Aloxi
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Aloxi
Aloxi Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Aloxi (palonosetron hydrochloride) is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation). It is an antiemetic and antinausea agent. Common side effects include headache, constipation, diarrhea, or dizziness.
Dosage of Aloxi for adults is a single 0.25 mg I.V. dose administered over 30 seconds, given approximately 30 minutes before the start of chemotherapy. Aloxi may interact with diuretics (water pills), or heart rhythm medication. Tel your doctor all medications you use. Aloxi should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk or may harm a nursing infant. Consult your doctor before breast-feeding.
Our Aloxi (palonosetron hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 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 (Palonosetron hydrochloride) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Aloxi Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Get medical help right away if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.
A serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Aloxi (Palonosetron hydrochloride)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aloxi 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 reported in practice.
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 (palonosetron hydrochloride) and ondansetron or dolasetron. Following is a listing of all adverse reactions reported by ≥2% of patients in these trials (Table 1).
Table 1: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies ≥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 mcg/kg oral dose in a postoperative 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 (palonosetron hydrochloride) 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 (palonosetron hydrochloride) 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.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ALOXI (palonosetron hydrochloride) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Very rare cases (<1/10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from postmarketing experience.
Read the entire FDA prescribing information for Aloxi (Palonosetron hydrochloride) »
Additional Aloxi Information
Aloxi - User Reviews
Aloxi User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Aloxi sorted by most helpful.
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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