Nusinersen (injection)

Generic name: nusinersen (injection) [ NUE-si-NER-sen ]
Brand name: Spinraza
Dosage form: intrathecal solution (12 mg/5 mL)
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Drugs.com on Sep 12, 2023. Written by Cerner Multum.

What is nusinersen?

Nusinersen works by helping the body produce a protein essential to the function of nerves that control muscle movement. This protein is lacking in people with an inherited disorder called spinal muscular atrophy caused by a mutation in a specific gene.

Nusinersen is used to treat spinal muscular atrophy in adults, children, and infants.

Nusinersen may also be used for purposes not listed in this medication guide.

Nusinersen side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nusinersen may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• chest pain, shortness of breath;

• a red skin rash; or

• kidney problems--foamy urine; red or brown colored urine; swelling in your face, stomach, hands, or feet.

Nusinersen may affect growth in children. Tell your doctor if your child is not growing at a normal rate while using nusinersen.

Common side effects of nusinersen may include:

• headache;

• back pain;

• nausea, vomiting, constipation; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Call your doctor for instructions if you miss an appointment for your nusinersen injection.

Before taking this medicine

You should not be treated with nusinersen if you are allergic to it.

Tell your doctor if you have ever had:

• kidney disease; or

• bleeding problems.

Tell your doctor if you are pregnant or breastfeeding.

How is nusinersen given?

Your doctor will perform blood and urine tests to make sure you do not have conditions that would prevent you from safely receiving nusinersen.

Nusinersen is injected directly into the fluid that surrounds the brain and spinal cord (cerebrospinal fluid). A healthcare provider will give you this injection.

The nusinersen injection takes about 1 to 3 minutes to complete. You may be given a sedative to help you relax and keep you comfortable during the injection.

Nusinersen is usually given in a series of 4 "loading dose" injections, followed by "maintenance" injections.

The first 3 loading doses are usually given 2 weeks apart, followed by a 4th loading dose given 1 month later. Maintenance doses are then given once every 4 months.

Nusinersen dosing information

Usual Adult Dose for Spinal Muscular Atrophy:

Loading dose: 12 mg intrathecally every 14 days for 3 doses, then 12 mg intrathecally 30 days after the 3rd dose
Maintenance dose: 12 mg intrathecally once every 4 months

Comments:
-For administration, consider sedation; consider ultrasound or other imaging techniques to guide therapy.
-Prior to administration, remove 5 mL from cerebrospinal fluid; administer as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle.
-If a loading dose is delayed or missed, administer it as soon as possible, with at least 14-days between doses and continue dosing as prescribed.
-If a maintenance dose is delayed or missed, administer it as soon as possible and continue dosing every 4 months.

Use: For the treatment of spinal muscular atrophy (SMA)

Usual Pediatric Dose for Spinal Muscular Atrophy:

Loading dose: 12 mg intrathecally every 14 days for 3 doses, then 12 mg intrathecally 30 days after the 3rd dose
Maintenance dose: 12 mg intrathecally once every 4 months

Comments:
-For administration, consider sedation; consider ultrasound or other imaging techniques to guide therapy, especially in younger patients.
-Prior to administration, remove 5 mL from cerebrospinal fluid; administer as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle
-If a loading dose is delayed or missed, administer it as soon as possible, with at least 14-days between doses and continue dosing as prescribed.
-If a maintenance dose is delayed or missed, administer it as soon as possible and continue dosing every 4 months.

Use: For the treatment of spinal muscular atrophy (SMA)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your nusinersen injection. Your dosing schedule may need to be adjusted to allow for enough time between doses.

What happens if I overdose?

Since nusinersen is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving nusinersen?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect nusinersen?

Other drugs may interact with nusinersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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