Contraindications : התוויות נגד

4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. listed in section 6.1 
Patients with severe (Child-Pugh Class C) hepatic impairment.

Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).

-   Applicable to darunavir boosted with ritonavir
-   The combination product lopinavir/ritonavir (see section 4.5).
-   Strong CYP3A inducers such as rifampicin and herbal preparations containing St John’s Wort (Hypericum perforatum). Co-administration is expected to reduce plasma concentrations of darunavir, ritonavir, which could lead to loss of therapeutic effect and possible development of resistance (see sections 4.4 and 4.5).

Darunavir boosted with ritonavir inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the co-administered medicinal product. Therefore, concomitant treatment with such medicinal products for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated (applies to darunavir boosted with ritonavir). These active substances include e.g.:
- alfuzosin
- amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine, astemizole, terfenadine
- colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - elbasvir/grazoprevir
- cisapride
-      dapoxetine
-      domperidone
-      naloxegol
- lurasidone, pimozide, quetiapine, sertindole (see section 4.5)
- triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)
- sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin and lomitapide) (see section 4.5)
- dabigatran, ticagrelor (see section 4.5).