Anakinra Application Scope

Indications: Anakinra is indicated for the treatment of:
- Moderately to severely active rheumatoid arthritis (RA) in adults who have failed one or more disease-modifying antirheumatic drugs (DMARDs).
- Neonatal-Onset Multisystem Inflammatory Disease (NOMID), a form of Cryopyrin-Associated Periodic Syndromes (CAPS).
- Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
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Anakinra Characteristics

Ingredients: Anakinra is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra), produced using an E. coli bacterial expression system.
Properties: Anakinra consists of 153 amino acids with a molecular weight of 17.3 kilodaltons. It differs from native human IL-1Ra by the addition of a single methionine residue at its amino terminus.
Specification: Available as a 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. The graduated syringe allows for doses between 20 mg and 100 mg.
Packaging Specification: Supplied in cartons containing 7 prefilled syringes.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Complies with FDA-approved standards for prescription medications.
Approval Number: FDA NDA #103950 (approved November 14, 2001).
Date of Revision: Refer to the latest revision date on the prescribing information.
Manufacturer: Swedish Orphan Biovitrum AB.

Dosage and Administration:
- Rheumatoid Arthritis: 100 mg administered daily by subcutaneous injection at approximately the same time each day.
- Severe Renal Insufficiency or End-Stage Renal Disease: Consider 100 mg every other day.
Adverse Reactions:
- Common adverse reactions include:
  - Injection-site reactions (71%)
  - Headache (12%)
  - Nausea (7%)
  - Diarrhea (7%)
  - Vomiting (14%)
  - Arthralgia (11.6%)
  - Pyrexia (11.6%)
  - Nasopharyngitis (11.6%)
Contraindications: Known hypersensitivity to E. coli-derived proteins, Anakinra, or any components of the product.
Precautions:
- Monitor for signs of infection; Anakinra may increase the risk of serious infections.
- Use with caution in patients with neutropenia; monitor neutrophil counts.
- Avoid live vaccines during treatment.

Drug Interactions:
- Avoid concurrent use with Tumor Necrosis Factor (TNF) blocking agents due to increased risk of serious infections.
- Live vaccines should be avoided during treatment and for at least 3 months after cessation.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.