Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 19–20

HOS-134515 · Präparat HOS-097580

19 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration Pravastatin pravastatin AUC ↑ 81%¶ When administration of pravastatin 40 mg single dose pravastatin Cmin ND and darunavir co-administered with pravastatin Cmax ↑ 63% low dose ritonavir is required, it is ¶ an up to five-fold increase was seen in recommended to start with the a limited subset of subjects lowest possible dose of pravastatin and titrate up to the desired clinical effect while monitoring for safety. Rosuvastatin rosuvastatin AUC ↑ 48%║ When administration of rosuvastatin 10 mg once daily rosuvastatin Cmax ↑ 144%║ and darunavir co- administered with ║ based on published data with low dose ritonavir is required, it is darunavir/ritonavir recommended to start with the lowest possible dose of rosuvastatin and titrate up to the desired clinical effect while monitoring for safety. OTHER LIPID MODIFYING AGENTS Lomitapide Based on theoretical considerations Co-administration is contraindicated boosted darunavir is expected to (see section 4.3). increase the exposure of lomitapide when co-administered. (CYP3A inhibition) H2-RECEPTOR ANTAGONISTS Ranitidine # darunavir AUC ↔ Darunavir co-administered with low 150 mg twice daily # darunavir Cmin ↔ dose ritonavir can be co- # darunavir Cmax ↔ administered with H2-receptor antagonists without dose adjustments. IMMUNOSUPPRESSANTS Ciclosporin Not studied. Exposure to these Therapeutic drug monitoring of the Sirolimus immunosuppressants will be increased immunosuppressive agent must be Tacrolimus when co-administered with darunavir done when co-administration co-administered with low dose occurs. ritonavir. (CYP3A inhibition) Everolimus Concomitant use of everolimus and darunavir co-administered with low dose ritonavir is not recommended. INHALED BETA AGONISTS Salmeterol Not studied. Concomitant use of Concomitant use of salmeterol and salmeterol and darunavir co- darunavir co-administered with low administered with low dose ritonavir dose ritonavir is not recommended. may increase plasma concentrations of The combination may result in salmeterol. increased risk of cardiovascular adverse event with salmeterol, including QT prolongation, palpitations and sinus tachycardia. NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone R(-) methadone AUC ↓ 16% No adjustment of methadone dosage individual dose ranging R(-) methadone Cmin ↓ 15% is required when initiating co- from 55 mg to 150 mg once R(-) methadone Cmax ↓ 24% administration with daily darunavir/ritonavir. However, increased methadone dose may be necessary when concomitantly administered for a longer period of time due to induction of metabolism by ritonavir. Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): methadone (HOS-086198) lomitapide (HOS-086160) rosuvastatin (HOS-086307) salmeterol (HOS-086285) tacrolimus (HOS-085202) ranitidine (HOS-085660) everolimus (HOS-086310) sirolimus (HOS-085172) ritonavir (HOS-084521) pravastatin (HOS-086306)