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Delstrigo contains doravirine, lamivudine, and tenofovir disoproxil, therefore any interactions identified for these individually are relevant to Delstrigo and are presented in Table 7.
Effects of other medicinal products on doravirine, lamivudine, and tenofovir disoproxil: Doravirine: Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine (see Pharmacology: Pharmacokinetics under Actions). Doravirine/lamivudine/tenofovir disoproxil should not be co-administered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine/lamivudine/tenofovir disoproxil (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Co-administration with the moderate CYP3A inducer rifabutin decreased doravirine concentrations (see Table 7). When Delstrigo is co-administered with rifabutin, a 100 mg dose of doravirine should be given daily, approximately 12 hours after doravirine/lamivudine/tenofovir disoproxil dose (see Dosage & Administration).
Co-administration of doravirine/lamivudine/tenofovir disoproxil with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected. If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, a 100 mg dose of doravirine should be administered daily, approximately 12 hours after the administration of doravirine/lamivudine/tenofovir disoproxil dose (see Dosage & Administration).
Co-administration of doravirine/lamivudine/tenofovir disoproxil and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine. However, no dose adjustment is needed when doravirine is co-administered with CYP3A inhibitors.
Lamivudine: Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see Pharmacology: Pharmacokinetics under Actions), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of lamivudine.
Tenofovir disoproxil: Because tenofovir is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see Pharmacology: Pharmacokinetics under Actions), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via OAT1, OAT3 or MRP4 may increase serum concentrations of tenofovir.
Due to the tenofovir disoproxil component of doravirine/lamivudine/tenofovir disoproxil, use of the product should be avoided with concurrent or recent use of nephrotoxic medicinal products. Some examples include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs (see Precautions).
Effects of doravirine, lamivudine, and tenofovir disoproxil on other medicinal products: Doravirine: Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolised by CYP enzymes.
However, co-administration of doravirine and the sensitive CYP3A substrate midazolam resulted in a 18 % decrease in midazolam exposure, suggesting that doravirine may be a weak CYP3A inducer. Therefore, caution should be used when co-administering doravirine with medicinal products that are sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and sirolimus).
Lamivudine: Lamivudine does not inhibit or induce CYP enzymes.
Tenofovir: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP-mediated interactions involving tenofovir with other medicinal products is low.
Interaction table: Table 7 shows the established and other potential medicinal product interactions with the individual components of Delstrigo but is not all inclusive (increase is indicated as ↑, decrease is indicated as ↓, and no change as ↔). For potential medicine product interactions with tenofovir disoproxil or lamivudine, see Precautions and Pharmacology: Pharmacokinetics under Actions. (See Tables 7a, 7b, 7c and 7d.)
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