UPLIZNA (Inebilizumab) – IgG4‑RD | HongKong DengYue Medicine

UPLIZNA Inebilizumab Application Scope

• Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • For adults who are AQP4-IgG positive, to reduce the risk of relapse.

• IgG4-Related Disease (IgG4-RD)

  • For adult patients with active IgG4-related disease to lower disease activity and prevent organ damage (FDA approved in 2025; regional availability may vary).

    

UPLIZNA Inebilizumab Characteristics

• Ingredients: Inebilizumab

• Properties:​ Clear to slightly opalescent, colorless to slightly yellow solution

• Packaging Specification:​ Single-dose vial containing 100 mg/10 mL

• Storage:​ Refrigerate at 2°C to 8°C (36°F to 46°F) and do not freeze

• Expiry Date: Refer to the expiration date printed on the packaging

• Executive Standard: ​Manufactured in compliance with Good Manufacturing Practices (GMP) and regulatory standards

• Approval Number:

  • FDA Approval No. 761142

  • EMA Approval No. EPAR/UPLIZNA/000001

• Date of Revision: Latest revision: April 2025

• Manufacturer: Amgen Inc.

Guidelines for the Use of UPLIZNA Inebilizumab

• Dosage and Administration:

  • • Recommended Dose: The recommended dosage is 300 mg per infusion.

  • Administration:

    It is administered as an intravenous (IV) infusion. The regimen consists of:

    1. Initial dose: 300 mg on Day 1.

    2. Second dose: 300 mg on Day 15.

    3. Maintenance doses: 300 mg every 6 months starting from the first infusion

  • Missed Dose:​ The search results do not provide specific guidance on handling a missed dose. This must be discussed with the treating physician.

• Adverse Reactions:

  • Common Adverse Reactions: Common side effects include infections (such as urinary tract infections, nasopharyngitis, and upper respiratory tract infections), joint pain (arthralgia), back pain, and headache.

  • Serious Adverse Reactions: The drug increases the risk of infections. Infusion reactions can also occur. Low levels of lymphocytes (a type of white blood cell) have been observed . As with many immunosuppressants, there is a potential risk of serious infections.

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• Contraindications:

  • History of life-threatening infusion reaction to UPLIZNA.

  • Active hepatitis B infection.

  • Active or untreated latent tuberculosis.

• Precautions:

  • Monitor for signs and symptoms of infection during treatment.

  • Assess immunoglobulin levels periodically.

  • Vaccination with live-attenuated vaccines is not recommended during treatment.

  • Use effective contraception during treatment and for six months after the last dose.

UPLIZNA Interactions

• Live Vaccines: Avoid administration during treatment.

• Immunosuppressive Agents: Use caution when co-administering with other immunosuppressive therapies.

• Concomitant Infections: Manage appropriately; consider delaying treatment initiation during active infections.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.