Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
This is a new medicine. Please report any side effects that you may experience with
this medicine. See the full CMI for further details.
1. Why am I taking LAGEVRIO?
LAGEVRIO contains the active ingredient molnupiravir. You are being given LAGEVRIO
for the treatment of coronavirus disease (COVID-19). LAGEVRIO may help you to feel
better and stay out of hospital. More information can be found in Section
1. Why am I taking LAGEVRIO? in the full CMI.
2. What should I know before I take LAGEVRIO?
Do not take LAGEVRIO if you have ever had an allergic reaction to molnupiravir or
any of the ingredients listed at the end of this CMI.
LAGEVRIO is not recommended in pregnancy. If there is a chance you might be pregnant, talk to your doctor about having a pregnancy
test prior to commencing LAGEVRIO. Use effective birth control while you are taking
LAGEVRIO and for 4 days after the last dose if there is a possibility of you getting
pregnant. If you are a male who is sexually active with a partner who has the potential
to become pregnant, use a reliable method of contraception during treatment and for
3 months after the last dose of LAGEVRIO.
Breastfeeding is not recommended during treatment and for 4 days after the last dose
of LAGEVRIO.
Talk to your doctor if you have any other medical conditions, take any other medicines,
have any allergies, or are pregnant or plan to become pregnant or are breastfeeding
or plan to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
4. How do I take LAGEVRIO?
Take LAGEVRIO exactly as your doctor tells you.
Take 4 capsules of LAGEVRIO every 12 hours (for example, at 8 am and at 8 pm).
Take LAGEVRIO for 5 days.
Take LAGEVRIO with or without food.
5. What should I know while taking LAGEVRIO?
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Things you should do
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Tell the doctor, dentist, or pharmacist you visit that you are taking LAGEVRIO.
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Things you should not do
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Do not stop taking this medicine without talking to your doctor first.
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Looking after your medicine
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Store LAGEVRIO in the original bottle in a cool dry place below 30°C, away from heat
or sunlight.
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6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and
temporary. Do not be alarmed by this list. You may not experience any of them. The
most common side effects (unintended or undesirable effects) of LAGEVRIO in adults
are diarrhoea, nausea, and dizziness. More information, including what to do if you
have any side effects, can be found in Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
molnupiravir
LAGEVRIO has provisional approval to treat COVID-19 in adults who are at increased risk for hospitalisation or death.
The decision to approve this medicine has been made on the basis of results of data
available at the time of provisional approval. More evidence is required to be submitted
when available to fully confirm the benefit and safety of LAGEVRIO for this use.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking LAGEVRIO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking LAGEVRIO.
Where to find information in this leaflet:
1. Why am I taking LAGEVRIO?
LAGEVRIO contains the active ingredient molnupiravir.
LAGEVRIO has provisional approval to treat COVID-19 in adults who are at increased
risk for hospitalisation or death.
The decision to approve this medicine has been made on the basis of results of data
available at the time of provisional approval. More evidence is required to be submitted
when available to fully confirm the benefit and safety of LAGEVRIO for this use.
LAGEVRIO is an antiviral drug that works against the virus that causes COVID-19.
You are being given LAGEVRIO for the treatment of coronavirus disease 2019 (COVID-19).
LAGEVRIO may help you to feel better and stay out of hospital.
What is COVID-19?
COVID-19 is caused by a virus called SARS CoV-2.
You can get COVID-19 through contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms)
to severe, including illness resulting in death. While information so far suggests
that most COVID-19 illness is mild, serious illness including breathing problems can
happen and may cause some of your other medical conditions to become worse.
Older people and people of all ages with severe, long lasting (chronic) medical conditions
like heart disease, lung disease, obesity, and diabetes, for example seem to be at
higher risk of being hospitalised for COVID-19.
What are the symptoms of COVID-19?
The symptoms of COVID-19 may include fever, cough, and shortness of breath.
2. What should I know before I take LAGEVRIO?
Do not take LAGEVRIO if:
You are allergic to molnupiravir, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can take this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have any allergies
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and Reproduction
Animal studies with molnupiravir have shown harmful effects to the unborn animal.
LAGEVRIO has not been studied in pregnancy in humans and it is not known if LAGEVRIO
will harm your baby while you are pregnant.
LAGEVRIO is not recommended in pregnancy. Discuss the need for a pregnancy test with
your doctor if you are of childbearing potential and sexually active.
Tell your doctor if you are pregnant or plan to become pregnant.
Use effective birth control while you are taking LAGEVRIO and for 4 days after the
last dose of LAGEVRIO if there is a possibility of you getting pregnant.
Animal studies have not shown effects on fertility. It is not known how LAGEVRIO may
affect sperm in humans. If you are a male who is sexually active with a partner who
has the potential to become pregnant, use a reliable method of contraception during
treatment and for 3 months after the last dose of LAGEVRIO.
Breastfeeding
It is not known if LAGEVRIO gets into breast milk and will be passed to the baby.
Tell your doctor if you are breastfeeding or plan to breastfeed before taking LAGEVRIO.
Breastfeeding is not recommended during treatment and for 4 days after the last dose
of LAGEVRIO.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
Some medicines may interfere with LAGEVRIO and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect LAGEVRIO.
4. How do I take LAGEVRIO?
How to take LAGEVRIO
Take LAGEVRIO exactly as your doctor tells you.
Take 4 capsules of LAGEVRIO every 12 hours (for example, at 8 am and at 8pm).
Take LAGEVRIO every day for 5 days.
Take LAGEVRIO with or without food.
If you forget to take LAGEVRIO
LAGEVRIO should be taken regularly at the same times each day. It is important that
you do not miss or skip doses of this medicine. What to do if you miss a dose?
If it has been less than 10 hours since the missed dose, take it as soon as you remember.
If it has been more than 10 hours since the missed dose, skip the missed dose and
take your dose at the next scheduled time.
Do not take a double dose to make up for the dose you missed. Call your doctor or
pharmacist if you are not sure what to do.
If you take too much LAGEVRIO
If you think that you have taken too much LAGEVRIO, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
call your doctor or pharmacist, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking LAGEVRIO?
Things you should do
Tell the doctor, dentist, or pharmacist you visit that you are taking LAGEVRIO and
follow their advice.
Things you should not do
Do not stop taking this medicine without talking to your doctor first.
Looking after your medicine
Follow the instructions on the carton on how to store your medicine properly.
Store LAGEVRIO in the original bottle in a cool dry place below 30°C, away from heat
or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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diarrhoea
nausea
vomiting
dizziness
itching
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Allergic reactions can happen in people taking LAGEVRIO, even after only 1 dose. Stop
taking LAGEVRIO and call your healthcare provider right away if you get any of the
following symptoms of an allergic reaction:
hives
rapid heartbeat
trouble swallowing or breathing
swelling of the mouth, lips or face
throat tightness
hoarseness
skin rash
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What LAGEVRIO contains
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Active ingredient
(main ingredient)
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Molnupiravir 200 mg
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
hyprolose
magnesium stearate
microcrystalline cellulose
purified water
Capsule shell:
hypromellose
iron oxide red
titanium dioxide
White ink on the capsule:
tert-butyl alcohol
ethanol absolute
isopropyl alcohol
potassium hydroxide
propylene glycol
purified water
shellac
strong ammonia solution
titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
What LAGEVRIO looks like
LAGEVRIO is supplied in a bottle containing 40 capsules.
LAGEVRIO is available as a Swedish Orange opaque capsule with corporate logo and “82”
printed with white ink for oral administration (AUST R 372650).
Who distributes LAGEVRIO
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113
This leaflet was prepared in October 2023
RCN: 000026043
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.