Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Anidulafungin 100 mg powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Anidulafungin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for 2. What you need to know before you use Anidulafungin 3. How to use Anidulafungin 4. Possible side effects 5. How to store Anidulafungin 6. Contents of the pack and other information
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Package leaflet: Information for the user Anidulafungin 100 mg Powder for concentrate for solution for infusion (Referred to as Anidulafungin in the remainder of the leaflet)
Anidulafungin contains the active substance Anidulafungin and is prescribed in adults and in paediatric patients aged 1month to less than 18 years to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by fungal cells (yeasts) called Candida. Anidulafungin belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections. Anidulafungin prevents normal development of fungal cell walls. In the presence of Anidulafungin, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
What you need to know before you take it
e Anidulafungin Do not use Anidulafungin
- if you are allergic to Anidulafungin, other echinocandins (e.g. caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist or nurse before using Anidulafungin. Your doctor may decide to monitor you.
- for liver function more closely if you develop liver problems during your treatment.
- if you are given anaesthetics during your treatment with Anidulafungin
- for signs of an allergic reaction such as itching, wheezing, blotchy skin
- for signs of an infusion-related reaction which could include a rash, hives, itching, redness,
- for shortness of breath/breathing difficulties, dizziness or lightheadedness Children and adolescents Anidulafungin should not be given to patients under 1 month of age. Other medicines and Anidulafungin Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding The effect of Anidulafungin in pregnant women is not known. Therefore Anidulafungin is not recommended during pregnancy. Effective contraception should be used in women of childbearing age. Contact your doctor immediately if you become pregnant while taking Anidulafungin. The effect of Anidulafungin in breast-feeding women is not known. Ask your doctor or pharmacist for advice before taking Anidulafungin while breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicines. Anidulafungin contains fructose and sodium This medicine contains 100mg fructose (a type of sugar) in each vial. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose in this medicine, which may cause serious side effects. You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea. This medicine also contains less than 1mmol sodium (23mg) per vial, that is to say "essentially sodium free". Anidulafungin contains polysorbate 80 This medicine contains 250 mg of polysorbate 80 in each 100 mg vial dose, which is equivalent to 1.92 mg/mL of polysorbate 80 in the solution that will be infused into you or your child. Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any known allergies. Polysorbates can have an effect on your heart and blood circulation ( e.g. irregular or abnormal heartbeat, or low blood pressure).
How to take it
Anidulafungin
Dose 100 mg 200 mg
Number of vials of powder 1 2
Total reconstituted volume 30 mL 60 mL
Infusion volume A 100 mL 200 mL
Total infusion volumeB 130 mL 260 mL
Rate of infusion 1.4 mL/min 1.4 mL/min
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Minimum duration of infusion 90 min 180 min
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Anidulafungin 100 mg powder Leaflet Wockhardt UK – (w)150 x (h)550mm XXX 10 pt. (9 pt. for tear-off section) Anidulafungin_100mg_Powder_Leaflet_108400-3.ai Adobe Illustrator CS5 Myriad Pro Regular / Italic / Bold 28th January, 2026
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NOTE: Material codes, pharmacodes and bleedmarks would be added while working on the country specific production artworks Anidulafungin Wockhardt 100 mg pow. for conc. for sol. for inf.- UK Farmakod/Pharmacode: XXX Malzeme kodu/Material code: XXXXXXXX-X Kağıt ağırlığı: 45 g/m2 Paper weight: 45 g/m2 Kağıt cinsi: 1. Hamur Papertype: Dough paper Kağıt su yönü: Su yolu uzun kenara paralel olmalıdır. Paper fiber direction (waterline): Long grain Ambalaj şekli: Uzun kenar (550 mm) 1 kez katlı olarak gelmelidir. Packaging type: it must be folded along the long side (550 mm)
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The following information is intended for medical or healthcare professionals only and applies only to the single vial Anidulafungin 100 mg powder for concentrate for solution for infusion presentation: The contents of the vial must be reconstituted with water for injections and subsequently diluted with ONLY 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion. The compatibility of reconstituted Anidulafungin with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established. Reconstitution Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL. The reconstitution time can be up to 2 minutes. The appearance after reconstitution is a clear, colourless to pale greenish yellow solution free from particles. After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified. The reconstituted solution may be stored up to 25°C for up to 24 hours prior to further dilution. Dilution and infusion Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If either particulate matter or discolouration is identified, discard the solution. Adult Patients Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion obtaining an Anidulafungin concentration of 0.77 mg/mL. The table below provides the volumes required for each dose. Dilution requirements for Anidulafungin administration
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Anidulafungin will always be prepared and given to you or your child by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only). For use in children and adolescents (age from 1 month to less than 18 years), the treatment starts with 3.0 mg/kg (not to exceed 200 mg) on the first day (loading dose). This will be followed by a daily dose of 1.5 mg/kg (not to exceed 100 mg) (maintenance dose). The dose that is given depends on the patient's weight. For use in adults, the treatment starts with 200 mg on the first day (loading dose). This will be followed by a daily dose of 100 mg (maintenance dose). Anidulafungin should be given to you once a day, by slow infusion (a drip) into your vein. For adults, this will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose. For children and adolescents, the infusion may take less time depending on the patient's weight. Your doctor will determine the duration of your treatment and how much Anidulafungin you will receive each day and will monitor your response and condition. In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood. If you receive more Anidulafungin than you should If you are concerned that you may have been given too much Anidulafungin, tell your doctor or another healthcare professional immediately. If you forgot to use Anidulafungin As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten. You should not be given a double dose by the doctor to make up for the forgotten dose.
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If you stop using Anidulafungin You should not experience any effects from Anidulafungin if your doctor stops Anidulafungin treatment. Your doctor may prescribe another medicine following your treatment with Anidulafungin to continue treating your fungal infection or prevent it from returning. If your original symptoms come back, tell your doctor or another healthcare professional immediately. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these side effects will be noted by your doctor while monitoring your response and condition. Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have been rarely reported during administration of Anidulafungin. Serious side effects – tell your doctor or another healthcare professional immediately should any of the following occur:
- convulsion (seizure)
- flushing
- rash, pruritis (itching)
- hot flush
- hives
- sudden contraction of the muscles around the airways resulting in wheezing or coughing
- difficulty of breathing. Other side effects Very common side effects (may affect more than 1 in 10 people) are:
- low blood potassium (hypokalaemia)
- diarrhoea
- nausea. Common side effects (may affect up to 1 in 10 people) are:
- convulsion (seizure)
- headache
- vomiting
- changes in blood tests of liver function
- rash, pruritis (itching)
- changes in blood tests of kidney function
- abnormal flow of bile from the gallbladder into the intestine (cholestasis)
- high blood sugar
- high blood pressure
- low blood pressure
- sudden contraction of the muscles around the airways resulting in wheezing or coughing
- difficulty of breathing. Uncommon side effects (may affect up to 1 in 100 people) are:
- disorder of blood clotting system
- flushing
- hot flush
- stomach pain
- hives
- pain at injection site. Not known (frequency cannot be estimated from the available data) are:
- life-threatening allergic reactions. Reporting of side effects If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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How to store it
Anidulafungin Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). The reconstituted solution may be stored up to 25°C for up to 24 hours. The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25°C (room temperature) within 48 hours. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Anidulafungin contains − The active substance is Anidulafungin. Each vial of powder contains 100 mg Anidulafungin. − The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment). What Anidulafungin looks like and contents of the pack Anidulafungin is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion. The powder is white to off-white. Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK Manufacturer: Laboratori FUNDACIO DAU, C/ De la letra C, 12-14, Polígono Industrial de la Zona Franca, 08040 Barcelona, Spain Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Product name Reference number Anidulafungin 100 mg powder for 29831/0705 concentrate for solution for infusion This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 01/2026. 108400/3
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Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion. Infusion solution concentration is 0.77 mg/mL The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 ml/min when reconstituted and diluted per instructions). Paediatric Patients For paediatric patients aged 1 month to < 18 years, the volume of infusion solution required to deliver the dose will vary depending on the weight of the patient. The reconstituted solution must be further diluted to a concentration of 0. 77 mg/mL for the final infusion solution. A programmable syringe or infusion pump is recommended. The rate of infusion should not exceed 1.1 mg/minute (equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions). 1. Calculate patient dose and reconstitute vial(s) required according to reconstitution instructions to provide a concentration of 3.33 mg/mL 2. Calculate the volume (mL) of reconstituted anidulafungin required:
- Volume ofanidulafungin (mL) = Dose ofanidulafungin (mg)+ 3.33 mg/mL 3. Calculate the total volume of dosing solution (mL) required to provide a final concentration of 0.77mg/mL:
- Total volume of dosing solution (mL) = Dose of anidulafungin (mg) + 0. 77 mg/mL 4. Calculate the volume of diluent [5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline)] required to prepare the dosing solution:
- Volume of diluent (mL) = Total volume of dosing solution (mL)- Volume of anidulafungin (mL) 5. Aseptically transfer the required volumes (mL) ofanidulafungin and 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) into an infusion syringe or IV infusion bag needed for administration. For single use only. Waste materials should be disposed of in accordance with local requirements. A
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Frequently asked questions about Anidulafungin 100 mg powder for concentrate for solution for infusion
How do I take Anidulafungin 100 mg powder for concentrate for solution for infusion?
Anidulafungin 100 mg powder for concentrate for solution for infusion comes as infusion containing 100mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Anidulafungin 100 mg powder for concentrate for solution for infusion?
The active substance in Anidulafungin 100 mg powder for concentrate for solution for infusion is anidulafungin.
Are there equivalent medicines to Anidulafungin 100 mg powder for concentrate for solution for infusion?
Medicines with the same active substance, strength and form include: ECALTA 100 mg powder for concentrate for solution for infusion, Anidulafungin 100 mg powder for concentrate for solution for infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Anidulafungin 100 mg powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Anidulafungin 100 mg powder for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: anidulafungin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years (see sections 4.4 and 5.1).
4.2. Posology and method of administration
Treatment with Anidulafungin should be initiated by a physician experienced in the management of invasive fungal infections.
Posology
Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Adult population (dosing and treatment duration)
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. Duration of treatment should be based on the patient's clinical response.
Duration of treatment
In general, antifungal therapy should continue for at least 14 days after the last positive culture.
There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Patients with renal and hepatic impairment
No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Anidulafungin can be given without regard to the timing of haemodialysis (see section 5.2).
Other special populations
No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).
Paediatric population (1 month to < 18 years) (dosing and treatment duration)
Duration of treatment should be based on the patient's clinical response.
In general, antifungal therapy should continue for at least 14 days after the last positive culture.
The safety and efficacy of ECALTA have not been established in neonates (< 1 month old) (see section 4.4).
Method of administration
For intravenous use only.
Anidulafungin should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL for the final infusion solution. For a paediatric patient, the volume of infusion solution required to deliver the dose will vary depending on the weight of the child. For instructions on reconstitution of the medicinal product before administration (see section 6.6).
The appearance after reconstitution is a clear, colourless to pale greenish yellow solution free from particles.
It is recommended that Anidulafungin be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Anidulafungin must not be administered as a bolus injection.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to other medicinal products of the echinocandin class.
4.4. Special warnings and precautions for use
Anidulafungin has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. The efficacy of Anidulafungin has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Paediatric population
Treatment with Anidulafungin in neonates (< 1 month old) is not recommended. Treating neonates requires consideration for coverage of disseminated candidiasis including central nervous system (CNS); nonclinical infection models indicate that higher doses of anidulafungin are needed to achieve adequate CNS penetration (see section 5.3), resulting in higher doses of polysorbate 80, a formulation excipient. High doses of polysorbates have been associated with potentially life-threatening toxicities in neonates as reported in the literature.
There is no clinical data to support the efficacy and safety of higher doses of anidulafungin than recommended in 4.2.
Hepatic effects
Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred. Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials. Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.
Anaphylactic reactions
Anaphylactic reactions, including shock, were reported with the use of anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
Infusion-related reactions
Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension. Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8).
Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a non-clinical (rat) study (see section 5.3). The clinical relevance of this is unknown. Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Fructose content
Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). Medicines (containing fructose) given intravenously may be lifethreatening and must be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium free'.
Polysorbate
This medicinal product contains Polysorbate 80. Polysorbates may cause allergic reactions and can have an effect on the heart and blood circulation (e.g., irregular or abnormal heartbeat, or low blood pressure). Risk minimization by lowering the rate of infusion is to be considered.
4.5. Interaction with other medicinal products and other forms of interaction
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). Of note, in vitro studies do not fully exclude possible in vivo interactions.
Drug interaction studies were performed with anidulafungin and other medicinal products likely to be co-administered. No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin.
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Anidulafungin is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Breast-feeding
It is unknown whether anidulafungin is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Anidulafungin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Summary of the safety profile
Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush and urticaria (uncommon events), summarized in Table 1 (see section 4.4).
Tabulated list of adverse reactions
The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1. Table of Adverse Reactions
System Organ Class
Very Common
≥ 1/10
Common
≥ 1/100 to < 1/10
Uncommon
≥ 1/1000 to <1/100
Rare
≥ 1/10,000 to <1/1,000
Very Rare
< 1/10,000
Not Known
Blood and Lymphatic System Disorders
Coagulopathy
Immune System Disorders
Anaphylactic shock,
anaphylactic reaction*
Metabolism and Nutrition Disorders
Hypokalaemia
Hyperglycaemia
Nervous System Disorders
Convulsion,
headache
Vascular Disorders
Hypotension,
hypertension
Flushing,
hot flush
Respiratory, Thoracic and Mediastinal Disorders
Bronchospasm,
Dyspnoea
Gastrointestinal Disorders
Diarrhoea,
nausea
Vomiting
Abdominal pain upper
Hepatobiliary Disorders
Alanine aminotransferase increased,
blood alkaline phosphatase increased,
aspartate aminotransferase increased,
blood bilirubin increased,
cholestasis
Gamma-glutamyltransferase increased
Skin and Subcutaneous Tissue Disorders
Rash,
pruritus
Urticaria
Renal and Urinary Disorders
Blood creatinine increased
General Disorders and Administration Site Conditions
Infusion site pain
* See section 4.4.
Paediatric population
The safety of anidulafungin was investigated in 68 paediatric patients (1 month to < 18 years) with invasive candidiasis including candidaemia (ICC) in a prospective, open-label, non-comparative paediatric study (see section 5.1). The frequencies of certain hepatobiliary adverse events, including alanine aminotransferase (ALT) increased and aspartate aminotransferase (AST) increased appeared at a higher frequency (7-10%) in these paediatric patients than has been observed in adults (2%). Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in paediatric patients compared to 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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
As with any overdose, general supportive measures should be utilised as necessary. In case of overdose, adverse reactions may occur as mentioned in section 4.8.
During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose. No clinical adverse reactions were reported. No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x Upper Limit of Normal (ULN)).
During a paediatric clinical trial, one subject received two doses of anidulafungin that were 143% of the expected dose. No clinical adverse reactions were reported.
Anidulafungin is not dialysable.
💬 Ask about this leaflet
Ask anything about Anidulafungin 100 mg powder for concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.