molunamax

Early Management of COVID-19 in adult patients* with SpO2 > 93%

For Max Recovery

Viral RNA clearance

Reduces hospitalisation risk and mortality

Stops viral replication

Viral RNA clearance

Significantly reduces viral load compared to SOC1

Molnupiravir showed accelerated SARS- CoV-2 RNA clearance and elimination of infectious virus2
SOC: Standard of Care

Reduces risk of hospitalisation by 31% and mortality by 89% 3

Molnupiravir
6.8%
atients hospitalised
1 death

Placebo
9.7%
patients hospitalised
9 deaths

Stops viral replication4

Accumulation of errors in the viral genome leads to inhibition of viral replication


Treatment with Molnupiravir has shown

Greater reduction in mean viral load than placebo at day 3 & 5

Greater percentage of patients showed improved clinical outcome

Indian Data (71% of patients reported negative RT-PCR at day 5 compared to SOC)

Proven Safety


Dosage

  • 800 mg (4 * 200 mg capsules) twice daily for 5 days
  • Treatment not to be continued beyond 5 days (Not exceeding maximum total dose of 8000 mg)

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 childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.

Other COVID Products

Frequently Asked Questions

  • Monulamax 200 is an antiviral prodrug which has an activity against SARS Cov-2. It has a molecule called molnupiravir, which is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis and is the 5 ́-isobutyrate ester of the ribonucleoside analog N4- hydroxycytidine (NHC).

  • Monulamax metabolize the cytidine nucleoside analogue NHC, which distributes into cells where NHC is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporation (as NHC-monophosphate [NHC-MP]) into SARS-CoV-2 RNA by the viral RNA polymerase (nsp12) results in an accumulation of errors in the viral genome leading to inhibition of replication. The mechanism of action (known as viral error catastrophe or viral lethal mutagenesis) is supported by biochemical and cell culture data.

  • Each Capsule of Monulamax 200 contains Molnupiravir 200 mg. The other ingredients include Crospovidone, Povidone K-30, Microcrystalline cellulose, Colloidal silicon dioxide, Sodium stearyl fumarate.

  • The recommended dose of Monulamax 200 is as follows:
    • Adult - 800 mg (four 200 mg capsules) orally every 12 hours for 5 days, with or without food. Monulamax 200 should be administered as soon as possible and within 5 days of symptom onset.
    • Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2. The patient may complete the full 5-day treatment course as per the healthcare provider’s direction.
    • No dosage adjustment is recommended based on renal or hepatic impairment or in geriatric patients.
  • Monulamax 200 is recommended for the treatment of adult patients with COVID-19, with SpO2˃93% and who are at a high risk of progression of disease including hospitalization or death.

  • The use of Monulamax 200 is restricted in the following conditions:

    • Individuals less than 18 years of age
    • Pregnant women
    • As initial treatment in COVID-19 patients who require immediate hospitalization .
    • For use for longer than 5 consecutive days
    • For pre-exposure or post-exposure prophylaxis for prevention of COVID-19
    • 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 childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose
  • The healthcare providers must assess and recommend the following conditions prior to prescribing Monulamax 200:

    • Whether or not a female of childbearing potential is pregnant.
    • Whether an individual is above 18 years of age
    • Lactating women- Breastfeeding should be interrupted during treatment and for 4 days after the last dose of Monulamax 200
    • Use a reliable method of contraception correctly and consistently for females of childbearing potential

    The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events.

  • Diarrhea, nausea, and dizziness are the most common adverse reaction.

  • No contraindications have been identified based on the available data.

  • No drug interactions have been identified based on the available data.

  • There is no human experience of overdosage with Monulamax 200 so far. However, the treatment for overdose should consist of general supportive measures including the monitoring of the clinical status of the patient.

  • Studies did not show any difference in safety and tolerability between patients above 65 years of age and younger patients who were treated with molnupiravir.

    No dosage adjustment is recommended based on age. The PK of NHC is similar in geriatric patients compared to younger patients.

References

*who have at least one risk factor for developing severe illness.1. Data on File (CTR/2021/06/033992) 2. W.A.Fischer et al.,Sci.Transl.Med.10.1126/scitranslmed.abl7430(2021) 3. Bernal AJ et al. Molnupiravir for oral treatment of COVID-19 in non-hospitalized patients. N Engl J Med 2021 Dec 16 .doi: 10.1056/NEJmoa2116044 4. Singh AK, Singh A, Singh R and Misra A. Molnupiravir in COVID-19: A systematic Review of literature. Diabetes and Metabolic Syndrome: Clinical research and Reviews 2021;15,102329.