Pronunciation:

nue-si-NER-sen

Brand Names:

• Spinraza

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Antisense Oligonucleotide

Uses of This Medicine:

Nusinersen injection is used to treat children and adults with spinal muscular atrophy (SMA).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Spinraza™ in children.

Older adults—

Use of Spinraza™ is not indicated in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Kidney problems or
• Thrombocytopenia (low number of platelets), severe—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed into your spinal cord.

This medicine needs to be given on a fixed schedule. If you or your child miss a dose of this medicine, call your doctor for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood and urine tests will be needed to check for unwanted effects.

This medicine may increase your risk for bleeding problems. Call your doctor right away if you have bleeding gums, pinpoint red spots on the skin, or unexpected or unusual bleeding, bruising, or weakness after receiving this medicine.

Severe kidney problems may occur after receiving this medicine. Tell your doctor right away if you or your child have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

black, tarry stools

bleeding gums

blood in the urine or stools

body aches or pain

chills

coma

confusion

cough

decreased urine output

depression

difficulty with breathing

dizziness

ear congestion

fever

headache

irritability

lethargy

loss of voice

muscle twitching

nausea

pinpoint red spots on the skin

rapid weight gain

runny or stuffy nose

seizures

sneezing

sore throat

stupor

swelling of the face, ankles, or hands

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

difficulty having a bowel movement (stool)

teething

Less common

Change in hearing

ear drainage

earache or pain in the ear

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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