openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 2 · 5 matching rows.
adverse reactions
6 ADVERSE REACTIONS The overall safety of aprepitant was evaluated in approximately 5300 individuals. 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. Clinical adverse experiences for the CINV regimen in conjunction with highly and moderately emetogenic chemotherapy (incidence >10%) are: alopecia, anorexia, asthenia/fatigue, constipation, diarrhea, headache, hiccups, nausea. ( 6.1 ) Clinical adverse experiences for the PONV regimen (incidence >5%) are: constipation, hypotension, nausea, pruritus, pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Chemotherapy Induced Nausea and Vomiting Highly Emetogenic Chemotherapy In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. EMEND was given in combination with ondansetron and dexamethasone. In Cycle 1, clinical adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 68% of patients treated with standard therapy. Table 1 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%. Table 1: Percent of Patients Receiving Highly Emetogenic Chemotherapy with Clinical Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen (N = 544) Standard Therapy (N = 550) Body as a Whole/Site Unspecified Asthenia/Fatigue Dizziness Dehydration Abdominal Pain Fever Mucous Membrane Disorder 17.8 6.6 5.9 4.6 2.9 2.6 11.8 4.4 5.1 3.3 3.5 3.1 Digestive System Nausea Constipation Diarrhea Vomiting Heartburn Gastritis Epigastric Discomfort 12.7 10.3 10.3 7.5 5.3 4.2 4.0 11.8 12.2 7.5 7.6 4.9 3.1 3.1 Eyes, Ears, Nose, and Throat Tinnitus 3.7 3.8 Hemic and Lymphatic System Neutropenia 3.1 2.9 Metabolism and Nutrition Anorexia 10.1 9.5 Nervous System Headache Insomnia 8.5 2.9 8.7 3.1 Respiratory System Hiccups 10.8 5.6 In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies. Moderately Emetogenic Chemotherapy During Cycle 1 of 2 moderately emetogenic chemotherapy studies, 868 patients were treated with the aprepitant regimen and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In the combined analysis of Cycle 1 data for these 2 studies, adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy. In the combined analysis of Cycle 1 data for these 2 studies, the adverse experience profile in both moderately emetogenic chemotherapy studies was generally comparable to the highly emetogenic chemotherapy studies. Table 2 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3%. Table 2: Percent of Patients Receiving Moderately Emetogenic Chemotherapy with Clinical Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen (N = 868) Standard Therapy (N = 846) Blood and Lymphatic System Disorders Neutropenia 5.8 5.6 Metabolism and Nutrition Disorders Anorexia 6.2 7.2 Psychiatric Disorders Insomnia 2.6 3.7 Nervous System Disorders Headache Dizziness 13.2 2.8 14.3 3.4 Gastrointestinal Disorders Constipation Diarrhea Dyspepsia Nausea Stomatitis 10.3 7.6 5.8 5.8 3.1 15.5 8.7 3.8 5.1 2.7 Skin and Subcutaneous Tissue Disorders Alopecia 12.4 11.9 General Disorders and General Administration Site Conditions Fatigue Asthenia 15.4 4.7 15.6 4.6 In a combined analysis of these two studies, isolated cases of serious adverse experiences were similar in the two treatment groups. Highly and Moderately Emetogenic Chemotherapy The following additional clinical adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen in either HEC or MEC studies: Infections and infestations: candidiasis, herpes simplex, lower respiratory infection, oral candidiasis, pharyngitis, septic shock, upper respiratory infection, urinary tract infection. Neoplasms benign, malignant and unspecified (including cysts and polyps): malignant neoplasm, non-small cell lung carcinoma. Blood and lymphatic system disorders: anemia, febrile neutropenia, thrombocytopenia. Metabolism and nutrition disorders: appetite decreased, diabetes mellitus, hypokalemia. Psychiatric disorders: anxiety disorder, confusion, depression. Nervous system: peripheral neuropathy, sensory neuropathy, taste disturbance, tremor. Eye disorders: conjunctivitis. Cardiac disorders: myocardial infarction, palpitations, tachycardia. Vascular disorders: deep venous thrombosis, flushing, hot flush, hypertension, hypotension. Respiratory, thoracic and mediastinal disorders: cough, dyspnea, nasal secretion, pharyngolaryngeal pain, pneumonitis, pulmonary embolism, respiratory insufficiency, vocal disturbance. Gastrointestinal disorders: abdominal pain upper, acid reflux, deglutition disorder, dry mouth, dysgeusia, dysphagia, eructation, flatulence, obstipation, salivation increased. Skin and subcutaneous tissue disorders: acne, diaphoresis, pruritus, rash. Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscular weakness, musculoskeletal pain, myalgia. Renal and urinary disorders: dysuria, renal insufficiency. Reproductive system and breast disorders: pelvic pain. General disorders and administrative site conditions: edema, malaise, pain, rigors. Investigations: weight loss. Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy in another CINV study. Laboratory Adverse Experiences Table 3 shows the percent of patients with laboratory adverse experiences reported at an incidence ≥3% in patients receiving highly emetogenic chemotherapy. Table 3: Percent of Patients Receiving Highly Emetogenic Chemotherapy with Laboratory Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen (N = 544) Standard Therapy (N = 550) Proteinuria ALT Increased Blood Urea Nitrogen Increased Serum Creatinine Increased AST Increased 6.8 6.0 4.7 3.7 3.0 5.3 4.3 3.5 4.3 1.3 The following additional laboratory adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen: alkaline phosphatase increased, hyperglycemia, hyponatremia, leukocytes increased, erythrocyturia, leukocyturia. The adverse experience profiles in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1. Postoperative Nausea and Vomiting In well-controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40 mg aprepitant orally and 538 patients were administered 4 mg ondansetron IV. Clinical adverse experiences were reported in approximately 60% of patients treated with 40 mg aprepitant compared with approximately 64% of patients treated with 4 mg ondansetron IV. Table 4 shows the percent of patients with clinical adverse experiences reported at an incidence ≥3% of the combined studies. Table 4: Percent of Patients Receiving General Anesthesia with Clinical Adverse Experiences (Incidence ≥3%) Aprepitant 40 mg (N = 564) Ondansetron (N = 538) Infections and Infestations Urinary Tract Infection 2.3 3.2 Blood and Lymphatic System Disorders Anemia 3.0 4.3 Psychiatric Disorders Insomnia 2.1 3.3 Nervous System Disorders Headache 5.0 6.5 Cardiac Disorders Bradycardia 4.4 3.9 Vascular Disorders Hypotension Hypertension 5.7 2.1 4.6 3.2 Gastrointestinal Disorders Nausea Constipation Flatulence Vomiting 8.5 8.5 4.1 2.5 8.6 7.6 5.8 3.9 Skin and Subcutaneous Tissue Disorders Pruritus 7.6 8.4 General Disorders and General Administration Site Conditions Pyrexia 5.9 10.6 The following additional clinical adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant: Infections and infestations: postoperative infection Metabolism and nutrition disorders: hypokalemia, hypovolemia. Nervous system disorders: dizziness, hypoesthesia, syncope. Vascular disorders: hematoma Respiratory, thoracic and mediastinal disorders: dyspnea, hypoxia, respiratory depression. Gastrointestinal disorders: abdominal pain, abdominal pain upper, dry mouth, dyspepsia. Skin and subcutaneous tissue disorders: urticaria General disorders and administrative site conditions: hypothermia, pain. Investigations: blood pressure decreased Injury, poisoning and procedural complications: operative hemorrhage, wound dehiscence. Other adverse experiences (incidence ≤0.5%) reported in patients treated with aprepitant 40 mg for postoperative nausea and vomiting included: Nervous system disorders: dysarthria, sensory disturbance. Eye disorders: miosis, visual acuity reduced. Respiratory, thoracic and mediastinal disorders: wheezing Gastrointestinal disorders: bowel sounds abnormal, stomach discomfort. There were no serious adverse drug-related experiences reported in the postoperative nausea and vomiting clinical studies in patients taking 40 mg aprepitant. Laboratory Adverse Experiences One laboratory adverse experience, hemoglobin decreased (40 mg aprepitant 3.8%, ondansetron 4.2%), was reported at an incidence ≥3% in a patient receiving general anesthesia. The following additional laboratory adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant 40 mg: blood albumin decreased, blood bilirubin increased, blood glucose increased, blood potassium decreased, glucose urine present. The adverse experience of ALT increased occurred with similar incidence in patients treated with aprepitant 40 mg (1.1%) as in patients treated with ondansetron 4 mg (1.0%). Other Studies In addition, two serious adverse experiences were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: one case of constipation, and one case of sub-ileus. Angioedema and urticaria were reported as serious adverse experiences in a patient receiving aprepitant in a non-CINV/non-PONV study. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the drug. Skin and subcutaneous tissue disorders: pruritus, rash, urticaria, rarely Stevens-Johnson syndrome/toxic epidermal necrolysis. Immune system disorders: hypersensitivity reactions including anaphylactic reactions.