FOR APPROPRIATE PATIENTS WITH SMA WHO ARE READY FOR MORE*

The High Dose Regimen of
SPINRAZA® (nusinersen) is here

Dosing

*See Section 2, Dosage and Administration,
 in the Prescribing Information.

WHY SPINRAZA/HIGH DOSE REGIMEN OF SPINRAZA

HIGH DOSE REGIMEN

Learn more about the High Dose Regimen of SPINRAZA

SPINRAZA is administered as an intrathecal injection, an injection into the fluid of the spine, by a healthcare professional experienced in performing lumbar punctures. For more information about the Low Dose Regimen of SPINRAZA, click here.

If you've talked with your doctor and decided that the High Dose Regimen is right for you, your doctor will explain your dosing plan based on where you are in your SPINRAZA treatment journey.

DOSING

The High Dose Regimen loading doses administer 2x more medicine in a quarter of the time

How the dosing schedule compares:

High Dose Regimen: 100 mg of SPINRAZA administered over 2 loading doses across 15 days
Low Dose Regimen: 48 mg administered over 4 loading doses across 59 days

SPINRAZA® is an intrathecal injection, an injection into the fluid of the spine, by a healthcare professional (HCP) experienced in performing lumbar punctures.

Your doctor may order blood and urine testing when starting treatment and prior to each dose to monitor for the potential risks of bleeding or kidney damage.

High Dose Regimen Dosing Schedules

Dosing schedules are different depending on whether you’re new to SPINRAZA or already taking it

Treatment starts with two 50 mg loading doses, one on Day 1 and the second loading dose 14 days later. After that, a 28 mg maintenance dose is given once every 4 months.

^†+/- 14 days.

Additional clinical benefit in patients who transition from the Low Dose Regimen to the High Dose Regimen has not been established in a controlled study.

SPINRAZA is given as a single 50 mg loading dose at least 4 months (+/- 14 days) after the last 12 mg maintenance dose, followed by a 28 mg maintenance dose once every 4 months thereafter.

Have you missed a dose?

Talk to your doctor about scheduling your missed dose as soon as possible.

Missed Second 50 mg Loading Dose

Get your missed 50 mg loading dose injected as soon as possible; then continue with your 28 mg maintenance doses every 4 months after.

Missed 28 mg Maintenance Dose

Less than 8 months from last maintenance dose
Get your missed 28 mg maintenance dose injected as soon as possible; get your next 28 mg maintenance dose injected on the originally scheduled date, as long as these 2 doses are given at least 14 days apart; then continue with 28 mg injections every 4 months after.

At least 8 months to less than 40 months from last maintenance dose
Get a 50 mg loading dose injected as soon as possible; then get 28 mg maintenance doses every 4 months after.

At least 40 months from last maintenance dose
Restart the High Dose Regimen with two 50 mg loading doses 14 days apart; then get a 28 mg maintenance dose every 4 months after that.

DEVOTE STUDY

A 3-Part Study

Evaluating the safety and efficacy of the High Dose Regimen in people with SMA.

DEVOTE Study Design

STUDY LIMITATIONS:

Due to how the DEVOTE study was designed, it was not possible to determine whether the High Dose Regimen worked better than the Low Dose Regimen
Part C did not have an untreated control or comparator group and the findings may not be sufficient on their own to draw conclusions

^‡No prior or current treatment with any SMN2-splicing modifier, gene therapy, or cell transplantation.
^§Dosing design for Part A differed from the approved High Dose Regimen dosing schedule.
^‖On approved 12 mg dose of nusinersen for ≥1 year.
SMN2=survival motor neuron 2 gene.

DEVOTE Part B Study DesignNew to SPINRAZA

Baseline characteristics between groups were similar; DEVOTE patients had symptoms appear earlier and their disease was more severe.

^‖Prespecified ENDEAR-untreated group based on disease duration and baseline CHOP INTEND score.

The High Dose Regimen significantly improved CHOP INTEND scores vs untreated group from the ENDEAR study

The safety of the High Dose Regimen was generally consistent with the known safety of the Low Dose Regimen

Select Safety Findings from DEVOTE in the High Dose Regimen

Acute respiratory failure=respiratory failure that happens quickly and without warning. It is often caused by a disease or injury that affects your breathing.
Anemia=low red blood cell count.
Aspirational pneumonia=infection caused by inhaling something other than air into lungs–this could be food, liquid, saliva, or stomach contents.
CHOP INTEND=Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders.
Myocardial necrosis marker increased=blood test changes related to heart muscle injury.
n=number.
NA=not applicable.
Respiratory failure=a condition where the lungs can't get enough oxygen into the blood.
SE=side effect.
Sham procedure=an inactive procedure that closely mimics the active procedure being studied, but without the active treatment.
SMA=spinal muscular atrophy.
SMN2=survival motor neuron 2 gene.
SSE=serious side effect: a side effect that may require hospital care, cause long-term health issues, or be life-threatening.

DEVOTE Part C Study DesignTransitioning from Low Dose SPINRAZA

Baseline Characteristics

Increases in motor function were seen in people who transitioned to the High Dose Regimen

Study Month 0 is baseline. Observed data and average change are shown. Two participants did not have HFMSE/RULM scores collected at baseline and are not included in the analysis.
Percentages are subject to rounding.

Select Safety Findings from DEVOTE Part C

In Part C, 93% of patients experienced any side effects and most side effects were mild or moderate in severity
Side effects considered related to treatment by the investigator occurred in 20% of patients
Side effects occurring in more than 15% of patients included headache related to the procedure, COVID-19
infection, and pain related to the procedure
There were no serious side effects reported in Part C that occurred in over 10% of patients

Ambulatory=a person able to walk about.
HFMSE=Hammersmith Functional Motor Scale–Expanded.
Median=the middle point in a dataset.
n=number.
Nonambulatory=a person not able to walk about.
RULM=Revised Upper Limb Module.
SMA=spinal muscular atrophy.
SMN2=survival motor neuron 2 gene.

Ready to take the next step? Download and refer to these resources as you discuss the High Dose Regimen with your doctor.

Download  Getting Started Guide

Download  Doctor Discussion Guide

Download  Dosing Planner

Sign up for
SPINRAZA Updates

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Meet your circle of support

Download Getting Started Guide

Download Doctor Discussion Guide

Download Dosing Planner

The High Dose Regimen of
SPINRAZA® (nusinersen) is here

WHY SPINRAZA/HIGH DOSE REGIMEN OF SPINRAZA

HIGH DOSE REGIMEN

Learn more about the High Dose Regimen of SPINRAZA

DOSING

The High Dose Regimen loading doses administer 2x more medicine in a quarter of the time

High Dose Regimen Dosing Schedules

Have you missed a dose?

DEVOTE STUDY

A 3-Part Study

Baseline characteristics between groups were similar; DEVOTE patients had symptoms appear earlier and their disease was more severe.

The High Dose Regimen significantly improved CHOP INTEND scores vs untreated group from the ENDEAR study

The safety of the High Dose Regimen was generally consistent with the known safety of the Low Dose Regimen

Baseline Characteristics

Increases in motor function were seen in people who transitioned to the High Dose Regimen

Select Safety Findings from DEVOTE Part C

Ready to take the next step? Download and refer to these resources as you discuss the High Dose Regimen with your doctor.

WHAT IS SPINRAZA?

IMPORTANT SAFETY INFORMATION

The High Dose Regimen of SPINRAZA® (nusinersen) is here

WHY SPINRAZA/HIGH DOSE REGIMEN OF SPINRAZA

HIGH DOSE REGIMEN

Learn more about the High Dose Regimen of SPINRAZA

DOSING

The High Dose Regimen loading doses administer 2x more medicine in a quarter of the time

High Dose Regimen Dosing Schedules

Have you missed a dose?

DEVOTE STUDY

A 3-Part Study

Baseline characteristics between groups were similar; DEVOTE patients had symptoms appear earlier and their disease was more severe.

The High Dose Regimen significantly improved CHOP INTEND scores vs untreated group from the ENDEAR study

The safety of the High Dose Regimen was generally consistent with the known safety of the Low Dose Regimen

Baseline Characteristics

Increases in motor function were seen in people who transitioned to the High Dose Regimen

Select Safety Findings from DEVOTE Part C

Ready to take the next step? Download and refer to these resources as you discuss the High Dose Regimen with your doctor.

Sign up for SPINRAZA Updates

The High Dose Regimen of
SPINRAZA® (nusinersen) is here

Sign up for
SPINRAZA Updates