Injection, nusinersen, 0.1 mg (J2326)

Name of the Procedure:

Common Name(s): Nusinersen Injection
Technical/Medical Term: Intrathecal Injection of Nusinersen

Summary

Nusinersen is a medication injected directly into the fluid surrounding the spinal cord. It's specifically designed to treat spinal muscular atrophy (SMA), a genetic disorder characterized by muscle weakness.

Purpose

Medical Conditions Addressed:

• Spinal Muscular Atrophy (SMA)

Goals/Expected Outcomes:

• Improve motor function
• Slow the progression of SMA
• Enhance quality of life for patients with SMA

Indications

Symptoms/Conditions:

• Muscle weakness
• Motor function difficulties
• Diagnosed cases of spinal muscular atrophy

Patient Criteria:

• Genetic confirmation of SMA
• Clinical symptoms correlating with SMA diagnosis

Preparation

• Pre-Procedure Instructions:

  • Patients may need to fast for several hours prior.
  • Adjustments to current medications as advised by the doctor.
  • Hydrate well unless otherwise instructed.

• Diagnostic Tests/Assessments:

  • MRI or imaging studies to determine the best injection site.
  • Pre-procedure physical examination.

Procedure Description

1. Patient is positioned to allow access to the spinal region.
2. Local anesthesia is applied to numb the injection site.
3. Using a fine needle, the medication is injected into the cerebrospinal fluid around the spinal cord.
4. The procedure is monitored using imaging guidance to ensure accurate placement.
5. The needle is then removed and a bandage is applied to the injection site.

Tools/Equipment:

• Sterilized injection needles
• Imaging guidance systems (e.g., fluoroscopy)
• Local anesthesia agents

Duration

The entire procedure typically takes about 1 to 2 hours, including preparation and post-procedure observation.

Setting

Injection of nusinersen is usually performed in a hospital setting or an outpatient clinic with facilities for intrathecal injections.

Personnel

• Neurologist or specialized physician performing the injection
• Nurses assisting with the procedure and patient care
• Radiology technician if imaging guidance is used

Risks and Complications

Common Risks:

• Pain or discomfort at the injection site
• Headache

Rare Risks:

• Infection
• Bleeding
• Nerve damage
• Allergic reactions to medication

Management of Complications:

• Pain: Over-the-counter pain relief or prescribed analgesics.
• Infection: Antibiotics if necessary.
• Ongoing monitoring for any severe adverse effects.

Benefits

• Significant improvement in motor functions.
• Slowing down or halting the progression of SMA.
• Enhanced overall quality of life. The benefits may start to become noticeable within a few weeks to a few months post-injection.

Recovery

Post-Procedure Care:

• Rest and limit activity for 24 hours.
• Keep the injection site clean and dry.
• Monitor for any unusual symptoms.

Expected Recovery Time:

• Most patients can resume normal activities within a day or two, but strenuous activities should be avoided for at least a week.

Follow-Up Appointments:

• Regular follow-ups to monitor progress and schedule subsequent doses.

Alternatives

Other Treatment Options:

• Physical therapy
• Genetic counseling
• Experimental medications or treatment trials

Pros and Cons:

• Alternatives may not be as effective in slowing disease progression.
• Physical therapy can help maintain mobility but doesn't address the underlying disease.

Patient Experience

During the Procedure:

• Minimal discomfort due to local anesthesia.
• Pressure or slight pain at the injection site.

After the Procedure:

• Some soreness or mild headache.
• Pain management includes rest, hydration, and over-the-counter pain relief.
• Patients typically feel well enough to go home the same day.