16 years of age at first dose but did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
‡Based on commercial patients in the US (including Puerto Rico) through May 2022.

a later-onset adult patient with spinal muscular atrophy on SPINRAZA

“Around age 32, I had moved across the country and started working with a new doctor. I was feeling weaker but learning to accept it. My doctor mentioned a treatment to me
called SPINRAZA.”

—Ian

IMPORTANT SAFETY INFORMATION

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications.

In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. SPINRAZA is present in and excreted by the kidney. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 SPINRAZA-treated patients (58%) had elevated urine protein, compared to 22 of 65 sham-controlled patients (34%).

Laboratory testing and monitoring to assess safety should be conducted. Perform a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing at baseline and prior to each dose of SPINRAZA and as clinically needed.

Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.

Cases of rash were reported in patients treated with SPINRAZA.

SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.

The most common adverse reactions (≥20% of SPINRAZA-treated patients and ≥5% more frequently than in control patients) that occurred in the infantile-onset controlled study were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (18%) than in control patients (10%). Because patients in this controlled study were infants, adverse reactions that are verbally reported could not be assessed. The most common adverse reactions that occurred in the later-onset controlled study were pyrexia, headache, vomiting, and back pain. Post-lumbar puncture syndrome has also been observed after the administration of SPINRAZA.

INDICATION

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Please see full Prescribing Information.

As a courtesy, our full Prescribing Information is also available en Español. For prescribing decisions, please refer to official approved labeling.

References

1. SPINRAZA. Prescribing Information. Biogen; 2020. 2. Food and Drug Administration, Center for Drug Evaluation and Research. Nusinersen clinical pharmacology and biopharmaceutics review(s). White Oak, MD; 2016. 3. Biogen Data on File [as of 05/22].

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