WARNINGS
Increased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests before you start treatment with SPINRAZA® and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs.
Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.
USES
SPINRAZA® (nusinersen) is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.
HOW TO USE
Please call your healthcare provider for more information.
The most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, back pain, and post-lumbar puncture syndrome.
These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
None.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
If a loading dose (any of the 4 loading doses) is missed, administer the missed loading dose as soon as possible; adjust the date for the subsequent doses to maintain the recommended interval between doses.
Missed Maintenance Dose
Less than 8 months from last dose: Administer the missed maintenance dose as soon as possible; then administer the next maintenance dose per the originally scheduled date, as long as these two doses are administered at least 14 days apart.
At least 8 months but less than 16 months from last dose: Administer the missed maintenance dose as soon as possible, followed by one additional dose 14 days later, and then administer the next maintenance dose 4 months thereafter.
At least 16 months but less than 40 months from last dose: Administer the missed maintenance dose as soon as possible, followed by two additional doses 14 days apart, and then administer the next maintenance dose 4 months thereafter.
At least 40 months from last dose: Restart dosing as described in Recommended Dosage.
STORAGE
Store in a refrigerator between 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F) in the original carton to protect from light. Do not freeze.
SPINRAZA should be protected from light and kept in the original carton until time of use. If no refrigeration is available, SPINRAZA may be stored in its original carton, protected from light at or below 30-degrees C (86-degrees F) for up to 14 days.
Prior to administration, unopened vials of SPINRAZA can be removed from and returned to the refrigerator, if necessary. 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-degrees C (77-degrees F).
NOTES
Medication Guide: revision date N/A
Prescribing Information: revision date 04/2024
Please call your healthcare provider for more information.
Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant
