Nusinersen (nue-si-NER-sen)

Treats spinal muscular atrophy.

Brand Name(s):

Spinraza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into your spinal cord.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or bleeding problems.
• This medicine may cause kidney problems.
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, blood in the urine, rapid weight gain, swelling in your hands, ankles, or feet
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088