CRESEMBA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200MG

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**4.2 Posology and method of administration** Posology Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly. _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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered (see sections 5.1 and 5.3 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Switch to oral isavuconazole_ CRESEMBA is also available as hard capsules containing 100 mg isavuconazole. On the basis of the high oral bioavailability (98%, see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), switching between intravenous and oral administration is appropriate when clinically indicated. _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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Isavuconazole 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 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 micrometre to 1.2 micrometre. 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.