Isavuconazole oral and parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Formulations containing isavuconazole as isavuconazonium sulfate.
Drugs List
Therapeutic Indications
Uses
Aspergillosis: treatment
Mucormycosis: treatment
Invasive aspergillosis.
Mucormycosis in patients for whom amphotericin B is inappropriate.
Dosage
For treatment beyond 6 months, the benefit and risk of treatment should be considered.
Isavuconazole is available as capsules and as powder for concentrate for solution for infusion. Switching between intravenous and oral administration is acceptable when clinically indicated due to the high oral bioavailability (98%).
Adults
Loading dose
200 mg isavuconazole every 8 hours for first 48 hours (6 administrations in total).
Maintenance dose
200 mg isavuconazole once daily, starting 12 to 24 hours after the last loading dose.
Administration
Capsules
For oral administration, swallowed whole. Do not crush, chew, dissolve or open.
Powder for solution for infusion
For intravenous infusion over a minimum of 1 hour to reduce the risk of infusion related reactions.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Shortened QT interval
Precautions and Warnings
Severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Capsules should not be opened or crushed
Monitor hepatic enzymes. Assess benefit/risk if significant rise
Consider discontinuing if severe infusion reactions occur
Discontinue if severe skin reaction occurs
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Female: Ensure adequate contraception during treatment
Pregnancy and Lactation
Pregnancy
Isavuconazole is contraindicated during pregnancy.
The manufacturer suggests that isavuconazole must not be used in pregnancy except in patients with severe or life-threatening infections when the benefits of treatment outweigh the possible risks to the foetus.
At the time of writing, there is limited published information regarding the use of isavuconazole during pregnancy. Studies in animals have shown reproductive toxicity.
Lactation
Isavuconazole is contraindicated during breastfeeding.
The manufacturer advises that breastfeeding should be discontinued during treatment with isavuconazole.
At the time of writing, available pharmacodynamic and toxicological data in animals have shown that isavuconazole and its metabolites are excreted in milk. A risk to newborns and infants cannot be excluded.
Effects on Ability to Drive and Operate Machinery
Isavuconazole has a moderate potential to influence ability to drive and use machinery. If symptoms occur such as confusion and syncope, patients should avoid driving or using machinery.
Side Effects
Abdominal distension
Abdominal pain
Abnormal liver function tests
Alanine aminotransferase increased
Alopecia
Anaemia
Aspartate aminotransferase increased
Asthenia
Atrial fibrillation
Atrial flutter
Back pain
Bradycardia
Bronchospasm
Changes in hepatic function
Chest pain
Circulatory collapse
Confusion
Constipation
Convulsions
Decreased appetite
Delirium
Depression
Dermatitis
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dyspnoea
ECG changes
Encephalopathy
Epistaxis
Extrasystoles
Fatigue
Gamma glutamyl transferase (GGT) increased
Haemoptysis
Headache
Hepatitis
Hepatomegaly
Hyperbilirubinaemia
Hypersensitivity reactions
Hypoalbuminaemia
Hypoglycaemia
Hypokalaemia
Hypomagnesaemia
Hypotension
Increase in alkaline phosphatase
Increased blood lactate levels
Increases in hepatic enzymes
Injection site reactions
Insomnia
Leukopenia
Malaise
Malnutrition
Nausea
Neutropenia
Palpitations
Pancytopenia
Paraesthesia
Peripheral neuropathy
Peripheral oedema
Petechiae
Presyncope
Pruritus
Rash
Renal failure
Respiratory failure
Seizures
Serum bilirubin increased
Skin eruption
Somnolence
Stevens-Johnson syndrome
Supraventricular tachycardia
Syncope
Tachycardia
Tachypnoea
Thrombocytopenia
Thrombophlebitis
Transient QT changes
Ventricular extrasystoles
Vertigo
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2019
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 January 2018
Summary of Product Characteristics: Cresemba 100 mg hard capsules. Revised March 2019.
Summary of Product Characteristics: Cresemba 200 mg powder for concentrate for solution for infusion. Revised March 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.