Isavuconazonium: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026🚩 Report this page

Isavuconazonium

Active ingredient

GB MHRA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 3

Overview

Isavuconazonium is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	April 10, 2026

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised August 22, 2025[1]

1) 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.

How to take

Drug interactions

Known interactions involving Isavuconazonium. Select one for details. This list is informational and not a complete interaction checker.

Acalabrutinib Alfentanil Amprenavir Apalutamide Atazanavir Avanafil Boceprevir Bosutinib Brexpiprazole Brigatinib Butorphanol Carbamazepine Ceritinib Cilostazol Cisapride Clarithromycin Cobicistat Cobimetinib Colchicine Conivaptan Deflazacort Delavirdine Eliglustat Encorafenib Entrectinib Enzalutamide Eplerenone Everolimus Fentanyl Flibanserin Fosamprenavir Fosphenytoin Guanfacine Halofantrine Hydrocodone Idelalisib Indinavir Itraconazole Ivabradine Ivacaftor Ivosidenib Ketoconazole Lomitapide Lurasidone Mitotane Naloxegol Nefazodone Nelfinavir Neratinib Olaparib Oxycodone Ozanimod Phenobarbital Phenytoin Pimozide Posaconazole Primidone Ranolazine Rifabutin Rifampin Rifapentine Ritonavir Saquinavir Siponimod Sonidegib Suvorexant Telaprevir Telithromycin Troleandomycin Venetoclax Voriconazole Abemaciclib Afatinib Albendazole Alfuzosin Aliskiren Alpelisib Alprazolam Ambrisentan Aminoglutethimide Amiodarone Amlodipine Amobarbital Apixaban Apremilast Aprepitant Aripiprazole Artesunate Astemizole Atorvastatin Axitinib Belinostat Bepridil Betamethasone Betrixaban Bexarotene Bicalutamide Binimetinib Bosentan Brentuximab Vedotin Bromocriptine Budesonide Buprenorphine Bupropion Buspirone Butabarbital Butalbital Cabazitaxel Cabozantinib Cariprazine Cerivastatin Cevimeline Chloramphenicol Chloroquine Cimetidine Ciprofloxacin Clonazepam Clorazepate Clotrimazole Copanlisib Crizotinib Cyclophosphamide Cyclosporine Dabrafenib Daclatasvir Dalfampridine Darifenacin Darunavir Dasatinib Daunorubicin Deferasirox Delafloxacin Dexamethasone Diazepam Dienestrol Digoxin Dihydrocodeine Dihydroergotamine Diltiazem Disopyramide Docetaxel Dofetilide Doxorubicin Dronedarone Dutasteride Edoxaban Efavirenz Elagolix Eletriptan Empagliflozin Epirubicin Ergotamine Erlotinib Erythromycin Eslicarbazepine Estazolam Estradiol Estrone Eszopiclone Ethinyl Estradiol Ethosuximide Etonogestrel Etoposide Etravirine Fedratinib Felbamate Felodipine Fesoterodine Fexofenadine Fluconazole Fludrocortisone Flurazepam Fluticasone Fluvoxamine Fostamatinib Galantamine Gefitinib Gilteritinib Glasdegib Granisetron Grazoprevir Grepafloxacin Griseofulvin Haloperidol Halothane Hydrocortisone Hydroxychloroquine Idarubicin Ifosfamide Iloperidone Imatinib Irinotecan Isradipine Ivermectin Ixabepilone Ketamine Lapatinib Larotrectinib Lefamulin Lenalidomide Letermovir Letrozole Levobupivacaine Levonorgestrel Linagliptin Loperamide Loratadine Lorlatinib Lovastatin Lusutrombopag Macitentan Maraviroc Medroxyprogesterone Mefloquine Mephobarbital Metformin Methadone Methylprednisolone Methysergide Metreleptin Miconazole Midazolam Midostaurin Mifepristone Mirtazapine Mitoxantrone Mycophenolic Acid Nafcillin Naldemedine Nevirapine Nicardipine Nifedipine Nilotinib Nimodipine Nintedanib Niraparib Nisoldipine Nitisinone Norethindrone Norgestrel

Showing 240 of 338. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB322050008 · revised August 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

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.
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.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised August 22, 2025[1]

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.
*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.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised August 22, 2025[1]

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.
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.

This is not medical advice. Consult a qualified healthcare professional.