Spinraza

Generic name: Nusinersen
Dosage form: intrathecal injection
Drug class: Miscellaneous uncategorized agents

Usage of Spinraza

Spinraza is a type of medication called an antisense oligonucleotide. It is used to treat children and adults with spinal muscular atrophy (SMA), a type of motor neuron disease. It was the first drug to be approved by the US Food and Drug Administration (FDA) for this group of people.

SMA is an inherited disorder that causes skeletal muscle weakness and wasting, which worsens with age. SMA is most commonly caused by mutations in a gene called SMN1 (survival motor neuron 1), which leaves the body without enough functional SMN protein to keep motor neurons healthy and functioning.

A back-up gene called SMN2 also produces SMN protein, but only a small percentage of the protein produced by SMN2 functions properly. This is because when the protein is being made a portion of the gene called exon 7 tends to be skipped over, so the resulting protein isn't supplied with all of the right building blocks of information it needs to function properly.

Spinraza works by fixing the protein produced by SMN2 so that it functions properly. It does this by making sure that the missing piece of information from exon 7 is included.

Spinraza was approved by the FDA in 2016.

Spinraza side effects

Spinraza may cause serious side effects including:

  • Thromocytopenia and coagulation abnormalities
  • Renal toxicity

    • The most common side effects of Spinraza include:

  • lower respiratory infection
  • fever, constipation
  • headache
  • vomiting
  • back pain
  • post-lumbar puncture syndrome

    • These are not all of the possible side effects of Spinraza. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Spinraza

    Tell your doctor if you are pregnant or plan to become pregnant before taking Spinraza. Spinraza may cause fetal harm according to the results of studies conducted in animals.

    Tell your doctor if you are breastfeeding or plan to breastfeed before taking Spinraza. Talk to your doctor about the best way to feed your baby while receiving treatment with Spinraza.

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    How to use Spinraza

  • The recommended dosage of Spinraza is 12 mg (5 mL) per administration
  • Spinraza treatment should be initiated with 4 loading doses. The first 3 loading doses should be administered at 14-day intervals. The 4th loading dose should be administered 30 days after the 3rd dose.
  • A maintenance dose of Spinraza should be administered once every 4 months thereafter.
  • See the full prescribing information for further dosing information.

    • Warnings

    Spinraza can cause serious side effects including:

  • Increased risk of bleeding. Complications linked to an increased risk of bleeding have been observed after administration of similar medicines. Your healthcare provider will perform blood tests before you start treatment with Spinraza and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs.
  • Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney. An increased risk of kidney damage has been observed after administration of similar medicines. Your healthcare provider will perform urine testing before you start treatment with Spinraza and before each dose to monitor for signs of this risk.

    • What other drugs will affect Spinraza

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

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