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Applies to tigecycline: intravenous powder for solution
Intravenous route (Powder for Solution)
An increase in all-cause mortality was observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI, 0.1 to 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable.
Along with its needed effects, tigecycline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking tigecycline:
Incidence not known
Some side effects of tigecycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to tigecycline: intravenous powder for injectionGeneral
In clinical trials, 2514 patients were treated with this drug. In comparative trials, serious side effects related to infection were reported more often in patients treated with this drug (7%) versus comparators (6%), with sepsis/septic shock reported in 2% and 1% of patients treated with this drug and comparator drugs, respectively. The most common side effects were nausea and vomiting which usually occurred within the first 2 days of therapy and were of mild or moderate severity. This drug was discontinued due to side effects in 7% of patients (compared to 6% for all comparators). Discontinuation was most often due to nausea (1%) and vomiting (1%) inpatients treated with this drug and nausea (less than 1%) in comparator-treated patients.
In all 13 phase 3 and 4 trials that included a comparator, death occurred in 4% and 3% of patients receiving this drug and comparator drugs, respectively. The cause of this imbalance has not been determined. In general, deaths resulted from worsening infection, complications of infection, or underlying comorbidities.Gastrointestinal
Acute pancreatitis (including fatal cases) has been associated with this drug. Cases have been reported in patients without known risk factors for pancreatitis. In general, patients improved after this drug was stopped.
Very common (10% or more): Nausea (up to 35%), vomiting (up to 20%), diarrhea (12%)
Common (1% to 10%): Abdominal pain, increased amylase, dyspepsia
Frequency not reported: Abnormal stools, Clostridium difficile-associated diarrhea, pseudomembranous colitis, pancreatitis (including interstitial/edematous pancreatitis, acute necrotizing pancreatitis), constipation, dry mouth
Postmarketing reports: Acute pancreatitisOther
Common (1% to 10%): Infection, asthenia, increased alkaline phosphatase, abnormal healing, abscess, sepsis/septic shock
Frequency not reported: Chills, death, mortality imbalance, lower cure rates, fever, pain, local reaction to procedure, increased lactic dehydrogenase, peripheral edema, wound infections
In a trial of patients with hospital-acquired (including ventilator-associated) pneumonia, patients used this drug or a comparator. In the subgroup of patients with ventilator-associated pneumonia, those who used this drug had lower cure rates (47.9% versus 70.1%) and greater mortality (19.1% versus 12.3% in comparator-treated patients). Patients with ventilator-associated pneumonia and bacteremia at baseline who used this drug had particularly high mortality (50% versus 7.7% in comparator-treated patients).Nervous system
Common (1% to 10%): Headache, dizziness
Frequency not reported: Taste perversion, somnolenceHepatic
Isolated cases of significant hepatic dysfunction and hepatic failure have been reported.
Liver function test abnormalities (e.g., increased ALT and AST) in patients treated with this drug were reported more often posttherapy than those in comparator-treated patients, which were reported more often on therapy.
Common (1% to 10%): Increased ALT, increased AST, bilirubinemia
Frequency not reported: Jaundice, significant hepatic dysfunction, hepatic failure, hyperbilirubinemia, increased liver enzymes, liver function test abnormalities
Postmarketing reports: Hepatic cholestasis, jaundiceHematologic
Common (1% to 10%): Anemia
Frequency not reported: Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased INR, thrombocythemia, leukocytosis
Postmarketing reports: Thrombocytopenia, hypofibrinogenemiaMetabolic
Common (1% to 10%): Hypoproteinemia, hyponatremia
Frequency not reported: Hypocalcemia, hypoglycemia, anorexia, hyperglycemia, hypokalemia
Postmarketing reports: Symptomatic hypoglycemia
Symptomatic hypoglycemia was reported in patients with and without diabetes mellitus.Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Pruritus, sweating, diffuse cutaneous hyperpigmentation
Postmarketing reports: Severe skin reactions (including Stevens-Johnson syndrome)Cardiovascular
Common (1% to 10%): Phlebitis
Frequency not reported: Thrombophlebitis, hypertension, hypotension, bradycardia, tachycardia, vasodilatationRenal
Common (1% to 10%): Increased BUN/serum urea
Frequency not reported: Increased creatinineRespiratory
Common (1% to 10%): Pneumonia
Frequency not reported: Increased cough, dyspnea, pulmonary changesHypersensitivity
Frequency not reported: Allergic reaction
Postmarketing reports: Anaphylactic reactionsLocal
Frequency not reported: Injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, injection site edemaGenitourinary
Frequency not reported: Vaginal moniliasis, vaginitis, leukorrheaMusculoskeletal
Frequency not reported: Back painPsychiatric
Frequency not reported: Insomnia
April 6, 2020
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February 1, 2021