Medication info

Yusetrone Injection (Palonosetron Hydrochloride)

Prescription medicationIntravenous injection
Ingredient · strength
Palonosetron Hydrochloride›0.056mg / 1mL
Manufacturer / importer
Yu Young Pharmaceutical Co., Ltd.
Appearance
A colorless and transparent liquid contained in a colorless and transparent prefilled syringe
Packaging
1.5mL x 5 prefilled syringes, 5mL x 1 prefilled syringe
Approval status
Active

MFDS item code 201708545 · Approved 2017.12.22 · Insurance code 648204111,648204121

Summary

Main use
Prevention of chemotherapy-induced nausea and vomiting; prevention and treatment of postoperative nausea and vomiting
Who receives it
Adults · Children
Adult administration
1. Adults 1) Prevention of nausea and vomiting induced by cancer chemotherapy: Administer palonosetron 0.25 mg intravenously once over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended for patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this drug is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. This drug must not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of this drug.
Child administration
2. Pediatric patients (2 months and older) 1) Prevention of acute nausea and vomiting induced by cancer chemotherapy: Administer palonosetron 0.02mg/kg (up to 1.5mg) by intravenous infusion once over at least 15 minutes, 30 minutes before the start of chemotherapy. The safety and efficacy of this drug in neonates have not been established (no data are available). Data on the use of this drug to prevent nausea and vomiting induced by cancer chemotherapy in infants (under 24 months) are limited.

Ingredients

Manufacturer
Yu Young Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention of chemotherapy-induced nausea and vomiting; prevention and treatment of postoperative nausea and vomiting

  • Acute nausea
  • vomiting
  • delayed nausea
  • nausea
  • vomiting
View approved original text

This medication is primarily used in adults and children to prevent acute and delayed nausea and vomiting due to moderately and severely emetogenic chemotherapy. It is also effective for the prevention of nausea and vomiting that may occur within 24 hours post-surgery, as well as for the treatment of nausea and vomiting that has already occurred post-surgery. In children, it is used to prevent acute nausea and vomiting caused by chemotherapy that leads to moderately and severely emetogenic outcomes. This medication effectively improves the vomiting symptoms of patients undergoing chemotherapy and after surgery.

How it is given

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by cancer chemotherapy: Administer palonosetron 0.25 mg intravenously once over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended for patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this drug is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. This drug must not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of this drug.

Child administration

2. Pediatric patients (2 months and older) 1) Prevention of acute nausea and vomiting induced by cancer chemotherapy: Administer palonosetron 0.02mg/kg (up to 1.5mg) by intravenous infusion once over at least 15 minutes, 30 minutes before the start of chemotherapy. The safety and efficacy of this drug in neonates have not been established (no data are available). Data on the use of this drug to prevent nausea and vomiting induced by cancer chemotherapy in infants (under 24 months) are limited.

Precautions

This medication should not be given to patients who are allergic to this medication or its components. Patients who have shown allergic reactions to similar class medications should exercise caution, as they may react to this medication as well. This medication can slow bowel movements; therefore, patients with constipation or signs of intestinal obstruction should be closely monitored. Patients taking other serotonin-related medications should be carefully monitored according to their physician's instructions, as they may experience side effects similar to serotonin syndrome. This medication is used to prevent or treat nausea and vomiting, and may cause side effects such as headaches, constipation, diarrhea, dizziness, and fatigue. Cardiovascular symptoms such as irregular heartbeat or changes in blood pressure have been reported, though most have no clear direct relation to this medication. While animal studies did not reveal significant issues during pregnancy, adequate research in pregnant women is lacking, thus it should be used only when absolutely necessary. For breastfeeding mothers, careful consideration should be given to whether to continue or discontinue breastfeeding, as this medication may be transferred to breast milk. Dizziness, drowsiness, and fatigue may occur, requiring caution when driving or operating machinery. In the case of overdose, there is no specific antidote, and supportive treatment according to symptoms is required; dialysis is not effective. This medication should be stored away from direct sunlight and at room temperature, and it should be checked for discoloration or foreign substances before administration. Elderly patients can use this medication at similar doses as general adults, but should be closely monitored for sensitive reactions.

Side effects

  • Headache
  • constipation
  • diarrhea
  • dizziness
  • fatigue
  • abdominal pain
  • insomnia
  • non-persistent tachycardia
  • bradycardia
  • hypotension
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  • hypertension
  • myocardial infarction
  • ectopic beats
  • sinus tachycardia
  • sinus arrhythmia
  • ventricular ectopic beats
  • QT prolongation
  • allergic dermatitis
  • rash
  • motion sickness
  • tinnitus
  • burning sensation in the eyes
  • amblyopia
  • indigestion
  • dry mouth
  • hiccups
  • abdominal bloating
  • weakness
  • fever
  • generalized heat sensation
  • flu-like syndrome
  • increased AST
  • increased ALT
  • elevated bilirubin
  • hyperkalemia
  • electrolyte changes
  • hyperglycemia
  • metabolic acidosis
  • diabetes
  • decreased appetite
  • anorexia
  • joint pain
  • drowsiness
  • hypersomnia
  • paresthesia
  • anxiety
  • euphoria
  • urinary retention
  • venous discoloration
  • venous dilation
  • neutropenia
  • itching
  • dyskinesia
  • injection site pain
  • skin disorders
  • ECG QT prolongation
  • sinus bradycardia
  • blood pressure drop
  • arrhythmia
  • ventricular ectopy
  • generalized edema
  • decreased T-wave amplitude on ECG
  • decreased platelet count
  • upper abdominal pain
  • excessive salivation
  • decreased intestinal motility
  • chills
  • increased liver enzyme levels
  • hypokalemia
  • respiratory depression
  • laryngospasm
  • anemia
  • dehydration
  • electrolyte imbalance
  • cough
  • wet cough
  • urticaria
  • shoulder pain
  • shoulder discomfort
  • musculoskeletal pain
  • myalgia
  • severe pain
  • bladder dilation
  • urethral disorders
  • dysuria
  • fatigue
  • chest discomfort
  • postoperative pain
  • procedure pain
  • postoperative anemia
  • wound discharge
  • hypersensitivity reactions
  • injection site reactions
  • leukopenia
  • generalized weakness
  • death
  • nausea
  • stomatitis
  • sputum disorders
  • chest pain
  • hepatotoxicity
  • hemoptysis
  • axillary pain
  • tuberculosis
  • hypercholesterolemia
  • pelvic pain
  • excessive skin hyperpigmentation
  • oral ulcer formation
  • muscle weakness
  • acute liver failure
  • eye inflammation
  • monocytosis
  • palpitations
  • numbness
  • back pain
  • increased sweating
  • tremors
  • lymphedema
  • dry cough
  • epigastric discomfort
  • neck/shoulder pain
  • numbness
  • weakness
  • taste disturbance
  • febrile neutropenia
  • abdominal discomfort
  • unspecified seizures
  • cystitis
  • dysuria
  • furunculosis
  • edema
  • frequency of urination
  • limb pain
  • upper respiratory infection
  • pigmentary abnormalities
  • palm/sole erythematous sensory disorder
  • changes in fingernails and toenails
  • postoperative pain
  • hoarseness
  • blurred vision
  • neurotoxicity
  • neuropathy
  • renal impairment
  • nocturia
  • facial flushing
  • acne
  • female perineal pain
  • dysphagia
  • flank pain
  • chills
  • sore throat
  • mouth opening disorder
  • oral pain
  • gingivitis
  • gum bleeding
  • decreased red blood cells
  • generalized edema
  • mucositis
  • vaginitis
  • weight loss
  • weight gain
  • pancreatitis
  • dental damage
  • hemorrhoids
  • toothache
  • cold
  • nasal congestion
  • nosebleed
  • runny nose
  • hair loss
  • pain
  • migraine
  • pneumonia
  • dry skin
  • skin rash
  • yawning
  • rectal bleeding
  • anal pain
  • hematuria
  • melena
  • eosinophilia
  • neutrophilia
  • dyspnea
  • erythema
  • flushing
  • pleural effusion
  • acute renal failure
  • shock
  • headache
  • atrioventricular block
  • heart disease
  • prolonged coagulation time
  • delayed prothrombin time
  • decreased prothrombin activity
  • drowsiness
  • tremor
  • delayed prothrombin time

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored at room temperature between 1°C and 30°C in a sealed container that does not allow air to enter. It is also important to store it in a dark place to avoid exposure to light.

Appearance and packaging

Appearance

A colorless and transparent liquid contained in a colorless and transparent prefilled syringe

Package unit

1.5mL x 5 prefilled syringes, 5mL x 1 prefilled syringe

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.