Nusinersen injection

Generic name: Nusinersen (injection)
Brand names: Spinraza
Dosage form: intrathecal solution (12 mg/5 mL)
Drug class: Miscellaneous uncategorized agents

Usage of Nusinersen injection

Nusinersen works by helping the body produce a protein essential to the function of nerves that control muscle movement. This protein is lacking in people with an inherited disorder called spinal muscular atrophy caused by a mutation in a specific gene.

Nusinersen is used to treat spinal muscular atrophy in adults, children, and infants.

Nusinersen may also be used for purposes not listed in this medication guide.

Nusinersen injection side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nusinersen may cause serious side effects. 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 nusinersen.

    Common side effects of nusinersen 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.

    Before taking Nusinersen injection

    You should not be treated with nusinersen if you are allergic to it.

    Tell your doctor if you have ever had:

  • kidney disease; or
  • bleeding problems.
  • Tell your doctor if you are pregnant or breastfeeding.

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    How to use Nusinersen injection

    Usual Adult Dose for Spinal Muscular Atrophy:

    Loading dose: 12 mg intrathecally every 14 days for 3 doses, then 12 mg intrathecally 30 days after the 3rd dose Maintenance dose: 12 mg intrathecally once every 4 months Comments:-For administration, consider sedation; consider ultrasound or other imaging techniques to guide therapy. -Prior to administration, remove 5 mL from cerebrospinal fluid; administer as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle. -If a loading dose is delayed or missed, administer it as soon as possible, with at least 14-days between doses and continue dosing as prescribed. -If a maintenance dose is delayed or missed, administer it as soon as possible and continue dosing every 4 months. Use: For the treatment of spinal muscular atrophy (SMA)

    Usual Pediatric Dose for Spinal Muscular Atrophy:

    Loading dose: 12 mg intrathecally every 14 days for 3 doses, then 12 mg intrathecally 30 days after the 3rd dose Maintenance dose: 12 mg intrathecally once every 4 months Comments:-For administration, consider sedation; consider ultrasound or other imaging techniques to guide therapy, especially in younger patients. -Prior to administration, remove 5 mL from cerebrospinal fluid; administer as an intrathecal bolus injection over 1 to 3 minutes using a spinal anesthesia needle-If a loading dose is delayed or missed, administer it as soon as possible, with at least 14-days between doses and continue dosing as prescribed. -If a maintenance dose is delayed or missed, administer it as soon as possible and continue dosing every 4 months.Use: For the treatment of spinal muscular atrophy (SMA)

    Warnings

    Call your doctor for instructions if you miss an appointment for your nusinersen injection.

    What other drugs will affect Nusinersen injection

    Other drugs may interact with nusinersen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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