Human medicines European public assessment report (EPAR): Entecavir Viatris (previously Entecavir Mylan), entecavir, Date of authorisation: 18/09/2017, Revision: 7, Status: Authorised
Entecavir Mylan can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg). Treatment with Entecavir Mylan should be started by a doctor with experience in the management of chronic hepatitis B.
Entecavir Mylan is taken once a day. For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Mylan (a nucleoside analogue, such as lamivudine). Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose. The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal. The treatment duration is determined by how the patient responds.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
When treatment is considered appropriate in children, the dose depends on their body weight. Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir should be used for children weighing less than 32.6 kg. For further information, see the package leaflet.
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