STARTING SPINRAZA / DOSING & ADMINISTRATION

SPINRAZA is delivered directly to the CSF

only 3 times a year after the starting-dose period1

SPINRAZA has one dosing regimen for all patients,
regardless of age or weight1

SPINRAZA is an intrathecal injection administered by, or under the direction of, healthcare professionals experienced in performing lumbar punctures. The recommended dosage is 12 mg (5 mL) per administration.

Treatment with SPINRAZA begins with 4 starting, or loading, doses. The first 3 doses are administered at 14-day intervals. The fourth dose should be administered 30 days after the third dose. After the starting dose period, a dose should be administered once every 4 months.

As part of intrathecal administration:

  • No daily administration
  • Medication is shipped directly to HCP. Patient is not
    responsible for storage
  • Is an option for patients with any bulbar status
  • Biogen Support Services can help patients coordinate logistics of treatment
Intrathecal injection is an option for many patients2-5
  • Consider sedation and ultrasound or other imaging techniques at the discretion of the healthcare provider1

CSF, cerebrospinal fluid; HCP, healthcare professional.

FREQUENTLY ASKED QUESTION:

What are the guidelines for administering SPINRAZA after a missed dose?1

This also includes patients who are restarting SPINRAZA after a treatment interruption.

Billing Code for SPINRAZA

The NDC for SPINRAZA is 64406-058-01

Did you know 14,000+ patients with SMA, including >5,300
adults, have been treated with SPINRAZA worldwide?6*

HEAR FROM PATIENTS & PEERS
GET ACCESS & REIMBURSEMENT RESOURCES

*Based on commercial patients and early access patients through June 2024.

SMA, spinal muscular atrophy.

INDICATION

SPINRAZA® (nusinersen) 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.

References

1. SPINRAZA. Prescribing Information. Biogen; 2024. 2. Łusakowska A, Wójcik A, Frączek A, et al. Long-term nusinersen treatment across a wide spectrum of spinal muscular atrophy severity: a real-world experience. Orphanet Rare Dis. 2023;18(1):230. doi:10.1186/513023-023-02769:4 3. Mercuri E, Darras BT, Chiriboga CA, et al; CHERISH Study Group. Nusinersen versus sham control in later-onset spinal muscular atrophy. N Engl J Med. 2018;378(7):625-635. 4. Haché M, Swoboda KJ, Sethna N, et al. Intrathecal injections in children with spinal muscular atrophy: nusinersen clinical trial experience. J Child Neurol. 2016;31(7):899-906. 5. Stolte B, Totzeck A, Kizina K, et al. Feasibility and safety of intrathecal treatment with nusinersen in adult patients with spinal muscular atrophy. Ther Adv Neurol Disord. 2018;11:1-9. doi:10.1177/1756286418803246 6. Biogen Data on File as of 7/24.

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About SPINRAZA How SPINRAZA Works Presymptomatic Efficacy Early-Onset Efficacy Later-Onset Efficacy Real-World Evidence Safety
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