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adverse reactions
ADVERSE REACTIONS Depressive illness and suicidal behavior, including suicidal ideation, suicide attempt, and suicides, have been reported in association with the use of alfa-interferon products. The incidence of reported depression has varied substantially among trials, possibly related to the underlying disease, dose, duration of therapy and degree of monitoring, but has been reported to be 15% or higher (see WARNINGS ). For Patients With Chronic Hepatitis C The most frequent adverse experiences were reported to be possibly or probably related to therapy with 3 MIU tiw Roferon-A, were mostly mild to moderate in severity and manageable without the need for discontinuation of therapy. A relative increase in the incidence, severity and seriousness of adverse events was observed in patients receiving doses above 3 MIU tiw. Adverse reactions associated with the 3 MIU dose include: Flu-like Symptoms: Fatigue (58%), myalgia/arthralgia (51%), flu-like symptoms (33%), fever (28%), chills (23%), asthenia (6%), sweating (5%), leg cramps (3%) and malaise (1%). Central and Peripheral Nervous System: Headache (52%), dizziness (13%), paresthesia (7%), confusion (7%), concentration impaired (4%) and change in taste or smell (3%). Gastrointestinal: Nausea/vomiting (33%), diarrhea (20%), anorexia (14%), abdominal pain (12%), flatulence (3%), liver pain (3%), digestion impaired (2%) and gingival bleeding (2%). Psychiatric: Depression (16%), irritability (15%), insomnia (14%), anxiety (5%) and behavior disturbances (3%). Pulmonary and Cardiovascular: Dryness or inflammation of oropharynx (6%), epistaxis (4%), rhinitis (3%), arrhythmia (1%) and sinusitis (<1%). Skin: Injection site reaction (29%), partial alopecia (19%), rash (8%), dry skin or pruritus (7%), hematoma (1%), psoriasis (<1%), cutaneous eruptions (<1%), eczema (<1%) and seborrhea (<1%). Other: Conjunctivitis (4%), menstrual irregularity (2%) and visual acuity decreased (<1%). Patients receiving 6 MIU tiw experienced a higher incidence of severe psychiatric events (9%) than those receiving 3 MIU tiw (6%) in two large US studies. In addition, more patients withdrew from these studies when receiving 6 MIU tiw (11%) than when receiving 3 MIU tiw (7%). Up to half of patients receiving 3 MIU or 6 MIU tiw withdrawing from the study experienced depression or other psychiatric adverse events. At higher doses anxiety, sleep disorders, and irritability were observed more frequently. An increased incidence of fatigue, myalgia/arthralgia, headache, fever, chills, alopecia, sleep disturbances and dry skin or pruritus was also generally observed during treatment with higher doses of Roferon-A. Generally there were fewer adverse events reported in the second 6 months of treatment than in the first 6 months for patients treated with 3 MIU tiw. Patients tolerant of initial therapy with Roferon-A generally tolerate re-treatment at the same dose, but tend to experience more adverse reactions at higher doses. Infrequent adverse events (>1% but <3% incidence) included: cold feeling, cough, muscle cramps, diaphoresis, dyspnea, eye pain, reactivation of herpes simplex, lethargy, edema, sexual dysfunction, shaking, skin lesions, stomatitis, tooth disorder, urinary tract infection, weakness in extremities. Triglyceride levels were not evaluated in the clinical trials. However, hypertriglyceridemia has been reported postmarketing in patients receiving Roferon-A therapy for chronic hepatitis C. For Patients With Chronic Myelogenous Leukemia For patients with chronic myelogenous leukemia, the percentage of adverse events, whether related to drug therapy or not, experienced by patients treated with rIFNα-2a is given below. Severe adverse events were observed in 66% and 31% of patients on study DM84-38 and MI400, respectively. Dose reduction and temporary cessation of therapy were required frequently. Permanent cessation of Roferon-A, due to intolerable side effects, was required in 15% and 23% of patients on studies DM84-38 and MI400, respectively. Flu-like Symptoms: Fever (92%), asthenia or fatigue (88%), myalgia (68%), chills (63%), arthralgia/bone pain (47%) and headache (44%). Gastrointestinal: Anorexia (48%), nausea/vomiting (37%) and diarrhea (37%). Central and Peripheral Nervous System: Headache (44%), depression (28%), decreased mental status (16%), dizziness (11%), sleep disturbances (11%), paresthesia (8%), involuntary movements (7%) and visual disturbance (6%). Pulmonary and Cardiovascular: Coughing (19%), dyspnea (8%) and dysrhythmia (7%). Skin: Hair changes (including alopecia) (18%), skin rash (18%), sweating (15%), dry skin (7%) and pruritus (7%). Uncommon adverse events (<4%) reported in clinical studies included chest pain, syncope, hypotension, impotence, alterations in taste or hearing, confusion, seizures, memory loss, disturbances of libido, bruising and coagulopathy. Miscellaneous adverse events that were rarely observed included Coombs' positive hemolytic anemia, aplastic anemia, hypothyroidism, cardiomyopathy, hypertriglyceridemia and bronchospasm. For Patients With Hairy Cell Leukemia Constitutional (100%): Fever (92%), fatigue (86%), headache (64%), chills (64%), weight loss (33%), dizziness (21%) and flu-like symptoms (16%). Integumentary (79%): Skin rash (44%), diaphoresis (22%), partial alopecia (17%), dry skin (17%) and pruritus (13%). Musculoskeletal (73%): Myalgia (71%), joint or bone pain (25%) and arthritis or polyarthritis (5%). Gastrointestinal (69%): Anorexia (43%), nausea/vomiting (39%) and diarrhea (34%). Head and Neck (45%): Throat irritation (21%), rhinorrhea (12%) and sinusitis (11%). Pulmonary (40%): Coughing (16%), dyspnea (12%) and pneumonia (11%). Central Nervous System (39%): Dizziness (21%), depression (16%), sleep disturbance (10%), decreased mental status (10%), anxiety (6%), lethargy (6%), visual disturbance (6%) and confusion (5%). Cardiovascular (39%): Chest pain (11%), edema (11%) and hypertension (11%). Pain (34%): Pain (24%) and pain in back (16%). Peripheral Nervous System (23%): Paresthesia (12%) and numbness (12%). Rarely (<5%), central nervous system effects including gait disturbance, nervousness, syncope and vertigo, as well as cardiac adverse events including murmur, thrombophlebitis and hypotension were reported. Adverse experiences that occurred rarely, and may have been related to underlying disease, included ecchymosis, epistaxis, bleeding gums and petechiae. Urticaria and inflammation at the site of injection were also rarely observed. In Other Investigational Studies of Roferon-A The following infrequent adverse events have been reported with the investigational use of Roferon-A. Gastrointestinal: Pancreatitis, colitis, gastrointestinal hemorrhage, stomatitis (<5%); constipation (<3%); hepatitis, abdominal fullness, hypermotility, excessive salivation, gastric distress (<1%). Cardiovascular: Palpitations (<3%); myocardial infarction, congestive heart failure, ischemic retinopathy, Raynaud's phenomenon, hot flashes (<1%). Pulmonary: Pneumonitis, some cases responded to interferon cessation and corticosteroid therapy (<5%); chest congestion (<3%); tachypnea (<1%). Central Nervous System and Psychiatric: Stroke, coma, encephalopathy, transient ischemic attacks, dysphasia, hallucinations, gait disturbance, psychomotor retardation, apathy, sedation, irritability, hyperactivity, claustrophobia, loss of libido, ataxia, neuropathy, poor coordination, dysarthria, aphasia, aphonia, amnesia (<1%). Autoimmune Disease: Vasculitis, arthritis, hemolytic anemia and lupus erythematosus syndrome (<3%). Other: Thyroid dysfunction including hypothyroidism and hyperthyroidism, diabetes requiring insulin therapy in some patients (<5%); anaphylactic reactions, eye irritation, earache, cyanosis, flushing of skin (<1%). Abnormal Laboratory Test Values The percentage of patients with chronic hepatitis C, hairy cell leukemia, and with chronic myelogenous leukemia who experienced a significant abnormal laboratory test value ( NCI or WHO grades III or IV ) at least once during their treatment with Roferon-A is shown in Table 2 : Table 2Significant Abnormal Laboratory Test Values Chronic Hepatitis C Chronic Myelogenous Leukemia Patients enrolled in the two clinical studies receiving at least one dose of Roferon-A. Hairy Cell Leukemia (n=203) 3 MIU tiw US Study (n=91) Non-US Study (n=219) (n=218) NAP = Not applicable. NA = Not assessed. Leukopenia 1.5% 20% 3% 45% In the majority of patients, initial hematologic laboratory test values were abnormal due to their underlying disease. Neutropenia 10% 22% 0% 68% Thrombocytopenia 4.5% 27% 5% 62% Anemia (Hb) 0% 15% 4% 31% SGOT NAP 5% 1% 9% Alk. Phosphatase 0% 3% 1% 3% LDH NAP NA NA <1% Proteinuria 0% NA NA 10% Ten percent of the patients experienced a proteinuria >1+ at least once. Elevated triglyceride levels have been observed in patients receiving interferon therapy, including Roferon-A. Chronic Hepatitis C The incidence of neutropenia ( WHO grades III or IV ) was over twice as high in those treated with 6 MIU tiw (21%) as those treated with 3 MIU tiw (10%). Chronic Myelogenous Leukemia In the two clinical studies, a severe or life-threatening anemia was seen in up to 15% of patients. A severe or life-threatening leukopenia and thrombocytopenia were observed in up to 20% and 27% of patients, respectively. Changes were usually reversible when therapy was discontinued. One case of aplastic anemia and one case of Coombs' positive hemolytic anemia were seen in 310 patients treated with rIFNα-2a in clinical studies. Severe cytopenias led to discontinuation of therapy in 4% of all Roferon-A treated patients. Transient increases in liver transaminases or alkaline phosphatase of any intensity were seen in up to 50% of patients during treatment with Roferon-A. Only 5% of patients had a severe or life-threatening increase in SGOT. In the clinical studies, such abnormalities required termination of therapy in less than 1% of patients. Hairy Cell Leukemia Increases in serum phosphorus (≥1.6 mmol/L) and serum uric acid (≥9.1 mg/dL) were observed in 9% and 10% of patients, respectively. The increase in serum uric acid is likely to be related to the underlying disease. Decreases in serum calcium (≤1.9 mmol/L) and serum phosphorus (≤0.9 mmol/L) were seen in 28% and 22% of patients, respectively. Postmarketing Central and Peripheral Nervous System: Somnolence, hearing impairment, hearing loss. Vision: Retinopathy including retinal hemorrhages and cotton-wool spots, papilledema, retinal artery and vein thrombosis and optic neuropathy. Skin: Injection site necrosis. Blood: Idiopathic thrombocytopenic purpura, cyanosis. Renal and Urinary System: Increased blood urea and serum creatinine, decreased renal function and acute renal failure. Endocrine: Hyperglycemia. Immune System Disorder: Sarcoidosis. Respiratory: Pulmonary edema. Metabolic and Nutritional: Cases of hypertriglyceridemia/hyperlipidemia have been reported including some occurring in association with pancreatitis.