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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in labeling: Nausea • [see Warnings and Precautions ( )] 5.1 Diarrhea • [see Warnings and Precautions ( )] 5.2 Dyspnea • [see Warnings and Precautions ( )] 5.3 Most common adverse reactions (incidence > 4%) in chronic idiopathic constipation are nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence • (6.1) Most common adverse reactions (incidence > 4%) in opioid-induced constipation are nausea and diarrhea ( ) • 6.1 Most common adverse reactions (incidence > 4%) in irritable bowel syndrome with constipation are nausea, diarrhea, and abdominal pain • (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-825-3327 or FDA at 1-800-FDA-1088 or . www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical studies 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. During clinical development of Amitiza for CIC, OIC, and IBS-C, 1234 patients were treated with Amitiza for 6 months and 524 patients were treated for 1 year (not mutually exclusive). Chronic Idiopathic Constipation The data described below reflect exposure to Amitiza 24 mcg twice daily in 1113 patients with chronic idiopathic constipation over 3- or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure (≤ 4 weeks). The placebo population (N = 316) had a mean age of 47.8 (range 21–81) years; was 87.3% female; 80.7% Caucasian, 10.1% African American, 7.3% Hispanic, 0.9% Asian; and 11.7% elderly (≥ 65 years of age). Of those patients treated with Amitiza 24 mcg twice daily (N=1113), the mean age was 50.3 (range 19-86) years; 86.9% were female; 86.1% Caucasian, 7.6% African American, 4.7% Hispanic, 1.0% Asian; and 16.7% elderly (≥ 65 years of age). Table 1 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in dose-finding, efficacy, and long-term clinical studies: Table 1: Percent of Patients with Adverse Reactions (Chronic Idiopathic Constipation) System/Adverse Reaction Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator). Placebo N = 316 % Amitiza 24 mcg Twice Daily N = 1113 % Gastrointestinal disorders Nausea 3 29 Diarrhea 1 12 Abdominal pain 3 8 Abdominal distension 2 6 Flatulence 2 6 Vomiting 0 3 Loose stools 0 3 Abdominal discomfort This term combines "abdominal tenderness," "abdominal rigidity," "gastrointestinal discomfort," “stomach discomfort”, and "abdominal discomfort." 1 3 Dyspepsia < 1 2 Dry mouth < 1 1 Nervous system disorders Headache 5 11 Dizziness 1 3 General disorders and site administration conditions Edema < 1 3 Fatigue 1 2 Chest discomfort/pain 0 2 Respiratory, thoracic, and mediastinal disorders Dyspnea 0 2 The most common adverse reactions (incidence > 4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence. Approximately 29% of patients who received Amitiza 24 mcg twice daily experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea. The rate of nausea associated with Amitiza 24 mcg twice daily was lower among male (8%) and elderly (19%) patients. No patients in the clinical studies were hospitalized due to nausea. Nausea: Approximately 12% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 2% of patients discontinued treatment due to diarrhea. Diarrhea: No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving Amitiza. Electrolytes: The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite. Less common adverse reactions: Opioid -induced Constipation The data described below reflect exposure to Amitiza 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks. The total population (N = 1492) had a mean age of 50.4 (range 20–89) years; was 62.7% female; 82.7% Caucasian, 14.2% African American, 0.8% American Indian/Alaska Native, 0.8% Asian; 5.2% were of Hispanic ethnicity; and 8.8% were elderly (≥ 65 years of age). Table 2 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in efficacy and long-term clinical studies: Table 2: Percent of Patients with Adverse Reactions (OIC Studies) System/Adverse Reaction Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator). Placebo N = 632 % Amitiza 24 mcg Twice Daily N = 860 % Gastrointestinal disorders Nausea 5 11 Diarrhea 2 8 Abdominal pain 1 4 Flatulence 3 4 Abdominal distension 2 3 Vomiting 2 3 Abdominal discomfort This term combines "abdominal tenderness," "abdominal rigidity," "gastrointestinal discomfort," “stomach discomfort”, and "abdominal discomfort." 1 1 Nervous system disorders Headache 1 2 General disorders and site administration conditions Peripheral edema < 1 1 The most common adverse reactions (incidence > 4%) in OIC were nausea and diarrhea. Approximately 11% of patients who received Amitiza 24 mcg twice daily experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea. Nausea: Approximately 8% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea. Diarrhea: The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, blood potassium decreased. Less common adverse reactions: Irritable Bowel Syndrome with Constipation The data described below reflect exposure to Amitiza 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks. The total population (N = 1267) had a mean age of 46.5 (range 18–85) years; was 91.6% female; 77.5% Caucasian, 12.9% African American, 8.6% Hispanic, 0.4% Asian; and 8.0% elderly (≥ 65 years of age). Table 3 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 8 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in dose-finding, efficacy, and long-term clinical studies: Table 3: Percent of Patients with Adverse Reactions (IBS-C Studies) System/Adverse Reaction Includes only those events associated with treatment (possibly or probably related, as assessed by the investigator). Placebo N = 435 % Amitiza 8 mcg Twice Daily N = 1011 % Gastrointestinal disorders Nausea 4 8 Diarrhea 4 7 Abdominal pain 5 5 Abdominal distension 2 3 The most common adverse reactions (incidence > 4%) in IBS-C were nausea, diarrhea, and abdominal pain. Approximately 8% of patients who received Amitiza 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea. Nausea: Approximately 7% of patients who received Amitiza 8 mcg twice daily experienced diarrhea; <1% of patients had severe diarrhea and <1% of patients discontinued treatment due to diarrhea. Diarrhea: The following adverse reactions (assessed by investigator as probably related to treatment) occurred in less than 1% of patients receiving Amitiza 8 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria. Less common adverse reactions: 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of Amitiza. 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. Voluntary reports of adverse reactions occurring with the use of Amitiza include the following: syncope, ischemic colitis, hypersensitivity/allergic-type reactions (including rash, swelling, and throat tightness), malaise, tachycardia, muscle cramps or muscle spasms, and asthenia.