Nusinersen injection

Nusinersen injection is used for the treatment of spinal muscular atrophy (an inherited condition that reduces muscle strength and movement). Nusinersen injection is in a class of medications called antisense oligonucleotide inhibitors. It works by increasing the amount of a certain protein necessary for the muscles and nerves to work normally.

Nusinersen injection comes as a solution (liquid) to inject intrathecally (into the fluid-filled space of the spinal canal). Nusinersen injection is given by a doctor in a medical office or clinic. It is usually given as 4 initial doses (once every 2 weeks for the first 3 doses and again 30 days after the third dose) and then is given once every 4 months thereafter.

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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.

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.

Data not available

Administration advice:
-This drug should be administered by, or under the direction of, a healthcare professional experienced in performing lumbar punctures.
-Consider sedation as indicated by the clinical condition of the patient.
-Consider ultrasound or other imaging techniques to guide intrathecal administration, particularly in younger patients.
-Prior to administration, remove 5 mL of cerebrospinal fluid (CSF).
-Administer as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle.
-Do not administer in areas of the skin where there are signs of infection or inflammation.

Storage requirements:
-Store in the original carton in the refrigerator until time of use.

Reconstitution/preparation techniques:
-Allow vial to warm to room temperature (25C) prior to administration; do not use external heat sources.
-Inspect vial for particulate matter and discoloration prior to administration; do not administer if visible particulates are observed or if the liquid in the vial is discolored.
-Withdraw 12 mg from the single-dose vial into a syringe and discard unused contents of vial.
-Administer within 4 hours of removal from vial.

IV compatibility:
-The manufacturer product information should be consulted.

Monitoring:
-Platelet count
-Prothrombin time; activated partial thromboplastin time
-Quantitative spot urine protein testing

Benefit should outweigh risk. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown.