Orencia (Abatacept Injection) – Arthritis | HongKong DengYue Medicine

  • Generic Name/Brand Name: ​Abatacept / Orencia
  • Indications: Rheumatoid arthritis (RA), Psoriatic arthritis (PsA), Juvenile idiopathic arthritis (JIA), and acute graft-versus-host disease (aGVHD)
  • Dosage Form: ​Lyophilized powder for intravenous (IV) infusion,Solution for subcutaneous (SC) injection.
  • Specification: 125 mg/ml × 1 vial

Orencia Abatacept Injection Arthritis Application Scope:

Indicated for the treatment of:
• Moderate to severe active rheumatoid arthritis in adults
• Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
• Active psoriatic arthritis in adults

orencia abatacept
orencia abatacept

Orencia Abatacept Injection Arthritis Characteristics

  • Ingredients: Abatacept (recombinant fusion protein of the extracellular domain of human CTLA-4 linked to a modified Fc portion of human IgG1)

  • Properties:​ A clear to slightly opalescent, colorless to pale yellow solution

  • Packaging Specification:​ Prefilled syringe: 125 mg/mL in 1 mL single-use prefilled syringe
    • Vial for IV infusion: 250 mg lyophilized powder per vial

  • Storage:​ Store refrigerated at 2°C–8°C. Do not freeze. Protect from light.

  • Expiry Date: 24 months from manufacturing date (refer to packaging)

  • Executive Standard: ​YBH08272020 (for Chinese NMPA-registered product)

  • Approval Number: S20200043

  • Date of Revision: February 2024

  • Manufacturer: Bristol-Myers Squibb Company / Imported and distributed by appropriate licensee in China

Guidelines for the Use of Orencia Abatacept Injection

  • Dosage and Administration:

    • Recommended Dose: 80 mg administered subcutaneously once every 4 weeks.

    • Administration: Administer via subcutaneous injection using the single-dose autoinjector.

    • Missed Dose: If a dose is missed, administer as soon as possible. Resume monthly dosing from the date of the most recently administered dose.

  • Adverse Reactions:

    • Common Adverse Reactions (≥5% and >3% higher than placebo):

      • Injection site reactions (19%)

      • Decreased platelet count (12%)

      • Arthralgia (9%)

    • Serious Adverse Reactions:

      • Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.

  • Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.

  • Precautions:

    • Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.

    • Platelet Count Monitoring: Monitor platelet counts during treatment.

    • Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Orencia Abatacept Injection Interactions

• Should not be used in combination with biologic TNF inhibitors due to increased risk of serious infections
• May affect the immune response to vaccinations
• No significant interaction with methotrexate or corticosteroids observed

 

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.
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