Drug Drug Interactions with VICTRELIS® (boceprevir) Informative ...

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Class of Drug 26 ANTIFUNGALS Substrate class Azole derivatives Drug Brand name (non exhaustive list, generics not listed). For a complete list, please consult www.bcfi.be or www.cbip.be Itraconazole Sporanox ® , Spozole ® Potential interaction Posaconazole Noxafil ® Potential interaction Ketoconazole Nizoral ® Potential interaction Voriconazole Vfend ® Potential interaction Fluconazole Diflucan ® , Fungimed ® , Candizole ® , Liverpool University (*) / Extra-information Potential interaction Amphotericine B Abelcet ® , Ambisome ® Not Clinically Significant Caspofungine Cancidas ® Potential interaction Terbinafine Lamisil ® Potential interaction May [itraconazole] and [BOC]* May [posaconazole] and [BOC]* May [ketoconazole]. Coadministration of ketoconazole (400 mg twice daily) and BOC (400 mg single dose) BOC Cmax by 1,4 fold and AUC by 2.31fold* May [voriconazole] and [BOC]* Could BOC exposure* May [terbinafine]* Recommendations SmPC/ Scientific Literature Doses of itraconazole should not exceed 200 mg/day* Doses of ketoconazole should not exceed 200 mg/day* No dose adjustment is required in patients with normal hepatic function. A dose reduction of caspofungin daily dose to 35 mg is recommended for adults with moderate hepatic impairment.* smpc: Caution should be exercised when BOC is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole) CYP pathway(s) (www.cbip/bcfi.be) (www.mims.com.au) CYP3A4 Substrate/ Inhibitor/ Inducer CYP3A4 Substrate, Inhibitor CYP3A4 Inhibitor CYP3A4 Inhibitor CYP3A4 / CYP2C9 / CYP2C19 Inhibitor CYP3A4 / CYP2C9 Inhibitor CYP2D6
Class of Drug 27 CONTRACEPTIVES Substrate class See SmPC for guidance on contraception Combined Pill Drug Brand name (non exhaustive list, generics not listed). For a complete list, please consult www.bcfi.be or www.cbip.be Norethisterone (NE) / Ethinylestradiol (EE) Drospirenone (DRSP) / Ethinylestradiol (EE) Liverpool University (*) / Extra-information Recommendations SmPC/ Scientific Literature CYP pathway(s) (www.cbip/bcfi.be) (www.mims.com.au) • BOC can not be used during pregnancy • Female patients: respect a 4 months’ period after stopping treatment before pregnancy • Male patients and female partners: respect a 7 months’ period after stopping treatment before pregnancy • Possible that hormonal contraceptives are not reliable when using BOC: treated patients and their partners must use 2 methods of effective non-hormonal contraception (eg. male/female condoms, contraceptive diaphragm, copper IUD) Ovysmen ® , Trinovum ® Potential interaction* Yaz ® , Yasmin ® , Yasminelle ® , Yaz ® , Armunia ® , Drospibel ® , Rhonya ® Coadministration Contraindicated* NE AUC and Cmax by 4% and 17% EE AUC and Cmax by 26% and 21% † DRSP AUC and Cmax by 99% and 57%, EE AUC 24% and EE Cmax * Co-administration of BOC with an oral contraceptive containing EE and at least 1 mg of NE is unlikely to alter the contraceptive effectiveness † Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics † smpc: Co-administration of BOC with an oral contraceptive containing EE and at least 1 mg of NE is unlikely to alter the contraceptive effectiveness. Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during co-administration of NE 1 mg/EE 0.035 mg with BOC. The ovulation suppression activity of oral contraceptives containing lower doses of NE/EE and of other forms of hormonal contraception during co-administration with BOC has not been established. Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency. Kiser et al., hepatology 2012: Progestin-only contraception is effective, but it is difficult to know with certainty whether BOC would increase the levels of all progestins or if it is unique to drosperinone. There may also be more progestin-associated adverse effects with increased progestin concentrations. Furthermore, because drosperinone Inhibitors potassium excretion in the kidneys, the increase in drosperinone concentrations could theoretically cause hyperkalemia. Thus, considering the potential for increased adverse effects with BOC. smpc: Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics. Alternative contraceptives should be considered for these patients. CYP3A4 Substrate/ Inhibitor/ Inducer CYP3A4 Substrate
Page 1 and 2: Updated version: March 2013 Drug Dr
Page 3 and 4: 3 Legend No clinically significant
Page 5 and 6: Class of Drug 5 OPIOID SUBSTITUTION
Page 7 and 8: Class of Drug 7 ANTICONVULSANTS Sub
Page 9 and 10: Class of Drug 9 ANTIDEPRESSANTS Sub
Page 11 and 12: Class of Drug 11 ANxIOLyTICS / SEDA
Page 13 and 14: Class of Drug 13 ACEI (ANGIOTENSIN
Page 15 and 16: Class of Drug 15 DIURETICS CALCIUM
Page 17 and 18: Class of Drug 17 ANTICOAGULANTS FIB
Page 19 and 20: Class of Drug 19 STATINS Substrate
Page 21 and 22: Class of Drug 21 HyPOGLyCAEMIC AGEN
Page 23 and 24: Class of Drug 23 IMMUNOSUPPRESSANTS
Page 25: Class of Drug 25 ANTIBIOTICS Substr
Page 29 and 30: Class of Drug 29 ANTIRETROVIRALS Su
Page 31 and 32: Class of Drug 31 ANTI HEP.B/HEP.C D
Page 33 and 34: 33 No clinically significant intera
Page 35 and 36: disorders Adverse Reactions Common:
Page 37 and 38: Etravirine* (etravirine 200 mg ever
Page 39 and 40: sedatives Midazolam* (oral administ

Drug Drug Interactions with VICTRELIS® (boceprevir) Informative ...

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