Regulatory Information
PFIZER PRIVATE LIMITED
PFIZER PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**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 two capsules (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 two capsules (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 intravenous infusion_ CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 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 CRESEMBA capsules can be taken with or without food. CRESEMBA capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsules.
ORAL
Medical Information
**4.1 Therapeutic indications** CRESEMBA is indicated in adults for the treatment of - invasive aspergillosis - mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Consideration should be given to official guidance on the appropriate use of antifungal agents.
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Co-administration with ketoconazole (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration with high-dose ritonavir (>200 mg every 12 hours) (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Co-administration with strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John’s wort or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with familial short QT syndrome (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J02AC05
isavuconazole
Manufacturer Information
PFIZER PRIVATE LIMITED
SwissCo Services AG
Almac Pharma Services Limited (Primary and Secondary packager)
Active Ingredients
Documents
Package Inserts
Cresemba Capsule PI.pdf
Approved: September 8, 2022