Alfa-fetoprotein (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Institute of New Medical Technologies CJS (Russia)

ATC Code

L04AX (Other immunosuppressants)

Active Substance

Human alpha-fetoprotein (Grouping name)

Dosage Forms

	Alfa-fetoprotein	Lyophilisate for preparation of solution for intravenous and intramuscular administration 75 mcg (1 dose): fl. 5 or 10 pcs.
		Lyophilisate for preparation of solution for intravenous and intramuscular administration 75 mcg (1 dose): amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for i/v and i/m administration in the form of a powder or porous mass from white to grayish-white, hygroscopic.

Excipients: rheopolyglucin – 4-6 mg.

75 mcg – glass bottles (5) – plastic contour packs (1) – cardboard packs.
75 mcg – glass bottles (5) – plastic contour packs (2) – cardboard packs.
75 mcg – glass bottles (10) – plastic contour packs (2) – cardboard packs.
75 mcg – glass bottles (10) – plastic contour packs (1) – cardboard packs.

Lyophilisate for preparation of solution for i/v and i/m administration in the form of a powder or porous mass from white to grayish-white, hygroscopic.

Excipients: rheopolyglucin – 4-6 mg.

75 mcg – glass ampoules (5) – plastic contour packs (1) – cardboard packs.
75 mcg – glass ampoules (5) – plastic contour packs (2) – cardboard packs.
75 mcg – glass ampoules (10) – plastic contour packs (2) – cardboard packs.
75 mcg – glass ampoules (10) – plastic contour packs (1) – cardboard packs.

Clinical-Pharmacological Group

Immunosuppressive drug

Pharmacotherapeutic Group

Immunomodulatory agent

Pharmacological Action

A drug of natural origin with a wide spectrum of regulatory action. The properties of human alpha-fetoprotein are due to its affinity for some key regulatory molecules in the body (including steroid hormones, prostaglandins, polyunsaturated fatty acids, extracellular matrix proteins).

Human alpha-fetoprotein has antiestrogenic and immunosuppressive properties. As a transport protein, it carries bilirubin, fatty acids, and various drugs.

When used as part of complex therapy for nonspecific ulcerative colitis, it helps reduce inflammatory-proliferative processes in the intestinal mucosa and allows for a reduction in glucocorticosteroid doses.

When used as part of complex therapy for autoimmune thyroiditis (Hashimoto’s disease), it helps reduce the level of antibodies against thyroglobulin, restores the initially reduced level of T-cells (CD3+), increases the content of CD8+ T-lymphocytes, increases the initially reduced level of IgA and IgM, and increases the production of endogenous thyroxine and triiodothyronine.

When used as part of complex therapy for chronic occlusive vascular diseases, it helps improve intravascular and tissue hemoperfusion and stimulates the healing of trophic ulcers. The effectiveness is due to the fact that Human alpha-fetoprotein is an inducer of endogenous prostaglandins E₁ and E₂, which relieve vascular spasms and block the development of autoimmune reactions.

Indications

As part of complex therapy: nonspecific ulcerative colitis; autoimmune thyroiditis (Hashimoto’s disease); chronic occlusive vascular diseases (thromboangiitis, obliterating endarteritis, atherosclerosis, infectious-allergic arteritis).

ICD codes

Dosage Regimen

Administer intramuscularly or intravenously as a bolus or by drip infusion.

Calculate the dose based on patient body weight. The standard range is 1 to 4 mcg/kg administered once daily.

For nonspecific ulcerative colitis, use a dose of 1-2 mcg/kg daily. The typical treatment course is 14 to 30 days.

For autoimmune thyroiditis, use a dose of 1-2 mcg/kg daily. The standard course duration is 14 to 30 days.

For chronic occlusive vascular diseases, use a dose of 2-4 mcg/kg daily. The recommended course is 14 to 30 days.

Reconstitute the 75 mcg lyophilisate immediately before use with the provided solvent or water for injection. Use the prepared solution without delay; do not store it.

Adjust the treatment duration and dosing frequency based on the disease severity and the patient’s clinical response. The maximum total course dose should not exceed established clinical guidelines.

Adverse Reactions

None identified.

Contraindications

Pregnancy, breastfeeding; hypersensitivity to blood components.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Drug Interactions

It is believed that Human alpha-fetoprotein increases the clinical efficacy of cytotoxic drugs during systemic chemotherapy. It reduces the toxic effect of cytostatics by reducing cytolysis of hepatocytes and providing a nephroprotective effect.

Increases the clinical efficacy of antiviral drugs – interferons.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.