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FDA Approved: 1996
Description: Allopurinol is a xanthine oxidase inhibitor used to treat hyperuricemia, gout, leukemia and lymphoma, and calcium oxalate calculi.
Use: The FDA recommends screening for the HLA–B*5801 allele prior to starting allopurinol in at-risk patients (Asian including Han Chinese, Korean, Thai, and Native Hawaiian/Pacific Islander ancestry).
Rationale: The HLA–B*5801 allele is associated with an increased risk of allopurinol hypersensitivity syndrome (skin rash and toxic epidermal necrolysis). The prevalence of the HLA-B*5801 allele is higher in at-risk patients (Asian including Han Chinese, Korean, Thai, and Native Hawaiian/Pacific Islander ancestry).
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FDA Approved: 2008
Description: Alvimopan is an opioid antagonist used to accelerate gut mobility following surgeries that include partial bowel resection with primary anastomosis.
Use: The FDA suggests monitoring for gastrointestinal adverse reactions in Japanese patients.
Rationale: Studies have found that Japanese patients have 2-fold higher plasma concentrations compared to Caucasian patients.
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FDA Approved: 1968
Description: Carbamazepine is an anticonvulsant used to treat epilepsy (partial seizures, generalized seizures, and mixed seizures) and trigeminal neuralgia.
Use: The FDA recommends screening for the HLA-B*1502 allele prior to starting carbamazepine in at-risk patients (Asian ancestry).
Rationale: The HLA-B*1502 allele is associated with an increased risk of severe cutaneous adverse reactions (SCARs), which include Stevens–Johnson syndrome and toxic epidermal necrolysis. The prevalence of the HLA-B*1502 allele is higher at-risk patients (Asian ancestry).
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FDA Approved: 2008
Description: Eltrombopag is a thrombopoietin receptor agonist used to treat thrombocytopenia and aplastic anemia.
Use: The FDA suggests the initiation of eltrombopag at half the usual dose in patients of East-/Southeast-Asian ancestry.
Rationale: Limited pharmacokinetic studies indicate that eltrombopag metabolism is reduced in patients of East-/Southeast-Asian ancestry.
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FDA Approved: 1953
Description: Isoniazid is an antibiotic used to treat all forms of tuberculosis in which organisms are susceptible.
Use: The FDA recommends isoniazid as preventive therapy for Black, Hispanic, and Native American patients. In addition, FDA warns that Black and Hispanic women are at increases risk of fatal hepatitis.
Rationale: Studies have identified Black, Hispanic, and Native American patients as high-risk for tuberculosis for whom preventive therapy is appropriate.
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FDA Approved: 2005
Description: The combination of isosorbide dinitrate and hydralazine hydrochloride is used to treat heart failure.
Use: The FDA recommends the combination of isosorbide dinitrate and hydralazine hydrochloride only for self-identified Black patients.
Rationale: Retrospective analyses of clinical trials showed that on this combination self-identified Black patients had improved survival over white patients.
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FDA Approved: 1989
Description: Omeprazole is a proton-pump inhibitor used to treat peptic ulcers and gastroesophageal reflux disease.
Use: The FDA suggests dose reduction in Asian patients.
Rationale: Studies found that the plasma concentration in Asian patients was higher compared to Caucasian patients.
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FDA Approved: 2000
Description: Oxcarbazepine is an anticonvulsant used to treat epilepsy (partial-onset seizures).
Use: The FDA recommends screening for the HLA-B*1502 allele prior to starting oxcarbazepine in at-risk patients (Han Chinese, Thai, Philippines and Malaysian populations).
Rationale: The HLA-B*1502 allele is associated with an increased risk of severe cutaneous adverse reactions (SCARs), which include Stevens–Johnson syndrome and toxic epidermal necrolysis. The prevalence of the HLA-B*1502 allele is higher in at-risk patients (Han Chinese, Thai, Philippines and Malaysian populations).
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FDA Approved: 2010
Description: Pegloticase is a pegylated, recombinant uricase used to treat chronic gout refractory to conventional therapy.
Use: The FDA recommends screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting pegloticase in at-risk patients (African, Mediterranean including Southern European and Middle Eastern, and Southern Asian ancestry).
Rationale: G6PD deficiency is associated with an increased risk of severe hemolytic reactions and methemoglobinemia. The prevalence of G6PD deficiency is higher in at-risk patients (African, Mediterranean including Southern European and Middle Eastern, and Southern Asian ancestry).
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FDA Approved: 2002
Description: Rasburicase is a recombinant urate oxidase enzyme used in the management of elevated plasma uric acid levels resulting from anti-cancer therapy.
Use: The FDA recommends screening for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting rasburicase in at-risk patients (African and Mediterranean ancestry).
Rationale: G6PD deficiency is associated with an increased risk of severe hemolytic reactions and methemoglobinemia. The prevalence of G6PD deficiency is higher in at-risk patients (African and Mediterranean ancestry).
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FDA Approved: 2003
Description: Rosuvastatin is an HMG-CoA reductase inhibitor used to treat hypertriglyceridemia, primary dysbetalipoproteinemia, and familial hypercholesterolemia.
Use: The FDA suggests the initiation of rosuvastatin at a lower dose in Asian patients.
Rationale: Studies have found that Asian patients have 2-fold higher plasma concentrations compared to Caucasian patients.
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FDA Approved: 2013
Description: Simeprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor used to treat chronic hepatitis C.
Use: The FDA does not make a dose recommendation for patients of East Asian ancestry.
Rationale: In clinical trials, higher simeprevir exposures have been associated with an increased frequency of adverse reactions, including rash and photosensitivity. And patients of East Asian ancestry exhibit higher simeprevir exposures.
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FDA Approved: 1991
Description: Simvastatin is an HMG-CoA reductase inhibitor used to treat cardiovascular and cerebrovascular disease and hypercholesterolemia.
Use: The FDA suggests increased monitoring for myopathy in Chinese patients.
Rationale: Studies have found that Chinese patients are at higher risk for myopathy.
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FDA Approved: 1994
Description: Tacrolimus is an immunosuppressant used for the prophylaxis of organ rejection in patients with organ transplants.
Use: The FDA suggests that African American patients may need higher dosages to attain comparable concentrations compared to Caucasian patients. In addition, FDA warns that African American and Hispanic patients are at increased risk of post-transplant diabetes mellitus.
Rationale: Studies in kidney transplant patients found that African American patients required a higher dose to attain comparable trough concentrations compared to Caucasian patients.
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FDA Approved: 1954
Description: Warfarin is an oral anticoagulant used to treat venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, and stroke.
Use: The FDA suggests dose reduction in Asian patients for initiation and maintenance of anticoagulation.
Rationale: Studies found that lower doses were needed to achieve a therapeutic international normalized ratio (INR) in Chinese patients.
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