palonosetron HCl injection Full Patient Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron HCl Injection [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonosetron HCl Injection and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.2)].

PATIENT INFORMATION
Palonosetron HCl
(PAL-oh-NOE-se-tron HYE-droe-KLOR-ide)
injection, for intravenous use
Read this Patient Information before you receive Palonosetron HCl Injection and each time you receive Palonosetron HCl Injection. 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 Palonosetron HCl Injection?
Palonosetron HCl Injection is a prescription medicine called an "antiemetic."
Palonosetron HCl Injection 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
Palonosetron HCl Injection 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 Palonosetron HCl Injection is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
  • It is not known if Palonosetron HCl Injection is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.
Who should not receive Palonosetron HCl Injection?
Do not receive Palonosetron HCl Injection if you are allergic to palonosetron hydrochloride or any of the ingredients in Palonosetron HCl Injection. See the end of this leaflet for a complete list of ingredients in Palonosetron HCl Injection.
What should I tell my doctor before receiving Palonosetron HCl Injection?
Before receiving Palonosetron HCl Injection, 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 Palonosetron HCl Injection will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Palonosetron HCl Injection passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you will receive Palonosetron HCl Injection.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Palonosetron HCl Injection and certain other medicines can affect each other, causing serious side effects.
How will I receive Palonosetron HCl Injection?
  • Palonosetron HCl Injection will be given to you in your vein by intravenous (I.V.) injection.
  • Palonosetron HCl Injection 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 Palonosetron HCl Injection?
Palonosetron HCl Injection may cause serious side effects, including:
  • Serious allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms.
  • hives
  • swollen face
  • breathing trouble
  • chest pain
  • Serotonin Syndrome. A possible life threatening problem called serotonin syndrome can happen with medicines called 5-HT3 receptor antagonists, including Palonosetron HCl Injection, especially when used with medicines used to treat depression and migraine headaches called serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines. Tell your doctor or nurse right away if you have any of the following symptoms of serotonin syndrome:
  • agitation, seeing things that are not there (hallucinations), confusion, or coma
  • dizziness, sweating, flushing, or fever
  • seizures
  • fast heartbeat or unusual and frequent changes in your blood pressure
  • tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination
  • nausea, vomiting, or diarrhea
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens with certain anti-cancer medicine (chemotherapy) include: headache and constipation.
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens while recovering from anesthesia after surgery include: serious or life-threatening heart rhythm changes (QT prolongation), slow heartbeat, headache, and constipation.
These are not all the possible side effects from Palonosetron HCl Injection.
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 Palonosetron HCl Injection
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 Palonosetron HCl Injection that is written for health professionals.
What are the ingredients in Palonosetron HCl Injection?
Active ingredient: palonosetron hydrochloride Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 04/2021

Rx only

Distributed by Hospira, Inc. Lake Forest, IL 60045 USA

Logo

LAB-0946-5.0

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Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron HCl Injection [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonosetron HCl Injection and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.2)].

PATIENT INFORMATION
Palonosetron HCl
(PAL-oh-NOE-se-tron HYE-droe-KLOR-ide)
injection, for intravenous use
Read this Patient Information before you receive Palonosetron HCl Injection and each time you receive Palonosetron HCl Injection. 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 Palonosetron HCl Injection?
Palonosetron HCl Injection is a prescription medicine called an "antiemetic."
Palonosetron HCl Injection 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
Palonosetron HCl Injection 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 Palonosetron HCl Injection is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
  • It is not known if Palonosetron HCl Injection is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.
Who should not receive Palonosetron HCl Injection?
Do not receive Palonosetron HCl Injection if you are allergic to palonosetron hydrochloride or any of the ingredients in Palonosetron HCl Injection. See the end of this leaflet for a complete list of ingredients in Palonosetron HCl Injection.
What should I tell my doctor before receiving Palonosetron HCl Injection?
Before receiving Palonosetron HCl Injection, 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 Palonosetron HCl Injection will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Palonosetron HCl Injection passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you will receive Palonosetron HCl Injection.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Palonosetron HCl Injection and certain other medicines can affect each other, causing serious side effects.
How will I receive Palonosetron HCl Injection?
  • Palonosetron HCl Injection will be given to you in your vein by intravenous (I.V.) injection.
  • Palonosetron HCl Injection 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 Palonosetron HCl Injection?
Palonosetron HCl Injection may cause serious side effects, including:
  • Serious allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms.
  • hives
  • swollen face
  • breathing trouble
  • chest pain
  • Serotonin Syndrome. A possible life threatening problem called serotonin syndrome can happen with medicines called 5-HT3 receptor antagonists, including Palonosetron HCl Injection, especially when used with medicines used to treat depression and migraine headaches called serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines. Tell your doctor or nurse right away if you have any of the following symptoms of serotonin syndrome:
  • agitation, seeing things that are not there (hallucinations), confusion, or coma
  • dizziness, sweating, flushing, or fever
  • seizures
  • fast heartbeat or unusual and frequent changes in your blood pressure
  • tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination
  • nausea, vomiting, or diarrhea
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens with certain anti-cancer medicine (chemotherapy) include: headache and constipation.
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens while recovering from anesthesia after surgery include: serious or life-threatening heart rhythm changes (QT prolongation), slow heartbeat, headache, and constipation.
These are not all the possible side effects from Palonosetron HCl Injection.
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 Palonosetron HCl Injection
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 Palonosetron HCl Injection that is written for health professionals.
What are the ingredients in Palonosetron HCl Injection?
Active ingredient: palonosetron hydrochloride Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 04/2021

Rx only

Distributed by Hospira, Inc. Lake Forest, IL 60045 USA

Logo

LAB-0946-5.0
Prescribing Information
Download Prescribing Information

Health Professional Information

Full Patient Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. Advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur with administration of Palonosetron HCl Injection [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise patients of the possibility of serotonin syndrome, especially with concomitant use of Palonosetron HCl Injection and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.2)].

PATIENT INFORMATION
Palonosetron HCl
(PAL-oh-NOE-se-tron HYE-droe-KLOR-ide)
injection, for intravenous use
Read this Patient Information before you receive Palonosetron HCl Injection and each time you receive Palonosetron HCl Injection. 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 Palonosetron HCl Injection?
Palonosetron HCl Injection is a prescription medicine called an "antiemetic."
Palonosetron HCl Injection 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
Palonosetron HCl Injection 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 Palonosetron HCl Injection is safe and effective in children less than 1 month old to help prevent nausea and vomiting after chemotherapy.
  • It is not known if Palonosetron HCl Injection is safe and effective in children for the prevention of nausea and vomiting while recovering from anesthesia after surgery.
Who should not receive Palonosetron HCl Injection?
Do not receive Palonosetron HCl Injection if you are allergic to palonosetron hydrochloride or any of the ingredients in Palonosetron HCl Injection. See the end of this leaflet for a complete list of ingredients in Palonosetron HCl Injection.
What should I tell my doctor before receiving Palonosetron HCl Injection?
Before receiving Palonosetron HCl Injection, 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 Palonosetron HCl Injection will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Palonosetron HCl Injection passes into your breast milk or if it will affect your baby or your breast milk. Talk to your doctor about the best way to feed your baby if you will receive Palonosetron HCl Injection.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Palonosetron HCl Injection and certain other medicines can affect each other, causing serious side effects.
How will I receive Palonosetron HCl Injection?
  • Palonosetron HCl Injection will be given to you in your vein by intravenous (I.V.) injection.
  • Palonosetron HCl Injection 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 Palonosetron HCl Injection?
Palonosetron HCl Injection may cause serious side effects, including:
  • Serious allergic reactions, such as anaphylaxis. Get emergency medical help right away if you get any of the following symptoms.
  • hives
  • swollen face
  • breathing trouble
  • chest pain
  • Serotonin Syndrome. A possible life threatening problem called serotonin syndrome can happen with medicines called 5-HT3 receptor antagonists, including Palonosetron HCl Injection, especially when used with medicines used to treat depression and migraine headaches called serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and certain other medicines. Tell your doctor or nurse right away if you have any of the following symptoms of serotonin syndrome:
  • agitation, seeing things that are not there (hallucinations), confusion, or coma
  • dizziness, sweating, flushing, or fever
  • seizures
  • fast heartbeat or unusual and frequent changes in your blood pressure
  • tremors, stiff muscles, muscle twitching, overactive reflexes, or loss of coordination
  • nausea, vomiting, or diarrhea
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens with certain anti-cancer medicine (chemotherapy) include: headache and constipation.
The most common side effects in adults who receive Palonosetron HCl Injection to help prevent nausea and vomiting that happens while recovering from anesthesia after surgery include: serious or life-threatening heart rhythm changes (QT prolongation), slow heartbeat, headache, and constipation.
These are not all the possible side effects from Palonosetron HCl Injection.
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 Palonosetron HCl Injection
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 Palonosetron HCl Injection that is written for health professionals.
What are the ingredients in Palonosetron HCl Injection?
Active ingredient: palonosetron hydrochloride Inactive ingredients: mannitol, disodium edetate, and citrate buffer in water

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 04/2021

Rx only

Distributed by Hospira, Inc. Lake Forest, IL 60045 USA

Logo

LAB-0946-5.0

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