Recombinant human interferon alfa 2b for nasal application for the prophylaxis of SARS-CoV-2 virus infection.
Solution for nasal administration
10 x 106 IU/mL
- Case for a low-density polyethylene dropper bottle with 2 mL
- Box of 10 boxes per dropper bottle of low-density polyethylene with 2 mL
- Case of 12 low-density polyethylene dropper bottles with 2 mL
Each mL (20 drops) contains:
- Recombinant human interferon alpha 2b 10 x 106 IU
- Thimerosal 0.01 mg
- 2- (Ethylmercury) thio benzoic acid sodium salt
- Aqueous vehicle
Store at 2 to 8ºC. Do not freeze.
- Nasalferon has biological actions as an antiviral and an immunomodulator.
- Nasalferon is indicated for the temporary prophylaxis of SARS-CoV-2 infection in individuals, aged between 19 and 80 years, with a high risk of exposure to the virus, such as health personnel, persons who are contacts of suspects o confirmed cases and travelers
- Nasal administration of recombinant human interferon alpha 2b is based on the fact that the nasal epithelial cells function as the first defensive barrier during the exposure of individuals to virus particles that reach the nasal mucosa.
- The beneficial effects of nasally administered recombinant human interferon alpha 2b are mediated by its interaction with the regulatory cell populations present in the mucosa of the upper respiratory tract, and are amplified by the mechanisms that occur in that area.
Nasalferon is contraindicated in individuals with hypersensitivity to interferon alfa or thiomersal.
Autoimmune diseases
The systemic use of different preparations of recombinant human interferon alpha 2b has been associated with an increase in allergic or autoimmune manifestations such as bronchoconstriction, systemic lupus erythematosus, psoriasis, atopic dermatitis or thyroiditis. Although these phenomena have occurred very infrequently with parenterally administered interferon (IFN) and there is no history of their occurrence with the nasal use of interferon alfa, caution should be exercised with the use of Nasalferon in individuals with allergic processes and autoimmune.
Use in pediatrics
Nasalferon has not been used in pediatric ages, so its use in pediatrics is not recommended.
- Nasalferon must be administered under a medical prescription.
- Nasalferon has the advantage of being a self-applying product, for which the instructions for correct dispensing must be followed, as described in the package insert.
- Although most of the adverse events associated with the use of Nasalferon are of mild intensity, in the event of higher intensity events you should consult your attending physician, who should define whether it is necessary to reduce the dose, temporarily withdraw the treatment or permanently suspend it.
- Although overall there are no large variations in laboratory determinations on the tenth day (once the Nasalferon treatment has been completed), some subjects may present changes in the values of hematological parameters. These hematological alterations have been described for the use of formulations containing interferon and, although they may reach clinical relevance, they are considered transient and resolve spontaneously without the need for pharmacological / non-pharmacological therapy. However, until a greater amount of clinical evidence accumulates, it is recommended to take precautions during the administration of Nasalferon in patients with myelosuppression or other medical conditions that present with hematological alterations.
- Nasalferon contains thiomersal. May cause allergic reactions.
- The Nasalferon vial is multidose; However, once opened, it can be reused for 10 consecutive days if it is stored at a temperature between 2 and 8 ºC (Refrigeration). After this time, the unused remains must be discarded.
- Keep out of the reach of children.
- In the phase I study, 82 adverse events were recorded (22 different adverse events in 45 subjects [56.3%]). 40% of manifestations were local around the nasal application area and 32% were hematological events. Of the total adverse events, 93% were of mild intensity, transitory and 91% resolved without requiring pharmacological measures. 7% of persistent events on the tenth day corresponded to mild hematological events. Despite these incidences in individual patients, all the hematological parameters evaluated remained within normal limits in the global paired comparison.
- The most frequently reported adverse events were: rhinorrhea (13.4%), headache (12.2%), nasal burning (12.2%), neutropenia (9.8%), leukopenia (8.5%), arterial hypertension (8.5%), lymphocytosis (7.3%). No serious adverse event was reported.
- In an early surveillance study that included 1,003 subjects between 18 and 81 years of age, who were administered Nasalferon as prophylaxis of SARS-CoV-2 infection, with the objective of characterizing the safety of the product, events were recorded adverse events in 266 (26.5%) of exposed subjects.
- According to the frequency of presentation of the events, very frequent events did not occur (≥ 10%). The frequent events (≥ 1% and <10%) were: headache (8.9%), rhinorrhea (6.3%), sneezing (4.0%), nasal pruritus (2.6%), pharyngeal irritation (2.0%), nasal congestion (1.8 %), asthenia (1.8%) and nasal itching (1.4%). The rest of the events were classified as infrequent (≥ 0.1% and <1%). Most of these events involved the upper respiratory system and were local. According to severity or intensity, 97.5% (385 events) were classified as mild, 2.8% (11 events) moderate, and there were no severe or serious events. The results of this study allowed us to characterize the safety of recombinant human interferon alpha 2b via the nasal route. and demonstrate that the product is safe, well tolerated and can be an effective alternative in the prophylaxis of COVID-19 in vulnerable populations.
- Recombinant human interferon alpha 2b preparations are immunogenic in a variable proportion of treated patients. The antibodies generated can neutralize the activity of interferon and, therefore, impede or reverse the response to treatment. The immunogenicity profile is influenced by the dose, the frequency, the route of administration and, fundamentally, by the duration of the therapeutic scheme.
- Studies carried out with recombinant human IFN alpha 2b used as the active principle of Nasalferon have shown that it is less immunogenic than similar formulations marketed on the international pharmaceutical market. Additionally, it is expected that the route of administration and the short duration of the therapeutic regimen associated with the use of Nasalferon will reduce the possibility of induction of anti-IFN alpha antibodies of a neutralizing nature.
Each drop of Nasalferon is equivalent to 0.05 mL and contains 0.5 MIU of recombinant human alpha-2b interferon. The recommended dose of Nasalferon is one drop in each nostril, twice a day (approximately every 12 hours), which represents 2 MIU of interferon daily. Higher doses of Nasalferon have not been evaluated.
The maximum recommended duration of treatment is 10 consecutive days, which is called a cycle. To achieve the satisfactory pharmacological effect of the drug, one cycle of treatment in the individual is sufficient.
For the administration of Nasalferon follow the following instructions:
1. Wash your hands well with soap and water.
2. To open the bottle for the first time, hold it vertically and turn the cap clockwise until it is fully lowered. This is enough to pierce the material in the bottle and allow the drop to escape.
3. Place the lid on a flat surface so that its interior does not come into contact with the surface. Do not touch the inside of the cap. This will help keep the inside of the lid clean and prevent potential contamination.
4. Tilt your head back and bring the end of the bottle to one of your nostrils. Do not put the end of the bottle in contact with your nostril to avoid possible contamination.
5. Gravity drop ONE drop of the medication into your nostril, the bottle should not be pressed.
6. Proceed in the same way with the other nostril.
7. Keep your head back for a few minutes.
8. Close the bottle with the cap again and place it under refrigerated conditions.
No drug interactions are reported.
Studies of recombinant human interferon alpha 2b in rat animal models have not shown any teratogenic or fertility effects. There are no clinical studies that have evaluated the effect of Nasalferon in pregnant and lactating women; therefore, its safe use during pregnancy cannot be established, and the doctor must do a risk-benefit analysis in each case before use.
They have not been described.
The influence of Nasalferon on the ability to drive and use machines is expected to be minimal. However, if after the onset the individual presents dizziness, confusion, drowsiness or fatigue, he should be advised that he should avoid driving vehicles or using machines.
It has not been described.