Moldavir 400 Boston treated Covid-19 mild to moderate (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Molnupiravir

Ingredient

Composition information	Content
Molnupiravir	400mg

Uses

Indications

Moldavir 400mg drug indicated to treat Covid-19 mild to medium to adult positive adults with SARS-COV-2 diagnostic test and at least one risk factor for severe progression.

Pharmacology

Pharmacological group: Antiviral drugs with systemic effect, direct antiviral.

ATC code: Not yet classified.

Active mechanism

molnupiravir is a medication converted into similar substance ribonucleosid N-hydroxyctidin (NHC).

NHC is distributed into tissues and is transformed into ribonucleosid triphosphate (NHC-TP). NHC-TP operates under the mechanism of mass errors for viruses. The NHC-TP is attached to the virus's RNA with the enzyme of polymerase and the fault in the genome of the virus leads to inhibition of the copy process.

antiviral activity

In cell culture test, NHC has the activity against SARS-COV-2 with an effective concentration of 50% (EC50) between 0.67 to 2.66 µm on A-549 cells and with concentrations between 0.32 to 2.03 µm on Vero E6 cells. The NHC has the same activity on SARS-COV-2 B.1.1.7 (Alpha), B.1351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) with EC50 values, respectively, 1.59; 1.77; 1.32 and 1.68 µm.

Do not observe the influence of NHC on In-Vitro viral anti-virus activity against SARS-COV-2 when trying to combine NHC with Abacavir, Emtricitabin, Hydroxycloroquin, Lamivudin, Nelfinavir, REMDESIVIR, Ribavirin, Sofosbir, or Tenofovovir.

Pharmacological effects

The relationship between the NHC and the intracellular bank and the anti-virus effect has not been clinically evaluated.

drug resistance

There is no replacement of amino acids in SARS-COV-2 related to NHC resistance determined in phase 2 clinical trials evaluating the molnuupiravir's CIVI-19 treatment ability. Studies evaluating selective resistance to NHC of SARS-COV-2 in cell culture have not been completed.

Safety and clinical effectiveness

This clinical data is based on data from 1433 patients who are randomly selected in the 3rd phase Move-out test (NCT04575597). This is a double clinical study, with a fake control, randomly studying molnupiravir's treatment ability in patients who are not hospitalized with mild to medium to medium and severe development.

The selection criteria for eligible participants are 18 years of age or older and have one or more risk factors for predetermined: 60 years or older, diabetes, obesity (BMI ≥ 30 kg/m2), chronic kidney disease, serious cardiovascular disease, chronic obstructive pneumonia or cancer are progressing.

Research includes symptoms, SARS-COV-2 vaccine has not been vaccinated and those who have been confirmed to SARS-COV-2 infection with symptoms of onset within 5 days. Patients are randomly selected 1: 1 to receive 800 mg of molnupiravir or fake, drink twice daily for 5 days.

Basically, in all patients randomized, the average age is 43 years old (range from: 18 to 90 years old); 17% of patients over 60 years old and 3% aged 75 and older, 49% of men are male, 57% are white, 5% black or African-American, 3% Asian, 50% of Spanish or Latin America. Most patients registered from locations in Latin America (46%) and Europe (33%); 12% of Africa registration, 6% registered in North America and 3% registered in Asia.

Forty-eight percent of patients who are used molnupiravir or fake within 3 days of the beginning of CIVIV-19 symptoms. The most common risk factors are obesity (74%), over 60 years old (17%) and diabetes (16%).

Of the 792 patients (55% of the total research patients are randomly selected), the initial SARS-COV-2 variant/variant is determined, 58% of Delta infection (strain B.1.617.2 and Ay), 20% of MU infection (B.1.621), 11% of gamma infection (P.1), and the rest are infected with other variants/strains.

In general, the demographic characteristics and the condition are distributed balanced between treatment groups.

Table 1 provides the results of the main ending point (the percentage of patients hospitalized or death within 29 days due to any cause). The results of effectiveness based on adult groups have not been vaccinated with a full 18 -year -old room and have one or more risk factors determined for the progression of the disease: over 60 years old, diabetes, obesity (BMI ≥ 30 kg/m2), chronic kidney disease, serious cardiovascular disease, chronic obstructive pulmonary disease or progressive cancer.

Data on some groups of patients who are at high risk of progressing into a serious CDC1 definition is not available.

Table 1: Effective results in adults infected with Covid-19 are not hospitalized*

molnupiravir (n = 709)
n (%)

placebo (n = 699)

n (%)

Risk difference*

% (95% CI)

all the causes leading to hospitalization for active treatment ≥ 24 hours or death for 29 days

48 (6.8%) 68 (9.7%) -3.0%(-5.9%, -1%) Leading to death in 29 days

1 (0.1%) 9 (1.3%) - At midterm analysis, 7.3% of patients taking molnupiravir must be hospitalized or died in 29 days (March 2885), compared to 14.1% of patients treated with placebo (53/377). The adjustment difference is -6.8% with 95% CI is (-11.3%, -2.4%) and 2-SIDED P-Value = 0.0024.

Relatively reduced risk reduction of molnupiravir compared to placebo for all patients who are randomly selected is 30%(CI 95%: 1%, 51%).

The analysis is adjusted by the stratified element over time of the onset of CIVI-19 symptoms (≤3 days compared to> 3 [4.5] days).

Figure 1: Effective results on subgroups in adults are not hospitalized with Covid -19 - all patients who have been randomly divided

Effective results on adult subgroups are not hospitalized with Covid-19

corresponding reliability interval based on Miettinen and Nurinen methods.

Population intended to be effective analytical population.

The original serum samples are assessed by Roche Elucsys Anti-N test to check the presence of antibodies (IGM, IgG and IGA) against SARS-COV-2 nucleocapsid protein. The findings in these small group analysis are considered as exploration.

Dynamic pharmacokinetics

molnupiravir is a precursor of 5'-IsobutyRat, hydrolyzed into NHC before absorption into the circulatory system.

The dynamic characteristics of the NHC on healthy patients and patients with Covid-19 are similar.

NHC pharmacokinetic parameters in a stable state after taking 800 mg molnupiravir every 12 hours are shown in Table 2.

Table 2: Pharmacokinetics of NHC after taking 800 mg molnupiravir every 12 hours

Average NHC (%CV) (16,8)

31,1 (124)

*: The values obtained from the dynamic analysis on the population.

+: The values obtained from a stage 1 study in healthy patients.

absorption

After taking the dose of 800 mg. 2 times/day, the average time reaches the concentration of NHC (TMAX) is 1.5 hours.

Distribution and metabolism

NHC is not linked to plasma proteins.

Elimination

Sales time of NHC is approximately 3.3 hours. No more than 3% of the dose is excreted in the form of the urine in healthy people.

Other special patients

Gender, race, age: Analysis of kinetic analysis in patients show that age, gender, race does not affect significance on the dynamic characteristics of the NHC.

Pediatric patients: Molnupiravir has not been studied in pediatric patients.

kidney failure:

Elimination through the kidney is not the main excretion path of the NHC. There is no need to adjust the dose in patients with renal impairment at all levels of renal failure. In a dynamic analysis, mild to moderate renal failure does not affect significance on the kinetic characteristics of the NHC. The dynamic characteristics of molnupiravir and NHC are not assessed in patients with glomerular filtration (EGFR

Hepatic failure:

The kinetic characteristics of molnupiravir and NHC have not been evaluated in patients with hepatic impairment. Subclinical data indicates that excretion through the liver is not the path of elimination of the main bank, so the liver failure almost does not affect the exposure to the NHC. No dose adjustment in patients with liver failure.

Before taking Moldavir 400 Boston treated Covid-19 mild to moderate (2 blisters x 10 tablets)

How to use

Moldavir 400mg hard capsules, used by oral, you can use or not with the same food.

Patients should take the whole pill with enough water (for example: 1 cup of water). Recommendation not to open, grind or chew tablets.

Dosage

Adults

Recommended dose: Take oral dose of 800 mg molnupiravir (2 tablets) every 12 hours in 5 days.

Safety and effectiveness of molnupiravir when used for more than 5 days has not been determined.

Patients with Covid-19 should take molnupiravir as soon as possible after being diagnosed with viral infection and within 5 days from the beginning of symptoms.

Shelf limit:

Do not use molnupiravir for more than 5 consecutive days. Due to the lack of the benefits of molnupiravir when starting to use in this patient object. Patients who were used before hospitalization could continue to use drugs for sufficient treatment.

Children

Safety and effectiveness of molnupiravir in patients under the age of 18 have not been determined.

There is no data on children's patients. Recommendation should not be used for children.

Other objects

Elderly: No need to adjust the molnupiravir dose in elderly patients.

People with renal failure: No need to adjust the molnupiravir dose in patients with renal failure.

People with liver failure: No need to adjust the molnupiravir dose in patients with liver failure.

Specific dose depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? If an overdose is used, it is necessary to handle it by general support measures, including monitoring the patient's clinical status. Hematoparoa is not effective in eliminating NHC (N-Hydroxycytidin).

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting a dose?

If you forget a dose of 10 hours, patients should not take the forgotten dose but need to take the next dose of the schedule. Do not use double the dose to compensate for the forgotten dose.

Side Effects

Unwanted effects have been observed in molnupiravir clinical research presented in Table 3. The unwanted ratio of the observed effects in these clinical trials cannot be directly with the ratio in the clinical tests of another drug and may not reflect the observed ratio in reality. Other undesirable effects related to molnupiravir may become clearer when used more widely.

In general, more than 900 patients have taken molnupiravir 800 mg 2 times/day in clinical trials. Evaluation of the safety of molnupiravir is mainly based on analysis from patients who are not hospitalized with COVIV-19, which is monitored until the 29th in phase 3 study (Move-out).

The safety of molnupiravir is evaluated based on the analysis of the Double-stage blind test (Move-Out), of which 1411 patients who are not hospitalized with CIVI-19 are randomly selected for treatment with molnupiravir (n = 710) or placebo (n = 701) up to 5 days. Understanding events are reported when patients are participating in research or within 14 days after completion/stop research.

Discontinuing research due to an adverse event occurred in 1% of patients using molnupiravir and 3% of patients can use fake. Serious adverse events occur in 7% of patients using molnupiravir and 10% placebo use; The most serious unfavorable events are related to Covid-19. Understanding events leading to death occurred in 2 patients (

The most unwanted effects in the molnupiravir treatment group in the Move-out are presented in Table 3, all at level 1 (light) or level 2 (medium).

Table 3: Unwanted effects occur 1% of patients using molnupiravir in Move-Out*

placbo (n = 701)

diarrhea 2% 2% 1%

Abnormalities in the test:

Level 3 and 4 abnormalities are selected in chemical tests (alanin aminotransferase, Aspartate aminotransferase, creatinine and lipase) and hematology (hemoglobin, platelet and leukocyte) occur at a ratio of ≤ 2% and similar to the rate between research groups in the moval-out.

Notify the physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Moldavir 400mg contraindicated drug in the following cases:

Patients with hypersensitivity to the active ingredient molnupiravir.

Caution when using

Warning

Clinical data of molnupiravir is limited. Serious and undesirable reactions may occur when using molnupiravir has not been recorded.

Toxicity for embryos and pregnancy

Based on the findings from animal reproductive studies, molnupiravir can be harmful to the fetus when used for pregnant women. Human data is not available for the use of molnupiravir in pregnant women to assess the risk of serious birth defects, miscarriage or adverse consequences for mother or fetus; Therefore molnupiravir is not recommended for use during pregnancy.

It is necessary to advise people who are reproductive age at risk for the fetus and need to use appropriate, uniform and effective contraception (if possible, while treatment with molnupiravir and in 4 days after the last dose.

If clinically indicated using molnupiravir, it is necessary to evaluate whether a patient of reproductive age is likely to be pregnant or not before starting treatment. There is no need to confirm pregnancy in patients who have permanently sterilized, are placing or transplanting or transplanting, or those who cannot get pregnant.

For all other patients, evaluate whether the patient is pregnant or not based on the first day of the last menstrual period in people with regular menstrual cycle, using appropriate, uniform and effective contraception or negative pregnancy. Pregnancy tests should be tested if the patient has an irregular, uncertain menstrual cycle about the first day of the last menstrual period or does not use appropriate and effective contraception.

Toxicity for bones and cartilage

Do not be used for patients under 18 years of age because the drug can affect the development of bones and cartilage. Toxicity on bones and cartilage has been observed in mice after using the reminded dose. The safety and effectiveness of molnupiravir has not been identified in the population of the Children's Patients.

Precautions

When using drugs for women of reproductive age

Before starting treatment with molnupiravir, it is necessary to assess patients of pregnancy or not, if the drug is clinically indicated.

Advice for women of reproductive age to use appropriate and effective contraception, which can be applied during treatment and in 4 days after the last molnupiravir dose.

When using drugs for men of reproductive age

It has not yet been determined whether molnupiravir affects sperm or not. Although the risk is thought to be low, animal studies fully evaluate the influence of molnupiravir to the children of male breeding animals using Molnupiravir has not been completed. It is necessary to advise men who are sexually active with women who have the ability to reproduce should use an appropriate and effective contraceptive method during treatment and at least 3 months after the last molnupiravir dose.

The risk of reproduction after 3 months from the last dose of molnupiravir has not been determined. Studies in this risk are being conducted.

excipients

Mollavir 400mg contains Tartrazine, Patent Blue V, Ponaceau 4R capable of causing allergies.

Each dose of 4 capsules/day contains less than 1 mmol (23 mg) sodium, basically considered "no sodium".

Using drugs for pregnant or lactating women

Moldavir 400mg medicine can be used for pregnant women?

There is no data on the use of molnupiravir in pregnant women. Animal studies show toxicity on reproductive system.

Do not use for pregnant women. Pregnant women need to use effective contraception during treatment and for 4 days after the last molnuptravir dose.

When other antiviral treatments are not available for pregnant women with Covid-19, the risk of severe CIVI-19 progress may be considered to use Molnupiruvir after being fully informed about risks, especially in patients during pregnancy that has passed the lung formation phase (over 10 weeks of age). In this case, the treatment doctor needs to take notes about the risk and benefits and ensure the patient agrees with this treatment option.

Moldavir 400mg medicine can be used for nursing women?

There is no data on the presence of molnupiravir or metabolites of the drug, n-hydroxyctidin (NHC) in breast milk. The NHC is discovered in the plasma of the breast -feeding mouse using molnupiravir. Whether molnupiravir has not yet been determined whether or not to breastfeed or affect the ability to create milk of the mother.

On the basis of the ability to experience harmful reactions in young children when using molnupiravir, it is not recommended for breastfeeding during treatment with molnupiravir and within 4 days after using the final dose. Breastfeeding women can consider stopping breastfeeding and can consider sucking and spining breast milk during the use of the drug and within 4 days after using the last molnupiravir.

Data

When molnupiravir is used for breastfeeding mice at a dose of ≥ 250 mg/kg/day in developed research before and after birth, NHC metabolites have been discovered in the plasma of the mouse sucking mę.

Reproduction

Research suggests that there is no influence on fertility, mating ability or early embryo development when MolnuPiravir is used for female rats or male rats at the level of NHC exposure, respectively 2 and 6 times compared to NHC exposure levels for humans.

The effect of the drug on driving and operating machinery

does not have enough information about the effect of the Mollavir 400mg drug on the ability to drive and operate machinery.

Drug interaction

There is no drug interaction determined based on existing limited data. Drug interaction studies with clinical molnupiravir have not been conducted. Molnupiravir is hydrolyzed into NHC before being absorbed into the circulatory system.

NHC absorption and metabolites are carried out through the intermediaries of the same paths related to endogenous pyrimidine metabolism. NHC is not the substrate of the basic metabolic enzyme or the main shipping. Therefore, molnupiravir or NHC IT has the ability to interact with the drug used simultaneously.

Tyeum of drugs

Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

Interactive drugs can affect the activity of the drug or cause side effects.

Patients should notify the doctor or pharmacist a list of drugs and functional foods you are using.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

Other drugs

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