on)
Tadalafil (for erectile dysfunction and benign
prostatic hyperplasia)
Tolterodine
Monitor for adverse reactions. Concomitant drug dose
reduction may be necessary. For sildenafil and tadalafil,
see also Cardiovascular Drugs above.
Miscellaneous Drugs and Other Substances
Colchicine Patients with renal or hepatic impairment:
Contraindicated during and 2 weeks after TOLSURA
treatment.
Other patients: Not recommended during and 2 weeks
after TOLSURA treatment.
Eliglustat CYP2D6 EMsc taking a strong or moderate CYP2D6
inhibitor, CYP2D6 IMsc
, or CYP2D6 PMsc
:
Contraindicated during and 2 weeks after TOLSURA
treatment.
CYP2D6 EMsc not taking a strong or moderate CYP2D6
inhibitor: Monitor for adverse reactions. Eliglustat dose
reduction may be necessary.
Lumacaftor/Ivacaftor Not recommended 2 weeks before, during, and 2 weeks
after TOLSURA treatment.
Alitretinoin (oral)
Cabergoline
Cannabinoids
Cinacalcet
Ivacaftor
Monitor for adverse reactions. Concomitant drug dose
reduction may be necessary.
Vasopressin Receptor Antagonists
Conivaptan
Tolvaptan
Not recommended during and 2 weeks after TOLSURA
treatment.
Drug Interactions with TOLSURA that Decrease Concomitant Drug Concentrations and May Reduce
Efficacy of the Concomitant Drug
Antineoplastics
Regorafenib Not recommended during and 2 weeks after TOLSURA
treatment.
Gastrointestinal Drugs
Saccharomyces boulardii Not recommended during and 2 weeks after TOLSURA
treatment.
Nonsteroidal Anti-Inflammatory Drugs
Meloxicama Concomitant drug dose increase may be necessary.
a Based on clinical drug interaction information with itraconazole.
b Based on 400 mg Bedaquiline once daily for 2 weeks.
c EMs: extensive metabolizers; IMs: intermediate metabolizers, PMs: poor metabolizers.
7.2 Effect of Other Drugs on TOLSURA
Itraconazole is mainly metabolized through CYP3A4. Other substances that either share thismetabolic pathway or modify CYP3A4 activity may influence the pharmacokinetics ofitraconazole. Some concomitant drugs have the potential to interact with TOLSURA resulting ineither increased or sometimes decreased concentrations of TOLSURA. Increased concentrationsmay increase the risk of adverse reactions associated with TOLSURA. Decreased concentrationsmay reduce TOLSURA efficacy.
Table 4 lists examples of drugs that may affect itraconazole concentrations, but is not acomprehensive list. Refer to the approved product labeling to become familiar with theinteraction pathways, risk potential and specific actions to be taken with regards to eachconcomitant drug prior to initiating therapy with TOLSURA.
Although many of the clinical drug interactions in Table 5 are based on information with asimilar azole antifungal, ketoconazole, these interactions are expected to occur with TOLSURA.
Table 5: Drug Interactions with Other Drugs that Affect TOLSURA Concentrations
Concomitant Drug Within Class Prevention or Management
Drug Interactions with Other Drugs that Increase TOLSURA Concentrations and May Increase Risk of
Adverse Reactions Associated with TOLSURA
Antibacterials
Ciprofloxacina
Erythromycina
Clarithromycina
Monitor for adverse reactions. TOLSURA dose reduction may
be necessary.
Antineoplastics
Idelalisib Monitor for adverse reactions. TOL |
