Description
Nusinersen injection is used to treat spinal muscular atrophy (SMA).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Spinraza® in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nusinersen injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your or your child's progress closely while receiving the medicine to make sure it is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause you or your child to bruise or bleed more easily. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.
Severe kidney problems may occur after receiving this medicine. Tell your doctor right away if you or your child have agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.
Side Effects
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.
DRG-20405995
