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SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures.1

Initiate SPINRAZA treatment with 4 loading doses. The first 3 loading doses should be administered at 14-day intervals. The fourth loading dose should be administered 30 days after the third dose. A maintenance dose should be administered once every 4 months.1

SPINRAZA is delivered as a 12-mg (5-mL) dose at each injection1

Loading dosing

Maintenance dosing

Loading dosing

Maintenance dosing

    If any loading dose is delayed or missed:

  • Administer SPINRAZA as soon as possible
    • Wait at least 14 days between doses
  • Continue dosing as prescribed

    If any maintenance dose is delayed or missed:

  • Administer SPINRAZA as soon as possible
  • Continue dosing every 4 months

Administration1

  • Prior to administration, remove 5 mL of CSF
  • Administer SPINRAZA as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle
  • Administer SPINRAZA within 4 hours of removal from vial
  • Do not administer SPINRAZA in areas of the skin where there are signs of infection or inflammation 

Considerations1

  • Consider sedation as indicated by the clinical condition of the patient
  • Consider ultrasound or other imaging techniques to guide intrathecal administration of SPINRAZA, particularly in younger patients

Key Icon

SPINRAZA is injected into the cerebrospinal fluid (CSF) and targets central nervous system (CNS) tissues.1

SPINRAZA is supplied as a single-dose vial1

SPINRAZA is a sterile, clear, and colorless solution for intrathecal injection.

  • Supplied as a 12-mg/5-mL (2.4-mg/mL) solution in a single-dose glass vial
  • Free of preservatives
  • NDC is 64406-058-01

Storage and handling1

Store in a refrigerator at 2°C-8°C (36°F-46°F)

Do not freeze

Protect from light and keep in original carton until time of use

If no refrigeration is available, store in original carton, protected from light, at or below 30°C (86°F) for up to 14 days

If removed from the original carton, the total combined time out of refrigeration should not exceed 30 hours at a temperature that does not exceed 25°C (77°F)

Key Icon

For information about how to prepare a SPINRAZA injection, please refer to the Prescribing Information.

Photo of Ruby aged 4 years old with Type 2 SMA coloring
Ruby
age 4

Later-onset (Type 2) SMA treated with SPINRAZA

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

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. Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.

In a clinical study, 11% of SPINRAZA-treated patients with normal or above normal platelet levels at baseline developed a platelet level below the lower limit of normal compared to zero sham-procedure control patients. No patient had a platelet count <50,000 cells per mcL and no patient developed a sustained low platelet count despite continued drug exposure.

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 a clinical study (mean treatment exposure 7 months), 33% of SPINRAZA-treated patients had elevated urine protein, compared to 20% of sham-control patients. In a group of later-onset SMA patients (mean treatment exposure 34 months), 69% had elevated urine protein.

No elevations in serum creatinine or cystatin C were observed in studies with SPINRAZA. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration >0.2 g/L, consider repeat testing and further evaluation.

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 that occurred in the controlled study in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were upper respiratory infection (39% vs 34%), lower respiratory infection (43% vs 29%), and constipation (30% vs 22%). Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (14%) than in control patients (5%). Because patients in the controlled study were infants, adverse reactions that are verbally reported could not be assessed in this study. In the open-label studies, the most common adverse events in later onset patients were headache (50%), back pain (41%) and post lumbar puncture syndrome (41%).

Please see full Prescribing Information for additional Important Safety Information.

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