Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.
In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, coadministered with low dose ritonavir (see section 5.1).
Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with Aptivus (especially as regards the contraindications, warnings and undesirable effects sections).
Aptivus should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.
Adults and adolescents (from 12-18 years of age) The recommended dose of Aptivus is 500 mg, co-administered with 200 mg ritonavir (low dose ritonavir), twice daily (see section 4.4 for precautionary measures in adolescents).
Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination. Since currently only limited efficacy and safety data are available for adolescents (see section 5.1) close monitoring of virologic response and tolerance is particularly warranted in this patient group.
Patients should be advised of the need to take Aptivus and ritonavir every day as prescribed. If a dose is missed by more than 5 hours, the patient should be instructed to wait and then to take the next dose of Aptivus and ritonavir at the regularly scheduled time. If a dose is missed by less than 5 hours, the patient should be instructed to take the missed dose immediately, and then to take the next dose of Aptivus and ritonavir at the regularly scheduled time.
Clinical studies of Aptivus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects (see section 5.2). In general, caution should be exercised in the administration and monitoring of Aptivus in older people reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy (see section 4.4).
Tipranavir is metabolised by the hepatic system. Liver impairment could therefore result in an increase of tipranavir exposure and a worsening of its safety profile. Therefore, Aptivus should be used with caution, and with increased monitoring frequency, in patients with mild hepatic impairment (ChildPugh Class A). Aptivus is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic impairment (see sections 4.3, 4.4 and 5.2).
No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
The safety and efficacy of Aptivus capsules in children aged 2 to 12 years has not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Also, appropriate dose adjustments for children under 12 years cannot be achieved with Aptivus capsules. Aptivus oral solution is available for children between 2 and 12 years of age (please refer to the respective SmPC for further details).
The safety and efficacy of Aptivus in children under 2 years of age has not been established. No data are available.
Oral use.
Aptivus soft capsules co-administered with low dose ritonavir should be taken with food (see section 5.2).
Human experience with tipranavir overdose is very limited. No specific signs and symptoms of overdose are known. Generally, an increased frequency and higher severity of adverse reactions may result from overdose.
There is no known antidote for tipranavir overdose. Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. If indicated, elimination of unabsorbed tipranavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid in removal of unabsorbed substance. Since tipranavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.
Shelf life: 3 years.
In use storage: 60 days (below 25°C), after first opening of the bottle. It is advisable that the patient writes the date of opening the bottle on the label and/or carton.
Store in a refrigerator (2°C-8°C).
High density polyethylene (HDPE) bottle with two-piece child-resistant closure (outer and inner shell polypropylene, with a pulpboard/aluminium liner). Each bottle contains 120 soft capsules.
No special requirements.
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