Tenofovir Alafenamide interactions

Conditions

Conditions in which Tenofovir Alafenamide needs care, as documented in this source.

• Hepatitis B

  Major

  Severe acute exacerbations of HBV have been reported in HBV-infected patients who have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (DF) and may occur with discontinuation of tenofovir alafenamide-containing products. It is recommended that all patients with HIV-1 infection be tested for the presence of chronic HBV before or when initiating products containing emtricitabine, tenofovir DF, or tenofovir alafenamide. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue antihepatitis B therapy. If appropriate, initiation or resumption of antihepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.

  6 sources

  1. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences (2020):
  2. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences (2022):
  3. "Product Information. Emtriva (emtricitabine)." Gilead Sciences (2018):
  4. "Product Information. Vemlidy (tenofovir)." Gilead Sciences (2022):
  5. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):
  6. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences (2022):

• Liver Diseases

  Major

  Hepatotoxicity including lactic acidosis, severe hepatomegaly with steatosis, fulminant hepatitis, and hepatic failure has been associated with the use of some nucleoside reverse transcriptase inhibitors (NRTIs) alone or in combination with other antiretroviral agents. Therapy with NRTIs should be administered cautiously in patients with preexisting liver disease, a history of alcohol abuse, or hepatitis. Therapy should be suspended if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. The use of abacavir is contraindicated in patients with moderate to severe hepatic impairment as its safety and efficacy has not been established on these patients.

  24 sources

  1. Yarchoan R, Mitsuya H, Pluda JM, et al. "The National Cancer Institute phase I study of 2',3'-dideoxyinosine administration in adults with AIDS-related complex: analysis of activity and toxicity profiles." Rev Infect Dis 12 (1990): s522-33
  2. Dolin R, Lambert JS, Morse GD, et al. "2',3'-dideoxyinosine in patients with AIDS or AIDS-related complex." Rev Infect Dis 12 (1990): s540-51
  3. Lai KK, Gang DL, Zawacki JK, Cooley TP "Fulminant hepatic failure associated with 2',3'-dideoxyinosine (ddI)." Ann Intern Med 115 (1991): 283-4
  4. Dubin G, Braffman MN "Zidovudine-induced hepatotoxicity." Ann Intern Med 110 (1989): 85-6
  5. Shriner K, Goetz MB "Severe hepatoxicity in a patient receiving both acetaminophen and zidovudine." Am J Med 93 (1992): 94-6
  6. Gradon JD, Chapnick EK, Sepkowitz DV "Zidovudine-induced hepatitis." J Intern Med 231 (1992): 317-8
  7. Chen SC, Barker SM, Mitchell DH, et al. "Concurrent zidovudine-induced myopathy and hepatoxicity in patients treated for human immunodeficiency virus (HIV) infection." Pathology 24 (1992): 109-11
  8. "Product Information. Videx (didanosine)." Bristol-Myers Squibb (2002):

  Show all 24 sourcesShow fewer sources

  9. "Product Information. HIVID (zalcitabine)." Roche Laboratories (2001):
  10. "Product Information. Retrovir (zidovudine)." Glaxo Wellcome (2001):
  11. Pike IM, Nicaise C "The didanosine Expanded Access Program: safety analysis." Clin Infect Dis 16 (1993): S63-8
  12. Shintaku M, Nasu K, Shimizu T "Fulminant hepatic failure in an AIDS patient: possible zidovudine- induced hepatotoxicity." Am J Gastroenterol 88 (1993): 464-6
  13. Montaner JSG, Rachlis A, Beaulieu R, Gill J, Schlech W, Phillips P, Auclair C, Boulerice F, Schindzielorz A, Smaldone L, Wainber "Safety profile of didanosine among patients with advanced HIV disease who are intolerant to or deteriorate despite zidovudine therapy: results of the canadian open ddi treatment program." J Acquir Immune Defic Syndr 7 (1994): 924-30
  14. "Product Information. Epivir (lamivudine)." Glaxo Wellcome (2001):
  15. "Product Information. Ziagen (abacavir)." Glaxo Wellcome (2001):
  16. Miller KD, Cameron M, Wood LV, Dalakas MC, Kovacs JA "Lactic acidosis and hepatic steatosis associated with use of stavudine: report of four cases." Ann Intern Med 133 (2000): 192-6
  17. Lhouri S, Cushing H "Lactic acidosis secondary to nucleoside analog antiretroviral therapy." Infect Med 17 (2000): 547-54
  18. Pai VB, Koranyi K, Nahata MC "Acute hepatitis and bleeding possibly induced by zidovudine and ritonavir in an infant with HIV infection." Pharmacotherapy 20 (2000): 1135-40
  19. Lonergan JT, Behling C, Pfander H, Hassanein TI, Mathews WC "Hyperlactatemia and hepatic abnormalities in 10 human immunodeficiency virus-infected patients receiving nucleoside analogue combination regimens." Clin Infect Dis 31 (2000): 162-6
  20. Kronenberg A, Riehle HM, Gunthard HF "Liver failure after long-term nucleoside antiretroviral therapy." Lancet 358 (2001): 759-601
  21. Boubaker K, Flepp M, Sudre P, et al. "Hyperlactatemia and Antiretroviral Therapy: The Swiss HIV Cohort Study." Clin Infect Dis 33 (2001): 1931-7
  22. Coghlan ME, Sommadossi JP, Jhala NC, Many WJ, Saag MS, Johnson VA "Symptomatic lactic acidosis in hospitalized antiretroviral-treated patients with human immunodeficiency virus infection: a report of 12 cases." Clin Infect Dis 33 (2001): 1914-21
  23. "Product Information. Viread (tenofovir)." Gilead Sciences (2001):
  24. "Product Information. Baraclude (entecavir)." Bristol-Myers Squibb (2005):

• Bone Diseases

  Moderate

  In clinical trials, tenofovir disoproxil fumarate (DF) was associated with slightly greater reductions in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. The effects of tenofovir DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk have not been established. Calcium and vitamin D supplementation may be beneficial; however, the effect of such supplementation was not studied. Assessment of BMD should be considered for patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. If bone abnormalities are suspected, appropriate consultation should be obtained.

  1 source

  1. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):

• Kidney Diseases

  Moderate

  Tenofovir is primarily eliminated by the kidneys via glomerular filtration and active tubular secretion. Serum creatinine, estimated CrCl, urine glucose, and urine protein should be assessed in all patients before/when starting tenofovir (alafenamide or disoproxil fumarate [DF]) and during therapy when clinically appropriate. Serum phosphorus should also be assessed in patients with chronic kidney disease.Postmarketing cases of renal impairment (including acute renal failure, proximal renal tubulopathy, and Fanconi syndrome) have been reported with tenofovir alafenamide-containing products; most cases had potential confounders that may have contributed to the reported renal events and may have predisposed patients to tenofovir-related side effects. Tenofovir alafenamide should be discontinued in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.Renal impairment (including acute renal failure and Fanconi syndrome) has been reported with tenofovir DF. Close monitoring of renal function and dosing interval adjustment are recommended for all patients with CrCl less than 50 mL/min. Creatinine clearance should be calculated in all patients before starting tenofovir treatment and during treatment when clinically appropriate. Routine monitoring of serum creatinine and phosphorus is recommended for patients at risk of or with a history of renal dysfunction. Safety and efficacy have not been evaluated in patients with renal dysfunction using dose adjustments; therefore, the benefit of tenofovir DF treatment should be weighed against the risk of renal toxicity. Renal function should be evaluated in patients at risk of renal dysfunction who have persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness (may be indicators of proximal renal tubulopathy).

  2 sources

  1. "Product Information. Vemlidy (tenofovir)." Gilead Sciences (2022):
  2. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):

• Kidney Diseases

  Moderate

  Tenofovir is primarily eliminated by the kidneys via glomerular filtration and active tubular secretion. Serum creatinine, estimated CrCl, urine glucose, and urine protein should be assessed in all patients before/when starting tenofovir (alafenamide or disoproxil fumarate [DF]) and during therapy when clinically appropriate. Serum phosphorus should also be assessed in patients with chronic kidney disease.Postmarketing cases of renal impairment (including acute renal failure, proximal renal tubulopathy, and Fanconi syndrome) have been reported with tenofovir alafenamide-containing products; most cases had potential confounders that may have contributed to the reported renal events and may have predisposed patients to tenofovir-related side effects. Tenofovir alafenamide should be discontinued in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.Renal impairment (including acute renal failure and Fanconi syndrome) has been reported with tenofovir DF. Close monitoring of renal function and dosing interval adjustment are recommended for all patients with CrCl less than 50 mL/min. Creatinine clearance should be calculated in all patients before starting tenofovir treatment and during treatment when clinically appropriate. Routine monitoring of serum creatinine and phosphorus is recommended for patients at risk of or with a history of renal dysfunction. Safety and efficacy have not been evaluated in patients with renal dysfunction using dose adjustments; therefore, the benefit of tenofovir DF treatment should be weighed against the risk of renal toxicity. Renal function should be evaluated in patients at risk of renal dysfunction who have persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness (may be indicators of proximal renal tubulopathy).

  2 sources

  1. "Product Information. Vemlidy (tenofovir)." Gilead Sciences (2022):
  2. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):

• Liver Diseases

  Moderate

  Tenofovir alafenamide (as a single ingredient product) is not recommended in patients with decompensated liver dysfunction (Child-Pugh B or C); safety and efficacy have not been established in these patients. No dose adjustment of tenofovir alafenamide is required in patients with mild liver dysfunction (Child-Pugh A).-Combination products containing tenofovir alafenamide have not been studied in patients with severe liver dysfunction; some of these products are not recommended for use in such patients. No dose adjustment of tenofovir alafenamide-containing products is required in patients with mild or moderate liver dysfunction (Child-Pugh A or B).The pharmacokinetics of tenofovir after a single 300 mg dose of tenofovir disoproxil fumarate (DF) have been studied in non-HIV infected subjects with moderate to severe liver dysfunction. There were no significant changes in tenofovir pharmacokinetics in subjects with liver dysfunction compared to those with normal liver function. No adjustment in tenofovir DF dosing is required in patients with liver dysfunction.

  8 sources

  1. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences (2020):
  2. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences (2022):
  3. "Product Information. Vemlidy (tenofovir)." Gilead Sciences (2022):
  4. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):
  5. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences (2022):
  6. "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences (2022):
  7. "Product Information. Odefsey (emtricitabine/rilpivirine/tenofovir)." Gilead Sciences (2021):
  8. "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenof)." Janssen Pharmaceuticals (2022):

• Liver Diseases

  Moderate

  Tenofovir alafenamide (as a single ingredient product) is not recommended in patients with decompensated liver dysfunction (Child-Pugh B or C); safety and efficacy have not been established in these patients. No dose adjustment of tenofovir alafenamide is required in patients with mild liver dysfunction (Child-Pugh A).-Combination products containing tenofovir alafenamide have not been studied in patients with severe liver dysfunction; some of these products are not recommended for use in such patients. No dose adjustment of tenofovir alafenamide-containing products is required in patients with mild or moderate liver dysfunction (Child-Pugh A or B).The pharmacokinetics of tenofovir after a single 300 mg dose of tenofovir disoproxil fumarate (DF) have been studied in non-HIV infected subjects with moderate to severe liver dysfunction. There were no significant changes in tenofovir pharmacokinetics in subjects with liver dysfunction compared to those with normal liver function. No adjustment in tenofovir DF dosing is required in patients with liver dysfunction.

  8 sources

  1. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences (2020):
  2. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences (2022):
  3. "Product Information. Vemlidy (tenofovir)." Gilead Sciences (2022):
  4. "Product Information. Viread (tenofovir)." Gilead Sciences (2019):
  5. "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences (2022):
  6. "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences (2022):
  7. "Product Information. Odefsey (emtricitabine/rilpivirine/tenofovir)." Gilead Sciences (2021):
  8. "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenof)." Janssen Pharmaceuticals (2022):