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adverse reactions
ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Three hundred twenty-four subjects, with ages ranging from eight months to 75 years, have been exposed to Neumega treatment in clinical studies. Subjects have received up to six (eight in pediatric patients) sequential courses of Neumega treatment, with each course lasting from one to 28 days. Apart from the sequelae of the underlying malignancy or cytotoxic chemotherapy, most adverse events were mild or moderate in severity and reversible after discontinuation of Neumega dosing. In general, the incidence and type of adverse events were similar between Neumega 50 mcg/kg and placebo groups. The most frequently reported serious adverse events were neutropenic fever, syncope, atrial fibrillation, fever and pneumonia. The most commonly reported adverse events were edema, dyspnea, tachycardia, conjunctival injection, palpitations, atrial arrhythmias, and pleural effusions. The most frequently reported adverse reactions resulting in clinical intervention (eg, discontinuation of Neumega, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction symptom) were atrial arrhythmias, syncope, dyspnea, congestive heart failure, and pulmonary edema (see WARNINGS, Fluid Retention and WARNINGS, Cardiovascular Events ). Selected adverse events that occurred in ≥10% of Neumega-treated patients are listed in Table 3 . TABLE 3 SELECTED ADVERSE EVENTS Body System Placebo 50 mcg/kg Adverse Event n=67 (%) n=69 (%) * Occurred in significantly more Neumega-treated patients than in placebo-treated patients. Body as a Whole Edema* 10 (15) 41 (59) Neutropenic fever 28 (42) 33 (48) Headache 24 (36) 28 (41) Fever 19 (28) 25 (36) Cardiovascular System Tachycardia* 2 (3) 14 (20) Vasodilatation 6 (9) 13 (19) Palpitations* 2 (3) 10 (14) Syncope 4 (6) 9 (13) Atrial fibrillation/flutter* 1 (1) 8 (12) Digestive System Nausea/vomiting 47 (70) 53 (77) Mucositis 25 (37) 30 (43) Diarrhea 22 (33) 30 (43) Oral moniliasis* 1 (1) 10 (14) Nervous System Dizziness 19 (28) 26 (38) Insomnia 18 (27) 23 (33) Respiratory System Dyspnea* 15 (22) 33 (48) Rhinitis 21 (31) 29 (42) Cough increased 15 (22) 20 (29) Pharyngitis 11 (16) 17 (25) Pleural effusions* 0 (0) 7 (10) Skin and Appendages Rash 11 (16) 17 (25) Special Senses Conjunctival Injection* 2 (3) 13 (19) The following adverse events also occurred more frequently in cancer patients receiving Neumega than in those receiving placebo: blurred vision, paresthesia, dehydration, skin discoloration, exfoliative dermatitis, and eye hemorrhage. Other than a higher incidence of severe asthenia in Neumega treated patients (10 [14%] in Neumega patients versus two [3%] in placebo patients), the incidence of severe or life-threatening adverse events was comparable in the Neumega and placebo treatment groups. Two patients with cancer treated with Neumega experienced sudden death that the investigator considered possibly or probably related to Neumega. Both deaths occurred in patients with severe hypokalemia (<3.0 mEq/L) who had received high doses of ifosfamide and were receiving daily doses of a diuretic (see WARNINGS, Cardiovascular Events ). Other serious events associated with Neumega were papilledema and cardiovascular events including atrial arrhythmias and stroke. In addition, cardiomegaly was reported in children. The following adverse events, occurring in ≥10% of patients, were observed at equal or greater frequency in placebo-treated patients: asthenia, pain, chills, abdominal pain, infection, anorexia, constipation, dyspepsia, ecchymosis, myalgia, bone pain, nervousness, and alopecia. The incidence of fever, neutropenic fever, flu-like symptoms, thrombocytosis, thrombotic events, the average number of units of red blood cells transfused per patient, and the duration of neutropenia <500 cells/μL were similar in the Neumega 50 mcg/kg and placebo groups. Immunogenicity In clinical studies that evaluated the immunogenicity of Neumega, two of 181 patients (1%) developed antibodies to Neumega. In one of these two patients, neutralizing antibodies to Neumega were detected in an unvalidated assay. The clinical relevance of the presence of these antibodies is unknown. In the post-marketing setting, cases of allergic reactions, including anaphylaxis have been reported (see WARNINGS, Allergic Reactions Including Anaphylaxis ). The presence of antibodies to Neumega was not assessed in these patients. The data reflect the percentage of patients whose test results were considered positive for antibodies to Neumega and are highly dependent on the sensitivity and specificity of the assay. Additionally the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparisons of the incidence of antibodies to Neumega with incidence of antibodies to other products may be misleading. Abnormal Laboratory Values The most common laboratory abnormality reported in patients in clinical trials was a decrease in hemoglobin concentration predominantly as a result of expansion of the plasma volume (see WARNINGS, Fluid Retention ). The increase in plasma volume is also associated with a decrease in the serum concentration of albumin and several other proteins (eg, transferrin and gamma globulins). A parallel decrease in calcium without clinical effects has been documented. After daily SC injections, treatment with Neumega resulted in a two-fold increase in plasma fibrinogen. Other acute-phase proteins also increased. These protein levels returned to normal after dosing with Neumega was discontinued. Von Willebrand factor (vWF) concentrations increased with a normal multimer pattern in healthy subjects receiving Neumega. Post-marketing Reports 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. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reactions, (2) frequency of reporting, or (3) strength of causal connection to Neumega. The following adverse reactions have been reported during the post-marketing use of Neumega: allergic reactions and anaphylaxis/anaphylactoid reactions papilledema visual disturbances ranging from blurred vision to blindness optic neuropathy ventricular arrhythmias capillary leak syndrome renal failure injection site reactions (dermatitis, pain, and discoloration) (see BOXED WARNING , WARNINGS , and CONTRAINDICATIONS ).