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What is Thymosin Alpha 1?
Thymosin alfa-1 (thymalfasin) is a synthetic peptide with immunomodulatory activity. Thymosin alpha-1 (thymalfasin) is a synthetic peptide of 28 amino acids, with a molecular weight of 3,108. The mechanism of action of thymosin in the treatment of chronic hepatitis B and C. is not fully understood. It produces the promotion of T-cell maturation by mitogen-stimulated peripheral blood lymphocytes. In addition, it increases the production of various lymphokines such as interferon-alpha, interferon-gamma, interleukin 2 (IL-2), and interleukin 3 (IL-3) by T cells, following antigen or mitogen activation and increases receptor levels of lymphokines in T cells. It also increases the reactions of mixed halogenic and autologous human lymphocytes by activation of T4 cells (assistants/inducers). Also, it may influence the recruitment of natural killer (NK) cells, which become cytotoxic after exposure to interferon in vitro, thymosin alpha-1 (thymalfasin) increases IL-2 receptors and IL-2 production in concanavalin A-stimulated mouse lymphocytes.
Studies with Thymosin Alpha 1
Clinical studies have shown that treatment with thymosin alpha 1 in patients with chronic hepatitis B and C (who have been seropositive for at least 6 months) with serum alanine aminotransferase (ALT) enzymes elevated, thymosin treatment produced remission of the plasma virus (HBV DNA negative) and normalization of serum aminotransferases. Thymosin alfa-1 (thymalfasin) is absorbed after subcutaneous application, reaching a maximum peak plasma concentration of approximately 25-30ng / ml at the time of administration with the recommended dose, maintaining these values for approximately 6 hours.
An increase in plasma levels proportional to the dose is observed, both in the maximum plasma concentration (Cmax) and in the area under the curve (AUC). Plasma levels return to baseline 24 hours after administration. The plasma half-life (t½) is approximately 2 hours and there is no evidence of accumulation from multiple doses. Between 31% and 61% of a single dose is excreted in the urine.
Treatment of chronic hepatitis B in patients over 18 years of age with compensated liver disease and proven viral replication. Treatment of chronic hepatitis C, in patients over 18 years of age with compensated liver disease and demonstrated viral replication. Adjuvant to anti-influenza vaccination in immunocompromised subjects.
Thymosin Alpha 1 Dosage
In the treatment of chronic hepatitis B (monotherapy or combination therapy): 1.6mg (0.9mg / m2 of body surface area) subcutaneously 2 times a week for 6 to 12 months.
In the treatment of chronic hepatitis C (combined therapy): 1.6mg (0.9mg / m2) subcutaneously twice a week for 12 months.
Those patients weighing less than 40kg should receive a thymosin alfa-1 dose of 40 mg/kg. The dose of interferon alfa 2b will be that recommended in the treatment regimens for chronic hepatitis. In adjuvant anti-influenza vaccination in immunosuppressed patients: 1.6mg (0.9mg / m2) subcutaneously once a week for 4 weeks, starting from time zero (first vaccination). Treatment should be repeated from week 8 (second vaccination) to week 12. It should not be administered intramuscularly or intravenously.
Thymosin Alpha 1 Side Effects
Thymosin alfa-1 is very well tolerated and its adverse reactions are rare. Occasionally a burning sensation at the injection site and very occasionally transient loss of muscle mass. Can be seen: fever, nausea. It may happen that at the beginning of treatment there is a transient increase in serum ALT, twice above the baseline level. In these cases, treatment can be continued unless other signs or symptoms of liver disease appear.
Cautions and Warnings
It should be used with caution in atopic subjects or with previous allergic reactions. In autoimmune diseases, the administration should be evaluated for each particular case. Mutagenic effects have not been demonstrated. Animal reproduction studies show no differences with control animals. It can only be administered to the pregnant woman if there is a clear need. It is unknown whether the drug is excreted in human milk. Safety and effectiveness have not been established in patients under 18 years of age.
Hypersensitivity to the active principle or to any other component of the formulation. Immunosuppression (unless the benefits outweigh the risks). Severe liver or kidney failure.