Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen (see sections 4.4 and 5.1).
Rukobia should be prescribed by physicians experienced in the management of HIV infection.
The recommended dose is 600 mg of fostemsavir twice daily.
If the patient misses a dose of fostemsavir, the patient should take the missed dose as soon as the patient remembers, unless it is almost time for the next dose. In this case, the missed dose should be skipped and the next dose should be taken according to the regular schedule. The patient should not take a double dose to make up for the forgotten dose.
No dosage adjustment is required (see sections 4.4 and 5.2).
No dosage adjustment is required for patients with renal impairment or those on haemodialysis (see section 5.2).
No dosage adjustment is required in patients with hepatic impairment (see section 5.2).
The safety and efficacy of fostemsavir in children and adolescents aged less than 18 years have not yet been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Oral use.
Fostemsavir can be taken with or without food (see section 5.2). The prolonged-release tablet should be swallowed whole with water, and not chewed, crushed or split.
There is no specific treatment for overdose with fostemsavir. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given appropriate symptomatic treatment. Standard supportive measures should be applied as required, including monitoring of vital signs as well as observation of the clinical status of the patient. As temsavir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
3 years.
This medicinal product does not require any special storage conditions.
White high density polyethylene (HDPE) bottles with polypropylene child resistant closures that include a polyethylene faced induction heat seal liner. Each pack consists of one or three bottles, each containing 60 prolonged-release tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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