Important Safety Information

Question 1

Drug induced hepatoxicity with fatal outcome in ….% pts across all clinical trials (n=1225)

Answer 1

.2%

Question 2

Liver function elevations generally occurred

Answer 2

within the first 2 months of treatment

Question 3

Monitor Liver function ….. during the first 2 months

Answer 3

every 2 weeks then once a month as indicated

Question 4

Permanently DC for ALT or AST ……… times ULN with bilirubin more than ……… ULN other wise temporarily suspend or dose reduce as needed

Answer 4

more than 3 times ULN

more than 1.5 times ULN

Question 5

Across clinical trials (1225 pts) % had ILD

Answer 5

2.5%

Question 6

ILD generally occurred …

Answer 6

during the first 2 months

Question 7

In patients with ILD ….

Answer 7

Permanently DC Xalkori

Question 8

QTc prolongation occurred in % of pts

Answer 8

2.7%

Question 9

Bradycardia occurred in …% of pts with a heart rate of less than 50 bbm.

Answer 9

11%

Question 10

Xalkori can cause fetal ….

Answer 10

harm

Question 11

Caution with concomitant use of CYP3A …..

Answer 11

inhibitors

Question 12

Avoid strong CYP3A …… & …….

Answer 12

inhibitors and inducers

Question 13

Use caution in patients with hepatic …

Answer 13

impairment

Question 14

Xalkori is extensively metabolized by the

Answer 14

liver

Question 15

Dose for severe renal patients

Answer 15

250mg once daily