<abstract xmlns="http://www.w3.org/1999/xhtml"><p>Antiviral drug Kagocel is widely used in Russia for prevention and treatment of acute respiratory infection, influenza, and herpes. The drug belongs to the group of interferon inductors. The article contains the review and analytical evaluation of safety of antiviral drug Kagocel. Kagocel is registered in the Russian Federation and some CIS countries and refers to the group of interferon inducers. This is a chemical compound of carboxymethyl cellulose and low-molecular natural polyphenol gossypol common in cotton-plant (Gossypium spp.) which protects the plant from depredators and diseases. Authors pay a special attention to the analysis and generalization of data from preclinical and clinical studies including the control of related substances. Absence of free gossypol impurities guaranteed by highly sensitive and specific quality control methods. Preclinical studies data was analyzed and the results were presented with focus on reproductive safety of Kagocel® in immature and mature animals.. No negative effect on animals’ reproductive function was revealed including spermatogenesis and generative function. No long-term product effect on reproductive system or next generations of animals was recorded both at therapeutic doses and at doses 10 times their exceeding. The safety of the drug demonstrated on data obtained from numerous clinical trials, including those involving children aged 2 years and older. Th is confirms the safety of antiviral drug Kagocel usage in clinical practice, including pediatrics.</p></abstract>

Antiviral drug Kagocel is widely used in Russia for prevention and treatment of acute respiratory infection, influenza, and herpes. The drug belongs to the group of interferon inductors. The article contains the review and analytical evaluation of safety of antiviral drug Kagocel. Kagocel is registered in the Russian Federation and some CIS countries and refers to the group of interferon inducers. This is a chemical compound of carboxymethyl cellulose and low-molecular natural polyphenol gossypol common in cotton-plant (Gossypium spp.) which protects the plant from depredators and diseases. Authors pay a special attention to the analysis and generalization of data from preclinical and clinical studies including the control of related substances. Absence of free gossypol impurities guaranteed by highly sensitive and specific quality control methods. Preclinical studies data was analyzed and the results were presented with focus on reproductive safety of Kagocel® in immature and mature animals.. No negative effect on animals’ reproductive function was revealed including spermatogenesis and generative function. No long-term product effect on reproductive system or next generations of animals was recorded both at therapeutic doses and at doses 10 times their exceeding. The safety of the drug demonstrated on data obtained from numerous clinical trials, including those involving children aged 2 years and older. Th is confirms the safety of antiviral drug Kagocel usage in clinical practice, including pediatrics.

Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Experimental and Applied Biomedical Research (EABR)

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Antiviral drug Kagocel is widely used in Russia for prevention and treatment of acute respiratory infection, influenza, and herpes. The drug belongs to the...

Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Published Online: Oct 29, 2018

Page range: 271 - 276

Received: Aug 11, 2018

Accepted: Sep 12, 2018

DOI: https://doi.org/10.2478/sjecr-2018-0040

Keywords
antiviral drug, interferon inducer, Kagocel, reproductive safety, pediatrics, preclinical and clinical studies

© 2018 Tatiana Gennadievna Borovskaya, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Preclinical and Clinical Evidence of Safety of Antiviral Drug with Immunomodulatory Activity

Published Online: Oct 29, 2018

Page range: 271 - 276

Received: Aug 11, 2018

Accepted: Sep 12, 2018

DOI: https://doi.org/10.2478/sjecr-2018-0040

Keywordsantiviral drug, interferon inducer, Kagocel, reproductive safety, pediatrics, preclinical and clinical studies

© 2018 Tatiana Gennadievna Borovskaya, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
antiviral drug, interferon inducer, Kagocel, reproductive safety, pediatrics, preclinical and clinical studies