Date of report 20 Jun 2019
Reported case interaction between
Cobicistat and Tamsulosin

FLS Science

Drugs suspected to be involved in the DDI-summary

Perpetrator
Cobicistat
Daily Dose
150 (mg)
Dose adjustment performed
No
Administration Route
Oral
Start date
July 23, 2018
End date
Ongoing
Victim
Tamsulosin
Daily Dose
0.4 (mg)
Dose adjustment performed
No
Administration Route
Oral
Start date
Oct. 15, 2017
End date
Ongoing

Complete list of drugs taken by the patient

Antiretroviral treatment
Darunavir/Cobicistat/Emtricitabine/Tenofovir-AF
Complete list of all comedications taken by the patient, included that involved in the DDI

Tamsulosin, indapamide, enalapril, atorvastatin 20 mg qd, omeprazol, vitamin D

Clinical case description

Gender
Male
Age
72
eGFR (mL/min)
>60
Liver function impairment
No
Description

72 year-old HIV patient on antiretroviral therapy with darunavir/cobicistat/FTC/TAF. Benign prostatic hypertrophy on treatment with tamsulosin 0.4 mg qd. Despite tamsulosin is metabolised mainly by CYP3A4, with potential increase in tansulosine exposure by cobicistat, no adverse events were observed in this patient using of low dose of tamsulosin.

Clinical Outcome

No unwanted outcome

Editorial Comment

The recommendation in the tamsulosin SmPC is that tamsulosin should be used with caution in combination with strong and moderate inhibitors of CYP3A4, and cobicistat is a strong inhibitor. There are data with ketoconazole showing a 2.8-fold increase in exposure. Although this particular case with no unwanted outcomes does not mean you can automatically extrapolate to other patients on tamsulosin, it suggests that the lower dose of 0.4 mg of tamsulosin may be adequate with both ritonavir and cobicistat.

University of Liverpool Recommendation

Potential interaction - may require close monitoring, alteration of drug dosage or timing of administration
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