Posology : מינונים

2        DOSAGE AND ADMINISTRATION

2.1 General Dosing Information
LEXIVA tablets may be taken with or without food.
Higher-than-approved dose combinations of LEXIVA plus ritonavir are not recommended due to an increased risk of transaminase elevations [see Overdosage (9)].
When LEXIVA is used in combination with ritonavir, prescribers should consult the full prescribing information for ritonavir.
2.2      Adults
Therapy-Naive Adults
• LEXIVA 1,400 mg twice daily (without ritonavir).
• LEXIVA 1,400 mg once daily plus ritonavir 200 mg once daily.
• LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily.
o Dosing of LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily is supported by pharmacokinetic data [see Clinical Pharmacology (11.2)].
• LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
o Dosing of LEXIVA 700 mg twice daily plus 100 mg ritonavir twice daily is supported by pharmacokinetic and safety data [see Clinical Pharmacology (11.2)].
Protease Inhibitor-Experienced Adults:
• LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.
2.3 Patients with Hepatic Impairment
See Clinical Pharmacology (11.2).
Unboosted (without ritonavir)
Mild to Moderate Hepatic Impairment (Child-Pugh Score Ranging from 5 to 9) LEXIVA tablets should be used with caution at a reduced dosage of 700 mg twice daily in therapy-naïve patients.
Severe Hepatic Impairment (Child-Pugh Score Ranging from 10 to 15)
LEXIVA tablets should not be used in patients with severe hepatic impairment because adequate dosage reduction cannot be achieved.

Boosted (with ritonavir)
Mild Hepatic Impairment (Child-Pugh Score Ranging from 5 to 6)
LEXIVA should be used with caution and at a reduced dosage of 700 mg twice daily with 100 mg ritonavir once daily (therapy-naïve or protease inhibitor-experienced patients).
Moderate Hepatic Impairment (Child-Pugh Score Ranging from 7 to 9)
LEXIVA tablets should not be used with ritonavir in patients with moderate hepatic impairment because adequate dosage reduction cannot be achieved.
Severe Hepatic Impairment (Child-Pugh Score Ranging from 10 to 15)
LEXIVA tablets must not be used with ritonavir in patients with severe hepatic impairment because adequate dosage reduction cannot be achieved.