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__NOTOC__
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== ====Clinical Trials Experience==== ==
==Adverse Reactions==
 
===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.
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
====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 [http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33f3b99b-fa82-42e0-26bf-f49891ae3d22#i4i_clinical_studies_id_4c57f901-8336-444e-9bc8-6629b9090087 Clinical Studies (14)]]. 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. [http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33f3b99b-fa82-42e0-26bf-f49891ae3d22#TABLE3 Table 3] 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%).
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 [http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33f3b99b-fa82-42e0-26bf-f49891ae3d22#i4i_clinical_studies_id_4c57f901-8336-444e-9bc8-6629b9090087 Clinical Studies (14)]]. 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. [http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33f3b99b-fa82-42e0-26bf-f49891ae3d22#TABLE3 Table 3] 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%).
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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 .
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 .


Additional adverse experiences that were reported with INVANZ with an incidence >0.1% within each body system are listed below
'''''Additional adverse experiences that were reported with INVANZ with an incidence >0.1% within each body system are listed below:'''''
 
======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


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======


Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage
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
======Digestive System======


Musculoskeletal System: leg pain
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


Nervous System & Psychiatric: anxiety, nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo
======Musculoskeletal System======


Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance
Leg pain


Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria
======Nervous System & Psychiatric======


Special Senses: taste perversion
Anxiety, nervousness, seizure, tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo


Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.
======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.
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
====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 4 shows the incidence of adverse experiences other than those previously described above for INVANZ that were reported regardless of causality in ≥2.0% of patients in this trial.
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 4 shows the incidence of adverse experiences other than those previously described above for INVANZ that were reported regardless of causality in ≥2.0% of patients in this trial.


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Additional 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 below:
'''''Additional 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 below:'''''


Gastrointestinal Disorders:C. difficile infection or colitis, dry mouth, hematochezia
======Gastrointestinal Disorders======


General Disorders and Administration Site Condition: crepitations
C. difficile infection or colitis, dry mouth, hematochezia


Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess
======General Disorders and Administration Site Condition======


Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion
Crepitations


Musculoskeletal and Connective Tissue Disorders: muscle spasms
======Infections and Infestations======


Nervous System Disorders: cerebrovascular accident
Cellulitis, abdominal abscess, fungal rash, pelvic abscess


Renal and Urinary Disorders: dysuria, pollakiuria
======Injury, Poisoning and Procedural Complications======


Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.
Incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion


Pediatric Patients Receiving INVANZ as a Treatment Regimen
======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 [seeClinical Studies (14)]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 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%).
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 [seeClinical Studies (14)]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 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%).
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'''''Additional adverse experiences that were reported with INVANZ with an incidence >0.5% within each body system are listed below:'''''
 
======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


|[[File:Ertapenem 11.jpg|thumb|400px|left]]
======usculoskeletal and Connective Tissue Disorders======
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Arthralgia


Additional adverse experiences that were reported with INVANZ with an incidence >0.5% within each body system are listed below:
======Nervous System Disorders======


Gastrointestinal Disorders: nausea
Dizziness, somnolence


General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth
======Psychiatric Disorders======


Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess
Insomnia


Metabolism and Nutrition Disorders: decreased appetite
======Reproductive System and Breast Disorders======


Musculoskeletal and Connective Tissue Disorders: arthralgia
Genital rash


Nervous System Disorders: dizziness, somnolence
======Respiratory, Thoracic and Mediastinal Disorders======


Psychiatric Disorders: insomnia
Wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea


Reproductive System and Breast Disorders: genital rash
======Skin and Subcutaneous Tissue Disorders======


Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea
Dermatitis, pruritus, rash erythematous, skin lesion


Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion
======Vascular Disorders======


Vascular Disorders: phlebitis.
Phlebitis


6.2 Post-Marketing Experience
====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.
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.


Immune System Disorders: anaphylaxis including anaphylactoid reactions
======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


Musculoskeletal and Connective Tissue Disorders: muscular weakness
======Psychiatric Disorders======


Nervous System Disorders: coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor
Altered mental status (including aggression, delirium), hallucinations


Psychiatric Disorders: altered mental status (including aggression, delirium), hallucinations
======Skin and Subcutaneous Tissue Disorders======


Skin and Subcutaneous Tissue Disorders: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)


6.3 Adverse Laboratory Changes in Clinical Trials
===Adverse Laboratory Changes in Clinical Trials===


Adults Receiving INVANZ as Treatment Regimen
====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 6. 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.
Laboratory adverse experiences that were reported during therapy in ≥2.0% of adult patients treated with INVANZ in clinical trials are presented in Table 6. 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.


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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.
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
====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 7. 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%).
Laboratory adverse experiences that were reported during therapy in ≥2.0% of pediatric patients treated with INVANZ in clinical trials are presented in Table 7. 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%).
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Additional 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.<ref>{{Cite web | last = |first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf |url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf |publisher = |date = | accessdate = }}</ref>
Additional 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.<ref>{{Cite web | last = |first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf |url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf |publisher = |date = | accessdate = }}</ref>
==References==
==References==
{{Reflist}}
{{Reflist}}



Latest revision as of 22:21, 5 January 2014

Ertapenem
INVANZ® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Adverse Reactions

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 Clinical Studies (14)]. 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 3 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%).

In 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 .

Additional adverse experiences that were reported with INVANZ with an incidence >0.1% within each body system are listed below:

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, 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 4 shows the incidence of adverse experiences other than those previously described above for INVANZ that were reported regardless of causality in ≥2.0% of patients in this trial.

Additional 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 below:

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 [seeClinical Studies (14)]. The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 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%).

Additional adverse experiences that were reported with INVANZ with an incidence >0.5% within each body system are listed below:

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

usculoskeletal 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.

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

Psychiatric Disorders

Altered mental status (including aggression, delirium), hallucinations

Skin and Subcutaneous Tissue Disorders

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome)

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 6. 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.

Additional 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 7. 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%).

Additional 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.[1]

References

  1. "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.