Tai’ai Telitacicept for Injection

1. Indications and Usage
Systemic Lupus Erythematosus (SLE):
Treatment of adult patients with active SLE who have an inadequate response to conventional therapy (e.g., positive for anti-dsDNA antibodies and low complement levels).
Rheumatoid Arthritis (RA):
Treatment of adult patients with moderately to severely active RA who have had an inadequate response to methotrexate.
Generalized Myasthenia Gravis (gMG):
Treatment of adult patients with anti-AChR antibody-positive generalized myasthenia gravis.
2. Dosage and Administration
Route of Administration:
For Subcutaneous (SC) Injection ONLY.
Recommended Dosage:
SLE and RA: 160 mg once weekly.
gMG: 240 mg once weekly.
Critical Administration Instructions:
Reconstitution: Reconstitute one vial (80 mg) with 1 mL of Sterile Water for Injection. Gently swirl for approximately 60 seconds; do not shake vigorously.
Timing: The total time from reconstitution to completion of SC injection must not exceed 4 hours at room temperature.
Site: Inject into the abdomen, thigh, or upper arm. Rotate injection sites to prevent local reactions.
3. Mechanism of Action
Dual Targeting:
Telitacicept is a recombinant fusion protein that acts as a decoy receptor. It simultaneously neutralizes BLyS (B-cell activating factor) and APRIL.
B-cell Regulation:
By blocking these two key cytokines, it inhibits the differentiation of B cells into antibody-secreting plasma cells, reducing autoantibody production and modulating pathogenic B-cell survival without causing profound B-cell depletion.
4. Safety and Warnings
Infections:
Increased risk of upper respiratory tract infections and urinary tract infections due to immunomodulatory effects.
Hypersensitivity:
Serious hypersensitivity reactions have been reported; monitor patients closely during administration.
Live Vaccines:
5.Avoid the use of live or live-attenuated vaccines during treatment.
Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Upper respiratory tract infections, injection site reactions (pain, erythema, pruritus), urinary tract infections, and decreased serum immunoglobulin M (IgM) and immunoglobulin G (IgG).
Clinical Research Highlights:
In Phase 3 trials (e.g., ORION study), telitacicept demonstrated significant improvement in SLE Responder Index (SRI-4) response rates compared to placebo in SLE patients.
6.Drug Interactions
Immunosuppressives:
Concomitant use with other immunosuppressives (e.g., methotrexate, mycophenolate mofetil) or biologics may increase the risk of infection.
Live Vaccines:
Live vaccines should not be administered concurrently with telitacicept.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Telitacicept (Recombinant human BLyS/APRIL fusion protein).
Appearance: White to pale yellow lyophilized powder.
Packaging: Single-use vial (80 mg).
Storage: Store in original carton at 2°C to 8°C. Do not freeze.