Cresemba

Cresemba

isavuconazole

Manufacturer:

Pfizer

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Isavuconazole (as isavuconazonium sulfate)
Indications/Uses
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.
Administration
Cap: May be taken with or without food: Swallow whole, do not chew/crush/dissolve/open the cap.
Contraindications
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
Antifungals
ATC Classification
J02AC05 - isavuconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Cresemba cap 100 mg
Packing/Price
14's
Form
Cresemba powd for concentrate for soln for infusion 200 mg
Packing/Price
1's
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