Contraindications : התוויות נגד

4      CONTRAINDICATIONS
LEXIVA is contraindicated:
• in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome) to any of the components of this product or to amprenavir.
• when coadministered with drugs that are highly dependent on cytochrome P450 3A4 (CYP3A4) for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (Table 1).

Table 1. Drugs Contraindicated with LEXIVA (Information in the table applies to LEXIVA with or without ritonavir, unless otherwise indicated.)
Drug Class/Drug Name                          Clinical Comment
Alpha 1-adrenoreceptor            Potentially increased alfuzosin concentrations can antagonists:                      result in hypotension.
Alfuzosin
Antiarrhythmics:                  POTENTIAL for serious and/or life-threatening Flecainide, propafenone           reactions such as cardiac arrhythmias secondary to increases in plasma concentrations of antiarrhythmics if LEXIVA is co-prescribed with ritonavir.
Antimycobacterials:               May lead to loss of virologic response and possible a
Rifampin                          resistance to LEXIVA or to the class of protease inhibitors.
Antipsychotics:                   POTENTIAL for serious and/or life-threatening Lurasidone                        reactions if LEXIVA is co-administered with ritonavir.


Antipsychotics:                    POTENTIAL for serious and/or life-threatening Pimozide                           reactions such as cardiac arrhythmias.



Ergot derivatives:                     POTENTIAL for serious and/or life-threatening Dihydroergotamine, ergonovine,         reactions such as acute ergot toxicity characterized ergotamine, methylergonovine           by peripheral vasospasm and ischemia of the extremities and other tissues.
GI motility agents:                    POTENTIAL for serious and/or life-threatening Cisapride                              reactions such as cardiac arrhythmias.
Herbal products:                       May lead to loss of virologic response and possible St. John’s wort (Hypericum             resistance to LEXIVA or to the class of protease perforatum)                            inhibitors.
HMG CoA-reductase inhibitors:          POTENTIAL for serious reactions such as risk of Lovastatin, simvastatin                myopathy including rhabdomyolysis.
Non-nucleoside reverse                 May lead to loss of virologic response and possible transcriptase inhibitor:               resistance to delavirdine.
Delavirdinea
PDE5 inhibitors:                    A safe and effective dose has not been established Sildenafil (REVATIO) (for           when used with LEXIVA. There is increased treatment of pulmonary arterial     potential for sildenafil-associated adverse events hypertension)                       (which include visual disturbances, hypotension, prolonged erection, and syncope).
Sedative/hypnotics:                POTENTIAL for serious and/or life-threatening Midazolam, triazolam               reactions such as prolonged or increased sedation or respiratory depression.
a
See Clinical Pharmacology (11.2) Tables 8, 9, 10, or 11 for magnitude of interaction.
• when coadministered with ritonavir in patients receiving the antiarrhythmic agents, flecainide and propafenone. If LEXIVA is coadministered with ritonavir, reference should be made to the full prescribing information for ritonavir for additional contraindications.