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Details for: ALOXI

Company: ELVIUM LIFE SCIENCES

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02381710ALOXIPALONOSETRON (PALONOSETRON HYDROCHLORIDE)0.25 MG / 5 MLSOLUTIONINTRAVENOUS
02381729ALOXIPALONOSETRON (PALONOSETRON HYDROCHLORIDE)0.5 MGCAPSULEORAL
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Summary Reports

Summary Basis of Decision
Summary Safety Review - Serotonin blocking drugs (serotonin antagonists) ALOXI® (palonosetron), ANZEMET® (dolasetron), KYTRIL® (granisetron) and generics, and ZOFRAN® (ondansetron) and generics - Serotonin Syndrome

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • To prevent nausea and vomiting in adults after taking certain anti-cancer medicines (chemotherapy).
What it does

ALOXI is a medicine called an “antiemetic”. ALOXI blocks the action of the natural substance called serotonin which can cause nausea and vomiting.

When it should not be used

Do not use ALOXI if:

  • you are allergic to palonosetron hydrochloride or any other ingredients in ALOXI capsules.
What the medicinal ingredient is

Medicinal ingredients: Palonosetron hydrochloride

What the non-medicinal ingredients are

Non-medicinal ingredients: Black printing ink, butylated hydroxyanisole, gelatin, glycerin, monoglycerides and diglycerides of capryl/capric acid, polyglyceryl oleate, sorbitol, titanium dioxide, water. May contain traces of medium chain triglyceride and lecithin.

What dosage form it comes in

ALOXI is available in light beige opaque soft gelatine capsules. Each capsule contains 0.5 mg palonosetron (as palonosetron hydrochloride).

Warnings and precautions

Serious Warnings and Precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ALOXI. Talk about any health conditions or problems you may have, including if you:

  • you have any heart disorder, including an irregular heartbeat, prolongation of the QT interval or a family history of QT prolongation or sudden cardiac death at less than 50 years of age.
  • you have low levels of potassium or magnesium.
  • you have high blood pressure.
  • you have liver or kidney problems.
  • you have acute bowel obstruction or a history of repeated constipation.
  • you are pregnant or are planning to become pregnant.
  • you are breast-feeding or plan to breast-feed.
  • you are allergic to other 5-HT3 receptor antagonists such as ondansetron, dolasetron, or granisetron.

Other warnings you should know about:

Serotonin Syndrome:
A rare but potentially life-threatening reaction that can occur with “antiemetic” medicines such as ALOXI. It can cause serious changes in how your brain, muscles and digestive system work.

Serotonin Syndrome symptoms include:

  • fever, sweating, shivering, diarrhea, nausea, vomiting;
  • muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
  • fast heartbeat, changes in blood pressure;
  • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

The reaction is more likely to occur if you also take certain other medications or herbal products. Be sure to tell your healthcare professional all the medicines and natural health products (such as St. John’s Wort) you are taking.

ALOXI may cause severe allergic reaction. Symptoms include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting.

Do not take ALOXI if you are less than 18 years.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

Proper use of this medication

How to take ALOXI:

  • Take one capsule by mouth one hour before the start of chemotherapy
  • ALOXI can be taken with or without food.

Usual Dose

Adults

  • Take one capsule (0.5 mg) by mouth one hour before the start of anti-cancer medicine (chemotherapy).

Overdose

If you think you have taken too much ALOXI, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking ALOXI. If you experience any side effects not listed here, contact your healthcare professional.

Common: headache, constipation
Uncommon: tiredness (fatigue)

Tell your health professional about any side effect that bothers you or that does not go away.

Serious allergic reactions can happen with ALOXI. Tell your doctor if you experience redness or swelling of the skin, itching, chest discomfort or shortness of breath.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Headache    
Uncommon
Fatigue    
Constipation    
Rare
Allergic reaction (swelling of the lips, face, tongue or throat, difficulty in breathing, rash, hives)    
Serotonin Syndrome (fever, sweating, shivering, diarrhea, nausea, vomiting; muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination; fast heartbeat, changes in blood pressure; confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma)    

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store
  • Store at 20 to 25°C; excursions permitted from 15 to 30°C.
  • Keep out of the reach and sight of children.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
  • Call toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about ALOXI:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website, or by calling 1-833-744-0005.

This leaflet was prepared by Elvium Life Sciences, Pickering, ON L1W 3W8.

Last Revised: September 4, 2020

Date modified: