Aloxi Capsules - Consumer Medicine Information
|Condition:||Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative|
|Class:||5HT3 receptor antagonists, Antiemetic/antivertigo agents|
|Ingredients:||palonosetron hydrochloride, Mono-glycerides and di-glycerides of capryl/capric acid, glycerin, polyglyceryl oleate, water, and butylate hydroxyanisole|
as palonosetron hydrochloride
About This Medication
What the Medication is Used For
ALOXI (Ah-lock-see) is a prescription medicine used in adults to help prevent the acute nausea and vomiting that happens with certain anti-cancer medicines (chemotherapy).
What It Does
ALOXI is a medicine called an “antiemetic”. ALOXI blocks the action of the natural substance, serotonin, which can cause nausea and vomiting.
When It Should not be Used
Do not take ALOXI if you are allergic to palonosetron hydrochloride or any of the other ingredients in ALOXI capsules.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Monoglycerides and diglycerides of capryl/capric acid, gelatin, sorbitol, glycerin, water, polyglyceryl oleate, titanium dioxide, butylated hydroxyanisole, and black printing ink. May contain traces of medium chain triglyceride and lecithin.
What Dosage Form It Comes InALOXI is available in light beige opaque soft gelatine capsules. Each capsule contains 0.5 mg palonosetron as palonosetron hydrochloride.
Warnings and Precautions
BEFORE you use ALOXI talk to your doctor or pharmacist if:
- 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
- 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
Serotonin Syndrome is a rare but potentially life-threatening reaction that can occur with “antiemetic” medicines. 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. Be sure to tell your healthcare professional all the medicines 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 old.
Interactions With This Medication
As with most medicines, interactions with other drugs are possible. To avoid potentially life-threatening reactions, tell your healthcare professional about ALL the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Proper Use of This Medication
0.5 mg (one capsule) by mouth about an hour before you get your anti-cancer medicine (chemotherapy). ALOXI can be taken with or without food.
If you take more ALOXI than you should or in case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side Effects and What to Do About Them
The possible side effects are:
Common: headache, constipation
Uncommon: tiredness (fatigue)/p>
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, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Allergic reaction (swelling of the lips, face, tongue or throat, difficulty in breathing, rash, hives)||✓|
This is not a complete list of side effects. For any unexpected effects while taking ALOXI, contact your doctor or pharmacist.
How to Store It
Store at 20-25°C; excursions permitted from 15-30°C.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Eisai Limited, at: 1-877-873-4724
ALOXI is a registered trademark of Helsinn Healthcare SA used under license by Eisai Limited.