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nusinersen (injection)

Pronunciation: NUE si NER sen

Brand: Spinraza

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 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 should I discuss with my healthcare provider before receiving nusinersen?

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 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.

What are the possible side effects of nusinersen?

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.

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.

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.

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