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Drug Interactions between darunavir and rifabutin

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

rifabutin darunavir

Applies to: rifabutin and darunavir

ADJUST DOSE: Coadministration of rifabutin and darunavir/ritonavir is expected to increase the plasma concentrations of rifabutin and its 25-O-desacetylrifabutin metabolite and may also increase the plasma concentrations of darunavir and ritonavir. The proposed mechanism involves ritonavir inhibition of rifabutin metabolism via CYP450 3A4. In 11 study subjects, administration of lower-dose rifabutin (150 mg every other day for 12 days) and darunavir/ritonavir (600 mg/100 mg twice daily for 12 days) resulted in non-significant changes in the peak plasma concentration (Cmax), systemic exposure (AUC), and trough plasma concentration (Cmin) of rifabutin, as compared to the standard dose of rifabutin alone (300 mg once daily). In the same study, Cmax, AUC, and Cmin of darunavir were increased by 57%, 42% and 75% respectively. Uveitis secondary to rifabutin toxicity has been reported in some cases.

MANAGEMENT: To minimize the risk of rifabutin toxicity including leukopenia, uveitis, arthralgias and skin discoloration, darunavir labeling recommends that rifabutin dosage be reduced to 150 mg every other day in patients treated with darunavir/ritonavir or darunavir/cobicistat. A complete blood count should be performed at least weekly and as clinically indicated to monitor for development of neutropenia. Local guidelines should be consulted for appropriate recommendations.

References (29)
  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical
  2. (2001) "Product Information. Crixivan (indinavir)." Merck & Co., Inc
  3. Gariano RF, Gooney EL (1997) "Uveitis following administration of the protease inhibitor indinavir to a patient with AIDS." Clin Infect Dis, 24, p. 529
  4. (2001) "Product Information. Viracept (nelfinavir)." Agouron Pharma Inc
  5. Cato A, Cavanaugh J, Shi H, Hsu A, Leonard J, Granneman R (1998) "The effect of multiple doses of ritonavir on the pharmacokinetics of rifabutin." Clin Pharmacol Ther, 63, p. 414-21
  6. Fournier S, Deplus S, Janier M, Poinsignon Y, Decazes JM, Modai J (1998) "Anterior uveitis in 3 HIV-infected patients treated with antiprotease." Presse Med, 27, p. 844-8
  7. (2001) "Product Information. Agenerase (amprenavir)." Glaxo Wellcome
  8. (2001) "Product Information. Fortovase (saquinavir)." Roche Laboratories
  9. Polk RE, Brophy DF, Israel DS, Patron R, Sadler BM, Chittick GE, Symonds WT, Lou Y, Kristoff D, Stein DS (2001) "Pharmacokinetic interaction between amprenavir and rifabutin or rifampin in healthy males." Antimicrob Agents Chemother, 45, p. 502-8
  10. Burman WJ, Jones BE (2001) "Treatment of HIV-related tuberculosis in the era of effective antiretroviral therapy." Am J Respir Crit Care Med, 164, p. 7-12
  11. (2000) "Notice to readers: updated guidelines for the use of rifabutin or rifampin for the treatment and prevention of tuberculosis among HIV-infected patients taking protease inhibitors or nonnucleoside reverse transcriptase inhibiotrs." MMWR Morb Mortal Wkly Rep, 49, p. 185-9
  12. Moyle GJ, Buss NE, Goggin T, Snell P, Higgs C, Hawkins DA (2002) "Interaction between saquinavir soft-gel and rifabutin in patients infected with HIV." Br J Clin Pharmacol, 54, p. 178-82
  13. Hamzeh FM, Benson C, Gerber J, et al. (2003) "Steady-state pharmacokinetic interaction of modified-dose indinavir and rifabutin." Clin Pharmacol Ther, 73, p. 159-69
  14. (2003) "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb
  15. American Thoracic Society, CDC, Infectious Diseases Society of America (2003) "Treatment of tuberculosis." MMWR Morb Mortal Wkly Rep, 52(RR-11), p. 1-77
  16. (2003) "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline
  17. (2005) "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim
  18. (2006) "Product Information. Prezista (darunavir)." Ortho Biotech Inc
  19. (2023) "Product Information. Prezista (darunavir)." Janssen Pharmaceuticals, SUPPL-68
  20. (2023) "Product Information. Mycobutin (rifabutin)." Pfizer Ltd, MY 14_0
  21. (2023) "Product Information. Mycobutin (rifabutin)." Pfizer Australia Pty Ltd, pfpmycoc11223
  22. (2023) "Product Information. Prezcobix (cobicistat-darunavir)." Janssen-Cilag Pty Ltd
  23. (2023) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen-Cilag Pty Ltd
  24. (2024) "Product Information. Rezolsta (cobicistat-darunavir)." Janssen-Cilag Ltd
  25. (2023) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen-Cilag Ltd
  26. (2024) "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals
  27. (2024) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen Pharmaceuticals
  28. (2024) "Product Information. Mycobutin (rifabutin)." Pfizer U.S. Pharmaceuticals Group
  29. (2023) "Product Information. Mycobutin (rifabutin)." Pfizer Canada Inc

Drug and food interactions

Moderate

darunavir food

Applies to: darunavir

ADJUST DOSING INTERVAL: Food enhances the absorption and oral bioavailability of darunavir administered in combination with low-dose ritonavir. The mechanism is unknown. When administered with food, the peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) of darunavir were approximately 30% higher than when administered in the fasting state. Darunavir exposure was similar for the range of meals studied. The total caloric content of the various meals evaluated ranged from 240 Kcal (12 grams fat) to 928 Kcal (56 grams fat).

MANAGEMENT: To ensure maximal oral absorption, darunavir coadministered with ritonavir should be taken with food. The type of food is not important.

References (1)
  1. (2006) "Product Information. Prezista (darunavir)." Ortho Biotech Inc

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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