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Chemotherapy Patients

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)
1.8 mg/kg
(n=695)
Ondansetron/
Granisetron*
(n=356)
Headache 169 (24.3%) 73 (20.5%)
Diarrhea 86 (12.4%) 25 (7.0%)
Fever 30 (4.3%) 18 (5.1%)
Fatigue 25 (3.6%) 12 (3.4%)
Hepatic Function Abnorma 25 (3.6%) 12 (3.4%)
Abdominal Pain 22 (3.2%) 7 (2.0%)
Hypertension 20 (2.9%) 9 (2.5%)
Pain 17 (2.4%) 7 (2.0%)
Dizziness 15 (2.2%) 7 (2.0%)
Chills/Shivering 14 (2.0%) 6 (1.7%)
*: Ondansetron 32 mg intravenous, granisetron 3 mg intravenous.
† : Includes events coded as SGOT- and/or SGPT-increased (see also Liver and Biliary System below)

Postoperative Patients

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)
12.5 mg
(n=615)
Placebo
(n=739)
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.

Gastrointestinal System: Constipation, dyspepsia, abdominal pain, anorexia; rarely - pancreatitis.

Hearing, Taste and Vision: Taste perversion, abnormal vision; rarely - tinnitus, photophobia.

Hematologic: Rarely - hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

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.

Musculoskeletal: Rarely - myalgia, arthralgia.

Nervous System: Flushing, vertigo, paraesthesia, tremor; rarely - ataxia, twitching. Psychiatric: Agitation, sleep disorder, depersonalization; rarely - confusion, anxiety, abnormal dreaming.

Respiratory System: Rarely - dyspnea, bronchospasm.

Urinary System: Rarely - dysuria, polyuria, acute renal failure.

Vascular (Extracardiac): Local pain or burning on IV administration; rarely - peripheral ischemia, thrombophlebitis/phlebitis.

Postmarketing Experience:

There are rare reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.