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In controlled clinical trials, 2265 adult patients received ANZEMET Injection (dolasetron mesylate injection) . The overall adverse event rates were similar with 1.8 mg/kg ANZEMET Injection (dolasetron mesylate injection) and ondansetron or granisetron. Patients were receiving concurrent chemotherapy, predominantly high-dose (≥ 50 mg/m2) cisplatin. Following is a combined listing of all adverse events reported in ≥ 2% of patients in these controlled trials (Table 4).
TABLE 4. ADVERSE EVENTS ≥ 2% FROM CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING STUDIES
|Event|| ANZEMET Injection (dolasetron mesylate injection)
|Hepatic Function Abnorma†||25||(3.6%)||12||(3.4%)|
| *: Ondansetron 32 mg intravenous, granisetron 3 mg intravenous.
† : Includes events coded as SGOT- and/or SGPT-increased (see also Liver and Biliary System below)
In controlled clinical trials with 2550 adult patients, headache and dizziness were reported more frequently with 12.5 mg ANZEMET Injection (dolasetron mesylate injection) than with placebo. Rates of other adverse events were similar. Following is a listing of all adverse events reported in ≥ 2% of patients receiving either placebo or 12.5 mg ANZEMET Injection (dolasetron mesylate injection) for the prevention or treatment of postoperative nausea and vomiting in controlled clinical trials (Table 5).
Table 5. Adverse Events ≥ 2% from Placebo-Controlled Postoperative Nausea and Vomiting Studies
|Event|| ANZEMET Injection (dolasetron mesylate injection)
|Headache||58 (9.4%)||51 (6.9%)|
|Dizziness||34 (5.5%)||23 (3.1%)|
|Drowsiness||15 (2.4%)||18 (2.4%)|
|Pain||15 (2.4%)||21 (2.8%)|
|Urinary Retention||12 (2.0%)||16 (2.2%)|
In clinical trials, the following infrequently reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of ANZEMET to adult patients receiving concomitant cancer chemotherapy or surgery:
Cardiovascular: Hypotension; rarely - edema, peripheral edema. The following events also occurred rarely and with a similar frequency as placebo and/or active comparator: Mobitz I AV block, chest pain, orthostatic hypotension, myocardial ischemia, syncope, severe bradycardia, and palpitations. See PRECAUTIONS section for information on potential effects on ECG.
In addition, the following asymptomatic treatment-emergent ECG changes were seen at rates less than or equal to those for active or placebo controls: bradycardia, tachycardia, T wave change, ST-T wave change, sinus arrhythmia, extrasystole (APCs or VPCs), poor R-wave progression, bundle branch block (left and right), nodal arrhythmia, U wave change, atrial flutter/fibrillation.
Furthermore, severe hypotension, bradycardia and syncope have been reported immediately or closely following IV administration.
Dermatologic: Rash, increased sweating.
Hypersensitivity: Rarely - anaphylactic reaction, facial edema, urticaria.
Liver and Biliary System: Transient increases in AST (SGOT) and/or ALT (SGPT) values have been reported as adverse events in less than 1% of adult patients receiving ANZEMET in clinical trials. The increases did not appear to be related to dose or duration of therapy and were not associated with symptomatic hepatic disease. Similar increases were seen with patients receiving active comparator. Rarely - hyperbilirubinemia, increased GGT.
Metabolic and Nutritional: Rarely - alkaline phosphatase increased.
Respiratory System: Rarely - dyspnea, bronchospasm.
Vascular (Extracardiac): Local pain or burning on IV administration; rarely - peripheral ischemia, thrombophlebitis/phlebitis.
There are rare reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.
Read the Anzemet Injection (dolasetron mesylate injection) Side Effects Center for a complete guide to possible side effects »
The potential for clinically significant drug-drug interactions posed by dolasetron and hydrodolasetron appears to be low for drugs commonly used in chemotherapy or surgery, because hydrodolasetron is eliminated by multiple routes. See PRECAUTIONS, General for information about potential interaction with other drugs that prolong the QTc interval. Blood levels of hydrodolasetron increased 24% when dolasetron was coadministered with cimetidine (nonselective inhibitor of cytochrome P-450) for 7 days, and decreased 28% with coadministration of rifampin (potent inducer of cytochrome P-450) for 7 days. ANZEMET Injection (dolasetron mesylate injection) has been safely coadministered with drugs used in chemotherapy and surgery. As with other agents which prolong ECG intervals, caution should be exercised in patients taking drugs which prolong ECG intervals, particularly QTc.
In patients taking furosemide, nifedipine, diltiazem, ACE inhibitors, verapamil, glyburide, propranolol, and various chemotherapy agents, no effect was shown on the clearance of hydrodolasetron. Clearance of hydrodolasetron decreased by about 27% when dolasetron mesylate was administered intravenously concomitantly with atenolol. ANZEMET did not influence anesthesia recovery time in patients. Dolasetron mesylate did not inhibit the antitumor activity of four chemotherapeutic agents (cisplatin, 5-fluorouracil, doxorubicin, cyclophosphamide) in four murine models.
Last reviewed on RxList: 10/27/2009
This monograph has been modified to include the generic and brand name in many instances.
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