`Page 3
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`28 JUNE 2005 FINAL VERSION
`
`
`
`
`Patient Information
`
`ALOXI™ (Ah-lock-see)
`Palonosetron HCI injection
`
`Read the Patient Information that comes with ALOXI before your treatment with ALOXI and
`each time you get ALOXI. There may be new information. This information does not take the
`place of talking with your doctor about your medical condition or your treatment. If you have
`questions about ALOXI, ask your doctor or pharmacist.
`
`
`What is ALOXI?
`
`ALOXI is a medicine called an “antiemetic.” ALOXI is used in adults to help prevent the
`nausea and vomiting that happens:
`•
`right away with certain anti-cancer medicines (chemotherapy)
`• or later with certain anti-cancer medicines
`
`
`What is ALOXI used for?
`
`ALOXI is used to prevent nausea and vomiting that may happen:
`• soon after taking certain anti-cancer medicines
`•
`later after taking certain anti-cancer medicines
`
`
`Who should not take ALOXI?
`Do not take ALOXI if you are allergic to any of the ingredients in ALOXI. The active
`ingredient is palonosetron hydrochloride. See the end of this leaflet for a complete list of
`
`ingredients in ALOXI.
`
`ALOXI has not been studied in children under 18 years of age.
`What should I tell my doctor before using ALOXI?
`Tell your doctor about all of your medical conditions, including if you:
`
`
`
`NDA 21-372/S-002
`Page 4
`
`
`• have heart problems including a problem called “congenital QT syndrome”
`• have low potassium in your blood
`• have low magnesium in your blood
`• are pregnant. It is not known if ALOXI may harm your unborn baby. You and your
`doctor should decide if ALOXI is right for you.
`• are breastfeeding. It is not known if ALOXI passes into your milk and if it can harm
`your baby. You should choose to either take ALOXI or breastfeed, but not both.
`
`
`Tell your doctor about all of the medicines you take including prescription and
`nonprescription medicines, vitamins and herbal supplements. ALOXI should be given
`with caution in patients who may be taking other medicines that have caused, or may cause,
`
`severe heart beat changes.
` Especially, tell your doctor if you take:
`“water pills” (diuretics)
`• medicine to control your heartbeat (anti-arrhythmics)
`
`•
`
`• anthracycline (an anti-cancer medicine)
`
`
`How should I use ALOXI?
`
`ALOXI is given in your vein by IV (intravenous) injection. It is only given to you by a
`healthcare provider in a hospital or clinic. ALOXI is usually injected into your vein about 30
`minutes before you get your anti-cancer medicine (chemotherapy).
`
`What are the possible side effects of ALOXI?
`
`ALOXI should be given with caution in patients who have or may develop severe heart beat
`changes from QT prolongation. This can happen in people who have certain heart or other
`
`medical problems or who take certain medicines.
`
`The most common side effects of ALOXI are headache and constipation. Diarrhea and
`dizziness have also been observed.
`
`These are not all the side effects from ALOXI. For more information ask your doctor or
`pharmacist.
`
`
`
`NDA 21-372/S-002
`Page 5
`
`
`General information about ALOXI
`
`Medicines are sometimes prescribed for conditions other than those listed in patient
`information leaflets. ALOXI was prescribed for your medical condition.
`
`This leaflet summarizes the most important information about ALOXI. If you would like more
`
`information, talk with your doctor. You can ask your doctor or pharmacist for information
`about ALOXI that is written for health professionals. You can also visit the ALOXI web site at
`www.ALOXI.com. Or visit www.ManageCINV.com. This is a web site for patients with
`nausea and vomiting from anti-cancer medicines.
`
`
`What are the ingredients in ALOXI?
`
`Active ingredient: palonosetron hydrochloride
`Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water
`
`Rx Only
`
`Mfd by Cardinal Health, Albuquerque, NM, USA and Helsinn Birex Pharmaceuticals, Dublin, Ireland.
`HELSINN, Mfd for Helsinn Healthcare SA, Switzerland
`
`
`MGI PHARMA, INC. Distributed and marketed by MGI PHARMA, INC. Bloomington, MN. 55437 under license of Helsinn Healthcare SA,
`
`Switzerland.
`
`
`ALOXI™ is a trademark of Helsinn Healthcare, SA, Lugano, Switzerland
`©2004 MGI PHARMA, INC. Bloomington, MN. 55437 U.S.A. 445091002 2/04
`
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