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Spinraza
Spinraza (generic name: nusinersen) is a biologic medication used to treat spinal muscular atrophy (SMA), a genetic disorder that affects motor neurons and leads to progressive muscle weakness and loss of movement. Spinraza works by increasing the production of survival motor neuron (SMN) protein, which is critical for the health and function of motor neurons. It is used in both children and adults diagnosed with SMA, including those with SMA Type 1, 2, or 3.
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Frequently Asked Questions
How long does it take for Spinraza to start working?
The time to see improvements can vary from patient to patient. Some patients may experience improvements in motor function within weeks or months of starting treatment, but it may take longer for others. Continued dosing is important for maintaining these improvements.
Is Spinraza a cure for spinal muscular atrophy (SMA)?
No, Spinraza is not a cure for SMA. It is a treatment that helps manage the disease by increasing SMN protein production, which can slow or stabilize the progression of symptoms.
What happens if I miss a dose of Spinraza?
It is important to adhere to the prescribed dosing schedule for Spinraza to ensure the best possible outcomes. If you miss a dose, contact your healthcare provider immediately to reschedule as soon as possible.
Can adults with SMA take Spinraza?
Yes, Spinraza is approved for use in both pediatric and adult patients with SMA, regardless of the type of SMA they have.
How is Spinraza different from other SMA treatments?
Spinraza is an intrathecal injection that targets the SMN2 gene to increase the production of SMN protein. Other SMA treatments, such as Zolgensma (a gene therapy) and Evrysdi (an oral medication), have different mechanisms of action but also aim to increase SMN protein production to improve motor neuron function.
Comprehensive Drug Guide
How Does Spinraza Work?
Spinraza works by modifying the SMN2 gene, which is responsible for producing a backup supply of SMN protein. SMA patients have mutations in the SMN1 gene, leading to insufficient production of SMN protein, which is necessary for motor neuron function. Spinraza increases the production of functional SMN protein from the SMN2 gene, helping to maintain and restore motor neuron function.
Common Dosages
- Spinraza is available as an intrathecal injection, typically administered in a hospital or specialized clinical setting.
Typical Dosing
- The initial dosing regimen consists of four loading doses: the first three doses are given 14 days apart, followed by the fourth dose 30 days after the third.
- After the loading doses, maintenance doses are administered once every 4 months (approximately every 120 days).
Typical Dosing
FDA Approved Indications
- Spinal muscular atrophy (SMA) in pediatric and adult patients. It is indicated for all types of SMA (Type 1, 2, and 3).
Who Shouldn't Take Spinraza?
- Hypersensitivity to nusinersen or any of the components of the formulation.
- Spinraza should be administered with caution in patients with bleeding disorders or those taking anticoagulant therapy, due to the risk of complications from the intrathecal injection.
Advice From The Pharmacist
- Spinraza is administered via intrathecal injection by a healthcare provider in a medical setting. It is important to follow the treatment schedule and attend all appointments to ensure effective treatment.
- After each injection, patients may experience mild headaches or discomfort at the injection site, which usually resolves on its own. If any severe side effects occur, such as prolonged headaches, nausea, or fever, contact your healthcare provider immediately.
- If you have a bleeding disorder or are taking blood-thinning medications, inform your healthcare provider before receiving Spinraza injections.
Side Effects of Spinraza
Common Side Effects
- Headache
- Nausea or vomiting
- Back pain
- Post-injection discomfort at the injection site
Uncommon/Severe Side Effects
- Increased risk of bleeding or thrombocytopenia (low platelet count)
- Renal toxicity: Spinraza can affect kidney function, so regular monitoring of kidney function through urine tests may be recommended.
- Infections at the injection site or cerebrospinal fluid infections
Risks and Warnings of Spinraza
- Bleeding Risk: Spinraza may increase the risk of bleeding due to potential effects on blood clotting. Patients should be closely monitored for signs of bleeding, particularly if they are taking anticoagulants or have a history of bleeding disorders.
- Renal Toxicity: Spinraza can accumulate in the kidneys, potentially causing renal damage. Regular monitoring of kidney function, including urine protein tests, may be recommended during treatment.
- Infections: There is a risk of infection associated with intrathecal injections, including meningitis or infections at the injection site. Patients should be monitored for symptoms such as fever, severe headache, or neck stiffness.
Interactions with Spinraza
Common Drug Interactions
- Anticoagulants: Patients taking blood thinners such as warfarin or heparin may be at increased risk of bleeding complications due to Spinraza's effects. Careful monitoring is required.
- Other biologics or immunosuppressants: Combining Spinraza with other biologic agents may increase the risk of side effects, including infections or immune system suppression. Always inform your healthcare provider of all medications you are taking.
Alternatives to Spinraza
- Zolgensma (onasemnogene abeparvovec): A gene therapy approved for SMA Type 1 that works by replacing the defective SMN1 gene with a functional copy. It is administered as a one-time intravenous infusion.
- Evrysdi (risdiplam): An oral medication approved for the treatment of SMA. It also works by increasing SMN protein production from the SMN2 gene and is taken daily.
