|
TOP
|
|
NOVANTRONE(十九)
|
|
8 |
|
1 |
1 |
|
Cardiac dysrhythmia |
7 |
7 |
|
3 |
3 |
|
Hypokalemia |
7 |
7 |
|
4 |
4 |
|
Neuro/constipation |
7 |
7 |
|
2 |
2 |
|
Neuro/motor disorder |
7 |
7 |
|
3 |
3 |
|
Neuro/mood disorder |
6 |
6 |
|
2 |
2 |
|
Skin disorder |
6 |
6 |
|
4 |
4 |
|
Cardiac ischemia |
5 |
5 |
|
1 |
1 |
|
Chills |
5 |
5 |
|
0 |
0 |
|
Hemorrhage |
5 |
5 |
|
3 |
3 |
|
Myalgias/arthralgias |
5 |
5 |
|
3 |
3 |
|
Other kidney/bladder |
5 |
5 |
|
3 |
3 |
|
Other endocrine |
5 |
6 |
|
3 |
4 |
|
Other pulmonary |
5 |
5 |
|
3 |
3 |
|
Hypertension |
4 |
4 |
|
5 |
5 |
|
Impotence/libido |
4 |
7 |
|
2 |
3 |
|
Proteinuria |
4 |
6 |
|
2 |
3 |
|
Sterility |
3 |
5 |
|
2 |
3 |
General
Allergic Reaction
Hypotension, urticaria, dyspnea, and rashes have been reported occasionally. Anaphylaxis/anaphylactoid reactions have been reported rarely.
Cutaneous
Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning, and/or blue discoloration of the skin. Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting. Phlebitis has also been reported at the site of the infusion.
Hematologic
Topoisomerase II inhibitors, including NOVANTRONE, in combination with other antineoplastic agents or alone, have been associated with the development of acute leukemia (see WARNINGS).
Leukemia
Myelosuppression is rapid in onset and is consistent with the requirement to produce significant marrow hypoplasia in order to achieve a response in acute leukemia. The incidences of infection and bleeding seen in the U.S. trial are consistent with those reported for other standard induction regimens.
Hormone-Refractory Prostate Cancer
In a randomized study where dose escalation was required for neutrophil counts greater than 1000/mm3, Grade 4 neutropenia (ANC < 500 /mm3) was observed in 54% of patients treated with NOVANTRONE + low-dose prednisone. In a separate randomized trial where patients were treated with 14 mg/m2, Grade 4 neutropenia in 23% of patients treated with NOVANTRONE + hydrocortisone wa |
