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Spinraza

nusinersen

Used for Musculoskeletal Conditions

Spinraza (nusinersen) is an injectable medication used to treat spinal muscular atrophy (SMA) in children and adults. This medication is injected into the spinal canal by a trained healthcare provider at a treatment facility.

Reviewed by:

Yen Nguyen, PharmD

Allison Gourley, PharmD

Last reviewed on June 1, 2022

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Alternatives Latest news Images Prices Medicare

What is Spinraza (nusinersen)?

What is Spinraza (nusinersen) used for?

Treatment of spinal muscular atrophy (SMA) in children and adults

How Spinraza (nusinersen) works

People with spinal muscular atrophy (SMA) don't have enough of a protein called survival motor neuron (SMN), which is needed for your nerves and muscles to function properly. Spinraza (nusinersen) is an antisense oligonucleotide that helps the body make more SMN proteins to treat people with SMA.

Drug Facts

Common BrandsSpinraza

Drug ClassAntisense oligonucleotide

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

What are the side effects of Spinraza (nusinersen)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Infantile-onset SMA (affects infants)

Lower respiratory infection (55%)
Constipation (35%)
Teething (18%)
Urinary tract infection (9%)
Stuffy nose (8%)
Ear infection (6%)
Passing gas (5%)
Weight loss (5%)

Later-onset SMA (affects children and adults)

Fever (43%)
Headache (29%)
Vomiting (29%)
Back pain (25%)
Nosebleed (7%)
Falls (5%)
Stuffy nose (5%)
Seasonal allergy (5%)

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.

Serious bleeds: bleeding that's difficult to stop, bloody or black-colored stool, vomiting or coughing up blood, dizziness, pale skin
Kidney damage: low urine amount, swelling in legs or feet, shortness of breath, tiredness, confusion, nausea, weakness, irregular heartbeat, headache, or itchiness
Atelectasis (collapsed lung): trouble breathing, fast heart rate, cough, chest pain, or skin and lips turning blue

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

Back pain
Constipation
Fever
Headache
Vomiting

Pros and cons of Spinraza (nusinersen)

Pros

Can be given to both children and adults of all ages

Maintenance dose only has to be given every 4 months

Medication gets injected directly into the spinal area, where movement is controlled

Cons

Must be given by injection, so it might be uncomfortable

Only given by a trained healthcare provider

Must complete blood work and urine test before each dose

Pharmacist tips for Spinraza (nusinersen)

Since Spinraza (nusinersen) can raise the risk of bleeding, it's important to get all of your blood work done so your provider can monitor your bleeding risk. Let your provider know if you experience any unexpected bleeding during your treatment.

Spinraza (nusinersen) can cause damage to your kidneys. It's important to get your urine tested before each treatment so your provider can monitor your kidney function.

Let your provider know if you are pregnant, planning to become pregnant, or breastfeeding because it's not known if Spinraza (nusinersen) can harm your baby.

Frequently asked questions about Spinraza (nusinersen)

Can Spinraza (nusinersen) be given by my primary care provider?

Spinraza (nusinersen) can only be given by a healthcare provider who's trained to inject medications into the spinal canal. You will have to receive Spinraza (nusinersen) injections at a treatment center.

What body functions can Spinraza (nusinersen) help with?

For infantile or early-onset SMA in infants, Spinraza (nusinersen) can help babies achieve milestones, such as head control, rolling, sitting, and standing. For later-onset SMA in children and adults, Spinraza (nusinersen) can help improve walking distance and upper limb function (e.g. arm movements).

When do people start seeing improvements with Spinraza (nusinersen)?

Studies showed that people experienced an improvement in their overall motor (movement) function as early as 6 months after starting treatment.

How often do I need to get blood work with Spinraza (nusinersen)?

Your provider will request blood work before you start your treatment and before each time you get your Spinraza (nusinersen) injection. Depending on your health conditions, you might need to get blood work more often. It's important to show up to all of your appointments, so speak to your provider to see how often you need to get your labs done.

What happens if I miss my injection appointment?

Contact your provider if you missed your injection apointment, and they will re-schedule you as soon as possible. Your future appointments will have to be rescheduled according to the last injection that you received to make sure there's enough time in between doses.

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What are the risks and warnings for Spinraza (nusinersen)?

Spinraza (nusinersen) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Bleeding risk

Spinraza (nusinersen) might raise the risk of bleeding and cause clotting problems, such as thrombocytopenia (low platelet level). Your provider will monitor your platelet levels and bleeding risk before you start your treatment with Spinraza (nusinersen) and before each dose is given. Let your provider know if you have signs and symptoms of bleeding, such as cuts or wounds that bleed for a long time, small red spots under the skin caused by blood leaking from blood vessels, discoloration of the skin caused by bleeding in the skin, nosebleeds, bleeding from your gums, blood in your urine or stool, or heavy menstrual bleeding.

Kidney damage

Spinraza (nusinersen) might raise the risk of kidney damage, including a serious condition called glomerulonephritis. Because Spinraza (nusinersen) gets removed by the kidneys, your provider will check for the health of your kidneys before you start your treatment with Spinraza (nusinersen) and before each dose is given. Let your provider know if you experience signs of kidney damage, such as low urine amount, swelling in your legs or feet, shortness of breath, tiredness, confusion, nausea, weakness, irregular heartbeat, headache, or itchiness while on this medication.

Spinraza (nusinersen) dosage forms

Typical dosing for Spinraza (nusinersen)

The typical dose is 12 mg (5 mL) injected by intrathecal route (into the spinal canal).

Spinraza (nusinersen) is injected as four loading doses. The first three doses are given every 2 weeks. The fourth dose given 1 month after the third dose. After all loading doses are complete, you'll continue on a maintenance dose given once every 4 months.