Adult: For the treatment of mild to moderate cases in nonhospitalised patients who are at high risk for progression to severe COVID-19 (including hospitalisation), and in whom alternative COVID-19 treatment options approved or authorised by the US Food and Drug Administration (US FDA) are inaccessible or not clinically appropriate: 800 mg 12 hourly for 5 days. Initiate therapy as soon as possible following diagnosis of COVID-19 and within 5 days of symptom onset. Safety and efficacy of therapy beyond 5 consecutive days have not been established. Missed dose: If a dose is missed within 10 hours of the time it is usually taken, take the missed dose as soon as possible then return to the normal dosing schedule. If the dose is missed by >10 hours, skip the missed dose and instead take the next dose at the usual dosing schedule. Do not double the dose to make up for a missed dose. Elderly: Same as adult dose. Child: <18 years Currently, the safety and efficacy of molnupiravir in children and adolescents have not been established; until such data are available, use in this age group is not recommended.
Administration
May be taken with or without food. Swallow whole & do not open/break/crush. For patients on NG/OG tube, may open cap & immediately administer mixt via their feeding tube. Consult product literature for specific instructions.
Reconstitution
Nasogastric (NG) or orogastric (OG) tube administration: Open the required number of caps and place the contents in a container with a lid. Mix the contents with 40 mL of water and shake the container thoroughly for 3 minutes. Contents of the cap may not completely dissolve and visible undissolved particulates are acceptable. Do not store the mixture for future use. Flush the NG/OG tube with 5 mL water before administration, then flush with 5 mL twice (10 mL total) after administering the mixture. Refer to detailed product guidelines for specific instructions on administration.
Contraindications
Hypersensitivity.
Special Precautions
Pregnancy and lactation; use only if potential benefits justify potential risks as there is limited data regarding the use of molnupiravir in pregnant and lactating women.
It should be noted that:
- Use of molnupiravir for the treatment of COVID-19 has not been fully established, some data are available from several initial clinical trials in the US and other countries.
- According to microbiological studies, β-D-N4-hydroxycytidine (NHC), the nucleoside analogue metabolite of molnupiravir, has shown cell culture antiviral activity against SARS-CoV-2 (USA-WA1/2020 isolate). Additionally, NHC exhibited similar antiviral activity against SARS-CoV-2 Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Lambda (C.37), Mu (B.1.621), and Omicron (B.1.1.529/BA.1, BA.1.1, BA.2, BA.4, and BA.5) variants. Data on the antiviral activity of molnupiravir evolve through time as clinical trials are being conducted continuously. For more information on the antiviral activity of molnupiravir, refer to the latest local guidelines.
- Molnupiravir may be available for use in some countries under emergency use authorisation (EUA) or conditional approval. Registration status and/or availability may vary between countries.
- The safety and efficacy of molnupiravir for the treatment of mild to moderate cases of COVID-19 continue to be evaluated. Preliminary clinical trial data showed that the use of molnupiravir early in the disease process when viral loads are high provided maximum benefit and reduced the risk of hospitalisation and/or death.
- Currently available COVID-19 treatment guidelines recommend limiting the use of molnupiravir to nonhospitalised patients with mild to moderate cases who are at high risk of progressing to severe COVID-19 (including hospitalisation) and are unable to use other preferred available medications. If the patient requires hospitalisation after treatment initiation, the remainder of the full 5-day treatment course may be completed at the discretion of the healthcare provider.
- Molnupiravir is not indicated for use as pre-exposure or post-exposure prophylaxis of COVID-19.
- Completion of the recommended full 5-day treatment course and continued isolation in accordance with the local public health guidelines are important to maximise viral clearance and minimise SARS-CoV-2 transmission.
For healthcare professionals:
- Refer to the local health authority for the most up-to-date information when prescribing molnupiravir.
- No specific drug-drug interaction data are available. Minimise any unnecessary co-medication whenever possible given the lack of information about interaction risk.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare providers to comply with certain regulations on the use of molnupiravir. Please refer to respective local regulatory agencies for further information.
Adverse Reactions
Significant: Hypersensitivity reactions, including anaphylaxis and angioedema. Gastrointestinal disorders: Nausea, diarrhoea, vomiting. Nervous system disorders: Dizziness, headache. Skin and subcutaneous tissue disorders: Rash, erythema, urticaria.
PO: Z (Animal studies showed reproductive and developmental toxicity. Not recommended during pregnancy.)
Patient Counseling Information
Women of childbearing potential must use a reliable birth control method during treatment and for 4 days after the last dose. Men with partners of childbearing potential must use a proven birth control method during treatment and for at least 3 months following the last dose. Breastfeeding is not recommended during treatment and for 4 days after the last dose; breastfeeding women may consider expressing and discarding breast milk during this time.
Monitoring Parameters
Verify pregnancy status before treatment initiation in women of childbearing potential if clinically indicated. Monitor for signs and symptoms of hypersensitivity reactions.
Action
Description: Mechanism of Action: Molnupiravir is an investigational antiviral prodrug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is hydrolysed during or after absorption to form the ribonucleoside analogue, β-D-N4-hydroxycytidine (NHC), which distributes into cells where it is further phosphorylated to the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporates into the RNA of SARS-CoV-2 by the viral RNA polymerase, resulting in the accumulation of errors in the viral genome and subsequent inhibition of viral replication. Pharmacokinetics: Absorption: Time to peak plasma concentration: NHC: 1.5 hours (range: 1-2 hours). Distribution: Volume of distribution: 142 L (NHC). NHC does not bind to plasma proteins. Metabolism: Metabolised to NHC, which undergoes further phosphorylation to form the pharmacologically active NHC-TP. Excretion: Via urine (≤3% as NHC). Elimination half-life: Approx 3.3 hours (NHC).
Chemical Structure
Molnupiravir Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 145996610, EIDD-2801. https://pubchem.ncbi.nlm.nih.gov/compound/eidd-2801. Accessed Feb. 22, 2022.
J05AB18 - molnupiravir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
References
Anon. Molnupiravir. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 03/03/2023.Anon. Molnupiravir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/03/2023.Buckingham R (ed). Molnupiravir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/03/2023.Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults. U.S. FDA. https://www.fda.gov. Accessed 09/02/2022.COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines: Molnupiravir. National Institutes of Health. https://www.covid19treatmentguidelines.nih.gov. Accessed 06/03/2023.EMA Issues Advice on Use of Lagevrio (Molnupiravir) for the Treatment of COVID-19. European Medicines Agency [online]. Accessed 08/02/2022.Fact Sheet for Healthcare Providers: Emergency Use Authorization for Lagevrio Capsules. U.S. FDA. https://www.fda.gov. Accessed 03/03/2023.Joint Formulary Committee. Molnupiravir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/03/2023.Lagevrio 200 mg Hard Capsule (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 03/03/2023.Lagevrio 200 mg Hard Capsules (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/03/2023.Lagevrio Capsule (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/03/2023.Molnupiravir. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 03/03/2023.
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