Name of the Procedure:

Injection, givosiran, 0.5 mg

Common Name(s): Givosiran injection
Technical/Medical Term: J0223

Summary

Givosiran injection is a medical procedure where a medication called givosiran is administered via injection to help manage and treat specific metabolic conditions.

Purpose

Medical Conditions/Problems Addressed:
Givosiran injection is used primarily to treat a rare genetic disorder called acute hepatic porphyria (AHP).

Goals/Expected Outcomes:
The procedure aims to reduce the frequency and severity of attacks caused by AHP, improve quality of life, and prevent long-term complications of the disorder.

Indications

Symptoms/Conditions Warranting the Procedure:

• Recurrent severe abdominal pain
• Nervous system symptoms such as seizures, mental changes, or neuropathy
• Gastrointestinal issues like constipation or nausea

Patient Criteria:

• Diagnosed with acute hepatic porphyria
• Experiencing frequent attacks that significantly impair daily function

Preparation

Pre-Procedure Instructions:

• No specific dietary restrictions unless advised by a healthcare provider.
• Continue taking routine medications unless otherwise instructed.

Diagnostic Tests/Assessments:

• Blood tests to confirm diagnosis and baseline liver function tests.

Procedure Description

Step-by-Step Explanation:

1. The patient will sit or lie comfortably.
2. The healthcare provider will clean the injection site, typically on the arm or thigh.
3. Givosiran (0.5 mg) is drawn into a syringe.
4. The medication is injected subcutaneously (under the skin).

Tools/Equipment Used:

• Sterile syringe and needle
• Alcohol wipe

Anesthesia/Sedation Details:

• Typically, no anesthesia or sedation is required.

Duration

Typical Duration:
The injection procedure itself takes about 5-10 minutes.

Setting

Where Performed:

• Outpatient clinic
• Hospital outpatient setting

Personnel

Healthcare Professionals Involved:

• Nursing staff or a healthcare provider trained in administering injections

Risks and Complications

Common Risks:

• Localized pain or swelling at the injection site
• Bruising

Rare Risks:

• Allergic reaction
• Infection at injection site

Possible Complications:

• Monitoring and management by healthcare providers if complications arise.

Benefits

Expected Benefits:

• Reduction in frequency and severity of AHP attacks
• Improved daily function and quality of life

Timeframe for Realization:

• Some benefits may be noticed after the first injection, but consistent improvement is generally observed with ongoing treatment.

Recovery

Post-Procedure Care and Instructions:

• Monitor the injection site for signs of infection.
• Resume normal activities immediately unless instructed otherwise.

Expected Recovery Time:

• No significant recovery time; patients can usually return to their regular activities right after the procedure.

Restrictions/Follow-Up:

• Regular follow-ups as advised by the healthcare provider to monitor treatment effectiveness and manage any side effects.

Alternatives

Other Treatment Options:

• Oral medications for symptom control
• Intravenous hemin therapy

Pros and Cons of Alternatives:

• Oral medications: Easier to administer but may be less effective.
• Intravenous hemin: Effective but requires hospital visits and IV access.

Patient Experience

During the Procedure:

• Minor discomfort or pain at the injection site.

After the Procedure:

• Mild soreness or swelling at the injection site, manageable with over-the-counter pain relief if needed.
• Regular monitoring and support from healthcare providers to ensure the treatment's effectiveness and manage any side effects.