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CRESEMBA is a brand name for Isavuconazonium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CRESEMBA hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of • invasive aspergillosis • mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of…
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Treatment 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. 1).
3). Elderly No dose adjustment is necessary for elderly patients; however, the clinical experience in elderly patients is limited. 2). No dose recommendation can be made for paediatric patients with renal impairment, as no relevant data are available.
2). Isavuconazole has not been studied in adult patients with severe hepatic impairment (Child-Pugh Class C). 2). No dose recommendation can be made for paediatric patients with hepatic impairment, as no relevant data are available. Paediatric population 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.
7%). 5%). Tabulated list of adverse reactions Table 4 presents adverse reactions with isavuconazole in the treatment of invasive fungal infections in adults, by System Organ Class and frequency. The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100); not known (frequency cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 4 Summary of adverse reactions by MedDRA System Organ Class and frequency System Organ Class Adverse Drug Reactions Blood and lymphatic system disorders Uncommon Neutropenia; Thrombocytopenia^; Pancytopenia; Leukopenia^; Anaemia^ Immune system disorders Uncommon Hypersensitivity^ Not known Anaphylactic reaction* Metabolism and nutrition disorders Common Hypokalaemia; Decreased appetite Uncommon Hypomagnesaemia; Hypoglycaemia; Hypoalbuminaemia; Malnutrition^; Hyponatraemia Psychiatric disorders Common Delirium^# Uncommon Depression; Insomnia^ Nervous system disorders Common Headache; Somnolence Uncommon Convulsion^; Syncope; Dizziness; Paraesthesia^; Encephalopathy; Presyncope; Neuropathy peripheral; Dysgeusia Ear and labyrinth disorders Uncommon Vertigo Cardiac disorders Uncommon Atrial fibrillation; Tachycardia; Bradycardia^; Palpitations; Atrial flutter; Electrocardiogram QT shortened; Supraventricular tachycardia; Ventricular extrasystoles; Supraventricular extrasystoles Vascular disorders Common Thrombophlebitis^ Uncommon Circulatory collapse; Hypotension Respiratory, thoracic and mediastinal disorders Common Dyspnoea^; Acute respiratory failure^ Uncommon Bronchospasm; Tachypnoea; Haemoptysis; Epistaxis Gastrointestinal disorders Common Vomiting; Diarrhoea; Nausea; Abdominal pain^ Uncommon Dyspepsia; Constipation; Abdominal distension Hepatobiliary disorders Common Elevated liver chemistry tests^# Uncommon Hepatomegaly; Hepatitis Skin and subcutaneous tissue disorders Common Rash^; Pruritus Uncommon Petechiae; Alopecia; Drug eruption; Dermatitis^ Musculoskeletal and connective tissue disorders Uncommon Back pain Renal and urinary disorders Common Renal failure General disorders and administration site conditions Common Chest pain^; Fatigue Uncommon Oedema peripheral^; Malaise; Asthenia ^ Indicates that grouping of appropriate preferred terms into a single medical concept occurred.
8). In case of anaphylactic reaction, isavuconazole should be discontinued immediately and appropriate medical treatment should be initiated. Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents.
Severe cutaneous adverse reactions Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported during treatment with azole antifungal agents. If a patient develops a severe cutaneous adverse reaction, CRESEMBA should be discontinued.
3). In a QT study in healthy human subjects, isavuconazole shortened the QTc interval in a concentration-related manner. 1 ms]. 4 ms]. Caution is warranted when prescribing isavuconazole to patients taking other medicinal products known to decrease the QT interval, such as rufinamide.
8). The elevations in liver transaminases rarely required discontinuation of isavuconazole. Monitoring of hepatic enzymes should be considered, as clinically indicated. Hepatitis has been reported with azole antifungal agents including isavuconazole.
Severe hepatic impairment 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.
2). Paediatric patients Isavuconazole has not been studied in paediatric patients with renal or hepatic impairment. Paediatric patients from 6 years to less than 18 years of age and with a bodyweight at least 32 kg may receive CRESEMBA 100 mg capsules.
However, the use of CRESEMBA 100 mg capsules has not been studied in paediatric patients. 3). For the strong CYP3A4 inhibitor lopinavir/ritonavir, a two-fold increase in isavuconazole exposure was observed. For other strong CYP3A4/5 inhibitors, a less pronounced effect can be expected.
1. 5). 5). g. phenobarbital), phenytoin and St. 5). 4).
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4). The safety and efficacy of CRESEMBA in paediatric patients aged less than 1 year has not been established. Switch to intravenous infusion CRESEMBA is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole.
2), switching between intravenous and oral administration is appropriate when clinically indicated. 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.
*ADR identified post-marketing. # See section Description of selected adverse reactions below. Description of selected adverse reactions Delirium includes reactions of confusional state. Elevated liver chemistry tests includes events of alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma- glutamyltransferase increased, hepatic enzyme increased, hepatic function abnormal, hyperbilirubinemia, liver function test abnormal, and transaminases increased.
4% of patients who received isavuconazole. 2% of patients on isavuconazole. Paediatric population The clinical safety of isavuconazole was assessed in 77 paediatric patients who received at least one dose of intravenous or oral isavuconazole.
This included 46 paediatric patients who received isavuconazole as a single dose and who also received other antifungals for prophylaxis, and 31 patients with suspected or confirmed invasive aspergillosis or mucormycosis who received isavuconazole as primary therapy for up to 181 days.
Overall, the safety profile of isavuconazole in the paediatric population was similar to that in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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5). 5). CYP3A4/5 substrates including immunosuppressants Isavuconazole can be considered a moderate inhibitor of CYP3A4/5, and systemic exposure to medicinal products metabolised by CYP3A4 may be increased when co- administered with isavuconazole.
Concomitant use of isavuconazole with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products. 5). CYP2B6 substrates Isavuconazole is an inducer of CYP2B6.
Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with isavuconazole. Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with isavuconazole.
3). P-gp substrates Isavuconazole may increase the exposure of medicinal products that are P-gp substrates. 5). Limitations of the clinical data The clinical data for isavuconazole in the treatment of mucormycosis are limited to one prospective non-controlled clinical study in 37 adult patients with proven or probable mucormycosis who received isavuconazole for primary treatment, or because other antifungal treatments (predominantly amphotericin B) were inappropriate.
1). Susceptibility data were available in only a small subset of cases. These data indicate that concentrations of isavuconazole required for inhibition in vitro are very variable between genera/species within the order of Mucorales, and generally higher than concentrations required to inhibit Aspergillus species.
It should be noted that there was no dose-finding study in mucormycosis, and patients were administered the same dose of isavuconazole as was used for the treatment of invasive aspergillosis.