Palonosetron Hydrochloride Injection

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer a single intravenous injection of palonosetron 0.25 mg over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer a single intravenous injection of 0.075 mg over at least 10 seconds immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended in 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 intravenous injection of 0.075 mg over at least 10 seconds. No dosage adjustment is necessary for elderly patients or patients with hepatic or renal impairment. No clinical data are available for patients with end-stage renal disease undergoing dialysis. Do not mix this medicine with other medicines. Flush the infusion line with normal saline before and after administration of this medicine.

Child administration

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

This medication should not be administered to patients who have hypersensitivity to this drug or its components. Patients who have shown hypersensitivity to other selective 5-HT3 receptor antagonists may also experience hypersensitivity when using this drug, and caution should be exercised. This drug may delay colonic transit time, so patients with a history of constipation or symptoms of subacute intestinal obstruction should be closely monitored during treatment. Patients taking other serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) should be carefully monitored for the occurrence of serotonin syndrome when used in combination with this drug. This drug is used to prevent nausea and vomiting induced by chemotherapy and postoperative nausea and vomiting. Possible side effects when using this drug include headache, constipation, diarrhea, dizziness, fatigue, and in rare cases cardiovascular abnormalities, skin rash, and elevated liver enzyme levels. Caution should be taken when driving or operating machinery due to the possibility of dizziness, drowsiness, and fatigue. When used in conjunction with drugs that have the potential to prolong the QT interval, caution should be exercised considering the possibility of heart-related issues. For pregnant or breastfeeding women, the safety of this drug has not been sufficiently established, so it should only be used when absolutely necessary, and nursing mothers should consult with a healthcare professional regarding the potential transfer of the drug into breast milk and its effects on infants. In cases of overdose, there are no specific antidotes, so supportive treatment should be based on symptoms, and dialysis may not be effective. This drug should be stored at room temperature protected from freezing and light, and before use, the presence of particulates or discoloration must be checked. Any remaining solution after administration should be discarded, and while it can be used in elderly or pediatric patients without special dosage adjustments, caution is required in children as the safety and efficacy have not been sufficiently established.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, 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 and/or ALT, increased bilirubin, hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, perception abnormalities, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, pruritus, dyskinesia, injection site pain, skin disorders, QT prolongation, dehydration, cardiovascular adverse reactions (intermittent tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, ectopic beats, sinus tachycardia, sinus arrhythmia, ventricular ectopic beats), electrocardiogram QT prolongation, sinus bradycardia, tachycardia, blood pressure reduction, arrhythmia, ventricular ectopic beats, generalized edema, electrocardiogram T-wave amplitude reduction, thrombocytopenia, chills, increased liver enzyme levels, hypokalemia, respiratory depression, laryngospasm, insomnia, anemia, dehydration, electrolyte imbalance, hypotension, cough, productive cough, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, extreme pain, bladder distension, urethral disturbances, otalgia, fatigue, fever, chest discomfort, postoperative pain, chills, procedural pain, postoperative anemia, wound secretion, hypersensitivity reactions, injection site reactions (burning sensation, induration, discomfort, pain), leukopenia, systemic weakness, death, nausea, stomatitis, sputum disorders, chest pain, hepatotoxicity, hemoptysis, armpit pain, tuberculosis, hypercholesterolemia, pelvic pain, hyperpigmentation of the skin, oral ulcer formation, muscle weakness, acute liver failure, eye inflammation, monocytosis, palpitations, numbness, back pain, increased sweating, tremors, lymph edema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, weakness, taste abnormalities, febrile neutropenia, abdominal discomfort, unspecified seizures, cystitis, dysuria, pustules, edema, increased urination, limb pain, upper respiratory infection, abnormal pigmentation, palm/sole erythema 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, jaw stiffness, oral pain, gingivitis, gum bleeding, erythrocytopenia, generalized edema, mucositis, vaginitis, weight loss, weight gain, pancreatitis, dental damage, hemorrhoids, toothache, nasal cold, nasal congestion, epistaxis, rhinorrhea, 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, atrioventricular block, heart disease, prolonged coagulation time, delayed prothrombin time, decreased prothrombin activity, drowsiness, tremors

This drug should be stored at room temperature between 1°C and 30°C in a sealed container to prevent air exposure. It is also important to store it away from direct sunlight to maintain the drug's efficacy.

Appearance

A colorless, transparent liquid in a colorless, transparent glass vial injection

Package unit

5 vials (1.5mL/1 vial), 1 vial (5mL/1 vial)