openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Other Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.1) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.2) ] Retinopathy and Other Serious Ocular Adverse Reactions [see Warnings and Precautions (5.3) ] Hepatic Failure [see Warnings and Precautions (5.4) ] Endocrinopathies [see Warnings and Precautions (5.5) ] Most common adverse reactions (>60%) are: fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation at 1-800-526-4099 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 clinical practice. The data described below reflect exposure to SYLATRON in 608 patients with surgically resected, AJCC Stage III melanoma. SYLATRON was studied in an open label, multicenter, randomized, observation controlled trial. The median age of the population was 50 years with 10% of patients 65 years or older, and 42% were female. Fourteen percent of patients completed the 5 year treatment schedule. Patients randomized to SYLATRON were to receive total doses of 48 mcg/kg (6 mcg/kg subcutaneous once weekly for 8 doses), and 780 mcg/kg (3 mcg/kg subcutaneous once weekly until disease recurrence or for up to 5 years), as tolerated. The median total dose received was 42 mcg/kg (range: 6 to 78 mcg/kg) for the first 8 doses, and 136 mcg/kg (range: 1 to 774 mcg/kg) for doses 9 to 260. Serious adverse events were reported in 199 (33%) patients who received SYLATRON and 94 (15%) patients in the observation group. The most common adverse reactions experienced by SYLATRON-treated patients were fatigue (94%), increased ALT (77%), increased AST (77%), pyrexia (75%), headache (70%), anorexia (69%), myalgia (68%), nausea (64%), chills (63%), and injection site reaction (62%). The most common serious adverse reactions were fatigue (7%), increased ALT (3%), increased AST (3%), and pyrexia (3%) in the SYLATRON-treated group vs. <1% in the observation group for these reactions. Thirty three percent of patients receiving SYLATRON discontinued treatment due to adverse reactions. The most common adverse reactions present at the time of treatment discontinuation were fatigue (27%), depression (17%), anorexia (15%), increased ALT (14%), increased AST (14%), myalgia (13%), nausea (13%), headache (13%), and pyrexia (11%). Adverse events that occurred in the clinical study at ≥ 5% incidence in the SYLATRON-treated group and with a greater incidence in patients receiving SYLATRON as compared to the observation group are presented in Table 4 . Table 4: Incidence of Adverse Reactions ( Adverse reactions were graded using NCI CTCAE, V.2.0. ) Occurring in ≥ 5% of Melanoma Patients Treated with SYLATRON and with a Greater Incidence as Compared to Observation Adverse Reaction SYLATRON N=608 Observation N=628 All Grades (%) Grade 3 and 4 (%) All Grades (%) Grade 3 and 4 (%) Any Adverse Reaction 100 51 82 18 General Disorders and Administrative Site Conditions Fatigue 94 16 41 1 Pyrexia 75 4 9 0 Chills 63 1 6 0 Injection Site Reaction 62 1.8 0 0 Metabolic/Laboratory ALT or AST Increased 77 11 26 1 Blood Alkaline Phosphatase Increased 23 0 11 <1 Weight Decreased 11 <1 1 <1 GGT Increased 8 4 1 <1 Proteinuria 7 0 3 0 Anemia 6 <1 2 <1 Nervous System Disorders Headache 70 4 19 1 Dysgeusia 38 0 1 0 Dizziness 35 2 11 <1 Olfactory Nerve Disorder 23 0 1 0 Paraesthesia 21 <1 14 <1 Metabolism and Nutrition Disorders Anorexia 69 3 13 0 Musculoskeletal and Connective Tissue Disorders Myalgia 68 4 23 <1 Arthralgia 51 3 22 1 Gastrointestinal Disorders Nausea 64 3 11 <1 Diarrhea 37 1 8 <1 Vomiting 26 1 4 0 Psychiatric Disorders Depression 59 7 24 <1 Skin and Subcutaneous Tissue Disorders Exfoliative Rash 36 1 4 0 Alopecia 34 0 1 0 Respiratory, Thoracic and Mediastinal Disorders Dyspnea 6 1 2 1 Cough 5 <1 2 0 6.2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. In a clinical study conducted in patients with melanoma, the incidence of binding antibodies to peg-interferon alfa-2b was approximately 35% (50/144 patients). Among the patients who tested positive for binding antibodies, one patient developed neutralizing antibodies. The impact of antibody formation on pharmacokinetics, safety and efficacy of peg-interferon alfa-2b could not be assessed based on limited available data. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SYLATRON with the incidence of antibodies to other products may be misleading. 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of peginterferon alfa-2b as monotherapy and in combination with ribavirin in chronic hepatitis C (CHC) patients. 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. Blood and Lymphatic System Disorders pure red cell aplasia, thrombotic thrombocytopenic purpura Ear and Labyrinth Disorders hearing loss, vertigo, hearing impairment Endocrine Disorders diabetic ketoacidosis Eye Disorders Vogt-Koyanagi-Harada syndrome Gastrointestinal Disorders aphthous stomatitis, pancreatitis, colitis Infusion reactions angioedema, urticaria, bronchoconstriction Immune System Disorders systemic lupus erythematosus, erythema multiforme, thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, and systemic lupus erythematosus Infections sepsis Metabolism and Nutrition Disorders hypertriglyceridemia Musculoskeletal and Connective Tissue Disorders rhabdomyolysis, myositis Nervous System Disorders seizures, memory loss, peripheral neuropathy, paraesthesia, migraine headache Respiratory, Thoracic and Mediastinal Disorders dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, sarcoidosis, pulmonary hypertension, and pulmonary fibrosis Skin and Subcutaneous Tissue Disorders Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis Vascular Disorders hypertension, hypotension, stroke