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Victoza (liraglutide，利拉鲁肽注射剂) (八)
In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions (6.1)], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established.
Laboratory TestsIn the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown.
7 DRUG INTERACTIONS7.1 Oral MedicationsVictoza causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, Victoza did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, caution should be exercised when oral medications are concomitantly administered with Victoza.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C.
There are no adequate and well-controlled studies of Victoza in pregnant women. Victoza should be used during pregnancy only if the potential benefit justifies the potential risk to the fe
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- |
|
Not classified |
1.2 (0.03) |
2.4 (0.04) |
- |
|
Add-on to Metformin |
Victoza + Metformin
(N = 724) |
Metformin + Sulfonylurea
(N = 242) |
Placebo + Metformin
(N = 121) |
|
Patient not able to self-treat |
0.1 (0.001) |
0 |
0 |
|
Patient able to self-treat |
3.6 (0.05) |
22.3 (0.87) |
2.5 (0.06) |
|
Add-on to Metformin + Rosiglitazone |
Victoza +Metformin + Rosiglitazone
(N = 355) |
None |
Placebo + Metformin + Rosiglitazone
(N = 175) |
|
Patient not able to self-treat |
0 |
- |
0 |
|
Patient able to self-treat |
7.9 (0.49) |
- |
4.6 (0.15) |
|
Not classified |
0.6 (0.01) |
- |
1.1 (0.03) |
|
Add-on to Metformin + Glimepiride |
Victoza + Metformin + Glimepiride
(N = 230) |
Insulin glargine + Metformin + Glimepiride (N = 232) |
Placebo + Metformin + Glimepiride
(N = 144) |
|
Patient not able to self-treat |
2.2 (0.06) |
0 |
0 |
|
Patient able to self-treat |
27.4 (1.16) |
28.9 (1.29) |
16.7 (0.95) |
|
Not classified |
0 |
1.7 (0.04) |
0 |
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