Isavuconazonium Brand Name– CRESEMBA
What is Isavuconazonium
Isavuconazonium is an azole antifungal indicated for the treatment of adults with invasive aspergillosis or invasive mucormycosis.
Isavuconazonium is a prodrug that can be administered either orally or via intravenous infusion (established bioequivalence between the formulations). Once in systemic circulation, isavuconazonium is rapidly converted to isavuconazole.
Isavuconazole is active against most strains of Aspergillus flavus, A. fumigatus, A. niger, Rhizopus oryzae, and Mucormycetes species. Approval was based on the results of two clinical trials.
In the first trial, isavuconazonium was found to have similar efficacy to voriconazole for the treatment of proven or probable invasive aspergillosis (35% vs. 38.9%).
The second trial was an open-label non-comparative study involving patients with invasive mucormycosis.
In this trial, efficacy was determined by mortality and assessed by an independent Data Review Committee.
At the end-of-treatment, all-cause mortality was 38% (n = 14/37), with the committee determining isavuconazonium treatment to be successful in 31% (n = 11/35) of patients.
Isavuconazonium was approved by the FDA in March 2015.
Indications
- aspergillosis
- Aspergillus flavus
- Aspergillus fumigatus
- Aspergillus niger
- Aspergillus sp.
- candidiasis prophylaxis
- esophageal candidiasis
- Mucor sp.
- mucormycosis
- Rhizopus sp.
Side Effects
- abdominal pain
- agitation
- agranulocytosis
- alopecia
- anorexia
- anxiety
- atrial fibrillation
- atrial flutter
- back pain
- bone pain
- bradycardia
- bronchospasm
- cardiac arrest
- chest pain (unspecified)
- chills
- cholecystitis
- cholelithiasis
- confusion
- constipation
- cough
- delirium
- depression
- diarrhea
- dizziness
- dysgeusia
- dyspepsia
- dyspnea
- elevated hepatic enzymes
- encephalopathy
- erythema
- exfoliative dermatitis
- fatigue
- gastritis
- gingivitis
- hallucinations
- headache
- hematuria
- hepatic failure
- hepatitis
- hepatomegaly
- hypoalbuminemia
- hypoesthesia
- hypoglycemia
- hypokalemia
- hypomagnesemia
- hyponatremia
- hypotension
- infusion-related reactions
- injection site reaction
- insomnia
- leukopenia
- malaise
- migraine
- nausea
- palpitations
- pancytopenia
- paresthesias
- peripheral edema
- peripheral neuropathy
- petechiae
- phlebitis
- proteinuria
- pruritus
- rash
- renal failure (unspecified)
- stomatitis
- supraventricular tachycardia (SVT)
- syncope
- tachypnea
- thrombosis
- tinnitus
- tremor
- urticaria
- vertigo
- vomiting
Monitoring Parameters
- CBC with differential
- LFTs
- pregnancy testing
Contraindications
- azole antifungals hypersensitivity
- breast-feeding
- contraception requirements
- hepatic disease
- infusion-related reactions
- pregnancy
- reproductive risk
- short QT syndrome
- shortened QT interval
Interactions
- Abacavir; Dolutegravir; Lamivudine
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