Cholestatic hepatic injury associated with vismodegib, aspirin, and naproxen use: A case study and review of vismodegib safety

International Journal of Dermatology

Volumn 54, Issue 3, 2015, Pages 370-374

  Ash, Mark M ^a   Jolly, Puneet S ^a  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; CYCLOBENZAPRINE; ESOMEPRAZOLE; GAMMA GLUTAMYLTRANSFERASE; NAPROXEN; NON PRESCRIPTION DRUG; POTASSIUM; TRIACYLGLYCEROL LIPASE; VISMODEGIB; ANILIDE; ANTINEOPLASTIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; PYRIDINE DERIVATIVE;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ADD ON THERAPY; AGED; AGEUSIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BASAL CELL CARCINOMA; BILIRUBIN BLOOD LEVEL; BLEEDING; BODY WEIGHT DISORDER; CANCER CHEMOTHERAPY; CANCER FATIGUE; CASE REPORT; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHOLESTATIC HEPATITIS; CONSTIPATION; CREATININE BLOOD LEVEL; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DISEASE ASSOCIATION; DIVERTICULITIS; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOXICITY; DRUG WITHDRAWAL; DYSGEUSIA; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL HEMORRHAGE; GLOMERULUS FILTRATION RATE; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPERTRANSAMINASEMIA; HYPOKALEMIA; HYPOVOLEMIC SHOCK; INTESTINE OBSTRUCTION; JAUNDICE; KIDNEY FAILURE; LEUKOCYTE COUNT; LOSS OF APPETITE; MALE; MEDICAL HISTORY; METALLIC TASTE; MUCOSA INFLAMMATION; MUSCLE CRAMP; MUSCLE SPASM; MYALGIA; POTASSIUM BLOOD LEVEL; STOMACH FUNCTION DISORDER; TOXIC HEPATITIS; UREA NITROGEN BLOOD LEVEL; XEROSTOMIA; CARCINOMA, BASAL CELL; CHEMICALLY INDUCED; CHOLESTASIS; DRUG INTERACTION; DRUG-INDUCED LIVER INJURY; SKIN NEOPLASMS;

AGED; ANILIDES; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTINEOPLASTIC AGENTS; ASPIRIN; CARCINOMA, BASAL CELL; CHOLESTASIS; DRUG INTERACTIONS; DRUG-INDUCED LIVER INJURY; DYSGEUSIA; HUMANS; MALE; MYALGIA; NAPROXEN; PYRIDINES; SKIN NEOPLASMS;

EID: 84923308546     PISSN: 00119059     EISSN: 13654632     Source Type: Journal    
DOI: 10.1111/ijd.12543     Document Type: Article

References (29)

1. Tang JY, So PL, Epstein EH Jr. Novel Hedgehog pathway targets against basal cell carcinoma. Toxicol Appl Pharmacol 2007; 224: 257-264.
2. Lo Muzio L. Nevoid basal cell carcinoma syndrome (Gorlin syndrome). Orphanet J Rare Dis 2008; 3: 32.
3. Evans DG, Howard E, Giblin C, et al. Birth incidence and prevalence of tumor-prone syndromes: estimates from a UK family genetic register service. Am J Med Genet A 2009; 152A: 327-332.
4. Robarge KD, Brunton SA, Castanedo GM, et al. GDC-0449-A potent inhibitor of the hedgehog pathway. Bioorg Med Chem Lett 2009; 19: 5576-5581.
5. Rudin CM. Vismodegib. Clin Cancer Res 2012; 18: 3218-3222.
6. Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med 2009; 361: 1164-1172.
7. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 2012; 366: 2171-2179.
8. Tang JY, Mackay-Wiggan JM, Aszterbaum M, et al. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med 2012; 366: 2180-2188.
9. Kaye SB, Fehrenbacher L, Holloway R, et al. A phase II, randomized, placebo-controlled study of vismodegib as maintenance therapy in patients with ovarian cancer in second or third complete remission. Clin Cancer Res 2012; 18: 6509-6518.
10. LoRusso PM, Piha-Paul SA, Mita M, et al. Co-administration of vismodegib with rosiglitazone or combined oral contraceptive in patients with locally advanced or metastatic solid tumors: a pharmacokinetic assessment of drug-drug interaction potential. Cancer Chemother Pharmacol 2013; 71: 193-202.
11. LoRusso PM, Jimeno A, Dy G, et al. Pharmacokinetic dose-scheduling study of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with locally advanced or metastatic solid tumors. Clin Cancer Res 2011; 17: 5774-5782.
12. Sharma MR, Karrison TG, Kell B, et al. Evaluation of food effect on pharmacokinetics of vismodegib in advanced solid tumor patients. Clin Cancer Res 2013; 19: 3059-3067.
13. LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res 2011; 17: 2502-2511.
14. Berlin J, Bendell JC, Hart LL, et al. A randomized phase II trial of vismodegib versus placebo with FOLFOX or FOLFIRI and bevacizumab in patients with previously untreated metastatic colorectal cancer. Clin Cancer Res 2013; 19: 258-267.
15. Wolfe CM, Green WH, Cognetta AB, et al. Basal cell carcinoma rebound after cessation of vismodegib in a nevoid basal cell carcinoma syndrome patient. Dermatol Surg 2012; 38: 1863-1866.
16. Hussaini SH, Farrington EA. Idiosyncratic drug-induced liver injury: an overview. Expert Opin Drug Saf 2007; 6: 673-684.
17. Lee WM. Drug-induced hepatotoxicity. N Engl J Med 2003; 349: 474-485.
18. Ostapowicz G, Fontana RJ, Schiodt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002; 137: 947-954.
19. Vree TB, Van Den Biggelaar-Martea M, Verwey-Van Wissen CP, et al. The pharmacokinetics of naproxen, its metabolite O-desmethylnaproxen, and their acyl glucuronides in humans. Effect of cimetidine. Br J Clin Pharmacol 1993; 35: 467-472.
20. Miners JO, Coulter S, Tukey RH, et al. Cytochromes P450, 1A2, and 2C9 are responsible for the human hepatic O-demethylation of R- and S-naproxen. Biochem Pharmacol 1996; 51: 1003-1008.
21. Ding X, Chou B, Graham RA, et al. Determination of GDC-0449, a small-molecule inhibitor of the Hedgehog signaling pathway, in human plasma by solid phase extraction-liquid chromatographic-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2010; 878: 785-790.
22. Katoh M, Nakajima M, Shimada N, et al. Inhibition of human cytochrome P450 enzymes by 1, 4-dihydropyridine calcium antagonists: prediction of in vivo drug-drug interactions. Eur J Clin Pharmacol 2000; 55: 843-852.
23. López-Morante AJ, Sáez-Royuela F, Díez-Sánchez V, et al. Aspirin-induced cholestatic hepatitis. J Clin Gastroenterol 1993; 16: 270-272.
24. Teoh NC, Farrell GC. Hepatotoxicity associated with non-steroidal anti-inflammatory drugs. Clin Liver Dis 2003; 7: 401-413.
25. Suzuki A, Andrade RI, Bjornsson E, et al. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase. Drug Saf 2010; 33: 503-522.
26. Ali S, Pimentel JD, Ma C. Naproxen-induced liver injury. Hepatobiliary Pancreat Dis Int 2011; 10: 552-556.
27. Rostom A, Goldkind L, Laine L. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol 2005; 3: 489-498.
28. Rubenstein JH, Laine L. Systematic review: the hepatotoxicity of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2004; 20: 373-380.
29. Traversa G, Bianchi C, Cas RD, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ 2003; 327: 18-22.