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Posology: Loading dose: Cap: The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).
Infusion: 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: Cap: The recommended maintenance dose is two capsules ( equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.
Infusion: 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 Pharmacology: Pharmacodynamics under Actions).
For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered (see Pharmacology: Pharmacodynamics and Toxicology: Preclinical safety data under Actions).
Cap: Switch to intravenous infusion: CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.
On the basis of the high oral bioavailability (98%, see Pharmacology: Pharmacokinetics under Actions), switching between intravenous and oral administration is appropriate when clinically indicated.
Infusion: 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 Pharmacology: Pharmacokinetics under Actions), switching between intravenous and oral administration is appropriate when clinically indicated.
Cap/Inj: 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 Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
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 considered to outweigh the risks. See Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions.
Paediatric population: The safety and efficacy of CRESEMBA in children aged below 18 years has not yet been established. No data are available.
Method of Administration: Cap: CRESEMBA capsules can be taken with or without food.
CRESEMBA capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsules.
Infusion: 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 details instructions on the reconstitution and dilution of CRESEMBA before administration, see Cautions for Usage.
