Molcovir 200

Molnupiravir Capsules 200 mg: Size '2' hard gelatin white opaque color capsules, filled with white to off white color granular powder.
Each hard gelatin capsule contains Molnupiravir 200 mg.
Excipients q.s.
Approved colours are used in Capsule shells: Titanium Dioxide.
Excipients/Inactive Ingredients: Capsule content: Crospovidone, Colloidal silicon dioxide, Microcrystalline cellulose, Povidone K-30, Sodium stearyl fumarate.
Capsule shell: Gelatin, Titanium Dioxide.

Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals. ATC code: Not yet assigned.
Pharmacology: Pharmacodynamics: Mechanism of action: Molnupiravir is a prodrug that is metabolised to the ribonucleoside analogue N-hydroxycytidine (NHC) which distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHCTP acts by a mechanism known as viral error catastrophe. NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication. The supporting mechanism of action was derived from biochemical and cultured cell data from SARS-CoV-2 infection studies in laboratory animal models and genome sequencing analyses in subjects treated with molnupiravir.
Pharmacodynamic effects: The relationship between NHC and intracellular NHC-TP with antiviral efficacy has not been evaluated clinically.
Clinical efficacy and safety: Clinical data to support emergency use authorization (EUA) were obtained by analyzing findings in randomized trials. Phase 3 [MOVe-OUT trial (NCT04575597)] with 1,433 participants in a clinical trial studying the use of molnupiravir in the treatment of mild to moderate covid-19 patients who were not hospitalized and at risk of developing severe symptoms of COVID-19 and/or hospitalization. Participants in study that meet the selection criteria must: Eligibility is that they are 18 years of age or older and have at least one risk of developing the severity of the disease; over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease or active cancer. The study also included people with symptoms but had not been vaccinated against SARS-CoV-2, and those who tested positive. Participants were randomized to take 800 mg of molnupiravir or placebo twice a day for a period of 5 days at a ratio of 1:1.
At baseline, in all randomised subjects, the median age was 43 years (range: 18 to 90 years); 17% of subjects were 60 years of age or older and 3% were over 75 years of age; 49% of subjects were male; 57% were White, 5% Black or African American, 3% Asian; 50% were Hispanic or Latino. The majority of participants enrolled from various research sites included Latin America (46%), Europe (33%), Africa (12%), North America (6%) and Asia (3%). Forty-eight percent of subjects received Molnupiravir or placebo within 3 days of COVID-19 symptom onset. The most common risk factors were obesity (74%), 60 years of age or older (17%), and diabetes (16%). Genetic testing results in 792 volunteers (representing 55% of the total randomized population) strains of the SARS-CoV-2 virus were found in the following clade groups: 58 percent infected with delta strains (B.1.617.2 and AY lineages), 20 percent infected with Mu strains (B.1.621), 11 percent infected with Gamma strains (P.1), and the rest infected with other clade strains or groups. Overall, baseline demographic and disease characteristics were well balanced between the treatment arms.
Table 1 provides the results of the primary endpoint (the percentage of subjects who were hospitalised or died through Day 29 due to any cause). Efficacy outcomes were obtained from adults aged 18 and older who were unvaccinated and had at least one risk of developing disease severity: over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. See figure showing the efficacy outcomes of each specific subgroup. There was no data on specific subgroups in subjects at high risk of developing disease severity according to the CDC's definition. (See Table 1.)

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Figure shows the efficacy outcomes of each specific subgroup. In adults with COVID-19 and not hospitalized (all subjects were randomly assigned to molnupiravir or placebo). (See figure.)

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The confidence interval using the Miettinen and Nurminen modified intent-to-treat population methods is to take all subjects randomly into each trial group and analyze them according to the randomized group, even if the data is lost.
Serum samples at the initiation were evaluated with the Roche Elecsys anti-N assay to detect IgM, IgG and IgA antibodies to the nucleocapsid protein of the SARS-CoV-2 virus.
The results of subgroup analyses are classified as exploratory research.
Pharmacokinetics: Molnupiravir is a 5'-isobutyrate prodrug that is hydrolysed to NHC prior to reaching systemic circulation. When entering, the cell is altered to NHC-TP by anabolism. NHC is metabolised by metabolism to uridine and/or cytidine, reacting through the same endogenous pathway as the synthesis process. The pharmacokinetics of NHC are provided as follows in Table 2. (See Table 2.)

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Other special populations: Population pharmacokinetic analysis showed that age, gender, race and ethnicity do not meaningfully influence the pharmacokinetics of NHC.
Paediatric Patients: Molnupiravir has not been studied in paediatric patients.
Renal Impairment: Renal clearance is not a meaningful route of elimination for NHC. No dose adjustment in patients with any degree of renal impairment is needed. In a population PK analysis, mild or moderate renal impairment did not have a meaningful impact on the pharmacokinetics of NHC. The pharmacokinetics of Molnupiravir and NHC has not been evaluated in patients with eGFR less than 30 mL/min/1.73 m² or on dialysis.
Hepatic Impairment: The pharmacokinetics of Molnupiravir and NHC has not been evaluated in patients with hepatic impairment. Preclinical data indicate that hepatic elimination is not expected to be a major route of NHC elimination therefore hepatic impairment is unlikely to affect NHC exposure.
Toxicology: Preclinical safety data: Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis: Carcinogenicity studies with molnupiravir in mouse is underway.
Mutagenesis: Molnupiravir and NHC were positive in the in vitro bacterial reverse mutation assay (Ames assay) with and without metabolic activation. In 2 distinct in vivo rodent mutagenicity models; Pig-a mutagenicity assay gives a well-balanced result, while Big Blue (cII Locus) transgenic rodent assay molnupiravir gives a negative result. Based on the in vitro micro nucleus test, molnupiravir gives a negative result and does not cause chromosome damage (both with and without metabolic activation) and according to micro nucleus tests, in vivo in rats, molnupiravir gives negative results. A study plan has been prepared to assess the impact on germ cells by studying the causing of mutations in the germ cells of male rodent animals that have undergone gene editing.
Based on all of the previously mentioned genotoxicity data and duration of treatment (5 days), molnupiravir has a low risk of causing genotoxicity.
Impairment of Fertility: There were no effects on fertility, mating performance or early embryonic development when Molnupiravir was administered to female or male rats at NHC exposures approximately 2 and 6 times, respectively, the human NHC exposure at the recommended human dose (RHD).
Toxicology and/or Pharmacology in Laboratory Animals: Bone and cartilage toxicity, consisting of an increase in the thickness of physeal and epiphyseal growth cartilage with decreases in trabecular bone was observed in the femur and tibia of rapidly growing rats in a 3-month toxicity study at ≥500 mg/kg/day (5 times the human NHC exposure at the RHD). There was no bone or cartilage toxicity in a 1-month toxicity study in rapidly growing rats up to 500 mg/kg/day (4 and 8 times the human NHC exposure at the RHD in females and males, respectively), in dogs dosed for 14 days up to 50 mg/kg/day (close to the human NHC exposure at the RHD), or in a 1-month toxicity study in mice up to 2,000 mg/kg/day (19 times the human NHC exposure at the RHD). Growth cartilage is not present in mature skeletons; therefore, the bone and cartilage findings are not relevant for adult humans. The clinical significance of these findings for paediatric patients is unknown.
Reversible, dose-related bone marrow toxicity affecting all haematopoietic cell lines was observed in dogs at ≥17mg/kg/day (less than the human NHC exposure at the recommended human dose (RHD)). Mild decreases in peripheral blood cell and platelet counts were seen after 7 days of Molnupiravir treatment progressing to more severe haematological changes after 14 days of treatment. Neither bone marrow nor haematological toxicity was observed in a 1-month toxicity study in mice up to 2,000 mg/kg/day (19 times the human NHC exposure at the RHD) and a 3-month toxicity study in rats up to 1,000 mg/kg/day (9 and 15 times the human NHC exposure at the RHD in females and males, respectively).
Microbiology: Antiviral Activity: NHC (nucleoside analogue metabolite of molnupiravir) was active in cell culture assays against SARS-CoV-2 with 50% effective concentrations (EC50) ranging between 0.67 to 2.66 μM in A549 cells and 0.32 to 2.03 μM in Vero E6 cells. NHC had similar activity against SARS-CoV-2 variants B.1.1.7 (Alpha), B.1351 (Beta), P.1 (Gamma),and B.1.617.2 (Delta) with EC50 values of 1.59, 1.77 and 1.32 and 1.68 μM, respectively. No impact was observed on the in vitro antiviral activity of NHC against SARS-CoV-2 when NHC was tested in combination with remdesivir.
Resistance: No amino acid substitutions in SARS-CoV-2 associated with resistance to NHC have been identified in Phase 2 clinical trials evaluating molnupiravir for the treatment of COVID-19. Studies to evaluate selection of resistance to NHC with SARS-CoV-2 in cell culture have not been completed. Studies have been conducted to detect drug resistance in other coronavirus, including MHV and MERS-CoV have found that it is less likely that the infection has developed drug resistance to the NHC. After 30 passages of cell cultures showed only 2 times reduced sensitivity and no changes in NHC-resistant amino acids were observed in cultured cells, NHC continued to have antiviral activity by replacing polymerase enzymes (nsp 12) such as F480L, V557L, and E802D, among others, in which these enzymes contributed to a decrease in sensitivity to remdesivir. Such data therefore indicates that there is no cross-resistance.
In clinical studies the sequence of amino acids changes (with substitutions that disappear or increase) is detected more often. In the entire genetic sequence of the virus from the group of patients treated with molnupiravir compared to the placebo group, a number of patients experienced changes in the amino acids directly, the spike proteins of the virus in the target site of action of the drug in the monoclonal antibodies and vaccines group. It is not yet known how the changes affect the public health system.
SARS-CoV-2 antiviral activity in laboratory animal models: The SARS-CoV-2 antiviral activity of molnupiravir was demonstrated in mouse, hamster, and ferret models infected with SARS-CoV-2 virus when administered within 1-2 days of infection with the virus. In ferrets infected with the SARS-CoV-2 virus, molnupiravir significantly reduces the SARS-CoV-2 virus titers in the upper respiratory tract significantly and 100% inhibits the spread of the virus to untreated laboratory animals. In Syrian strains of hamsters infected with SARS-CoV-2 virus, molnupiravir reduces viral RNA and viral titers in the lungs of laboratory animals. Analysis of the microbiology of lung tissue from biopsy after infection revealed a significant decrease in the level of SARS-CoV-2 viral antigen. Previously damaged lesions of the lungs were significantly reduced in the Laboratory animals treated with molnupiravir compared with the control group.
Cytotoxicity from in vitro studies: NHC (nucleoside metabolite analogue of molnupiravir) has cytotoxicity to many mammalian cells. Concentrations that can inhibit cell survival by 50% (CC50) range from 7.5 μM (human lymphoid CEM cell line) to >100 μM. From the trial, administered for 3 days, molnupiravir also suppresses the proliferation of progenitor cells from the human bone marrow with CC50 values equal > to 24.9 μM for the growth of prototype cells in the erythroid phase and 7.7 μM for the growth of prototype cells in the myeloid phase based on colony formation assays, the number of colonies that occur after incubation is counted for 14 days.

Molnupiravir has provisional approval for the treatment of adults with COVID 19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death [see Dosage & Administration and Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions].

Posology: Adults: The recommended dose of Molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food [see Pharmacology: Pharmacokinetics under Actions]. Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset [see Pharmacology: Pharmacodynamics: Clinical efficacy and safety under Actions].
Take the drug for 5 consecutive days of the course of treatment and continue quarantine in accordance with public health advice. To eliminate the virus as much as possible and reduce the spread of infection SARS-CoV-2.
Restrictions on Use: The safety and efficacy of Molnupiravir when administered for periods longer than 5 days have not been established.
Molnupiravir not to be used in the case of before or after exposure to prevent COVID-19.
Molnupiravir not to be used in the case of any indication other than the treatment of COVID-19.
Missed dose: If the patient misses a dose of Molnupiravir within 10 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
In the event that the patient has to be hospitalized due to COVID-19 with severe or critical condition after starting treatment with Laquefrio Patients should receive the drug for the full 5-day course of treatment, at the discretion of their healthcare provider.
Patient group selection: The following medical conditions or other factors put adult patients 18 years of age or older at higher risk of progression to COVID-19 with severe symptoms: Age >60 years; Active cancer (This excludes non-invasive cancers that are not associated with immunosuppression or significant morbidity/mortality [e.g. melanoma basal cell carcinomas]); Chronic kidney disease (This does not include patients requiring dialysis or those with a decrease in eGFR <30ml/min/1.73 m² [see Pharmacology: Pharmacokinetics under Actions]); Chronic obstructive pulmonary disease; Obesity (BMI ≥ 30 kg/m²); Severe heart conditions, including congestive heart failure, coronary artery disease or cardiomyopathies; Diabetes.
Special populations: Elderly: No dose adjustment is recommended for geriatric patients.
Renal impairment: No dose adjustment is required for patients with renal impairment [see Pharmacology: Pharmacokinetics under Actions].
Hepatic impairment: No dose adjustment is required for patients with hepatic impairment [see Pharmacology: Pharmacokinetics under Actions].
Paediatric population: Molnupiravir is not approved for use in pediatric patients under 18 years of age.
From repeated drug toxicity studies with a period of 3 months in rats bone and cartilage toxicity was found. The safety and efficacy of molnupiravir in pediatric patients have not been studied. [See Use in Children: Bones and cartilage toxicity under Precautions and Pharmacology: Toxicology: Preclinical safety data under Actions.]
Method of administration: For oral use.
Molnupiravir 200 mg capsules can be taken with or without food.
The capsules should be swallowed whole with a sufficient amount of fluid (e.g., a glass of water). The capsules should not be opened, crushed or chewed.

There is no human experience of overdosage with Molnupiravir. Treatment of overdose with Molnupiravir should consist of general supportive measures including the monitoring of the clinical status of the patient. Haemodialysis is not expected to result in effective elimination of NHC.

Hypersensitivity to the active substance (molnupiravir) or to any of the excipients listed in Description.

Clinical data on the use of molnupiravir are limited. Serious adverse events or previously unknown adverse events that have not been reported with the use of molnupiravir may occur.
The occurrence of hypersensitivity, including severe acute intolerance to the drug (anaphylaxis), hypersensitivity, including severe acute intolerance, has been reported. Anaphylaxis from molnupiravir if the patient experience signs or symptoms of hypersensitivity or acute severe allergic reaction to the drug. If there is clinically significant anaphylaxis, discontinue molnupiravir immediately and institute drug and/or supportive therapy.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed
Use in Pregnancy: Embryo-fetal toxicity: Based on data found in animal fertility studies, molnupiravir can cause fetal harm when administered to pregnant women. There are no data on the use of molnupiravir in pregnant women to assess the risk of congenital malformations, miscarriage or problems that are unfavorable to the mother and the fetus. Therefore, molnupiravir is not recommended for use during pregnancy. If molnupiravir is considered to be administered to pregnant women, the prescribing physician must communicate the benefits and risks of using molnupiravir during pregnancy. Molnupiravir is approved for use in pregnant women only if the benefit is determined by the physician to outweigh the risks for a specific patient outcome. If it is decided to use molnupiravir during pregnancy, the prescribing physician must have documentation that explains the benefits and risks of using molnupiravir during pregnancy to the pregnant woman.
Advise those of childbearing age to the risks to the baby and to use effective methods of contraception (use properly and regularly) during treatment up to 4 days after the last dose of molnupiravir.
Prior to initiating molnupiravir therapy, assess whether individuals of childbearing age are individualized if clinically indicated. It is not necessary to confirm pregnancy status in patients undergoing permanent vasectomy. People who are using an IUD or using contraceptives implanted under the skin including those who are unable to become pregnant. Other patients with normal menstrual cycles, assess whether the patient is pregnant or not from the first day of the last menstruation. People who use effective methods of contraception (use correctly and regularly) or have a negative pregnancy test, patients with irregular menstrual cycles or unsure of when the first day of their last menstruation was or did not use effective methods of contraception (use properly and consistently). Pregnancy test kits are recommended.
Use in Children: Bones and cartilage toxicity: Molnupiravir is not approved for use in pediatric patients under 18 years of age because the drug may affect bone and cartilage growth. Bone and cartilage toxicity was found in rats after repeated dosing [see Pharmacology: Toxicology: Preclinical safety data: Toxicology and/or Pharmacology in Laboratory Animals under Actions]. The safety and efficacy of molnupiravir in pediatric patients have not been studied.

Pregnancy: Risks in summary: Based on data on laboratory animals Molnupiravir may cause harm to infants when administered in pregnant women, but there is no data on the use of molnupiravir in pregnant women to assess the risk of birth defects. Therefore, molnupiravir is not recommended during pregnancy. Based on the information found in reproductive studies in laboratory animals, oral administration of molnupiravir to pregnant rats at the period of organogenesis were found the death of embryo and teratogenesis when given NHC at a dose 8 times the recommended dose in humans. Decreased foetal body weights at a dose 3 times the recommended dose in humans.
Oral administration of molnupiravir to pregnant rabbits during the period of organogenesis showed that the weight of the embryo decreased when receiving the NHC at a dose of 18 times the recommended dose in humans. If it is determined that molnupiravir must be administered in pregnant women, the prescribing physician must communicate the benefits and risks of molnupiravir during pregnancy to the pregnant woman. Only if the doctor determines that the benefits outweigh the risks for a particular patient. If it is decided to take molnupiravir in women during pregnancy, the prescribing physician must have a document explaining the benefits and risks of molnupiravir during pregnancy to the pregnant woman. However, there are other risks to mothers and fetuses in pregnant women who have not been treated for COVID-19 (see Clinical considerations as follows).
The likelihood of birth defects and miscarriages in general is still unknown. In general, all pregnant women are at risk of developing birth defects. The chances of birth defects and general miscarriages in the U.S. pregnant population are 2-4 percent and 15-20 percent, respectively.
Clinical considerations: Diseases associated with maternal and/or fetal risks: Pregnant women with COVID-19 is associated with problems in mothers and foetuses such as preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and infant death in the womb.
Data: Data in animals: In an embryofoetal development (EFD) study in rats, Molnupiravir was administered orally to pregnant rats at 0, 100, 250 or 500 mg/kg/day from gestation days (GDs) 6 to 17. Molnupiravir was also administered orally to pregnant rats at up to 1,000 mg/kg/day from GDs 6 to 17 in a preliminary EFD study. Developmental toxicities included post-implantation losses, malformations of the eye, kidney, and axial skeleton, and rib variations at 1,000 mg/kg/day (8 times the human NHC exposure at the RHD) and decreased foetal body weights and delayed ossification at ≥500 mg/kg/day (3 times the human NHC exposure at the RHD). There were no developmental toxicities at ≤250 mg/kg/day (less than the human NHC exposure at the RHD). Maternal toxicities included decreased food consumption and body weight losses, resulting in the early sacrifice of individual animals at 1,000 mg/kg/day, and decreased body weight gain at 500 mg/kg/day.
In an EFD study in rabbits, Molnupiravir was administered orally to pregnant rabbits at 0, 125, 400, or 750 mg/kg/day from GDs 7 to 19. Developmental toxicity was limited to reduced foetal body weights at 750 mg/kg/day (18 times the human NHC exposures at the RHD). There was no developmental toxicity at ≤400 mg/kg/day (7 times the human NHC exposures at the RHD). Maternal toxicities included reduced food consumption and body weight gains, and abnormal faecal output at 750 mg/kg/day.
In a pre- and post-natal developmental study, molnupiravir was administered orally to female rats at doses up to 500 mg/kg/day (close to the human NHC exposure at the RHD) from gestation day (GD) 6 through lactation day 20. No effects were observed in offspring.
Breast-feeding: Risks in summary: It is unknown whether Molnupiravir or its metabolites are present in human milk. NHC was detected in the plasma of nursing pups from lactating rats administered molnupiravir. It is unknown whether molnupiravir affect human milk production, or have effect on the breastfed infant.
Based on the potential for adverse reactions on the infant from Molnupiravir. Therefore, it is recommended to refrain from breastfeeding during treatment with molnupiravir until 4 days after receiving the last dose. In some cases, breastfeeding may be considered to stop breastfeeding while discarding pumped milk during treatment with molnupiravir until 4 days after receiving the final dose.
Data: Studies of embryo development either prenatal or postpartum, molnupiravir was administered to lactating rats at ≥250 mg/kg/day, NHC was detected in plasma of nursing pups.
Fertility: Females and males who are childbearing: From animal studies molnupiravir can cause harm to the baby when administered in pregnant women.
Pregnancy Tests: Before starting treatment with molnupiravir, evaluate whether a person of childbearing age is pregnant, in the case of clinical indications.
Birth control: Female: Women of childbearing age are advised to use effective contraceptive methods (used correctly and regularly) during treatment up to 4 days after receiving the last dose of molnupiravir.
Male: Despite the low risk, nonclinical studies evaluating the effects on children of men treated with molnupiravir have not been completed. It is recommended to those who have sex with women of childbearing age to use effective contraceptive methods (use correctly and regularly). The risk is still unknown after receiving the last dose of molnupiravir for 3 months due to the ongoing project.
As a result of tests, in vivo mutations of molnupiravir give unclear results at first (no clear positive or negative results are shown). The analysis of reticulocytes and the number of red blood cells reflects the initial impact on hematopoietic stem cells derived from the bone marrow. When the second assessment was conducted by testing in vivo mutations in the liver (somatic cells and stem cells) of transgenic rats with molnupiravir for 28 days, it was found that molnupiravir does not cause mutations, in contrast to somatic cells. Genetic information can be passed on to the cub generation. The study plan, which will study the germ cells of the testes of male rats undergoing gene modified, will evaluate the feasibility of molnupiravir whether it will affect the offspring generation of men treated with molnupiravir.

Adverse reactions observed in clinical studies: The following adverse reactions are adverse reactions found in clinical studies of molnupiravir to support emergency use. It can be directly compared with the incidence of adverse reactions in clinical trials of other drugs and may not reflect the incidence rates found in medical practice. Additional molnupiravir-associated adverse events may occur when the drug is widely used.
Overall, more than 900 subjects received molnupiravir at a dose of 800 mg twice daily in clinical studies. Initial evaluation of the safety of molnupiravir by monitoring and analysis subjects with COVID-19 and were not hospitalized over a 29-day period in the Phase 3 study (MOVe-OUT).
The safety of molnupiravir was assessed based on a randomized and double-blind trial, Phase 3 (MOVe-OUT) in 1,411 covid-19 and non-hospitalized subjects, randomized with 710 to receive molnupiravir or 701 to placebo for a period of up to 5 days, with adverse reactions similar to those reported during treatment up to 14 days after receiving the final dose from the completed/discontinued intervention study.
Intervention studies that ended due to adverse reactions found 1 percent in the group of subjects who received molnupiravir and 3 percent in the placebo group, while 7 percent of serious adverse reactions were found in the group of subjects who received molnupiravir and 10 percent in the placebo group, with the most common serious adverse reactions associated with COVID-19. Two death-causing adverse reactions (<1%) were observed in the subject group who received molnupiravir and 12 (2%) in the placebo group.
The most common adverse reactions among those receiving molnupiravir from the MOVe-OUT study are shown in Table 3, with the severity of these symptoms being grade 1 (mild symptoms) or Grade 2 (moderate symptoms). (See Table 3.)

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Abnormal laboratory results: Abnormal laboratory results in Grade 3 and 4 of biochemical parameter values (i.e., alanine aminotransferase, aspartate aminotransferase, creatinine, and lipase) and parameters from hematological examinations (including hemoglobin, platelets, and leukocytes) were all found at a rate of ≤2 percent and similar in both groups of the MOVe-OUT study.
Post-marketing Experience: The following adverse reactions occur during the use of molnupiravir after the drug is approved. These adverse reactions were reported voluntarily from an unknown population. Therefore, it cannot be estimated frequency, or it is not reliably conclude a causal relationship with drug exposure.
Immune system Disorders: Hypersensitivity, anaphylaxis, angioedema.
Skin and subcutaneous tissue disorders: Erythema, rash, urticaria.

Based on limited information available under the license of molnupiravir products in emergency situations, no drug interactions were found. There have been no studies on the interaction between molnupiravir and other drugs or in combination with other treatments for the treatment of mild to moderate symptoms of COVID-19 [see Pharmacology: Pharmacokinetics under Actions].
Drug interaction studies: The results from in vitro studies indicate that both molnupiravir and NHC are not inhibitors of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4, as well as non-inhibitors of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2K, MRP2, MDR1, and BCRP. It does not induce CYP1A2, 2B6, and 3A4 enzymes. However, drug interaction has not been evaluated in combination with molnupiravir or in combination with other treatments for the treatment of mild to moderate symptoms of COVID-19.

Incompatibilities: None.
Special precautions for disposal and other handling: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store below 30°C.
Shelf-life: 24 months.

Antivirals

J05AB - Nucleosides and nucleotides excl. reverse transcriptase inhibitors ; Used in the systemic treatment of viral infections.

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