Palonosetron Hydrochloride Injection

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Inject 0.25 mg of palonosetron intravenously once over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Inject 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 medicine is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the probability of its occurrence after surgery is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, inject 0.075 mg intravenously once over at least 10 seconds. 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 receiving dialysis. This medicine must not be mixed with other medicines. Flush the infusion line with normal saline before and after administration of this medicine.

Child administration

Children (2 months and older): 1) Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer 0.02mg/kg (maximum 1.5mg) of palonosetron by intravenous infusion once over at least 15 minutes, 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 who are allergic to it or any of its components. Patients who have had allergic reactions to similar class agents may also experience allergic reactions when using this medication, so caution is advised. This medication may slow intestinal movement, so patients with constipation or symptoms of intestinal obstruction should be observed carefully while using it. Furthermore, serious side effects such as serotonin syndrome can occur when used in combination with other serotonergic medications like selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), so careful observation is necessary. This medication is used to prevent or treat nausea and vomiting and may cause side effects such as headache, constipation, diarrhea, dizziness, and fatigue. Regarding cardiovascular issues, arrhythmias or blood pressure changes may rarely occur, so caution should be exercised. Similar side effects may occur when used before or after surgery, particularly dizziness, headache, or constipation have been reported. Patients should be cautious when driving or operating machinery while taking this medication, as dizziness or drowsiness may occur. During pregnancy, there is insufficient research on the safety of this medication, so it should only be used when absolutely necessary, and during breastfeeding, consultation with a healthcare professional is advised as the medication may be excreted in breast milk. No special dosage adjustment is needed for the elderly, but careful observation is recommended due to potential sensitivity. In case of overdose, there is no specific antidote available; therefore, appropriate treatment should be provided according to the symptoms, and dialysis is ineffective. This medication should be stored away from direct sunlight and in a cool place, and it is necessary to check for discoloration or foreign substances before administration. Do not reuse any remaining solution and dispose of it properly.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, severe constipation, non-sustained tachycardia, bradycardia, hypotension, 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, dyspepsia, dry mouth, hiccups, abdominal distension, weakness, fever, generalized warmth, flu-like syndrome, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte fluctuation, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, pruritus, dyskinesia, pain at the administration site, skin diseases, dehydration, ECG QT prolongation, bradycardia, hypotension, arrhythmia, ventricular ectopic beats, generalized edema, decreased T-wave amplitude on ECG, decreased platelet count, abdominal distension, epigastric pain, excessive salivation, reduced motility of the small intestine, chills, increased liver enzyme levels, hypokalemia, respiratory depression, laryngospasm, anemia, electrolyte imbalance, cough, moist cough, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, severe pain, bladder enlargement, urethral disorder, dysuria, fatigue, fever, chest discomfort, post-operative pain, chills, procedural pain, post-operative anemia, wound exudate, hypersensitivity reaction, injection site reaction, leukopenia, neutropenia, 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, numbness, back pain, increased sweating, tremors, lymphedema, dry cough, discomfort in the epigastric region, neck/shoulder pain, numbness, weakness, taste disturbance, febrile neutropenia, abdominal discomfort, unspecified seizures, cystitis, dysuria, boils, edema, frequent urination, limb pain, upper respiratory infection, pigmentary alteration, palm/sole erythema with altered sensation, nail changes, post-operative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, pain in the female perineum, dysphagia, flank pain, sore throat, 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, rhinitis, 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, drowsiness, tremor, prothrombin time delay, reduced prothrombin activity

This medication should be stored at room temperature between 1°C and 30°C, in a sealed container to prevent exposure to air. Additionally, it is important to store it in a dark place to maintain its effectiveness and avoid direct sunlight.

Appearance

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

Package unit

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