Interactions : אינטראקציות

7 DRUG INTERACTIONS

7.1   Drugs Having Clinically Important Interactions with DAYVIGO

Table 2: Clinically Important Drug Interactions with DAYVIGO
Effect of Other Drugs on DAYVIGO
Strong, Moderate, and Weak CYP3A Inhibitors
Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases Clinical Impact:   lemborexant AUC and Cmax which may increase the risk of DAYVIGO adverse reactions [see Clinical Pharmacology (12.3)].
Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Dosage and Administration (2.2)].
Intervention:
The maximum recommended dose of DAYVIGO with weak CYP3A inhibitors is 5 mg [see Dosage and Administration (2.2)].
Strong CYP3A inhibitors: itraconazole, clarithromycin
Examples:           Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine
Strong and Moderate CYP3A Inducers
Concomitant use with a strong or moderate CYP3A inducer decreases
Clinical Impact:    lemborexant exposure, which may reduce DAYVIGO efficacy [see Clinical Pharmacology (12.3)].

Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers Intervention:
[see Dosage and Administration (2.2)].
Strong CYP3A inducers: rifampin, carbamazepine, St. John’s wort
Examples:
Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil
Alcohol
Concomitant use of alcohol increases lemborexant Cmax and AUC. Co- administration of DAYVIGO with alcohol produced a numerically greater Clinical Impact:    negative impact on postural stability and memory as compared with alcohol alone when assessed near the tmax of DAYVIGO (2 hours post-dose) [see Clinical Pharmacology (12.2)].
Avoid alcohol consumption with DAYVIGO [see Warnings and Precautions
Intervention:       (5.1)].

Effect of DAYVIGO on Other Drugs
CYP2B6 Substrates
Concomitant use of DAYVIGO decreases the AUC of drugs that are CYP2B6 Clinical Impact:    substrates, which may result in reduced efficacy for these concomitant medications [see Clinical Pharmacology (12.3)].


Patients receiving DAYVIGO and CYP2B6 substrates concurrently should be Intervention:        monitored for adequate clinical response. Increasing the doses of CYP2B6 substrates may be considered as needed.

Examples:            Bupropion, methadone