DCH Auriga - Healthcare
Concise Prescribing Info
Isavuconazole (as isavuconazonium sulfate)
In adults for the treatment of invasive aspergillosis & mucormycosis in patients for whom amphotericin B is inappropriate.
Dosage/Direction for Use
Loading dose: 200 mg of isavuconazole every 8 hr for the 1st 48 hr. Maintenance dose: 200 mg of isavuconazole once daily, starting 12-24 hr after the last loading dose. No dose adjustment is needed for elderly or patient w/ renal/hepatic impairment. Infusion To be reconstituted & then further diluted to a conc corresponding to approx 0.8 mg/mL isavuconazole prior to administration by IV infusion over a min of 1 hr. Must only be given as an IV infusion. On the basis of high oral bioavailability (98%), switching between IV & oral administration is appropriate when clinically indicated.
Cap: May be taken with or without food: Swallow whole, do not chew/crush/dissolve/open the cap.
Hypersensitivity to isavuconazole or any of the excipients. Co-administration w/ ketoconazole; high-dose ritonavir (>200 mg every 12 hr); strong or moderate CYP3A4/5 inducers. Patients w/ familial short QT syndrome.
Special Precautions
Hypersensitivity to azoles; infusion-related reactions (IV only); severe cutaneous adverse reactions. Contraindicated in patients w/ familial short QT syndrome & caution in patients taking other medicinal products known to decrease the QT interval. Monitoring of hepatic enzymes or in patients w/ severe hepatic impairment. Caution in patients having co-administration w/ strong CYP3A4/5 inhibitors, or CYP2B6 substrates. Avoid co-administration w/ mild CYP3A4/5 inducers. Appropriate therapeutic drug monitoring & dose adjustment may be necessary in patients w/ concomitant use of P-gp substrates or CYP3A4/5 substrates including immunosuppressants. Must not be used during pregnancy except in patients w/ severe or potentially life-threatening fungal infections. Breast-feeding should be discontinued during treatment. Safety & efficacy in childn <18 yr has not been established.
Adverse Reactions
Elevated liver chemistry tests, nausea, vomiting, dyspnea, abdominal pain, diarrhea, inj site reaction, headache, hypokalemia, rash.
Drug Interactions
CYP450 isoenzymes (CYP3A4/5 inhibitors or inducers, CYP2B6 substrates); P-glycoprotein substrates; BCRP substrates; Organic cation transporter 2 substrates; UGT substrates.
MIMS Class
ATC Classification
J02AC05 - isavuconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Cresemba cap 100 mg
Cresemba powd for concentrate for soln for infusion 200 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in