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TOP
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CAPRELSA(vandetanib)tablet(十)
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Potassium Increased
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13 (6%)
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1 (<1%)
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4 (4%)
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2 (2%)
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Glucose Increased
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12 (5%)
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4 (2%)
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7 (7%)
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0
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Magnesium Increased
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6 (3%)
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0
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4 (4%)
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0
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Hematologic
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WBC Decreased
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45 (19%)
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0
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25 (25%)
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0
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Hemoglobin Decreased
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31 (13%)
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1 (<1%)
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19 (19%)
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2 (2%)
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Neutrophils Decreased
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21 (10%)
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1 (<1%)
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5 (5%)
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2 (2%)
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Platelets Decreased
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18 (9%)
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0
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3 (3%)
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0
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Alanine aminotransferase elevations occurred in 51% of patients on CAPRELSA in the randomized medullary thyroid cancer (MTC) study. Grade 3-4 ALT elevations were seen in 2% of patients and no patients had a concomitant increase in bilirubin. Elevations in ALT have resulted in temporary discontinuation of CAPRELSA. However, 16 of 22 patients with a grade 2 elevation in ALT continued 300 mg CAPRELSA. Seven patients who continued CAPRELSA had a normal ALT within 6 months. In the protocol, ALT was monitored every 3 months and more frequently as indicated.
7. DRUG INTERACTIONS
7.1 CYP3A4 Inducers
Drugs that are CYP3A4 inducers can alter CAPRELSA plasma concentrations. The concomitant use of known strong CYP3A4 inducers should be avoided while receiving CAPRELSA therapy. St. John’s Wort may decrease CAPRELSA exposure unpredictably and should be avoided [see Dosage and Administration (2.3) and Warnings and Precautions (5.11)].
7.2 CYP3A4 Inhibitors
In healthy subjects, no clinically significant interaction was shown between CAPRELSA and the potent CYP3A4 inhibitor, itraconazole.
7.3 Drugs that Prolong the QT Interval
The administration of CAPRELSA with agents that may prolong the QT interval should be avoided [see Warnings and Precautions (5.11)].
8. USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
Pregnancy Category D [see Warnings and Precautions (5.14)]
CAPRELSA can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of CAPRELSA in pregnant women. CAPRELSA is embryotoxic, fetotoxic, and teratogenic to rats, at exposures equivalent to or lower than those expected at the recommended human dose of 300 mg/day. When vandetanib was administered to female rats prior to mating and through the first week of pregnancy, there were increases in pre-implantation loss and post-implantation loss resulting in a significant reduction in the number of live embryos. This dose administered to rats during organogenesis, caused an increase in post-implantation loss including embryofetal death. Vandetanib caused total |
