CIPMOLNU 200 Capsules (Molnupiravir)

Table of Content

CIPMOLNU 200 Capsules (Molnupiravir)

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). NHC-TP 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. Molnupiravir has received restricted emergency use approval from the CDSCO for the treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death.

Molnupiravir 800 mg (four 200 mg CIPMOLNU capsules) should be taken twice daily with or without food for 5 days. In vitro data has suggested antiviral activity against SARS CoV-2. Phase 3 has shown relative risk reduction of hospitalization or death by 30%, greater improvement in WHO Clinical Progression Scale and consistent efficacy among SARS-CoV-2 variants (delta, gamma, and mu).

 

To be sold by retail only under prescription of medical specialists

1.Generic Name

Molnupiravir 200 mg Capsules

2.Brand Name

CIPMOLNU 200

3.Qualitative and Quantitative Composition

Each capsule contains Molnupiravir 200 mg

Approved colours shall be used in capsule shell

4.Dosage Form and Strength

Oral, Capsule 200 mg

5.Clinical Particulars

5.1Therapeutic Indication

Molnupiravir capsules are indicated for the treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death.

Limitations of Authorized Use

Molnupiravir is not authorized:

  • for use in patients less than 18 years of age
  • for initiation of treatment in patients requiring immediate hospitalization due to COVID-19 at that stage, (however, if it was initiated before hospitalization due to COVID 19, it may be continued).
  • for use for longer than 5 consecutive days.
  • for pre-exposure or post-exposure prophylaxis for prevention of COVID-19
  • for pregnant women
  • Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
  • Males of reproductive potential who are sexually active with females of child bearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose

5.2Posology and Method of Administration

Posology

Adults

The recommended dose of Molnupiravir is 800 mg (four 200 mg capsules) twice daily for 5 days.

The safety and efficacy of molnupiravir when administered for periods longer than 5 days have not been established.

Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.

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.

Special populations

Elderly

No dose adjustment of Molnupiravir is required based on age.

Renal Impairment

No dose adjustment is required for patients with renal impairment.

Hepatic Impairment

No dose adjustment is required for patients with hepatic impairment.

Pediatric Population

The safety and efficacy of Molnupiravir in patients below 18 years of age have not been established. No data are available.

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.

5.3Contraindications

Hypersensitivity to the active substance or to any of its excipients.

5.4Special Warnings and Precautions for Use

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially 'sodium-free'.

5.5Drugs Interactions

No drug interactions have been identified based on the limited available data. No clinical interaction studies have been performed with molnupiravir. Molnupiravir is hydrolysed to n-hydroxycytidine (NHC) prior to reaching systemic circulation. Uptake of NHC and metabolism to NHC-TP are mediated by the same pathways involved in endogenous pyrimidine metabolism. NHC is not a substrate of major drug metabolising enzymes or transporters. Based on in vitro studies, neither molnupiravir nor NHC are inhibitors or inducers of major drug metabolising enzymes or inhibitors of major drug transporters. Therefore, the potential for molnupiravir or NHC to interact with concomitant medications is considered unlikely.

5.6Use in Special Populations

Pregnancy

There are no data from the use of Molnupiravir in pregnant women. Studies in animals have shown reproductive toxicity.

Molnupiravir is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of Molnupiravir (molnupiravir).

Breast-feeding

It is unknown whether molnupiravir or any of the components of molnupiravir are present in human milk, affect human milk production, or have effect on the breastfed infant. Animal lactation studies with molnupiravir have not been conducted.

Based on the potential for adverse reactions on the infant from Molnupiravir, breast-feeding is not recommended during treatment and for 4 days after the last dose of Molnupiravir.

Fertility

There were no effects on female or male fertility in rats at NHC exposures approximately 2 and 6 times respectively, the exposure in humans at the recommended human dose (RHD).

Paediatric Patients

There is no administration experience in children. Safety and efficacy is not established in paediatric population.

5.7Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed

5.8Undesirable Effects

Summary of Safety Profile

In an interim analysis of a Phase 3 trial of subjects with mild to moderate COVID-19 treated with molnupiravir (n=386), the most common adverse reactions (≥1% of subjects) reported during treatment and during 14 days after the last dose were diarrhoea (3%), nausea (2%), dizziness (1%) and headache (1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

Tabulated list of adverse reactions

The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).

Table 1: Tabulated list of adverse reactions

Frequency

Adverse Reaction

Nervous system disorders

Common

dizziness, headache

Gastrointestinal disorders

Common

diarrhoea, nausea

Uncommon

vomiting

Skin and subcutaneous tissue disorders

Uncommon

rash, urticaria

Phase 3 Study being conducted in India

Safety profile in the interim analysis of the ongoing phase 3 clinical study titled ‘A Prospective, Randomized, Multicenter, open label, Parallel Group,  Phase III Trial to Evaluate Safety and Efficacy of Oral Molnupiravir as add on to Standard supportive Care for treatment of Mild Patients with COVID-19 Disease in a subset of 823  subjects was as follows:

  • Molnupiravir 800 mg orally twice daily for 5 days was generally well tolerated
  • Incidence of AE and drug related AE was comparable between Molnupiravir and Placebo arm
  • Only one SAE (in the placebo arm) was considered drug-related by the investigator and most SAEs were COVID-19 related
Table 2: Treatment Emergent Adverse Events

Parameter, n (%)

Molnupiravir + SOC (N = 363)

SOC (N = 367)

Abdominal pain

1 (0.3%)

0

Diarrhea

1 (0.3%)

0

Gastritis

3 (0.8%)

0

Nausea

4 (1.1%)

0

Chills

0

1 (0.3%)

Fatigue

1 (0.3%)

0

Malaise

2 (0.6%)

0

Pyrexia

3 (0.8%)

3 (0.8%)

COVID Pneumonia

0

1 (0.3%)

Sinusitis

1 (0.3%)

0

Muscle Spasm

0

2 (0.6%)

Myalgia

3 (0.8%)

0

Aguesia

1 (0.3%)

0

Headache

2 (0.6%)

1 (0.3%)

Sleep deficit

1 (0.3%)

0

Nephrolithiasis

0

1 (0.3%)

Cough

1 (0.3%)

0

Erythema

0

1 (0.3%)

Reporting of Suspected Adverse Reactions

If you experience any side effects, talk to your doctor or write to drugsafety@cipla.com.

By reporting side effects, you can help provide more information on the safety of this product. You can also report side effects directly via the National Pharmacovigilance Program of India (PvPI) by calling on 1800 180 3024 or you can report to Cipla Ltd on 1800 267 7779. By reporting side-effects, you can help provide more information on the safety of this product.

5.9Overdose

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

6.Pharmacological Properties

Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: not yet assigned.

6.1Mechanism 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). NHC-TP 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.

6.2Pharmacodynamic Properties

Antiviral Activity

NHC was active in cell culture assays against SARS-CoV-2 with 50% effective concentrations (EC50) ranging between 0.67 to 2.66 μM in A-549 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 abacavir, emtricitabine, hydroxychloroquine, lamivudine, nelfinavir, remdesivir, ribavirin, sofosbuvir, or tenofovir.

Pharmacodynamic Effects

The relationship between NHC and intracellular NHC-TP with antiviral efficacy has not been evaluated clinically.

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.

Clinical Efficacy and Safety

Clinical data are based on an interim analysis of data from 775 randomised subjects in the Phase 3 MOVe-OUT trial. MOVe-OUT was a randomised, placebo-controlled, double-blind clinical trial studying molnupiravir for the treatment of non-hospitalised patients with mild to moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalisation. Eligible subjects were 18 years of age and older and had one or more pre-defined risk factors for disease progression: 60 years of age or older, diabetes, obesity (BMI >30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. The study included symptomatic subjects not vaccinated against SARS-CoV-2 and who had laboratory confirmed SARS-CoV-2 infection and symptom onset within 5 days of enrolment. Subjects were randomised 1:1 to receive 800 mg of molnupiravir or placebo orally twice daily for 5 days.

At baseline, in all randomised subjects, the median age was 44 years (range: 18 to 88 years); 14% of subjects were 60 years of age or older and 3% were over 75 years of age; 52% of subjects were male; 52% were White, 6% Black or African American, 2% Asian; 58% were Hispanic or Latino. Forty-nine percent of subjects received molnupiravir or placebo within 3 days of COVID-19 symptom onset. The most common risk factors were obesity (77%), 60 years of age or older (14%), and diabetes (14%). Overall, baseline demographic and disease characteristics were well balanced between the treatment arms.

Clinical Outcome Summary

  • Molnupiravir significantly reduces the risk of hospitalization or death through Day 29
  • Nine of the 10 deaths through Day 29 occurred in the placebo group
  • Molnupiravir was associated with improved clinical outcomes based on self-reported COVID-19 signs/symptoms and WHO 11-point ordinal scale

Virological Response

Molnupiravir was associated with lower mean SARS-CoV-2 RNA at Days 3 and 5 compared with placebo.

Phase 2 study results demonstrated molnupiravir reduces percentage of participants with infectious virus compared to placebo and lead to increase in viral substitution consistent with proposed mechanism of action.

Table 3 provides the results of the primary endpoint (the percentage of subjects who were hospitalised or died through Day 29 due to any cause). Treatment with molnupiravir resulted in a 6.8 percentage point reduction in the risk of hospitalisation or death (approximately 50% relative risk reduction). All 8 subjects who died through Day 29 were in the placebo group and were hospitalised prior to their death.

Table 3: Interim Efficacy Results in Non-Hospitalised Adults with COVID-19

 

Molnupiravir

(N=385)

n (%)

Placebo

(N=377)

n (%)

Risk

difference*

(95% CI)

p-value

 

All-cause hospitalisation

or death through Day 29†

28 (7.3%)

53 (14.1%)

 

-6.8

(-11.3, -2.4)

0.0012

 

Hospitalisation

 

28 (7.3%)

52 (13.8%)

 

 

Death

0 (0%)

8 (2.1%)

 

 

Unknown‡

0 (0%)

1 (0.3%)

 

 

 

* Risk difference of molnupiravir-placebo based on Miettinen and Nurminen method stratified by

time of COVID-19 symptom onset (≤3 days vs. >3 days).

† Defined as ≥24 hours of acute care in a hospital or an acute care facility (e.g., emergency room).

‡ Subjects with unknown status at Day 29 are counted as having an outcome of all-cause

hospitalisation or death in the efficacy analysis.

Note: All subjects who died through Day 29 were hospitalised prior to death.

 

Efficacy results were consistent across sub-groups including age (>60 years), at risk medical conditions (e.g., obesity, diabetes) and SARS-CoV-2 variants.

Phase 3 Study being conducted in India

A Prospective, Randomized, Multicenter, open label, Parallel Group, compared to standard of care Phase III Trial to Evaluate Safety and Efficacy of Oral Molnupiravir as add on to Standard supportive Care for treatment in Mild Patients with COVID-19 Disease. This study plans to enroll 1218 patients.

Interim analysis was conducted when 75% subjects (411 in test arm vs. 412 in SOC arm) were enrolled. Analysis of 800 subjects is presented-

Interim results of 800 (app 75%) subjects till day 14 indicate significantly faster clinical improvement: Faster RT-PCR negativity, better symptomatic reduction per WHO scale, higher reduction in viral load, and reduction in inflammatory marker (CRP) e and with faster as well as higher reductions in the SARS-Cov-2 viral load, which is expected to translate into better clinical outcomes in due course of follow-up.

Primary endpoint; only 1 patient hospitalized in SOC arm

Secondary endpoints: RT-PCR Negativity-No Significant Difference was observed in High Risk Population except for D5 where 83.5% vs 77.8% subjects showed improvement with Molnupiravir

Table 4: Time to Clinical Improvement-Statistically significant difference at Day 5 and 10 was observed in both 1 point improvement and 2 point improvement on WHO cardinal scale in Molnupiravir arm.

Time to achieve at least one-point improvement in 11-Point ordinal scale by WHO

Time to achieve at least two-point improvement in 11-Point ordinal scale by WHO

Parameter

Molnupiravir 800 mg +SOC (N=406)

SOC (N=405)

Molnupiravir 800 mg +SOC (N=406)

SOC (N=405)

N

401

398

383

383

N1

5

7

23

22

Median time

5

5

6

9

95% CI for Median

(NE:NE)

(5:6)

(5:6)

(NE:NE)

Q1:Q3

5:9

5:10

5:10

5:13

p-value

<.0001

 

<.0001

 

  • Molnupiravir addition to SOC significantly reduces the viral load at D5 and D10 in overall population. In high risk group it shows numerical improvement
  • Relief of Specific Symptoms( fever, cough, loss of smell and loss of taste-Overall)- India study shows improvements in line with Merck Study
  • Molnupiravir Leads to Greater Reduction in the CRP values in Patients with High Baseline CRP

Pediatric Population

This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.

6.3Pharmacokinetic Properties

Molnupiravir is a 5´-isobutyrate prodrug that is hydrolysed to NHC prior to reaching systemic circulation. The pharmacokinetics of NHC are similar in healthy subjects and patients with COVID-19.

The pharmacokinetics of NHC at steady-state following administration of 800 mg molnupiravir every12 hours are provided below in Table 5.

Table 5: Pharmacokinetics of NHC after administration of 800mg Molnupiravir every 12 hours

NHC Geometric Mean (%CV)

AUC0-12hr (ng×hr/mL)*

Cmax (ng/mL) †

C12hr (ng/mL)*

 

8260 (41.0)

2970 (16.8)

31.1 (124)

 

%CV: Geometric coefficient of variation.

* Values were obtained from population PK analysis.

†Values were obtained from a Phase 1 study of healthy subjects.

Absorption

Following twice daily oral administration of 800 mg molnupiravir, the median time to peak plasma NHC concentrations (Tmax) was 1.5 hours.

Effect of Food on Oral Absorption

In healthy subjects, the administration of a single 200 mg dose of molnupiravir with a high-fat meal resulted in a 35% reduction in NHC peak concentrations (Cmax), AUC was not significantly affected.

Distribution

NHC does not bind to plasma proteins.

Elimination

The effective half-life of NHC is approximately 3.3 hours. The fraction of dose excreted as NHC in the urine was ≤3% in healthy participants.

Other Special Populations

Gender, Race, Age

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 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. No dose adjustment in patients with hepatic impairment is needed.

7.Nonclinical properties

7.1Animal Toxicology or Pharmacology

General Toxicity

Reversible, dose-related bone marrow toxicity affecting all haematopoietic cell lines was observed in dogs at ≥17 mg/kg/day (0.4 times 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 (9.3 and 15 times the human NHC exposure at the RHD in females and males, respectively).

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 (5.4 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 (4.2 and 7.8 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 (1.6 times 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.

Carcinogenesis

Carcinogenicity studies with molnupiravir have not been conducted.

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 and Big Blue® (cII Locus) transgenic rodent assay) molnupiravir did not induce increased mutation rates relative to untreated historical control animals, and therefore is not mutagenic in vivo. Molnupiravir was negative for induction of chromosomal damage in in vitro micronucleus (with and without metabolic activation) and in vivo rat micronucleus assays. Based on the totality of the genotoxicity data, molnupiravir is of low risk for genotoxicity or mutagenicity in clinical use.

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).

Development

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 (2.9 times the human NHC exposure at the RHD). There were no developmental toxicities at ≤250 mg/kg/day (0.8 times 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 onsumption and body weight gains, and abnormal faecal output at 750 mg/kg/day.

8.Description

Molnupiravir (also known as EIDD-2801/MK-4482) is a prodrug of the active antiviral ribonucleoside analog b-D-N4-hydroxycytidine (NHC; EIDD-1931).

EIDD-2801 is the isopropylester prodrug of . With improved oral bioavailability in non-human primates, it is hydrolyzed in vivo, and distributes into tissues where it becomes the active 5’-triphosphate form. The active drug incorporates into the genome of RNA viruses, leading to an accumulation of mutations known as viral error catastrophe. Recent studies have shown EIDD-2801 inhibits replication of human and bat coronaviruses, including SARS-CoV-2, in mice and human airway epithelial cells. A resistant mutant mouse hepatitis virus has also been shown to have increased sensitivity to N4-hydroxycytidine.

Molecular Formula: C13H19N3O7

Molecular Weight:  329.31 g/mol

Chemical name: oxolan-2-yl]methyl 2-methylpropanoate

9.Pharmaceutical Particulars

9.1Incompatibilities

Not applicable.

9.2Shelf-life

As on the pack.

9.3Packaging Information

CIPMOLNU 200 Capsules: Container pack of 40 capsules

9.4Storage and Handing Instructions

Store at a temperature not exceeding 30˚C.

Keep out of the reach of children.

10.Patient Counselling Information

This medicine is intended for adult patients only

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or health care provider
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms of illness are the same as yours.
  • If you get any side effects, talk to your doctor or health care provider. This includes any possible side effects not listed in this leaflet.

What is in this leaflet?

  1. What Molnupiravir is and what it is used for 
  2. What you need to know before you take Molnupiravir
  3. How to take Molnupiravir
  4. Possible side effects
  5. How to store Molnupiravir

1. What Molnupiravir is and what it is used for 

Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19

2. What you need to know before you use Molnupiravir

Do not take Molnupiravir:

  • Allergic to Molnupiravir or any of the ingredients. 

Before taking Molnupiravir, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Molnupiravir will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take Molnupiravir during pregnancy.
  • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Molnupiravir.
  • are breastfeeding or plan to breastfeed. It is not known if Molnupiravir passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Molnupiravir.

Tell your healthcare provider about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements.

Molnupiravir and other medicines may affect each other causing possible serious side effects. Molnupiravir may affect the way other medicines work, and other medicines may affect how Molnupiravir works.

Your healthcare provider can tell you if it is safe to take Molnupiravir with your other medicines. Do not start or stop any other medicines during treatment with Molnupiravir without talking to your healthcare provider first.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.

Driving and using machines

Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.

3. How to take Molnupiravir.

Always take this medicine exactly as your doctor has told you.  Do not change the dose or stop taking Molnupiravir without first talking to your healthcare provider.  Check with your doctor or health care provider if you are not sure.

How much to take

Your dose will be decided by your doctor and may depend on:

  • How well you respond to a dose
  • If you are taking some other medicines 
  • If you have kidney or liver problems.

The recommended dose of Molnupiravir is 800 mg (administered as 4 capsules of 200 mg) orally every 12 hours for 5 days as add on to standard supportive care

Taking this medicine

Swallow your tablet(s) whole with water. You should take your dose regularly every day at the same time of the day, so that it is easier to remember it.

If you take more Molnupiravir than you should

If you take more of this medicine than you should, contact your doctor immediately. Overdose with Molnupiravir has not been observed in the clinical trial setting.

If you forget to take Molnupiravir

Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose on the day after the missed dose. If you miss two or more doses, contact your doctor. 

If you stop taking Molnupiravir

If you stop taking this medicine you will lose the effects of the medicine. You should not stop this medicine unless told to do so by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or health care provider.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In an ongoing Phase 3 study of 386 patients with mild to moderate COVID-19, treated with molnupiravir, the most common adverse reactions reported during treatment and during 14 days after the last dose were diarrhoea, nausea, dizziness and headache all of which were mild or moderate.

Common (may affect upto 1 in 10 people)

  • dizziness
  • headache
  • diarrhoea
  • nausea

Uncommon (may affect upto 1 in 100 people)

  • vomiting
  • rash
  • hives

In an ongoing Phase 3 study being conducted by Dr. Reddy’s Laboratories Ltd, of 823 patients treated with Molnupiravir as add on to Standard supportive Care for treatment of Mild Patients with COVID-19 Disease, adverse reactions reported were

Uncommon (may affect upto 1 in 100 people)

  • nausea

Rare (may affect upto 1 in 1000 people)

  • eye irritation
  • abdominal pain
  • weakness
  • sinusitis
  • muscle pain
  • headache
  • cough
  • fever

5. How to store Molnupiravir

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and/or bottle after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering. Store in the original package.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

11.Details of Manufacturer

Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India

12.Details Of Permission or Licence Number with Date

MF-FF-ND-352/2021 dated 28 Dec 2021

13.Date of Revision

28/12/2021