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Avycaz Side Effects

Generic Name: avibactam / ceftazidime

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.

For the Consumer

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:

Less common or rare
  • Agitation
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • bluish color changes in skin color
  • chest pain
  • chills
  • coma
  • confusion
  • convulsions
  • cough
  • decreased urine
  • dizziness
  • fever
  • headache
  • hostility
  • increased thirst
  • irregular heartbeat
  • lethargy
  • loss of appetite
  • muscle pain or cramps
  • muscle twitching
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pinpoint red spots on the skin
  • rapid weight gain
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, hands, foot, or leg
  • swollen glands
  • tenderness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
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:

More common
  • Abdominal or stomach pain
  • diarrhea
  • difficulty having a bowel movement (stool)
Less common or rare
  • Change in taste
  • loss of taste
  • redness of the skin
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash

For Healthcare Professionals

Applies to avibactam / ceftazidime: intravenous powder for injection

General

The most common side effects reported were Coombs direct test positive, nausea, diarrhea, and vomiting.[Ref]

Hematologic

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%): Eosinophilia, thrombocytosis, thrombocytopenia
Uncommon (0.1% to 1%): Neutropenia, leukopenia, lymphocytosis
Frequency not reported: Agranulocytosis, hemolytic anemia

Ceftazidime:
-Frequency not reported: Agranulocytosis, hemolytic anemia, leukopenia, lymphocytosis, neutropenia, thrombocytosis, eosinophilia, prolonged prothrombin time[Ref]

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 a phase 3 complicated intraabdominal infection (cIAI) trial, seroconversion from negative to positive direct Coombs test result at any time up to the last visit occurred in 31 of 240 patients using this drug plus metronidazole with initial negative Coombs test and at least 1 follow-up test and in 7 of 235 patients using meropenem. In a phase 3 complicated urinary tract infection trial, seroconversion from negative to positive direct Coombs test result at any time up to the last visit occurred in 7 of 216 patients using this drug with initial negative Coombs test and at least 1 follow-up test and in 2 of 214 patients using doripenem; no side effects indicating hemolytic anemia were reported in any treatment group.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, constipation, upper abdominal pain
Uncommon (0.1% to 1%): Clostridium difficile colitis, pseudomembranous colitis
Frequency not reported: Clostridium difficile-associated diarrhea[Ref]

Other

Common (1% to 10%): Increased blood alkaline phosphatase, increased blood lactate dehydrogenase, pyrexia, candidiasis (including vulvovaginal and oral), death/increased mortality
Frequency not reported: Decreased clinical response, accidental overdose

Ceftazidime:
-Frequency not reported: Increased blood lactate dehydrogenase[Ref]

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.[Ref]

Nervous system

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.[Ref]

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Paresthesia, dysgeusia

Ceftazidime:
-Frequency not reported: Paresthesia, seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonus/myoclonia, neurological sequelae, tremor, convulsion[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased GGT
Frequency not reported: Jaundice

Ceftazidime:
-Frequency not reported: Jaundice[Ref]

Dermatologic

Common (1% to 10%): Maculopapular rash, urticaria, pruritus
Frequency not reported: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), rash, skin and subcutaneous tissue disorders

Beta-lactam antibacterial drugs:
-Frequency not reported: Serious skin reactions

Ceftazidime:
-Frequency not reported: Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Local

Common (1% to 10%): Infusion site thrombosis, infusion site phlebitis
Frequency not reported: Injection site phlebitis

Ceftazidime:
-Frequency not reported: Infusion site inflammation, injection site hematoma, injection site thrombosis[Ref]

Renal

Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, acute kidney injury
Very rare (less than 0.01%): Tubulointerstitial nephritis
Frequency not reported: Acute renal failure, renal impairment, nephrolithiasis

Ceftazidime:
-Frequency not reported: Tubulointerstitial nephritis[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction

Beta-lactam antibacterial drugs:
-Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions[Ref]

Psychiatric

Frequency not reported: Anxiety[Ref]

Metabolic

Frequency not reported: Hypokalemia[Ref]

Cardiovascular

Frequency not reported: Atrial fibrillation[Ref]

Genitourinary

Ceftazidime:
-Frequency not reported: Vaginal inflammation[Ref]

References

1. "Product Information. Avycaz (avibactam-cefTAZidime)." Forest Pharmaceuticals, St. Louis, MO.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Some side effects of Avycaz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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