Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Anidulafungin contains the active substance anidulafungin and is prescribed in adults and in paediatric patients aged 1 month 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.
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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. Ask your doctor or pharmacist for advice before taking any medicines. Anidulafungin contains fructose This medicine contains 119 mg fructose (a type of sugar) in each vial. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 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. Anidulafungin contains sodium This medicine contains less than 1 mmol sodium (23 mg) 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).
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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 doctor. 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.
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.
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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, 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 at: 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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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 (2oC – 8oC). The reconstituted solution may be stored up to 25oC for up to 24 hours. The infusion solution may be stored at 25oC (room temperature) for 48 hours (do not freeze) and should be administered at 25oC (room temperature) within 48 hours. Do not throw away any medicines via wastewater or household waste.
Aseptically reconstitute each vial with 30 mL water for injection to provide a concentration of 3.33 mg/mL. The reconstitution time can be up to 5 minutes. After subsequent dilution, the solution is to be discarded if particulate matter or discolouration is identified. The reconstituted solution may be stored up to 25oC 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 to obtain the appropriate anidulafungin concentration. The table below provides the dilution to a concentration of 0.77 mg/mL for the final infusion solution and infusion instructions for each dose. Dilution requirements for Anidulafungin administration
Dose Numbe
Total reconstituted
Infusion volume A
r of vials
volume
of powder
100 mg 1 30 mL 100 mL 130 mL 1.4 mL/min or 84 mL/ hour
200 mg 2 60 mL 200 mL 260 mL 1.4 mL/min or 84 mL/ hour
A Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
B 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 or 84 mL/hour when reconstituted and diluted per instructions).
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Total infusion
Rate of infusion Minimum duration of
volume B
infusion
90 min
180 min
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 of anidulafungin (mL) = Dose of anidulafungin (mg) 3.33 mg/mL 3. Calculate the total volume of dosing solution (mL) required to provide a final concentration of 0.77 mg/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) of anidulafungin 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. Ref: AFW 3_0
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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.
The active substance in Anidulafungin 100 mg powder for concentrate for solution for infusion is anidulafungin.
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.
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.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years (see sections 4.4 and 5.1).
Treatment with this medicine 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. 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) A single loading dose of 3.0 mg/kg (not to exceed 200 mg) should be administered on Day 1 followed by a daily maintenance dose of 1.5 mg/kg (not to exceed 100 mg) thereafter. 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 Anidulafungin have not been established in neonates (< 1 month old) (see section 4.4). Method of administration For intravenous use only. This medicine should be reconstituted with water for injection 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). It is recommended that this medicine 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). This medicine must not be administered as a bolus injection. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
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. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
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. Excipients with known effect Fructose This medicine contains fructose. Patients with hereditary fructose intolerance (HFI) should not be given this medicine unless strictly necessary. Babies and young children (below 2 years of age) may not yet be diagnosed with HFI. Medicines (containing fructose) given intravenously may be life-threatening and should not be administered 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 This medicine contains less than 1 mmol sodium (23 mg) per vial. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'. Anidulafungin may be diluted with sodium-containing solutions (see section 6.6) and this should be considered in relation to the total sodium from all sources that will be administered to the patient. Polysorbate ECALTA 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. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
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. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
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).
Not relevant.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store <summary id="OVERDOSE" data-evt="smpcSectionOpen"
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.
This medicine is not dialysable.
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.
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