|
TOP
|
|
INLYTA (axitinib) tablet(七)
|
|
319 |
59 |
2 |
|
ALP increased |
336 |
30 |
1 |
319 |
34 |
1 |
|
Hyperglycemia |
336 |
28 |
2 |
319 |
23 |
2 |
|
Lipase increased |
338 |
27 |
5 |
319 |
46 |
15 |
|
Amylase increased |
338 |
25 |
2 |
319 |
33 |
2 |
|
ALT increased |
331 |
22 |
<1 |
313 |
22 |
2 |
|
AST increased |
331 |
20 |
<1 |
311 |
25 |
1 |
|
Hypernatremia |
338 |
17 |
1 |
319 |
13 |
1 |
|
Hypoalbuminemia |
337 |
15 |
<1 |
319 |
18 |
1 |
|
Hyperkalemia |
333 |
15 |
3 |
314 |
10 |
3 |
|
Hypoglycemia |
336 |
11 |
<1 |
319 |
8 |
<1 |
|
Hyponatremia |
338 |
13 |
4 |
319 |
11 |
2 |
|
Hypophosphatemia |
336 |
13 |
2 |
318 |
49 |
16 |
Selected laboratory abnormalities (all grades) that were reported in <10% of patients treated with Inlyta included hemoglobin increased (above the upper limit of normal) (9% for Inlyta versus 1% for sorafenib).
Drug Interactions
In vitro data indicate that axitinib is metabolized primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
CYP3A4/5 Inhibitors
Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers. Co-administration of Inlyta with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the Inlyta dose should be reduced [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
CYP3A4/5 Inducers
Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers. Co-administration of Inlyta with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Moderate CYP3A4/5 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, and nafcillin) may also reduce the plasma exposure of axitinib and should be avoided if possible.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category D [see Warnings and Precautions (5.12)].
There are no adequate and well- |
