A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Anzemet Side Effects, and Drug Interactions - Dolasetron
Anzemet Side Effects, and Drug Interactions - Dolasetron
SIDE EFFECTS
Chemotherapy Patients
In controlled clinical
trials, 943 adult cancer
patients received ANZEMET Tablets. These patients were receiving
concurrent chemotherapy,
predominantly cyclophosphamide and doxorubicin regimens. The following
adverse events were reported in >2% of patients receiving either
ANZEMET 25 mg or ANZEMET
100 mg tablets for prevention
of cancer chemotherapy
induced nausea
and vomiting in controlled clinical
trials (Table 4).
|
Table 4. Adverse Events
>2% from Chemotherapy-Induced Nausea and Vomiting Studies
|
|
Event
|
ANZEMET |
25 mg
(N=235) |
100mg
(N=227) |
| Headache |
42 (17.9%) |
52 (22.9%) |
| Fatigue |
6 (2.6%) |
13 (5.7%) |
| Diarrhea |
5 (2.1%) |
12 (5.3%) |
| Bradycardia |
12 (5.1%) |
9 (4.0%) |
| Dizziness |
3 (1.3%) |
7 (3.1%) |
| Pain |
0 |
7 (3.1%) |
| Tachycardia |
7 (3.0%) |
6 (2.6%) |
| Dyspepsia |
7 (3.0%) |
5 (2.2%) |
| Chills/Shivering |
3 (1.3%) |
5 (2.2%) |
Postoperative Patients
In controlled clinical
trials, 936 adult female
patients have received oral ANZEMET for the prevention
of postoperative nausea
and vomiting. Following is a listing of all adverse events reported
in >2% of patients receiving either placebo
or ANZEMET for prevention
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 100 mg
(N=228)
|
Placebo
(N=231)
|
| Headache |
16 (7.0%) |
11 (4.8%) |
| Hypotension |
12 (5.3%) |
15 (6.5%) |
| Dizziness |
10 (4.4%) |
0 (0.0%) |
| Fever |
8 (3.5%) |
7 (3.0%) |
| Pruritus |
7 (3.1%) |
8 (3.5%) |
| Oliguria |
6 (2.6%) |
3 (1.3%) |
| Hypertension |
5 (2.2%) |
7 (3.0%) |
| Tachycardia |
5 (2.2%) |
2 (0.9%) |
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, T wave
change, ST-T wave change,
sinus arrhythmia,
extrasystole (APCs or VPCs), p.o.
R-wave progression, bundle
branch block
(left and right), nodal
arrhythmia, U wave
change, atrial flutter/fibrillation.
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, paresthesia,
tremor; rarely--ataxia, twitching.
Psychiatric: Agitation, sleep
disorder, depersonalization; rarely--confusion, anxiety, dreaming
abnormal.
Respiratory System: Rarely--dyspnea, bronchospasm.
Urinary System: Rarely--dysuria, polyuria,
acute renal
failure.
Vascular (Extracardiac): Rarely--peripheral ischemia,
thrombophlebitis/phlebitis.
DRUG INTERACTIONS
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 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 does 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.
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