Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Basilea Pharmaceutica Deutschland GmbH, Marie-Curie-Strasse 8, 79539, Lörrach, Germany
CRESEMBA hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of
Consideration should be given to official guidance on the appropriate use of antifungal agents.
CRESEMBA 40 mg hard capsules are intended to be used for paediatric patients.
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.
Detailed information on dosage recommendations is provided in the following tables:
Table 1. Recommended dosage for CRESEMBA in adult patients:
| Loading dose (three times daily)1 | Maintenance dose (once daily)2 | |
| every 8 hours during Days 1 and 2 | total daily dose during Days 1 and 2 | |
| Two 100 mg capsules | Six 100 mg capsules | Two 100 mg capsules |
1 Six administrations in total.
2 Starting 12 to 24 hours after the last loading dose.
Table 2. Recommended Dosage for CRESEMBA in paediatric patients aged from 6 years to less than 18 years:
| Bodyweight (kg) | Loading dose (three times daily)1 | Maintenance dose (once daily)2 | |
| every 8 hours during Days 1 and 2 | total daily dose during Days 1 and 2 | ||
| 16 kg to <18 kg | Two 40 mg capsules | Six 40 mg capsules | Two 40 mg capsules |
| 18 kg to <25 kg | Three 40 mg capsules | Nine 40 mg capsules | Three 40 mg capsules |
| 25 kg to <32 kg | Four 40 mg capsules | Twelve 40 mg capsules | Four 40 mg capsules |
| 32 kg to <37 kg | One 100 mg capsule and two 40 mg capsules | Three 100 mg capsules and six 40 mg capsules | One 100 mg capsule and two 40 mg capsules |
| ≥37 kg | Five 40 mg capsules or two 100 mg capsules | Fifteen 40 mg capsules or six 100 mg capsules | Five 40 mg capsules or two 100 mg capsules |
1 Six administrations in total.
2 Starting 12 to 24 hours after the last loading dose.
The maximum of any individual loading or daily maintenance dose to be administered to any patient is 200 mg isavuconazole.
All capsules per dose must be taken at the same time.
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).
No dose adjustment is necessary for elderly patients; however, the clinical experience in elderly patients is limited.
No dose adjustment is necessary in adult patients with renal impairment, including patients with end-stage renal disease (see section 5.2).
No dose recommendation can be made for paediatric patients with renal impairment, as no relevant data are available.
No dose adjustment is necessary in adult patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).
Isavuconazole has not been studied in adult 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).
No dose recommendation can be made for paediatric patients with hepatic impairment, as no relevant data are available.
Paediatric patients from one year to below 6 years of age, or with a bodyweight less than 16 kg, or are not able to swallow CRESEMBA hard capsules may receive CRESEMBA as intravenous infusion.
The use of CRESEMBA 100 mg capsules has not been studied in paediatric patients (see section 4.4). The safety and efficacy of CRESEMBA in paediatric patients aged less than 1 year has not been established.
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), switching between intravenous and oral administration is appropriate when clinically indicated.
CRESEMBA capsules can be taken with or without food.
CRESEMBA capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsules.
Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia
Isavuconazole is not removed by haemodialysis. There is no specific antidote for isavuconazole. In the event of an overdose, supportive treatment should be instituted.
30 months.
Do not store above 30°C.
Store in the original packaging in order to protect from moisture.
CRESEMBA 40 mg hard capsules: 35 hard capsules (in seven aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
CRESEMBA 100 mg hard capsules: 14 hard capsules (in two aluminum blisters), with each capsule pocket connected to a pocket with desiccant.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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