Medication info

Megapaloju (Palonosetron Hydrochloride)

Prescription medicationIntravenous injectionApproval withdrawn
Ingredient · strength
Palonosetron Hydrochloride›0.056mg / 1mL
Manufacturer / importer
LNC Bio Co., Ltd.
Appearance
A colorless, transparent solution in a colorless, transparent prefilled syringe
Packaging
1.5 mL × 5 prefilled syringes, 5 mL × 1 prefilled syringe
Approval status
Approval withdrawn

MFDS item code 202001990 · Approved 2020.03.20

This product's status changed to Approval withdrawn on 2024.09.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of acute and delayed nausea and vomiting associated with cancer treatment; prevention and treatment of postoperative nausea and vomiting
Who receives it
Adults · Children
Adult administration
Adults 1) Prevention of nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.25 mg once by intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection 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 must be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. No dosage adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data for 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
Children (2 months and older) 2 months and older: Prevention of acute nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) once by intravenous infusion over at least 15 minutes, 30 minutes before the start of chemotherapy. Neonates: The safety and efficacy of this drug have not been established (no data are available). Infants (under 24 months): Data on the use of this drug for the prevention of nausea and vomiting induced by antineoplastic chemotherapy are limited.

Ingredients

Manufacturer
LNC Bio Co., Ltd.

Efficacy & effects

Prevention of acute and delayed nausea and vomiting associated with cancer treatment; prevention and treatment of postoperative nausea and vomiting

  • Nausea
  • vomiting
View approved original text

This medication is used to prevent nausea and vomiting induced by chemotherapy in adults and children. It effectively prevents acute and delayed nausea and vomiting occurring in the initial and repeated cycles of moderate to highly emetogenic chemotherapy. Additionally, it helps in preventing nausea and vomiting that may occur within 24 hours of surgery and treats already occurring symptoms. Thus, this drug is used to prevent and treat vomiting symptoms associated with chemotherapy and surgery.

How it is given

Adult administration

Adults 1) Prevention of nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.25 mg once by intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection 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 must be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: Administer 0.075 mg once by intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. No dosage adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data for 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

Children (2 months and older) 2 months and older: Prevention of acute nausea and vomiting induced by antineoplastic chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) once by intravenous infusion over at least 15 minutes, 30 minutes before the start of chemotherapy. Neonates: The safety and efficacy of this drug have not been established (no data are available). Infants (under 24 months): Data on the use of this drug for the prevention of nausea and vomiting induced by antineoplastic chemotherapy are limited.

Precautions

This drug should not be administered to patients who have a hypersensitivity to this drug or its components. Patients who have had hypersensitivity reactions to other selective 5-HT3 receptor antagonists should be cautious as similar reactions may occur with this drug. Since this drug may slow bowel movements, patients with a history of constipation or those with symptoms of intestinal obstruction need to be carefully monitored when administered. Patients taking other serotonergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) should be observed closely due to the risk of serotonin syndrome. This drug is used to prevent nausea and vomiting induced by chemotherapy or to alleviate postoperative nausea and vomiting, and may have side effects such as headache, constipation, diarrhea, dizziness, and fatigue. Rare cardiovascular side effects reported include arrhythmias or blood pressure changes, and skin rashes, pruritus, burning eyes, or dyspepsia may also occur. Caution is advised as this medication may cause dizziness, drowsiness, or fatigue when driving or operating machinery. It should be used during pregnancy only if absolutely necessary, and if breastfeeding, it should be discussed with a doctor whether to stop nursing due to the possibility of the medication being passed into breast milk. No special dosage adjustment is required for the elderly, but caution should be taken as sensitive reactions may occur. In case of overdose, there are no specific antidotes available, so appropriate treatment should be based on symptoms, and dialysis is ineffective. This drug should be stored in a sealed container to avoid exposure to air or moisture, maintaining room temperature between 1°C and 30°C. Additionally, it should be stored away from direct sunlight or strong light to maintain its effectiveness. There are few drug interactions, but caution is required when used with drugs that may prolong the QT interval. If any abnormal symptoms occur while using this medication, the healthcare provider should be notified immediately to take appropriate measures.

Side effects

  • Headache
  • constipation
  • diarrhea
  • dizziness
  • fatigue
  • abdominal pain
  • insomnia
  • nonpersistent tachycardia
  • bradycardia
  • hypotension
Show 186 more
  • hypertension
  • myocardial infarction
  • ectopic beats
  • sinus tachycardia
  • sinus arrhythmia
  • supraventricular 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
  • increased bilirubin
  • hyperkalemia
  • electrolyte disturbances
  • hyperglycemia
  • metabolic acidosis
  • diabetes
  • decreased appetite
  • anorexia
  • arthralgia
  • drowsiness
  • hypersomnia
  • paresthesia
  • anxiety
  • euphoria
  • urinary retention
  • venous discoloration
  • venous dilation
  • neutropenia
  • pruritus
  • dyskinesia
  • injection site pain
  • skin disorders
  • QT prolongation
  • dehydration
  • ECG QT prolongation
  • bradycardia
  • pruritus
  • upper abdominal pain
  • excessive salivation
  • decreased intestinal motility
  • chills
  • increased liver enzyme levels
  • hypokalemia
  • respiratory depression
  • laryngeal spasms
  • anemia
  • dehydration
  • electrolyte imbalance
  • insomnia
  • cough
  • wet cough
  • abdominal distension
  • musculoskeletal pain
  • myalgia
  • severe pain
  • bladder distension
  • urethral disorders
  • nephralgia
  • fatigue
  • fever
  • chest discomfort
  • postoperative pain
  • chills
  • procedural pain
  • postoperative anemia
  • wound secretion
  • hypersensitivity reactions
  • injection site reactions
  • leukopenia
  • generalized weakness
  • death
  • nausea
  • stomatitis
  • sputum diseases
  • chest pain
  • hepatotoxicity
  • hemoptysis
  • axillary pain
  • tuberculosis
  • hypercholesterolemia
  • pelvic pain
  • excessive skin pigmentation
  • oral ulcer formation
  • muscle weakness
  • acute liver failure
  • monocytosis
  • palpitations
  • insensitivity
  • back pain
  • increased sweating
  • tremors
  • lymphedema
  • dry cough
  • epigastric discomfort
  • neck/shoulder pain
  • numbness
  • weakness
  • taste disturbances
  • febrile neutropenia
  • abdominal discomfort
  • unspecified seizures
  • cystitis
  • dysuria
  • dermatitis
  • edema
  • frequent urination
  • limb pain
  • upper respiratory infection
  • pigmentary disorders
  • palm/sole erythromelalgia
  • nail changes
  • postoperative pain
  • hoarseness
  • blurred vision
  • neurotoxicity
  • neuropathy
  • renal impairment
  • nocturia
  • facial flushing
  • acne
  • female perineal pain
  • dysphagia
  • flank pain
  • pharyngitis
  • oral opening disorder
  • oral pain
  • gingivitis
  • gum bleeding
  • decreased red blood cells
  • generalized edema
  • mucositis
  • vaginitis
  • weight loss
  • weight gain
  • pancreatitis
  • dental damage
  • hemorrhoids
  • toothache
  • nasal cold
  • nasal congestion
  • nosebleed
  • runny nose
  • hair loss
  • migraine
  • pneumonia
  • dry skin
  • skin rash
  • yawning
  • anal bleeding
  • anal pain
  • hematuria
  • melena
  • eosinophilia
  • neutrophilia
  • dyspnea
  • erythema
  • flushing
  • pleural effusion
  • acute renal failure
  • shock
  • headache
  • chest pain
  • nausea
  • palpitations
  • peripheral edema
  • atrioventricular block
  • heart disease
  • prolonged coagulation time
  • drowsiness
  • tremor
  • prolonged prothrombin time
  • decreased prothrombin activity
  • flushing

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. It is important to maintain room temperature between 1°C and 30°C. Additionally, storing it away from direct sunlight or strong light is essential to preserve its effectiveness.

Appearance and packaging

Appearance

A colorless, transparent solution in a colorless, transparent prefilled syringe

Package unit

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

Same-ingredient medicines

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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.