ALOXI SIDE EFFECTS

SIDE EFFECTS

Serious or otherwise clinically significant adverse reactions reported in other sections of labeling:

• Hypersensitivity Reactions
• Serotonin Syndrome

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 associated with moderately emetogenic chemotherapy, 161 adult patients received a single oral dose of ALOXI 0. 5 mg. The most common adverse reactions reported in at least 2% of patients in two clinical trials were headache (4%) and constipation (1%). In other clinical trials, fatigue was also reported in 1% of patients.

Less common adverse reactions, reported in less than 1%, were:

• Blood and Lymphatic System: anemia.
• Cardiovascular: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation.
• Hearing and Labyrinth: motion sickness.
• Eye: eye swelling.
• Gastrointestinal System: gastritis, nausea, vomiting.
• General: fatigue, chills, pyrexia.
• Infections: sinusitis.
• Liver: transient, asymptomatic increases in bilirubin.
• Nutrition: anorexia.
• Musculoskeletal: joint stiffness, myalgia, pain in extremity.
• Nervous System: postural dizziness, dysgeusia.
• Psychiatric: insomnia.
• Respiratory System: dyspnea, epistaxis.
• Skin: generalized pruritus, erythema, alopecia.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of palonosetron HCl. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Hypersensitivity reactions: including dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticarial, anaphylaxis and anaphylactic shock with intravenous administration of palonosetron HCl.