Posology : מינונים

4.2   Posology and method of administration
Posology

Loading dose

The recommended loading dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).

Maintenance dose

The recommended maintenance dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.

Duration of therapy should be determined by the clinical response (see section 5.1).

For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered (see sections 5.1 and 5.3).

Switch to oral isavuconazole

CRESEMBA® is also available as hard capsules containing 100 mg isavuconazole, equivalent to 186 mg isavuconazonium sulfate.

On the basis of the high oral bioavailability (98%, see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.

Cresemba 200 mg IV, LPD, Israel       WC 16 Sep 2024
Elderly

No dose adjustment is necessary for elderly patients; however, the clinical experience in elderly patients is limited.

Renal impairment

No dose adjustment is necessary in patients with renal impairment, including patients with end-stage renal disease (see section 5.2).

Hepatic impairment

No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).

CRESEMBA® has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks. See sections 4.4, 4.8 and 5.2.

Paediatric population

CRESEMBA® is not indicated for children aged below 18 years
Method of administration

Intravenous use.

Precautions to be taken before handling or administering the medicinal product 
CRESEMBA® must be reconstituted and then further diluted to a concentration corresponding to approximately 0.8 mg/mL isavuconazole prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions. The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm. CRESEMBA® must only be given as an intravenous infusion.

For detailed instructions on the reconstitution and dilution of CRESEMBA® before administration, see section 6.6.