Aloxi (palonosetron hydrochloride) is an antiemetic and anti-nausea agent used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation).
What Are Side Effects of Aloxi?
Common side effects of Aloxi include:
headache,
constipation,
diarrhea,
dizziness, or
tired feeling.
Aloxi may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin. Get medical help right away if you develop the following symptoms while taking Aloxi:
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.
What Drugs, Substances, or Supplements Interact with Aloxi?
Aloxi may interact with diuretics (water pills), or heart rhythm medication.
Aloxi During Pregnancy and Breastfeeding
Tell 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 breastfeeding.
Additional Information
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.
Aloxi Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
nausea, vomiting;
constipation;
slow heartbeats; or
headache.
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.
Serious or otherwise clinically significant adverse reactions reported in other sections of labeling:
Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
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 associated with moderately emetogenic chemotherapy, 161 adult patients received a single oral dose of ALOXI 0. 5 mg. The most common adverse reactions reported in at least 2% of patients in two clinical trials were headache (4%) and constipation (1%). In other clinical trials, fatigue was also reported in 1% of patients.
Less common adverse reactions, reported in less than 1%, were:
Blood and Lymphatic System: anemia.
Cardiovascular: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation.
Liver: transient, asymptomatic increases in bilirubin.
Nutrition: anorexia.
Musculoskeletal: joint stiffness, myalgia, pain in extremity.
Nervous System: postural dizziness, dysgeusia.
Psychiatric: insomnia.
Respiratory System: dyspnea, epistaxis.
Skin: generalized pruritus, erythema, alopecia.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of palonosetron HCl. 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.
Hypersensitivity reactions: including dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticarial, anaphylaxis and anaphylactic shock with intravenous administration of palonosetron HCl [see WARNINGS AND PRECAUTIONS]
&Copy; Aloxi Patient Information is supplied by Cerner Multum, Inc. and Aloxi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
