Nusinersen (Intrathecal route)
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Spinraza™ in children.
Use of Spinraza™ is not indicated in geriatric patients.
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.
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.
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:
- More common
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- body aches or pain
- decreased urine output
- difficulty with breathing
- ear congestion
- loss of voice
- muscle twitching
- pinpoint red spots on the skin
- rapid weight gain
- runny or stuffy nose
- sore throat
- swelling of the face, ankles, or hands
- unusual bleeding or bruising
- unusual tiredness or weakness
- More common
- Back pain
- difficulty having a bowel movement (stool)
- Less common
- Change in hearing
- ear drainage
- earache or pain in the ear
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:
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:
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.
Last Updated: 8/2/2019