Aloktron Injection (Palonosetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg as a single 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 as a single intravenous injection 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 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 as a single intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is necessary 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

2. Pediatric patients (2 months and older) 1) 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 drug in neonates have not been established (no data are available). Data on the use of this drug for the prevention of nausea and vomiting induced by anticancer chemotherapy in infants (under 24 months) are limited.

This drug should not be used in patients who have allergic reactions to this drug or its components. Patients who have had allergic reactions to similar drugs should be particularly cautious when using this drug. This drug may slow intestinal movement, so patients who frequently experience constipation or have symptoms of intestinal obstruction should be administered carefully under medical supervision. Patients taking other serotonergic medications may experience a serious side effect called serotonin syndrome when combined with this drug, so they should be carefully monitored. This drug is used to prevent or treat nausea and vomiting associated with chemotherapy or surgery and may cause side effects such as headache, constipation, diarrhea, dizziness, etc. Particularly, it can impact the cardiovascular system, so patients with heart diseases or those at risk of QT interval prolongation should use it cautiously. Patients should be attentive while driving or operating machinery as dizziness or drowsiness may occur. Pregnant women should only use this medication when absolutely necessary, and breastfeeding women should consult with experts since the drug may be passed into breast milk. It can also be administered to children and the elderly, but the physician’s judgment is required regarding safety and efficacy. There is no specific antidote for overdose, so immediate medical attention is required for appropriate treatment, and supportive care may be necessary. This medication should be stored away from direct sunlight and at room temperature, and any discoloration or particulate matter should be checked before administration. Leftover medication after administration should be disposed of, and there is a low possibility of drug interactions, but caution is needed when combined with specific medications.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, severe constipation, non-sustained tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, premature 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, generalized warmth, flu-like syndrome, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, pruritus, movement disorders, pain at the injection site, skin disease, QT prolongation, dehydration, electrocardiogram QT prolongation, bradycardia, blood pressure drop, arrhythmia, ventricular premature contractions, generalized edema, decreased T wave amplitude on electrocardiogram, decreased platelet count, abdominal bloating, epigastric pain, excessive salivation, decreased small intestine motility, chills, increased liver enzyme levels, hypokalemia, respiratory depression, laryngospasm, anemia, dehydration, electrolyte imbalance, cough, productive cough, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, extreme pain, bladder distension, urethral disorder, dysuria, fatigue, chest discomfort, postoperative pain, chills, procedural pain, postoperative anemia, wound discharge, hypersensitivity reaction, injection site reaction, leukopenia, systemic weakness, death, nausea, stomatitis, sputum disease, chest pain, hepatotoxicity, hemoptysis, axillary pain, tuberculosis, hypercholesterolemia, pelvic pain, excessive skin pigmentation, oral ulcer formation, muscle weakness, acute liver failure, eye inflammation, monocytosis, palpitations, insensitivity, back pain, increased sweating, tremor, lymphedema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, asthenia, taste disorder, febrile neutropenia, abdominal discomfort, detailed unspecified seizures, cystitis, dysuria, abscess, edema, increased urination, limb pain, upper respiratory tract infection, abnormal pigmentation, palm/soles hyperesthesia, nail changes, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, sore throat, trismus, 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, atrioventricular block, heart disease, prolonged clotting time, drowsiness, tremor, prolonged prothrombin time, decreased prothrombin activity

This medication should be stored at room temperature between 1°C and 30°C, and it is important to keep it sealed in a container to prevent air entry. It should also be stored in a dark place to safely maintain its efficacy and avoid exposure to light.

Appearance

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

Package unit

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