Palonosetron Injection (Palonosetron Hydrochloride)

Adult administration

1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer a single 0.25 mg dose of palonosetron by intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer a single 0.075 mg dose 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 medicine is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer a single 0.075 mg dose by intravenous injection over at least 10 seconds. No dose adjustment is required in elderly patients or patients with hepatic or renal impairment. No clinical data are available for patients with end-stage renal disease undergoing dialysis.

Child administration

Aged 2 months or older: For the prevention of acute nausea and vomiting induced by anticancer chemotherapy, administer palonosetron 0.02mg/kg (maximum 1.5mg) by intravenous infusion over at least 15 minutes as a single dose, 30 minutes before the start of chemotherapy. Neonates: The safety and efficacy of this medicine have not been established (no data are available). Infants (under 24 months): Data on the use of this medicine for the prevention of nausea and vomiting induced by anticancer chemotherapy are limited.

This medication should not be administered to patients with a known allergy to this drug or its components. Care must be taken for patients who have shown hypersensitivity to other 5-HT3 receptor antagonists, as hypersensitivity reactions may also occur with this drug. This medication may delay intestinal transit; therefore, careful observation is necessary for patients with a history of constipation or symptoms of bowel obstruction. When used concomitantly with other serotonergic drugs, serious side effects such as serotonin syndrome may occur, thus it should be administered under strict medical supervision. This drug is used to prevent or treat nausea and vomiting, and side effects such as headache, constipation, diarrhea, dizziness, and fatigue may occur after administration. Rarely, cardiovascular adverse reactions such as arrhythmias or blood pressure changes have been reported, thus caution is required in patients with heart diseases. Pregnant women should only use this medication when absolutely necessary as its safety has not been fully established, and breastfeeding women should consult with experts considering the possibility of drug transmission into breast milk. Caution is advised when driving or operating machinery due to the potential symptoms of dizziness or drowsiness.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, severe constipation, non-sustained tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, premature ventricular contractions, sinus tachycardia, sinus arrhythmia, ventricular premature contractions, QT prolongation, allergic dermatitis, rash, motion sickness, tinnitus, burning sensation in the eyes, amblyopia, dyspepsia, dry mouth, hiccups, abdominal bloating, weakness, fever, systemic warmth, flu-like syndrome, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte disturbances, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, perceptual disturbances, anxiety, euphoria, urine retention, venous discoloration, venous dilation, neutropenia, pruritus, abnormal movement disorder, injection site pain, skin diseases, QTc prolongation, dehydration, ECG QT prolongation, bradycardia, pruritus, epigastric pain, excessive salivation, decreased bowel 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 distension, urethral disorder, dysuria, fatigue, chest discomfort, postoperative pain, chills, procedural pain, postoperative anemia, wound exudate, hypersensitivity reaction, injection site reaction, leukopenia, systemic weakness, death, nausea, stomatitis, sputum disease, chest pain, hepatotoxic effects, hemoptysis, axillary pain, tuberculosis, hypercholesterolemia, pelvic pain, excessive skin pigmentation, oral ulceration, muscle weakness, myalgia, 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, boils, edema, frequent urination, limb pain, upper respiratory infection, abnormal pigmentation, palm/sole erythematous sensory disturbance, nail changes, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, sore throat, oral opening disorder, oral pain, gingivitis, gum bleeding, anemia, systemic edema, mucositis, vaginitis, weight loss, weight gain, pancreatitis, dental damage, hemorrhoids, toothache, nasal cold, nasal congestion, nosebleed, runny nose, hair loss, pain, migraine, pneumonia, dry skin, skin rash, yawning, anal bleeding, anal pain, hematuria, hematochezia, eosinophilia, neutrophilia, dyspnea, erythema, flushing, pleural effusion, acute renal failure, shock, headache, atrioventricular block, heart disease, increased coagulation time, drowsiness, tremor, prolonged prothrombin time, reduced prothrombin activity

This drug should be stored at room temperature between 1 and 30 degrees Celsius. It should be placed in a tightly sealed container to avoid air exposure, and it is advisable to store it in a cool place away from direct sunlight or strong light.

Appearance

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

Package unit

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