Dolutegravir + Midazolam = Unknown or no reaction

Effect on Concentration

Dolutegravir
No change
Applies within class?
No
Midazolam
No change
Applies within class?
No

Pharmacologic Effects

Dolutegravir
Effect
N/A
Applies within class?
No
Midazolam
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Dolutegravir versus Midazolam ^

Study Design

In phase I study, the interaction between dolutegravir (DTG) and midazolam was evaluated in healthy subjects (n=14).

Study Results

Although no specific values were indicated, the investigators concluded that DTG does not have a clinically important effect on the pharmacokinetics of midazolam. Consistent with this, in a PK study (n=10) presented in DTG (TivicayŽ) prescribing information, when midazolam 3 mg was given concomitantly with DTG 25 mg once daily, the geometric mean ratios (GMRs; DTG + midazolam / midazolam) [90% CIs] of midazolam AUC was 0.95 [0.79, 1.15].

Study Conclusions

DTG does not have a clinically important effect on the PK of midazolam. Dosage adjustments are not necessary if midazolam is used with DTG.

References

Cottrell ML, Hadzic T, Kashuba AD. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clinical Pharmacokinetics. 2013; 11: 981-994.