Aloxi Capsules
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Aloxi Capsules
Aloxi Capsules Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Aloxi Capsules in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include:
- headache;
- constipation; or
- tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Aloxi Capsules (Palonosetron HCl Capsules) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aloxi Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy, 693 adult patients received oral palonosetron in doses ranging from 0.25 mg to 0.75 mg. Following is a listing of drug related adverse reactions reported by ≥ 2% of patients from two clinical trials.
Table 1: Adverse Reactions ≥ 2% from Chemotherapy-Induced Nausea
and Vomiting Studies
| Event | 0.25 mg (N=157) |
0.5 mg (N=161) |
0.75 mg (N=375) |
0.25 mg I.V. (N=163) |
| Headache | 6 (3.8%) | 6 (3.7%) | 21 (5.6%) | 14 (8.6%) |
| Constipation | 1 (0.6%) | 1 (0.6%) | 9 (2.4%) | 5 (3.1%) |
The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI (palonosetron hcl capsules) Capsules to adult patients receiving concomitant cancer chemotherapy. Of these adverse events, fatigue (incidence 1%), was the only adverse event reported at an incidence of ≥ 1%. In general, adverse reactions were similar between oral and I.V. formulations.
Blood and Lymphatic System: <1%: anemia.
Cardiovascular: <1%: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation.
Hearing and Labyrinth: <1%: motion sickness.
Eye: <1%: eye swelling.
Gastrointestinal System: <1%: gastritis, nausea, vomiting.
General: 1%: fatigue, <1%: chills, pyrexia.
Infections: <1%: sinusitis.
Liver: <1%: transient, asymptomatic increases in bilirubin.
Nutrition: <1%: anorexia.
Musculoskeletal: <1%: joint stiffness, myalgia, pain in extremity.
Nervous System: <1%: postural dizziness, dysgeusia.
Psychiatric: <1%: insomnia.
Respiratory System: <1%: dyspnea, epistaxis.
Skin: <1%: generalized pruritus, erythema, alopecia.
Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI (palonosetron hcl capsules) from post-marketing experience.
Read the entire FDA prescribing information for Aloxi Capsules (Palonosetron HCl Capsules) »
Additional Aloxi Capsules Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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