Anaferon^® kid (Tablets, Drops) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Clinical-Pharmacological Group

Antiviral and immunostimulating drug

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Mechanism of Action and Pharmacodynamic Effects

For preventive and therapeutic use, the drug has an immunomodulatory and antiviral effect.

The mechanism of action of the drug is based on changing the conformational characteristics of one of the key cytokines of the antiviral response – interferon gamma (IFN γ), which leads to an increase in the number of IFN γ molecules bound to their receptors (CD119) and subsequent activation of intracellular signaling pathways. Due to this, under infection conditions, the blocking effect of viruses on signal transmission from the IFN γ receptor is reduced. A cascade of subsequent natural antiviral defense reactions is launched.

The drug increases the expression of IFN γ, IFN α/β and associated interleukins (IL-2, IL-4, IL-10, etc.); increases the expression of IFN γ receptors CD119; stimulates interferon-dependent biological processes significant for improving recognition and accelerating the elimination of viruses, as well as protecting healthy cells from infection: it initiates the expression of IFN-dependent genes, increases the activity of neutrophils, macrophages, natural killer (NK) cells, activates the development of cellular and humoral immune response, regulates the Th1/Th2 cell balance, enhances the production of immunoglobulins, including secretory IgA (sIgA).

Experimental and clinical efficacy has been established against RNA and DNA viruses: influenza A and B viruses, parainfluenza viruses, rhinovirus, respiratory syncytial virus, adenoviruses, coronaviruses (seasonal and highly pathogenic MERS-CoV), metapneumovirus, bocavirus, herpesviruses (varicella-zoster virus, Epstein-Barr virus), rotavirus, calicivirus. Experimental studies have established that the drug reduces the concentration of viruses in affected tissues. Furthermore, it has been experimentally proven that when used in combination with oseltamivir, the drug enhances the inhibition of replication of both oseltamivir-sensitive and oseltamivir-resistant strains of influenza A virus.

Clinical Efficacy and Safety

The efficacy and safety of the drug Anaferon^® kid have been studied in a series of multicenter double-blind placebo-controlled randomized clinical trials (RCTs), including international ones. The results of the studies showed that Anaferon^® kid is an effective and safe drug for the prevention and treatment of ARVI, including influenza, infectious mononucleosis and chickenpox, acute intestinal viral infections of rota- and calicivirus etiology.

In a meta-analysis of 9 double-blind placebo-controlled RCTs of the efficacy and safety of the drug Anaferon^® kid for influenza and other ARVIs involving 2790 patients from 1 month of age, including those with comorbidities and frequently ill children, when assessing therapeutic efficacy by the criteria “duration of illness” and “duration of fever,” superiority over placebo was demonstrated in the form of a reduction in the duration of illness by 1.4 times and febrile syndrome by 1.5 times when taking the drug (p<0.001). For the criterion "duration of illness," the weighted mean effect size was 1.05 [95% CI 0.44; 1.67], for the criterion "duration of fever" - 0.97 [95% CI 0.61; 1.33] (p<0.001; two-sided Z-test; random effects model). Efficacy exceeding placebo by more than 1.5 times was shown in reducing the duration of the intoxication period and the duration of catarrhal symptoms: rhinitis - by 1.3 times; cough - by 1.9 times (p<0.001). The meta-analysis confirmed the effect of the drug Anaferon^® kid on the level of induced IFN γ on days 2-3 of treatment with the effect persisting until the end of therapy – the weighted mean effect size for induced IFN γ production on days 2-3 of therapy was 0.99 [95% CI 0.66; 1.33] (p<0.001 two-sided Z-test; fixed effects model) - 1.27 [95% CI 0.06; 2.48] (p=0.039, two-sided Z-test; random effects model). It was found that the therapeutic efficacy of the drug did not depend on the ARVI pathogen, clinical picture, or the presence of comorbidity in patients. Evaluation of the preventive efficacy of the drug Anaferon^® kid by the criterion “proportion of patients who did not get ARVI/influenza” demonstrated its superiority over placebo by 1.3 times (CMH=38.8; p<0.0001) with OR 1.25 [95% CI 1.2; 1.3] and OR 2.2 [95% CI 1.7; 2.9], clinical efficacy index - 32%. The total number of adverse events (AEs) during the use of the drug was comparable to placebo.

An analysis of PCR diagnostics of nasopharyngeal samples in patients with a positive rapid test for influenza, conducted in an international multicenter double-blind placebo-controlled RCT of the efficacy and safety of the drug Anaferon^® kid in the treatment of influenza and other ARVIs involving 569 patients from 3 years of age, showed almost 2 times more pronounced dynamics of viral load reduction compared to placebo during treatment with Anaferon^® kid, both separately and in total for influenza A/B viruses (p=0.0009). At the same time, the proportion of children with recovery/improvement was significantly greater daily than with placebo therapy (p=0.0026), and the severity of the disease was significantly lower (AUC; p=0.0233) with a reliably smaller number of antipyretic doses already on the 2nd day of treatment (p=0.0303).

In an international multicenter double-blind placebo-controlled RCT of the preventive efficacy of the drug Anaferon^® kid against influenza and other ARVIs involving 1036 children aged from 1 month, the proportion of children who did not get influenza/ARVI during prophylactic use of the drug exceeded placebo and amounted to 99.2% after 4 weeks (p=0.0003). No participant was hospitalized for influenza/ARVI or their complications.

The efficacy and safety of the drug Anaferon^® kid for the treatment of intestinal infections caused by rotavirus in children from 6 months of age was demonstrated in a multicenter double-blind placebo-controlled RCT. A faster reduction in the duration of the main symptoms and the disease as a whole by almost a day compared to placebo was established – the duration was 4.4±0.14 (p<0.001). A positive effect of the drug on reducing the febrile period, which was 1.9±0.12 days versus 2.7±0.14 days with placebo, and the intoxication syndrome - 2.4±0.10 and 3.1±0.14 days, respectively (p<0.001), was demonstrated. The efficacy of the drug Anaferon^® kid in relieving gastrointestinal symptoms was characterized by faster normalization of stool frequency on the 1st day, which was 1.9±0.13 days versus 2.9±0.20 days with placebo, a reduction in the duration of vomiting and, as a result, earlier relief of dehydration – 1.5±0.05 days with the drug versus 2.1±0.08 days with placebo (p<0.001). The duration of flatulence was reduced by 1.4 times (p<0.001). During the use of the drug, positive dynamics of immunological parameters were observed with statistically significant differences: an increase in sIgA in nasal secretions, induction of IFN γ and IFN α (p<0.001).

The efficacy and safety of the use of the drug Anaferon^® kid for the treatment of infections caused by herpesviruses was demonstrated in two multicenter double-blind placebo-controlled RCTs on the treatment of infectious mononucleosis and chickenpox. The use of the drug Anaferon^® kid according to the therapeutic regimen for 14 days for the treatment of infectious mononucleosis in children from 1 year of age led to a reliable reduction in the duration of clinical symptoms of the disease compared to placebo (p<0.01): fever was relieved on average 2 days faster - 4.0±0.32 days versus 6.0±0.40 days in the placebo group, symptoms of acute tonsillitis and tonsil plaque were relieved 1.5 days faster, enlargement of cervical and submandibular lymph nodes - 1.4 days faster, splenomegaly resolved 3.4 days faster, nasal congestion - 1.2 days faster, pallor of the skin was noted 2.4 days less, and decreased appetite passed 1.4 days faster.

When using the drug Anaferon^® kid for the treatment of chickenpox in children from 1 year of age for 7 days, a reliable reduction in the duration of clinical symptoms of the disease and faster recovery compared to placebo (p<0.001) was observed: fever - on average by 2.6 days, the period of new rashes - by 3.7 days, skin itching - by 2.1 days, intoxication - by 3.2 days, the period of lymph node enlargement - on average, by 1.6 days. When using the drug Anaferon^® kid, a faster dynamics of rash regression was noted: the time to disappearance of spots-papules and vesicles was shorter by an average of 1.5 and 3.4 days than with placebo, respectively (p<0.001). A reduction in the severity of the disease was demonstrated: the proportion of patients with a moderate form of chickenpox during observation dynamics was 1.7% in the Anaferon^® kid group and 20% in the placebo group. Treatment with the drug Anaferon^® kid was not accompanied by the development of complications; in no case was additional therapy required.

The results of clinical studies demonstrate a favorable safety profile of the drug Anaferon^® kid. During the studies, no negative effect of the drug on the vital functions of patients was detected, and not a single AE with a reliable connection to the study therapy was registered. The frequency of AE development during the use of the drug Anaferon^® kid has no significant differences from placebo. Also, no cases of negative interaction of the drug with drugs of various classes were registered. The use of the drug Anaferon^® kid is well tolerated by patients and has a high percentage of compliance.

Preclinical Safety Data

Preclinical safety studies on sexually mature and immature animals, including assessment of toxicity with single and repeated administration, genotoxicity, reproductive toxicity, as well as allergenic and local irritant properties, did not reveal the presence of toxic or potentially dangerous effects for humans in the drug Anaferon^® kid.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

• Prevention and treatment of influenza and acute respiratory viral infections (ARVI) in children aged from 1 month to 18 years;
• Treatment of infections caused by herpesviruses (infectious mononucleosis, chickenpox), as part of complex therapy in children aged from 1 year to 18 years;
• Treatment of acute intestinal infections caused by rota- and caliciviruses, as part of complex therapy in children aged from 6 months to 18 years.

ICD codes

Dosage Regimen

Tablets

The score line is not intended for dividing the tablet. The drug is taken orally, not during a meal. The tablet should be kept in the mouth until completely dissolved.

When prescribing the drug to young children (from 1 month to 3 years), it is recommended to dissolve the tablet in a small amount (1 tablespoon) of boiled water at room temperature.

ARVI, Influenza

Children aged 1 month and older on the 1st day of treatment are prescribed 8 tablets according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (5 tablets total in 2 hours), then on the same day, 1 tablet 3 more times at equal intervals. On the 2nd day and thereafter – 1 tablet 3 times a day until complete recovery.

If there is no improvement on the 3rd day of treatment for ARVI and influenza with the drug, a doctor should be consulted.

For preventive purposes, the drug is taken daily, 1 tablet once a day for 1-3 months.

Acute intestinal infections caused by rota- and caliciviruses, as part of complex therapy

Children aged 6 months and older on the 1st day of treatment are prescribed 8 tablets according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (5 tablets total in 2 hours), then on the same day, 1 tablet 3 more times at equal intervals. On the 2nd day and thereafter – 1 tablet 3 times a day until complete recovery.

Treatment of infections caused by herpesviruses (infectious mononucleosis, chickenpox), as part of complex therapy

Children aged 1 year and older on the 1st day of treatment are prescribed 8 tablets according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (5 tablets total in 2 hours), then on the same day, 1 tablet 3 more times at equal intervals. On the 2nd day and thereafter – 1 tablet 3 times a day. The duration of treatment for chickenpox is 7 days, for infectious mononucleosis – 14 days.

Special Patient Groups

Dose adjustment in patients with impaired renal function is not required.

Dose adjustment in patients with impaired hepatic function is not required.

No adjustment of the dosing regimen is required depending on the child’s age.

The safety and efficacy of the drug Anaferon^® kid in children aged 0 to 1 month have not been studied. Data are not available.

Drops

The drug is taken orally, between meals. On the first day of treatment, the first 5 doses of the drug should be administered in the interval between feedings or 15 minutes before feeding the child or fluid intake.

10 drops per dose (drops are dosed into a spoon).

On the first day of treatment: first 2 hours: 10 drops every 30 minutes, then, in the remaining time, 3 more times at equal intervals. From day 2 to day 5: 10 drops 3 times a day.

Adverse Reactions

Possible allergic reactions and manifestations of increased individual sensitivity to the components of the drug.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Children under 1 month of age (for the prevention and treatment of influenza and other ARVIs);
• Children under 1 year of age (for the treatment of infections caused by herpesviruses (chickenpox, infectious mononucleosis));
• Children under 6 months of age (for the treatment of acute intestinal infection caused by rota- and caliciviruses);
• Lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption.

Use in Pregnancy and Lactation

Pregnancy

The safety of using the drug Anaferon^® kid in pregnant women has not been studied. During pregnancy, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus. The “benefit – risk” ratio is determined by the attending physician.

Breastfeeding period

The safety of using the drug Anaferon^® kid during lactation has not been studied. During lactation, the drug is used only if the intended benefit to the mother outweighs the potential risk to the child. The “benefit – risk” ratio is determined by the attending physician.

Pediatric Use

The use of the drug is approved in children aged 1 month and older according to the indications.

Special Precautions

Excipients

The drug contains lactose, therefore patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

Effect on ability to drive vehicles and mechanisms

No negative effect of the drug Anaferon^® kid on the ability to drive vehicles (including bicycles, scooters, etc.) and other potentially dangerous mechanisms has been identified.

Overdose

In case of overdose, dyspeptic phenomena are possible due to the excipients included in the drug.

Treatment: symptomatic.

Drug Interactions

No cases of incompatibility with other drugs have been identified to date.

If necessary, the drug can be combined with other antiviral, antibacterial and symptomatic agents.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). During the period of use of the drug, store the blister pack in the cardboard package provided by the manufacturer.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a prescription.

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.