SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
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Individual results may vary based on several factors, including severity of disease, initiation of treatment, and duration of therapy.

7500+ pediatric and adult patients with spinal muscular atrophy (SMA) have been treated with SPINRAZA worldwide.1*

*Based on commercial patients, early access patients, and clinical trial participants as of March 2019.

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Use this Locator Tool to help find a treatment center near you that might be able to administer SPINRAZA.
 

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Getting started with SPINRAZA

Once you and your patient have decided to begin treatment, submit a Start Form to enroll your patient in Biogen support services.†

Mechanism of action (MOA) Video for Healthcare Professionals
How does SPINRAZA work?

Watch the MOA video to learn how SPINRAZA increases the production of full-length survival motor neuron (SMN) protein.

†Depending on your method of procurement, the Start Form may be used as a prescription.

The SPINRAZA clinical trials included >325 patients with SMA, ranging from ages 3 days to 16 years at first dose.1

Clinical Overview

Clinical trial results

Get a closer look at the study results across a broad range of individuals with SMA.

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Presymptomatic SMA

Sofia aged 2.5 with infantile-onset (type 1) SMA playing guitar
Infantile-onset SMA

Image of Claire aged 19 with later-onset (type 2) SMA applying makeup
Later-onset SMA

Individual results may vary based on several factors, including severity of disease, initiation of treatment, and duration of therapy.
 

Available resources for you and your patients

PATIENT MOA VIDEO

Discussing SPINRAZA with your patients?

Help them learn about the MOA from Emma, a patient treated with SPINRAZA.

SMA360°™

A circle of support for your patients

Biogen’s SMA360° support program provides services for patients and their families that address nonmedical barriers to access.

REIMBURSEMENT

Guide to SPINRAZA reimbursement

A comprehensive guide to reimbursement considerations for SPINRAZA.
 

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Reference

1. Data on file. Biogen, Cambridge, MA.

INDICATION

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

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.

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.

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