Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom
Lagevrio is indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness (see sections 4.2 and 5.1 for information on posology and limits of clinical trial population).
The recommended dose of Lagevrio is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days.
The safety and efficacy of molnupiravir when administered for periods longer than 5 days have not been established (see section 5.1).
Lagevrio should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset (see section 5.1).
If the patient misses a dose of Lagevrio 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.
No dose adjustment of Lagevrio is required based on age (see section 5.2).
No dose adjustment is required for patients with renal impairment (see section 5.2).
No dose adjustment is required for patients with hepatic impairment (see section 5.2).
The safety and efficacy of Lagevrio in patients below 18 years of age have not been established. No data are available (see section 5.1).
For oral use.
Lagevrio 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.
There is no human experience of overdosage with Lagevrio. Treatment of overdose with Lagevrio 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.
18 months.
This medicinal product does not require any special storage conditions.
Store in the original package.
High-density polyethylene (HDPE) bottles with a polypropylene closure containing 40 capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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