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
Aloxi Side Effects, and Drug Interactions - Palonosetron Hydrochloride
Aloxi Side Effects, and Drug Interactions - Palonosetron Hydrochloride
SIDE EFFECTS
In clinical trials for the prevention of nausea and vomiting
induced by moderately or highly emetogenic chemotherapy, 1374 adult patients
received palonosetron. Adverse reactions were similar in frequency and severity
with ALOXI and ondansetron or dolasetron. Following is a listing of all adverse
reactions reported by ³ 2% of patients in these trials
(Table 4).
|
Table 4:Adverse Reactions from Chemotherapy-Induced
Nausea and Vomiting Studies ³ 2% in
any Treatment Group
|
|
Event
|
ALOXI 0.25 mg (N=633)
|
Ondansetron 32 mg IV (N=410)
|
Dolasetron 100 mg IV (N=194)
|
|
Headache
|
60 (9%)
|
34 (8%)
|
32 (16%)
|
|
Constipation
|
29 (5%)
|
8 (2%)
|
12 (6%)
|
|
Diarrhea
|
8 (1%)
|
7 (2%)
|
4 (2%)
|
|
Dizziness
|
8 (1%)
|
9 (2%)
|
4 (2%)
|
|
Fatigue
|
3 (<1%)
|
4 (1%)
|
4 (2%)
|
|
Abdominal Pain
|
1 (<1%)
|
2 (<1%)
|
3 (2%)
|
|
Insomnia
|
1 (<1%)
|
3 (1%)
|
3 (2%)
|
In other studies,2 subjects experienced severe constipation
following a single palonosetron dose of approximately 0.75 mg, three times the
recommended dose. One patient received a 10 µg/kg oral dose in a post-operative
nausea and vomiting study and one healthy subject received a 0.75 mg IV dose
in a pharmacokinetic study.
In clinical trials, the following infrequently reported adverse
reactions, assessed by investigators as treatment-related or causality unknown,
occurred following administration of ALOXI to adult patients receiving concomitant
cancer chemotherapy:
Cardiovascular: 1%:non-sustained tachycardia, bradycardia,
hypotension,< 1%:hypertension, myocardial ischemia, extrasystoles, sinus
tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation.
In many cases, the relationship to ALOXI was unclear.
Dermatological: < 1%:allergic dermatitis, rash.
Hearing and Vision: < 1%:motion sickness, tinnitus,
eye irritation and amblyopia.
Gastrointestinal System: 1%:diarrhea,< 1%:dyspepsia,abdominal
pain, dry mouth, hiccups and flatulence.
General: 1%:weakness,< 1%:fatigue,fever,hot flash,
flu-like syndrome.
Liver: < 1%:transient,asymptomatic increases in AST
and/or ALT and bilirubin. These changes occurred predominantly in patients receiving
highly emetogenic chemotherapy.
Metabolic: 1%:hyperkalemia,< 1%:electrolyte fluctuations,
hyperglycemia, metabolic acidosis, glycosuria, appetite decrease, anorexia.
Musculoskeletal: < 1%:arthralgia.
Nervous System: 1%:dizziness,< 1%:somnolence,insomnia,hypersomnia,paresthesia.
Psychiatric: 1%:anxiety,< 1%:euphoric mood.
Urinary System: < 1%:urinary retention.
Vascular: < 1%:vein discoloration, vein distention.
DRUG INTERACTIONS
Palonosetron is eliminated from the body through both renal
excretion and metabolic pathways. Therefore, the potential for clinically significant
drug interactions with palonosetron appears to be low (See CLINICAL
PHARMACOLOGY, Drug-Drug Interactions section).
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