Zadaxin Thymalfasin for Injection

1. Indications and Usage
Chronic Hepatitis B:
Indicated for the treatment of patients with chronic hepatitis B.
Immuno-adjuvant for Vaccines:
Indicated as an immunoadjuvant for vaccination in immunocompromised individuals. It enhances the immune response to viral vaccines (e.g., influenza or hepatitis B vaccines) in patients with suppressed immune systems, including those on chronic hemodialysis and elderly patients.
2. Dosage and Administration
Reconstitution and Administration:
Dissolve each vial (1.6 mg) with 1 mL of Sterile Water for Injection immediately before use.
Administer by subcutaneous injection.
Contraindicated Routes: Do not administer via intramuscular (IM) or intravenous (IV) injection.
Recommended Dosage:
For Chronic Hepatitis B: 1.6 mg twice weekly, with doses 3–4 days apart. Treatment should be continuous for 6 months (total of 52 injections) without interruption.
For Vaccine Immune Response Enhancement: 1.6 mg twice weekly, with doses 3–4 days apart. Administer for 4 consecutive weeks (total of 8 injections). The first injection should be given immediately after vaccination.
3. Mechanism of Action
Immunomodulator:
Thymalfasin (Thymosin alpha-1) is a synthetic 28 amino acid peptide.
Physiological Effect:
It promotes the maturation of T lymphocytes and increases the production of lymphokines (such as Interferon-alpha, Interferon-gamma, Interleukin-2, and Interleukin-3) and the expression of lymphokine receptors on T cells following antigen or mitogen activation. It also enhances the cytotoxicity of Natural Killer (NK) cells.
4. Safety and Warnings
Hepatotoxicity Monitoring:
When used for chronic hepatitis B, liver function tests (ALT, albumin, and bilirubin) should be evaluated regularly. HBsAg, HBeAg, and HBV-DNA should be tested after treatment completion.
ALT Fluctuation:
A transient elevation of ALT levels (up to twice the baseline) may occur during treatment. Therapy should generally continue unless there are signs of hepatic decompensation or failure.
5. Adverse Reactions
Tolerability:
Thymalfasin is generally well tolerated.
Most Common:
Injection site pain or discomfort.
Rare Reactions:
Erythema, transient muscle atrophy, polyarthralgia with edema, and rash are extremely rare.
6. Drug Interactions
Combination Therapy:
Thymalfasin can be used in combination with Interferon-alpha to improve immune response.
Injection Precautions:
The drug should be used with caution in combination with other medications and must not be mixed with other drugs in the same syringe for injection.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Thymalfasin (Thymosin alpha-1).
Excipients: Mannitol, Disodium Hydrogen Phosphate, Sodium Dihydrogen Phosphate.
Storage:
Store in the original package, protected from light, at 2°C to 8°C (refrigerated). Do not freeze.