Anidulafungin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulation of anidulafungin.
Drugs List
Therapeutic Indications
Uses
Invasive candidiasis: treatment
Dosage
Adults
200mg loading dose should be administered on day 1, followed by 100mg daily thereafter.
Usually, the treatment should continue for at least 14 days after the last positive culture. There is inadequate data to support the 100mg dose for longer than 35 days.
Children
A single loading dose of 3mg/kg (not to exceed 200mg) should be administered on day 1, followed by a daily maintenance dose of 1.5mg/kg (not to exceed 100mg) thereafter.
Usually, the treatment should continue for at least 14 days after the last positive culture.
Administration
For intravenous infusion only, after reconstitution and dilution.
The rate of infusion should not exceed 1.1mg/minute (1.4ml/minute of the diluted infusion solution). Infusion related reactions are less frequent when the rate does not exceed 1.1mg/minute.
Contraindications
Neonates
Breastfeeding
Hereditary fructose intolerance
Pregnancy
Precautions and Warnings
Children 1 month to 18 years
Consult national/regional policy on the use of anti-infectives
Not all available products are licensed for all age groups
Treatment to be initiated and supervised by a specialist
Contains fructose
Concentrate must be diluted and used as an infusion
Monitor hepatic enzymes. Assess benefit/risk if significant rise
Monitor patient for infusion-associated reactions (IARs)
Discontinue if serious allergic or anaphylactic reaction occurs
Anidulafungin has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. There is not enough experience with the use of anidulafungin in neutropenic patients.
Before therapy is initiated, specimens for fungal culture should be taken. Therapy may be started before the results of these tests are known and dosage may be adjusted accordingly when results are obtained.
Pregnancy and Lactation
Pregnancy
Anidulafungin is contraindicated during pregnancy.
The manufacturer recommends anidulafungin is avoided in pregnancy, unless the benefit to the mother clearly outweighs the potential risk to the developing foetus. Animal studies have shown anidulafungin to cross the placenta, and reproductive toxicity has been documented. At the time of writing, there are insufficient data regarding the use of anidulafungin during pregnancy.
Lactation
Anidulafungin is contraindicated during breastfeeding.
The manufacturer recommends evaluating the benefits of breastfeeding for the child against the benefits of therapy for the breastfeeding woman, and discontinuing either anidulafungin therapy or breastfeeding accordingly. It is not known if anidulafungin is excreted in human breast milk, but animal studies have shown excretion of anidulafungin in animal milk. Anidulafungin's large molecular weight but long degradation half-life and moderate plasma protein binding suggest that excretion into breast milk may occur. The potential effect on the nursing infant is unknown.
Side Effects
Anaphylactic reaction
Anaphylactic shock
Bronchospasm
Cholestasis
Coagulation disorders
Convulsions
Diarrhoea
Dyspnoea
Flushing
Gamma glutamyl transferase (GGT) increased
Headache
Hepatitis
Hot flushes
Hyperglycaemia
Hypertension
Hypokalaemia
Hypotension
Increase in alkaline phosphatase
Increase in serum ALT/AST
Infusion-related symptoms
Local pain (injection site)
Nausea
Pruritus
Rash
Serum bilirubin increased
Serum creatinine increased
Upper abdominal pain
Urticaria
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: February 2022.
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Anidulafungin 100mg powder for concentrate for solution for infusion. Wockhardt UK Ltd. Revised March 2020.
Summary of Product Characteristics: Ecalta 100mg powder for solution for concentrate for infusion. Pfizer Ltd. Revised October 2020.
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