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Note: This document contains side effect information about avibactam / ceftazidime. Some of the dosage forms listed on this page may not apply to the brand name Avycaz.
Applies to avibactam/ceftazidime: intravenous powder for solution
Along with its needed effects, avibactam / ceftazidime 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 avibactam / ceftazidime:
Incidence not known
Some side effects of avibactam / ceftazidime 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:
Incidence not known
Applies to avibactam / ceftazidime: intravenous powder for injection
The most common side effects reported were Coombs direct test positive, nausea, diarrhea, and vomiting.
Very common (10% or more): Coombs direct test positive, direct antiglobulin test (DAGT or Coombs test) seroconversion, seroconversion from negative to positive direct Coombs test result
Common (1% to 10%): Thrombocytosis, thrombocytopenia, anemia
Uncommon (0.1% to 1%): Leukopenia
-Common (1% to 10%): Eosinophilia
-Uncommon (0.1% to 1%): Neutropenia, lymphocytosis
-Frequency not reported: Agranulocytosis, hemolytic anemia, prolonged prothrombin time
DAGT seroconversion in patients using this drug was very common in clinical studies; the estimated range of seroconversion across phase 3 trials was 3.2% to 20.8% in patients with negative Coombs test at baseline and at least 1 follow-up test.
In the phase 3 trials, seroconversion from negative to positive direct Coombs test result among patients with initial negative Coombs test and at least 1 follow-up test was reported in 12.9% (complicated intraabdominal infection [cIAI]), 3% (complicated urinary tract infection [cUTI]), and 21.4% (hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia [HABP/VABP]) of patients using this drug and 3% (cIAI), 0.9% (cUTI), and 7% (HABP/VABP) of patients using a carbapenem comparator. No side effects indicating hemolytic anemia were reported in any treatment group.
Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, constipation, upper abdominal pain, lower abdominal pain
Uncommon (0.1% to 1%): Clostridium difficile colitis, pseudomembranous colitis
Frequency not reported: Clostridium difficile-associated diarrhea
Common (1% to 10%): Increased blood alkaline phosphatase, pyrexia, candidiasis (including vulvovaginal and oral), death/increased mortality, peripheral edema
Uncommon (0.1% to 1%): Asthenia
Frequency not reported: Decreased clinical response, accidental overdose
-Common (1% to 10%): Increased blood lactate dehydrogenase
In a phase 3 cIAI trial, death occurred in 13 of 529 patients using this drug plus metronidazole and 8 of 529 patients using meropenem. In a subgroup of patients with baseline CrCl 30 to 50 mL/min, death occurred in 8 of 41 patients using this drug plus metronidazole and 3 of 43 patients using meropenem; patients using this drug received a 33% lower daily dose than is currently recommended for this patient population. In patients with baseline CrCl greater than 50 mL/min, death occurred in 5 of 485 patients using this drug plus metronidazole and 5 of 484 patients using meropenem. Cause of death varied; contributing factors included progression of underlying infection, baseline pathogens isolated that were unlikely to respond to study drug, and delayed surgical intervention.
In 2 studies in patients with cIAI, the most common diagnosis (about 42%) was appendiceal perforation or peri-appendiceal abscess. About 87% of patients had APACHE II scores up to 10 and 4% had bacteremia at baseline. Death occurred in 18 of 857 patients who used this drug plus metronidazole and in 12 of 863 patients who used meropenem. In a subgroup with baseline CrCl 30 to 50 mL/min, death occurred in 9 of 54 patients who used this drug plus metronidazole and 4 of 59 patients who used meropenem; these patients used a lower dose of this drug than is currently recommended for patients with CrCl 30 to 50 mL/min.
In the phase 3 HABP/VABP trial, death occurred in 42 of 436 patients using this drug and 36 of 434 patients using meropenem.
Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, especially in those with renal dysfunction. Neurological sequelae (including tremor, myoclonus, nonconvulsive status epilepticus, convulsion, encephalopathy, coma) were occasionally reported with ceftazidime when the dose was not reduced in patients with renal dysfunction.
Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Dysgeusia
-Uncommon (0.1% to 1%): Paresthesia
-Frequency not reported: Seizures/convulsion, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonus/myoclonia, neurological sequelae, tremor
Common (1% to 10%): Increased ALT, increased AST, increased GGT
-Frequency not reported: Jaundice
Common (1% to 10%): Maculopapular rash, urticaria, pruritus
Uncommon (0.1% to 1%): Rash
Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)
-Frequency not reported: Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Beta-lactam antibacterial drugs:
-Frequency not reported: Serious skin reactions, severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP)
Common (1% to 10%): Anxiety, insomnia
Common (1% to 10%): Hypokalemia
Common (1% to 10%): Hypertension, hypotension
Uncommon (0.1% to 1%): Tachycardia
Frequency not reported: Atrial fibrillation
Common (1% to 10%): Pneumonia, cough
Uncommon (0.1% to 1%): Pleural effusion, dyspnea
Common (1% to 10%): Urinary tract infection
-Frequency not reported: Vaginal inflammation
Common (1% to 10%): Infusion site thrombosis, infusion site phlebitis
Frequency not reported: Injection site phlebitis
-Frequency not reported: Infusion site inflammation, injection site hematoma, injection site thrombosis
Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, acute kidney injury
Frequency not reported: Renal impairment, nephrolithiasis
-Very rare (less than 0.01%): Tubulointerstitial nephritis
Uncommon (0.1% to 1%): Back pain
Frequency not reported: Anaphylactic reaction
Beta-lactam antibacterial drugs:
-Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions