symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or whithout gastrointestinal symptoms [see Warnings and Precautions (5.2)].
Patients should be instructed to read the Patient Information.
PATIENT PACKAGE INSERT
Patient Information
ALOXI®(Ah-lock-see)
(palonosetronHCl) Injection for Intravenous Use
Read this Patient Information before you receive ALOXI and each time you receive 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.
What is ALOXI?
ALOXI is a prescription medicine called an “antiemetic.”
ALOXI is used in adults to help prevent the nausea and vomiting that happens:
right away or later with certain anti-cancer medicines (chemotherapy)
up to 24 hours while recovering from anesthesia after surgery
ALOXI is used in children 1 month old to less than 17 years of age to help prevent the nausea and vomiting that happens right away with certain anti-cancer medicines (chemotherapy).
It is not known if ALOXI is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
It is not known if ALOXI is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.
Who should not receive ALOXI?
Do not receive ALOXI if you are allergic to palonosetron hydrochloride or any of the ingredients in ALOXI. See the end of this leaflet for a complete list of ingredients in ALOXI.
What should I tell my doctor before receiving ALOXI?
Before receiving ALOXI, tell your doctor about all of your medical conditions, including if you:
have had an allergic reaction to another medicine for nausea or vomiting
are pregnant or plan to become pregnant. It is not known if ALOXI will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ALOXI passes into your breast milk. You and your doctor should decide if you will receive ALOXI if you breastfeed.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive ALOXI?
ALOXI will be given to you in your vein by intravenous (I.V.) injection.
ALOXI is usually given about 30 minutes before you receive your anti-cancer medicine (chemotherapy) or right before anesthesia for surgery.
What are the possible side effects of ALOXI?
ALOXI can cause allergic reactions that can sometimes be serious. Tell your doctor or nurse right away if you have any of the following symptoms of a serious allergic reaction with ALOXI:
hives
swollen face
breathing trouble
chest pain
The most common side effects of ALOXI in adults are headache and constipation.
These are not all the possible side effects from ALOXI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ALOXI
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about ALOXI that is written for health professionals.
What are the ingredients in ALOXI?
Active ingredient: palonosetron hydrochloride
Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water
Mfd by OSO Biopharmaceuticals, LL |
