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Oral treatments for COVID-19 – Prescribing information for GPs

Lagevrio (molnupiravir)

Adults who have mild to moderate COVID-19 confirmed by a PCR or medically verified RAT and who can start treatment within five days of symptom onset, can be prescribed PBS-subsidised Lagevrio if:

  • they are 70 years of age or older*
  • they are 50 years of age or older with two other risk factors for severe disease
  • they identify as Aboriginal or Torres Strait Islander origin, and are 30 years of age or older with one other risk factor for severe disease; or
  • they are 18 years of age or older and moderately to severely immunocompromised.
*in people aged 70 years of age and above treatment can be initiated as soon as possible after diagnosis is confirmed even if the patient is asymptomatic

Risk factors include:
  • living in residential aged care
  • living with disability with multiple conditions and/or frailty (but not limited to living in supported accommodation)
  • neurological conditions like stroke or dementia and demyelinating conditions e.g. multiple sclerosis, Guillain-Barre Syndrome
  • chronic respiratory conditions including COPD, moderate or severe asthma
  • obesity or diabetes (type I or II requiring medication)
  • congestive heart failure, coronary artery disease, cardiomyopathies
  • kidney failure or cirrhosis
  • living remotely with reduced access to higher level healthcare.
For people aged 18 years and older who are moderately to severely immunocompromised, conditions include:
  • blood cancer or some red blood cell disorders (thalassemia, sickle cell disease)
  • transplant recipient
  • primary or acquired (HIV) immunodeficiency
  • chemotherapy or whole-body radiotherapy in the last 3 months
  • high dose corticosteroids or pulse corticosteroid therapy in the last 3 months
  • immunosuppressive treatments in the last 3 months
  • rituximab in the last 12 months
  • cerebral palsy or down syndrome
  • congenital heart disease
  • living with disability with multiple conditions and/or frailty

When prescribing Lagevrio via the PBS, ensure the patient meets the eligibility criteria outlined on the PBS listing.

National Clinical Evidence Taskforce recommendations

The latest recommendation on the use of Lagevrio from the National Clinical Evidence Taskforce is ‘Do not routinely use molnupiravir for the treatment of COVID-19.’

The Taskforce has stated that there may be specific circumstances for the highest risk patients, where all other treatment options are contraindicated or inappropriate, in which non-routine use of Lagevrio might be considered. See the Taskforce’s rationale for the updated recommendations.
Please note that the PBS eligibility for Lagevrio is broader than the Taskforce recommendations.

The standard dose of Lagevrio is 800 mg (administered as four 200 mg capsules), taken every 12 hours for five days, with or without food.

Lagevrio should be taken regularly at the same time each day. If a dose is missed and it has been less than 10 hours since the last dose the patient can take it as soon as it is remembered. If it has been more than 10 hours since the missed dose this should be skipped, and the next dose taken at the scheduled time. A double dose should not be taken to make up for a missed dose. Patients should not stop taking Lagevrio without speaking to their GP or physician.

The capsules should not be opened, broken or crushed, and must be swallowed whole.

A person should not take Lagevrio if they are allergic to molnupiravir or any of the other ingredients listed in the product information, listed below.

Croscarmellose sodium Potassium hydroxide
Ethanol absolute Propylene glycol
Hyprolose Purified water
Hypromellose Shellac
Iron oxide red Strong ammonia solution
Isopropyl alcohol Tert-butyl alcohol
Magnesium stearate Titanium dioxide
Microcrystalline cellulose  

To date, there have been no medicine interactions identified with Lagevrio based on the limited data currently available.

Lagevrio is not recommended during pregnancy.

People of childbearing potential should use effective contraception for the duration of treatment and for four days after the last dose of Lagevrio. Men who are sexually active with a person of childbearing potential should use an effective contraception during treatment and for three months after treatment with Lagevrio.

Breastfeeding is not recommended during treatment and for four days after the last dose of Lagevrio.

The most common side effects of Lagevrio are diarrhoea, nausea and dizziness. These side effects can lead to significant morbidity in frail and elderly patients, including dehydration, delirium and increased falls risk. It is important older people who are administered Lagevrio are closely monitored. Patients should be advised to speak with their GP or prescribing physician if they are concerned about any side effects while taking the medication.

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