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nusinersen (injection)

Generic Name: nusinersen (injection) (NUE si NER sen)
Brand Name: Spinraza

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.

What is the most important information I should know about nusinersen?

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

What should I discuss with my healthcare provider before receiving nusinersen?

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

To make sure nusinersen is safe for you, tell your doctor if you have:

  • kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether nusinersen passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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 this medicine.

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.

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 this medicine 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.

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.

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 this medicine.

Common side effects 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.

See also: Side effects (in more detail)

Nusinersen dosing information

Usual Adult Dose for Spinal Muscular Atrophy:

-Initial dose: 12 mg intrathecally per administration; initiate therapy with 4 loading doses; administer the first 3 loading doses at 14-day intervals; administer the 4th loading dose 30 days after the 3rd dose
-Maintenance dose: 12 mg intrathecally once every 4 months

Comments:
-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:

17 years and older: Use adult dosing

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.

Where can I get more information?

  • Your pharmacist can provide more information about nusinersen.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03.

Date modified: July 02, 2017
Last reviewed: April 28, 2017

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