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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT 3 receptor antagonists ( 5.1 ) Serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs ( 5.2 ) 5.1 Hypersensitivity Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT 3 receptor antagonists . Hypersensitivity reactions have been very rarely reported post-marketing for intravenous palonosetron: dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticaria. No hypersensitivity reactions have been reported for oral palonosetron. 5.2 Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT 3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g.,tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ALOXI and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ALOXI and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs [ see Drug Interactions ( 7 ), Patient Counseling Information ( 17 ) ].
6 ADVERSE REACTIONS No adverse reactions have been reported at an incidence of ≥5 % for the 0.5 mg dose. Headache and constipation are the most common adverse reactions but occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact EISAI at 1- 888-422-4743 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy, 693 adult patients received oral palonosetron in doses ranging from 0.25 mg to 0.75 mg. Following is a listing of drug related adverse reactions reported by ≥ 2% of patients from two clinical trials. Table 1: Adverse Reactions ≥ 2% from Chemotherapy-Induced Nausea and Vomiting Studies Event 0.25 mg (N=157) 0.5 mg (N=161) 0.75 mg (N=375) 0.25 mg I.V. (N=163) Headache 6 (3.8%) 6 (3.7%) 21 (5.6%) 14 (8.6%) Constipation 1 (0.6%) 1 (0.6%) 9 (2.4%) 5 (3.1%) The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI Capsules to adult patients receiving concomitant cancer chemotherapy. Of these adverse events, fatigue (incidence 1%), was the only adverse event reported at an incidence of ≥1%. In general, adverse reactions were similar between oral and I.V. formulations. Blood and Lymphatic System: <1%: anemia. Cardiovascular: <1%: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation. Hearing and Labyrinth: <1%: motion sickness. Eye: <1%: eye swelling. Gastrointestinal System: <1%: gastritis, nausea, vomiting. General: 1%: fatigue, <1%: chills, pyrexia. Infections: <1%: sinusitis. Liver: <1%: transient, asymptomatic increases in bilirubin. Nutrition: <1%: anorexia. Musculoskeletal: <1%: joint stiffness, myalgia, pain in extremity. Nervous System: <1%: postural dizziness, dysgeusia. Psychiatric: <1%: insomnia. Respiratory System: <1%: dyspnea, epistaxis. Skin: <1%: generalized pruritus, erythema, alopecia. Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI from post-marketing experience.