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CRESEMBA is a brand name for Isavuconazole, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 11/2024 4 DOSAGE AND ADMINISTRATION 11/2024 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
11/2024 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
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, and 10 CLINICAL PHARMACOLOGY. • Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy.
Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. 6 mg of isavuconazonium sulfate d 6 doses in total e Maintenance dose: Starting 12 to 24 hours after the last loading dose f After reconstitution and dilution Pediatrics • The maximum of any individual loading or daily maintenance dose to be administered to any pediatric patient is 200 mg isavuconazole.
• The safety and efficacy of isavuconazole in pediatric patients below 1 year of age has not been established. • The use of CRESEMBA 100 mg capsules has not been studied in pediatric patients. Geriatrics • No dose adjustment is necessary for elderly patients.
Renal Impairment • No dose adjustment is necessary in adult patients with renal impairment, including patients with end-stage renal disease. See 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY. CRESEMBA (isavuconazole as isavuconazonium sulfate) Page 7 of 59 • Data for CRESEMBA use in pediatrics patients from 1 year up to 18 years with renal impairment is limited.
Therefore, no dose recommendations can be made for these patients. See 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY Hepatic Impairment • No dose adjustment is necessary in adult patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B).
Use in patient with severe hepatic impairment (Child-Pugh Class C) is not recommended unless the potential benefit is considered to outweigh the risks. See 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS and 10 CLINICAL PHARMACOLOGY.
, Sensitivity/Resistance 04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 13 8 ADVERSE REACTIONS ................................................................................................
18 9 DRUG INTERACTIONS ................................................................................................ 28 10 CLINICAL PHARMACOLOGY .......................................................................................
28 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 32 PART II: SCIENTIFIC INFORMATION .......................................................................................
CRESEMBA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Co-administration with strong CYP3A4 inhibitor ketoconazole because this strong CYP3A4 inhibitor can significantly increase the plasma concentration of isavuconazole. See 9 DRUG INTERACTIONS. • Co-administration with strong CYP3A4 inducers, such as rifampin, rifabutin, carbamazepine, phenytoin, St.
g. phenobarbital) because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole. See 9 DRUG INTERACTIONS. • Co-administration with moderate CYP3A4/5 inducers such as efavirenz and etravirine. See 9 DRUG INTERACTIONS.
• Patients with familial short QT syndrome. See 7 WARNINGS AND PRECAUTIONS. CRESEMBA (isavuconazole as isavuconazonium sulfate) Page 5 of 59
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• No data is available for CRESEMBA use in pediatrics patients from 1 year up to 18 years with hepatic impairment. Therefore, no dose recommendations can be made for these patients. 3 Reconstitution Parenteral Products: Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in CRESEMBA (isavuconazole for injection) or in the materials specified for reconstitution.
One vial of CRESEMBA (isavuconazole for injection) should be reconstituted by addition of 5 mL water for injections to the vial. The reconstituted concentrate contains 40 mg isavuconazole per mL. The vial should be gently shaken to dissolve the powder completely.
See Table 2. The reconstituted solution should be inspected visually for particulate matter and discoloration. Reconstituted concentrate should be clear and free of visible particulate. It must be further diluted prior to administration.
The reconstituted solution may be stored below 25°C for maximum 1 hour prior to preparation of the patient infusion solution. 8 mg/mL of isavuconazole prior to administration by intravenous infusion. 9% sodium chloride solution for injection • 5% dextrose solution for injection After the reconstituted concentrate is further diluted, the diluted solution may show fine white-to- translucent particulates of isavuconazole that do not sediment (but will be removed by in-line filtration).
The diluted solution should be mixed gently, or the bag should be rolled to minimize the formation of particulates. Unnecessary vibration or vigorous shaking of the solution should be avoided. Do not use a pneumatic transport system.
Adults and pediatric patients with bodyweight from 37 kg:
After reconstitution, the entire content of the reconstituted concentrate should be removed from the vial and added to an infusion bag containing 250 mL of diluent (Table 3). 5 mg/mL isavuconazonium sulfate). Table 3 – Dilution for Adults and pediatric patients with bodyweight from 37 kg Infusion Bag size Volume of Diluent to be Added to Reconstituted Concentrate Approximate Available Volume Concentration per mL […]
33 13 PHARMACEUTICAL INFORMATION ............................................................................ 33 14 CLINICAL TRIALS ........................................................................................................
34 15 MICROBIOLOGY ........................................................................................................ 38 16 NON-CLINICAL TOXICOLOGY .....................................................................................
38 PATIENT […]