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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 practice.
Adults Receiving INVANZ as a Treatment Regimen: Clinical trials enrolled 1954 patients treated with INVANZ; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Pharmacology: Clinical Studies under Actions]. Most adverse experiences reported in these clinical trials were described as mild to moderate in severity. INVANZ was discontinued due to adverse experiences in 4.7% of patients. Table 6 shows the incidence of adverse experiences reported in ≥2.0% of patients in these trials. The most common drug-related adverse experiences in patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%). (See Table 6.)
Click on icon to see table/diagram/imageIn patients treated for complicated intra-abdominal infections, death occurred in 4.7% (15/316) of patients receiving INVANZ and 2.6% (8/307) of patients receiving comparator drug. These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators.
In clinical trials, seizure was reported during study therapy plus 14-day follow-up period in 0.5% of patients treated with INVANZ, 0.3% of patients treated with piperacillin/tazobactam and 0% of patients treated with ceftriaxone [see Seizure Potential under Precautions].
Additional adverse experiences that were reported with INVANZ with an incidence >0.1% within each body system are listed as follows: Body as a Whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, asthenia/fatigue, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis, flank pain, syncope.
Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage.
Digestive System: acid regurgitation, oral candidiasis, dyspepsia, gastrointestinal hemorrhage, anorexia, flatulence, C. difficile-associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis.
Musculoskeletal System: leg pain.
Nervous System & Psychiatric: anxiety, nervousness, seizure [see Seizure Potential under Precautions], tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo.
Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance.
Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria.
Special Senses: taste perversion.
Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with INVANZ, the adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery: In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of INVANZ 1 hour prior to surgery and were then followed for safety 14 days post-surgery, the overall adverse experience profile was generally comparable to that observed for INVANZ in previous clinical trials. Table 7 shows the incidence of adverse experiences other than those previously described for INVANZ that were reported regardless of causality in ≥2.0% of patients in this trial. (See Table 7.)
Click on icon to see table/diagram/imageAdditional adverse experiences that were reported in this prophylaxis trial with INVANZ, regardless of causality, with an incidence >0.5% within each body system are listed as follows: Gastrointestinal Disorders: C. difficile infection or colitis, dry mouth, hematochezia.
General Disorders and Administration Site Condition: crepitations.
Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess.
Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion.
Musculoskeletal and Connective Tissue Disorders: muscle spasms.
Nervous System Disorders: cerebrovascular accident.
Renal and Urinary Disorders: dysuria, pollakiuria.
Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.
Pediatric Patients Receiving INVANZ as a Treatment Regimen: Clinical trials enrolled 384 patients treated with INVANZ; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Pharmacology: Clinical Studies under Actions]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 8 shows the incidence of adverse experiences reported in ≥2.0% of pediatric patients in clinical trials. The most common drug-related adverse experiences in pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, were diarrhea (6.5%), infusion site pain (5.5%), infusion site erythema (2.6%), vomiting (2.1%). (See Table 8.)
Click on icon to see table/diagram/imageAdditional adverse experiences that were reported with INVANZ with an incidence >0.5% within each body system are listed as follows: Gastrointestinal Disorders: nausea.
General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth.
Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess.
Metabolism and Nutrition Disorders: decreased appetite.
Musculoskeletal and Connective Tissue Disorders: arthralgia.
Nervous System Disorders: dizziness, somnolence.
Psychiatric Disorders: insomnia.
Reproductive System and Breast Disorders: genital rash.
Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea.
Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion.
Vascular Disorders: phlebitis.
Post-Marketing Experience: The following additional adverse reactions have been identified during the post-approval use of INVANZ. 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.
Gastrointestinal Disorders: teeth staining.
Immune System Disorders: anaphylaxis including anaphylactoid reactions.
Musculoskeletal and Connective Tissue Disorders: muscular weakness.
Nervous System Disorders: coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor, encephalopathy (recovery was prolonged in patients with renal impairment).
Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations.
Skin and Subcutaneous Tissue Disorders: Acute Generalized Exanthematous Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), hypersensitivity vasculitis.
Adverse Laboratory Changes in Clinical Trials: Adults Receiving INVANZ as Treatment Regimen: Laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with INVANZ in clinical trials are presented in Table 9. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, in clinical trials were ALT increased (6.0%), AST increased (5.2%), serum alkaline phosphatase increased (3.4%), and platelet count increased (2.8%). INVANZ was discontinued due to laboratory adverse experiences in 0.3% of patients. (See Table 9.)
Click on icon to see table/diagram/imageAdditional laboratory adverse experiences that were reported during therapy in >0.1% of patients treated with INVANZ in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, WBC, platelet count, and segmented neutrophils.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with INVANZ, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery: In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of INVANZ 1 hour prior to surgery and were then followed for safety 14 days post-surgery, the overall laboratory adverse experience profile was generally comparable to that observed for INVANZ in previous clinical trials.
Pediatric Patients Receiving INVANZ as a Treatment Regimen: Laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with INVANZ in clinical trials are presented in Table 10. Drug-related laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with INVANZ, including those who were switched to therapy with an oral antimicrobial, in clinical trials were neutrophil count decreased (3.0%), ALT increased (2.2%), and AST increased (2.1%). (See Table 10.)
Click on icon to see table/diagram/imageAdditional laboratory adverse experiences that were reported during therapy in >0.5% of patients treated with INVANZ in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.
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