670
Table 22.1
Drugs with genetic information in their labels
Drug
Company
Indication
Genotype
Effect
Label
Abacavir
(Ziagen)
GlaxoSmithKline
HIV-1
HLA-B*5701
Hypersensitivity
Screening for the HLA-B*5701 allele
should be done prior to initiating therapy with abacavir
Azathioprine
(Imuran)
Prometheus
Renal allograft
transplantation
TPMT*2, TPMT*3A,
TPMT*3C
Severe myelotoxicity
TPMT genotyping can help identify
patients who are at an increased risk for developing Imuran toxicity
Carbamazepine
(Tegretol)
Novartis
Epilepsy, trigeminal
neuralgia
HLA-B*1502
Stevens-Johnson
syndrome (toxic epidermal necrolysis)
Patients in genetically at-risk populations
should be screened for HLA-B*1502 prior to initiating treatment and those testing positive not be treated with Tegretol
Cetuximab
(Erbitux)
Imclone
Metastatic colorectal
cancer
KRAS mutations
Effi
cacy
Use of Erbitux is not considered effective
for the treatment of patients colorectal cancer who have KRAS mutations in codon 12 or 13
Clopidogrel
(Plavix)
Bristol-Myers
Squibb
Anti-platelet:
prevents strokes and heart attacks
CYP2C19*2*3
Effi
cacy
Alternative treatment should be considered
for patients identifi ed as CYP2C19 poor metabolizers
Irinotecan
(Camptosar)
Pfi zer
Metastatic colorectal
cancer
UGT1A1*28
Diarrhea, neutropenia
A reduction in the starting dose by at least
one level of Camptosar should be considered for patients known to be homozygous for UGT1A1*28 allele
Panitumumab
(Vectibix)
Amgen
Metastatic colorectal
cancer
KRAS mutations
Effi
cacy
Vectibix is ineffective in patients whose
tumors have KRAS mutations
© Jain PharmaBiotech
22 Regulatory Aspects of Personalized Medicine