Zadaxin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

SciClone Pharmaceuticals International, Ltd. (China)

Manufactured By

Patheon Italia, S.P.A. (Italy)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Thymalfasin (Rec.INN registered by WHO)

Dosage Form

Zadaxin

Lyophilisate for preparation of solution for subcutaneous administration 1.6 mg: fl. incl. with solvent

Dosage Form, Packaging, and Composition

Solvent water for injections – 1 ml.

Vials (2) in a set with solvent (amp. 2 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Immunomodulatory agent. The mechanism of action is primarily due to the stimulation of T-lymphocyte function. In the course of numerous in vitro studies, the ability of thymalfasin to activate the process of T-lymphocyte differentiation and promote cell maturation was noted. An increase in the number of CD4+, CD8+, CD3+ lymphocytes was observed.

As studies have shown, Thymalfasin stimulates the production of IFN, IL-2, IL-3 and the expression of the IL-2 receptor after mitogenic or antigenic activation. Thymalfasin also increases the activity of NK cells, increases the production of migration inhibitory factor (MIF) and increases the antibody response to T-dependent antigens.

In vitro studies have shown that Thymalfasin is an antagonist of apoptosis in thymocytes provoked by dexamethasone.

During in vivo studies, Thymalfasin was administered to animals whose immunity was suppressed by chemotherapy or radiation. At the same time, a protective role of thymalfasin against cytotoxic lesions of the bone marrow, development of tumors and opportunistic infections was noted, thereby increasing the survival rate and the number of surviving individuals. Some results of in vitro and in vivo studies caused by the action of thymalfasin are interpreted as an effect on the differentiation of multipotent stem cells and the formation of lymphocytes or activation of thymocytes before the production of activated T-cells.

Indications

For the treatment of chronic hepatitis B (when used as monotherapy or as part of combination therapy with interferon).

For the treatment of chronic hepatitis C (as part of combination therapy with interferon).

As an adjuvant that enhances the immune response during influenza vaccination in patients with a weakened immune system (for example, in elderly patients) and as an adjuvant therapy during influenza and hepatitis B vaccination in patients on hemodialysis, whose antibody titers have not reached the desired level after previous vaccination.

ICD codes

Dosage Regimen

Administered subcutaneously. Should not be administered intravenously.

The recommended dose for chronic hepatitis B when used as monotherapy or combination therapy with interferon is 1.6 mg. Thymalfasin is administered subcutaneously, twice a week, for 6 or 12 months. Patients with a body weight of less than 40 kg should receive a dose of 40 mcg/kg.

The recommended dose for chronic hepatitis C when used in combination therapy with interferon is 1.6 mg. Thymalfasin is administered subcutaneously, twice a week, for 12 months. Patients with a body weight of less than 40 kg should receive a dose of 40 mcg/kg.

The recommended dose as an adjuvant to enhance the effect of the vaccine is 1.6 mg. Thymalfasin is administered subcutaneously, twice a week, at intervals of 3-4 days, the first injection is given during vaccination. The duration of therapy is 4 weeks (with a total of 8 doses) after a single administration of the vaccine preparation. With a vaccination regimen consisting of several injections, the course of therapy should be continued twice a week between vaccine administration and for 3 weeks (with a total of 5-6 doses) after the last vaccine.

Adverse Reactions

Side effects are rare, are moderate and in most cases consist of irritation at the injection site.

Rarely: erythema, muscle atrophy (transient), rash.

Contraindications

Hypersensitivity to thymalfasin.

Since the therapeutic effect is manifested in the stimulation of the immune system, Thymalfasin is contraindicated in patients who are prescribed immunosuppressive therapy, for example, during organ transplantation, except in cases where the expected benefit of therapy outweighs the potential risk.

Use in Pregnancy and Lactation

The use of thymalfasin during pregnancy is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

There is no information on whether Thymalfasin passes into breast milk. Caution should be exercised when using it in nursing mothers.

In experimental studies on mice and rabbits, no differences in the number of fetal development anomalies were found when using thymalfasin and in the control group. It has not been established whether taking thymalfasin can harm pregnant women or in any way affect reproductive functions.

Pediatric Use

The safety and efficacy of thymalfasin have been established for use in patients under 18 years of age.

Special Precautions

The safety and efficacy of thymalfasin have been established for use in patients under 18 years of age.

Drug Interactions

Interactions of thymalfasin with other drugs have not been studied.

Caution should be exercised when administering thymalfasin in combination with other immunomodulators.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.