Consumer medicine information

Eraxis

Anidulafungin

BRAND INFORMATION

Brand name

Eraxis

Active ingredient

Anidulafungin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Eraxis.

SUMMARY CMI

Eraxis®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is subject to additional monitoring due to approval of an extension of indications. Please report side effects. See the full CMI for further details.

1. Why am I being treated with Eraxis?

Eraxis contains the active ingredient anidulafungin. It is used to treat serious fungal infections caused by yeast, such as candidiasis and candidaemia in adults and children one month and older. For more information, see Section 1. Why am I being treated with Eraxis? in the full CMI.

2. What should I know before treatment with Eraxis?

Do not start treatment if you/ your child have ever had an allergic reaction to any medicine containing anidulafungin, any of the ingredients listed at the end of this CMI, or any other similar medicines such as Cancidas (not all brands given)

Tell the doctor if you/your child have had any allergic reaction to any antifungal, or any foods, preservatives or dyes or any other medicines, have liver problems, have intolerance to sugars such as fructose if you are pregnant, plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before treatment with Eraxis? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Eraxis and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Eraxis given?

Eraxis is given as a slow injection into the vein. The doctor will decide how much Eraxis will be given to you each day and for how long. It will depend on your condition and other factors. More instructions can be found in Section 4. How is Eraxis given? in the full CMI.

5. What should I know during treatment with Eraxis?

Things you should do
  • Tell the doctor if you/your child have liver problems, have intolerance to sugars such as fructose if you are pregnant, plan to become pregnant or are breastfeeding
  • For more information on "Things you should do" can be found in Section 6 in the full CMI
Things you should not do
  • Do not start treatment if you/ your child have ever had an allergic reaction to any medicine containing anidulafungin, any of the ingredients listed at the end of this CMI, or any other similar medicines such as Cancidas (not all brands given)
  • You should not breastfeed your infant while on treatment with Eraxis
Looking after your medicine
  • Eraxis should be stored in the pharmacy or on the hospital ward and is kept in a refrigerator at 2°C to 8°C. The reconstituted solution can be utilised for up to 24 hours when stored at 25°C and the infusion solution can be utilised for up to 48 hours from preparation when stored at 25°C.

For more information, see Section 5. What should I know while during treatment with Eraxis? in the full CMI.

6. Are there any side effects?

Side effects may include low blood potassium (hypokalaemia), stomach pain, indigestion, diarrhoea, nausea, fainting, seizures or fits, dizziness, headache, vomiting, changes in liver function, rash, pruritis (itching), blood in urine, changes in blood pressure, increased heart rate, hot flushes, hives, asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, abnormal flow of bile from the gallbladder into the intestine (cholestasis), uncontrollable bleeding, bruising, aching muscles, joints or bones, back pain, blurred vision, eye pain, soreness at the injection site, signs of frequent or worsening infections.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.



FULL CMI

Eraxis®

Active ingredient(s): anidulafungin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Eraxis. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about Eraxis

Where to find information in this leaflet:

1. Why am I being treated with Eraxis?
2. What should I know before treatment with Eraxis?
3. What if I am taking other medicines?
4. How is Eraxis given?
5. What should I know during treatment with Eraxis?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Eraxis?

Eraxis contains the active ingredient anidulafungin. ERAXIS belongs to a group of medicines called echinocandins which work by preventing the growth of fungal organisms causing your infection.

Eraxis is used to treat serious fungal infections caused by yeast, such as candidiasis and candidaemia, in adults and children one month and older.

These are serious fungal infections in the bloodstream or in tissues or organs such as the food pipe or eyes

2. What should I know before treatment with Eraxis?

Warnings

Do not use start treatment with Eraxis if you/your child:

  • are allergic to anidulafungin, or any of the ingredients listed at the end of this leaflet, or any other similar medicines such as Cancidas (not all brands given)
  • Always check the ingredients to make sure you can use this medicine.
  • Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; skin rash, itching or hives.

Check with your doctor if you/your child:

  • have any other medical conditions [liver problems]
  • Your doctor may need to monitor the function of the liver using blood tests. Be sure to follow the doctor's advice if regular checks on your/ your child's liver are recommended.
  • have allergies to any foods, preservatives or dyes or any other medicines
  • are taking medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

ERAXIS should not be used during pregnancy. Effective contraception should be used in women of childbearing potential. Your doctor can discuss with you the risks and benefits involved. ERAXIS should not be used whilst breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Eraxis contains fructose

  • This medicine contains fructose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
  • If you/your child have hereditary fructose intolerance (HFI), a rare genetic disorder, you/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/your child have HFI or if your child can no longer have sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.

3. What if I am taking other medicines?

Tell your doctor if you/your child are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

It is not expected that ERAXIS will interact with other medications or that any adjustments will be necessary to other medicines you/your child may be taking such as

  • tacrolimus, used to help prevent organ transplant rejection or to treat certain problems with the immune system
  • rifampicin, an antibiotic used to treat tuberculosis and other infections
  • ciclosporin, a medicine used to prevent organ transplant rejection or to treat certain problems with the immune system
  • voriconazole, used to treat fungal infections
  • liposomal amphotericin B, used to treat fungal infections or to prevent fungal infection following liver transplant.

However, do not start or stop any other medications without your/ your child's doctor or pharmacist's approval.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Eraxis.

4. How is Eraxis given?

How much will be given

  • Eraxis is given as a slow injection into a vein. Eraxis will only be given by a doctor or nurse. Your doctor will decide how much ERAXIS you will be given each day.

How long will Eraxis need to be given?

  • Your doctor will decide for how long you will receive ERAXIS. This depends on your condition and other factors.

Follow the instructions provided by your/your child's doctor carefully.

If too much Eraxis is given

Your/your child's doctor will monitor your/your child's response and condition to determine what ERAXIS treatment is needed. However, if you are concerned that you/your child may have been given too much ERAXIS you/your child may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know during treatment with Eraxis?

Things you should do

If you are a woman of childbearing potential, you should use effective contraceptive methods to prevent pregnancy during treatment with Eraxis.

Call your doctor straight away if you:

  • Become pregnant while receiving Eraxis

Remind any doctor, dentist, or pharmacist you visit that you are using Eraxis.

Things you should not do

  • You should not breastfeed your infant while on treatment with Eraxis
  • Do not start treatment if you/your child have hereditary fructose intolerance (HFI)
  • Do not start treatment if you/ your child have ever had an allergic reaction to any medicine containing anidulafungin, any of the ingredients listed at the end of this CMI
  • Do not start or stop any other medications without your/your child's doctor or pharmacist's approval

Driving or using machines

No information available

Drinking alcohol

No information available

Looking after your medicine

Eraxis should be stored in the pharmacy or on the hospital ward and should be kept in a refrigerator at 2°C to 8°C (Do not freeze).

The reconstituted solution can be utilised for up to 24 hours when stored at 25°C and the infusion solution can be utilised for up to 48 hours from preparation when stored at 25°C.

When to discard your medicine

Discard any medicine that has passed the expiry date.

This medicine should only be used on one patient on one occasion only.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effectsWhat to do
  • blurred vision, eye pain
  • nausea, vomiting
  • headache
  • hot flushes
  • soreness at the injection site
  • itching, rash, hives
  • pain on swallowing
  • stomach pain, indigestion, diarrhoea, constipation
  • changes in blood pressure
  • aching muscles, joints or bones, back pain
  • intense itching, dark urine and light-coloured bowel movements (cholestasis)
  • low blood potassium which can result in fatigue, muscle cramps and abnormal heart rhythms (hypokalemia)*
  • changes in liver function*
  • changes in kidney function*
* These side effects may show up when you have a blood test.		Speak to your doctor if you/your child have any of these less serious side effects and they worry you.
Serious side effectsWhat to do
  • swelling of the face, lips or tongue
  • difficulty in swallowing or breathing
  • asthma, wheezing, shortness of breath
  • fainting, seizures or fits, dizziness
  • increased heart rate
  • blood in urine
  • uncontrollable bleeding, bruising
  • signs of frequent or worsening infections.
An additional side effect in low-birth weight infants may be nausea, vomiting, fast breathing and lethargy (metabolic acidosis)		Call your/your child's doctor immediately, or go to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you/your child experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Eraxis contains

Active ingredientAnidulafungin
Other ingredientsfructose
mannitol (E421)
polysorbate 80 (E433) (250mg/vial)
tartaric acid (E334)
sodium hydroxide
hydrochloric acid

Do not take this medicine if you are allergic to any of these ingredients.

What Eraxis looks like

Eraxis is available as white to off-white lyophilised powder in a clear glass vial. This is to be dissolved with water for injections prior to use in an infusion.

ERAXIS is supplied as a pack containing 1 vial of 100 mg anidulafungin

Australian Registration Number (Aust R 134398).

Who distributes Eraxis

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

This leaflet was prepared in October 2021.

Published by MIMS December 2021

BRAND INFORMATION

Brand name

Eraxis

Active ingredient

Anidulafungin

Schedule

S4

 

1 Name of Medicine

Anidulafungin.

2 Qualitative and Quantitative Composition

Eraxis is a sterile, lyophilised powder for injection that contains 100 mg anidulafungin.

3 Pharmaceutical Form

Powder for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of invasive candidiasis, including candidaemia in adult and in paediatric patients one month and older (see Section 5.1).

4.2 Dose and Method of Administration

Specimens for Candida culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
For patients with hereditary fructose intolerance (HFI) and all patients under 2 years of age see Section 4.4 Special Warnings and Precautions for Use.

Adult patients.

Invasive candidiasis, including candidaemia.

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. The duration of treatment should not exceed one month.

Paediatric patients (one month and older).

The recommended dose is 3.0 mg/kg (not to exceed 200 mg) loading dose of anidulafungin on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) daily dose thereafter. In general, antifungal therapy should continue for at least 14 days after the last negative culture (defined as the second of two consecutive negative cultures, separated by at least 24 hours, following the last positive culture) and improvement of clinical signs and symptoms of invasive candidiasis including candidaemia (ICC). Switch to an oral antifungal may occur after a minimum of 10 days on anidulafungin intravenous therapy.
The efficacy and safety of anidulafungin has not been established in neonates (less than 1 month) (see Section 4.4).

Preparation of Eraxis for administration.

Eraxis must not be given by bolus injection.
Eraxis 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 Eraxis with intravenous substances, additives, or medications other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established. The infusion solution must not be frozen.

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 5 minutes. The reconstituted solution should be clear and free from visible particulates. After subsequent dilution, the solution is to be discarded if particulate matter or discolouration is identified.
The reconstituted solution may be stored at up to 25°C for 24 hours. Do not freeze.

Dilution and infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or discoloration is identified, discard the solution.

Adult patients.

Aseptically transfer the contents of the reconstituted vial(s) into an IV 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. Table 1 provides the dilution to a concentration of 0.77 mg/mL for the final infusion solution and infusion instructions for each dose.
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) (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

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) (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
1. Calculate patient dose and reconstitute vial(s) required according to reconstitution instructions to provide a concentration of 3.33 mg/mL (see Section 2; Section 4.2).
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.
Eraxis powder for injection contains no antimicrobial preservative. Use in one patient on one occasion only. Discard any residue.

Special populations.

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. Eraxis can be given without regard to the timing of haemodialysis.

Other special populations.

No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV status or geriatric status.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients.
Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).

4.4 Special Warnings and Precautions for Use

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 (see Section 4.8 Adverse Effects (Undesirable Effects)).

Infusion-related reactions.

Eraxis must not be given by bolus injection.
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/minute (see Section 4.2 Dose and Method of Administration; Section 4.8 Adverse Effects (Undesirable Effects)).

Hepatic effects.

Laboratory abnormalities in liver function tests have been seen in healthy subjects and patients treated with anidulafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with anidulafungin, clinically significant hepatic abnormalities have occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to anidulafungin has not been established. Patients who develop abnormal liver function tests during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.

Patients with hereditary fructose intolerance.

Patients with hereditary fructose intolerance (HFI) should not be given this medicine unless strictly necessary.
A detailed history with regard to HFI symptoms should be taken of each patient prior to being given this medicinal product.
Infants and 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.

Use in the elderly.

See Section 5.2 Pharmacokinetic Properties, Special populations.

Paediatric use.

Treatment with anidulafungin in neonates (less than 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, 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.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Nonclinical in vitro and in vivo studies and clinical studies have demonstrated that anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes. Interaction studies have only been performed in adults. Anidulafungin has negligible renal clearance (< 1%). Minimal interactions are expected with the concomitant medications.
In vitro studies showed that anidulafungin is not metabolised by human cytochrome P450 or by isolated human hepatocytes, and anidulafungin does not significantly inhibit the activities of human CYP isoforms (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4) at clinically relevant concentrations.
No clinically relevant drug-drug interactions were observed with the following drugs likely to be co-administered with anidulafungin.

Cyclosporin (CYP3A4 substrate).

No dosage adjustment of either drug is required when they are co-administered. In a study of 12 healthy adult subjects who received 100 mg/day anidulafungin following a 200 mg loading dose alone and in combination with 1.25 mg/kg oral cyclosporin twice daily, the steady state plasma peak concentration (Cmax) of anidulafungin was not significantly altered by cyclosporin; however the steady state area under the concentration-time curve (AUC) was increased by 22%. An in vitro study has shown that anidulafungin has no effect on the metabolism of cyclosporin. Adverse events observed in this study were consistent with those observed in other studies where anidulafungin only was administered.

Voriconazole (CYP2C19, CYP2C9, CYP3A4 inhibitor and substrate).

No dosage adjustment of either drug is required when co-administered. In a study of 17 healthy subjects who received 100 mg/day anidulafungin alone following a 200 mg loading dose, 200 mg twice daily oral voriconazole alone following 400 mg twice on the first day as loading doses, and both in combination, the steady state Cmax and AUC of anidulafungin and voriconazole were not significantly altered by co-administration.

Tacrolimus (CYP3A4 substrate).

No dosage adjustment of either drug is required when co-administered. In a study of 35 healthy subjects who received a single oral dose of 5 mg tacrolimus alone, 100 mg/day anidulafungin alone following a 200 mg loading dose and both in combination, the steady state Cmax and AUC of anidulafungin and tacrolimus were not significantly altered by co-administration.

Liposomal amphotericin B.

No dosage adjustment of either drug is required when co-administered. The pharmacokinetics of anidulafungin were examined in 27 patients (100 mg/day anidulafungin) who were co-administered with liposomal amphotericin B (doses up to 5 mg/kg/day). The population pharmacokinetic analysis showed that the pharmacokinetics of anidulafungin were not significantly altered by co-administration with amphotericin B when compared to data from patients who did not receive amphotericin B.

Rifampicin (potent CYP450 inducer).

No dosage adjustment of either drug is required when co-administered. The pharmacokinetics of anidulafungin were examined in 27 patients (50 or 75 mg/day anidulafungin) who were co-administered with rifampicin (doses up to 600 mg/day). The population pharmacokinetic analysis showed that when compared to data from patients who did not receive rifampicin, the pharmacokinetics of anidulafungin were not significantly altered by co-administration with rifampicin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Anidulafungin produced no adverse effects on fertility in male or female rats at intravenous doses of 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).
(Category B3)
Anidulafungin should not be taken during pregnancy, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential. Contact your doctor immediately if you become pregnant while taking anidulafungin.
Embryo-foetal development studies were conducted with doses up to 20 mg/kg/day in rats and rabbits (equivalent to 2 and 4 times, respectively, the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). Anidulafungin administration resulted in skeletal changes in rat foetuses including incomplete ossification of various bones and wavy, misaligned or misshapen ribs. These changes were not dose-related and were within the range of the laboratory's historical control database. Developmental effects observed in rabbits (slightly reduced foetal weights) occurred in the high dose group, a dose that also produced maternal toxicity. Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
 Adequate studies in lactating mothers have not been performed. Anidulafungin should not be administered to lactating mothers unless recommended by the clinician after considering the benefit of breast feeding to the child.
A study in lactating rats administered up to 20 mg/kg/day showed no adverse effects on the pups. Anidulafungin was excreted in milk and was detectable in the blood of suckling pups.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Fifteen hundred and sixty-five (1565) patients received intravenous anidulafungin in clinical trials (1308 in phase 2/3 studies and 257 in phase I studies).
The safety profile of anidulafungin is based on 840 patients with candidaemia/invasive candidiasis receiving the recommended daily dose of 100 mg in 9 studies. Three studies (one comparative vs. fluconazole, 2 non-comparative) assessed the efficacy of anidulafungin (100 mg) in patients with candidaemia and other deep tissue Candida infections. In these three studies [invasive candidiasis/candidaemia (ICC) database], a total of 204 patients received anidulafungin, 119 for ≥ 14 days. In six additional studies (two comparative vs. caspofungin and four non-comparative), 636 patients including 53 neutropenic patients and 131 patients with deep tissue infection were studied; the mean durations of intravenous treatment in neutropenic patients and patients with deep tissue infection in these studies were 10.0 (range, 1 to 42 days) and 14.0 (range, 1 to 42 days) days, respectively. Adverse events were typically mild to moderate and seldom led to discontinuation.
Table 2 includes the all-causality adverse events (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin.
Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension (see Section 4.4 Special Warnings and Precautions for Use).
In the safety assessment of the phase 2/3 patient population (N = 669), the following additional adverse events, were of note: neutropenia, leukopenia, anaemia, hyperuricaemia, hypocalcaemia, hyponatraemia, hypoalbuminaemia, hypophosphataemia, anxiety, delirium, confusional state, hallucination auditory, dizziness, paraesthesia, central pontine myelinolysis, dysgeusia, Guillain-Barré syndrome, tremor, altered visual depth perception, deafness unilateral, phlebitis, thrombophlebitis superficial, hypotension, lymphangitis, dyspepsia, dry mouth, oesophageal ulcer, hepatic necrosis, angioneurotic oedema, hyperhidrosis, myalgia, monoarthritis, renal failure, haematuria, pyrexia, chills, oedema peripheral, injection site reaction, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, lymphocyte count decreased.

Paediatric population.

The safety of anidulafungin was investigated in 68 paediatric subjects (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 adverse event profile of these 68 paediatric subjects was similar to that observed in adults with ICC but hepatobiliary adverse events, in particular Alanine aminotransferase (ALT) increased and Aspartate aminotransferase (AST) increased appeared at a higher frequency in these paediatric patients than has been observed in adults. 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.

Risk of neonatal toxicity associated with polysorbates.

Eraxis contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis have been reported in low-birth weight infants receiving high doses of polysorbate. Polysorbate toxicity has not been reported with Eraxis. Eraxis is not approved in pediatric patients younger than 1 month of age [see Section 4.1; Section 4.2].

Postmarketing data.

Drug-related adverse events (MedDRA terms) from post-marketing reports with frequency not known (cannot be estimated from the available data) are shown below:

Immune system disorders.

Not known: anaphylactic shock, anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders.

Not known: bronchospasm.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

As with any overdose, general supportive measures should be utilised as necessary.
During clinical trials a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, anidulafungin was well tolerated with no dose limiting toxicity; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤ 3 x 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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.

Activity in vitro.

Against Candida spp.

Anidulafungin is active in vitro against Candida spp. including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. lusitaniae, and C. guilliermondii.

Against Aspergillus spp.

Anidulafungin is active in vitro against Aspergillus spp. including A. fumigatus, A. flavus, A. niger, and A. terreus. Its activity is not affected by resistance to other classes of antifungal agents, in particular fluconazole.
MICs were determined according to the Clinical and Laboratory Standards Institute (CLSI) approved standard reference method M27 for yeasts.
Anidulafungin breakpoints have not been established. The relationship between clinical response and in vitro activity remains to be elucidated. Significant increases in anidulafungin MICs have been observed in the presence of 50% human serum.
There have been reports of Candida isolates with reduced susceptibility to echinocandins including anidulafungin, but the clinical significance of this observation is unknown.

Activity in vivo.

Against Candida spp.

Parenterally administered anidulafungin was effective against Candida spp. in immunocompetent and immunocompromised mouse and rabbit models. Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida spp.
Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.

Against Aspergillus spp.

Anidulafungin has also demonstrated activity against Aspergillus fumigatus in mouse and rabbit infection models.

In combination with other antifungal agents.

In vitro studies of anidulafungin in combination with fluconazole, itraconazole and amphotericin B suggest no antagonism of antifungal activity against Candida species. The clinical significance of these results is unknown. In vitro studies have evaluated the activity of anidulafungin in combination with itraconazole, voriconazole, and amphotericin B against Aspergillus spp. The combination of anidulafungin and amphotericin B showed indifference for 16 of 26 isolates, while anidulafungin in combination with either itraconazole or voriconazole showed synergy against 18 of 26 isolates. The clinical significance of these results is unknown.

Mechanism of resistance.

As breakpoints have not been established for any echinocandin, potential resistance may be assumed if there is a significant rise in MICs for an isolate. No increase in anidulafungin MICs was seen in isolates from clinical trials. In addition, resistance was not seen in in vitro studies. Among a number of isolates with elevated echinocandin MICs, only two isolates were reported to have an increased anidulafungin MIC, suggesting the lack of complete cross resistance among echinocandins.

Clinical trials.

Invasive candidiasis including candidaemia.

The safety and efficacy of Eraxis were evaluated in a pivotal, phase 3, randomised, double-blind, multicentre, multinational study of patients with candidaemia and/or other forms of invasive candidiasis, associated with clinical signs of infection. Patients were randomised to receive once daily Eraxis (200 mg IV loading dose followed by 100 mg IV maintenance dose) or IV fluconazole (800 mg loading dose followed by 400 mg maintenance dose). Patients were stratified by APACHE II score (≤ 20 and > 20) and the presence or absence of neutropenia. Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were excluded from the study. Treatment was administered for at least 14 and not more than 42 days. Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medication, were afebrile for at least 24 hours, and the most recent blood cultures were negative for Candida species.
Patients who received at least one dose of study medication and who had a positive culture for Candida species from a normally sterile site before entry into the study (modified intent-to-treat [MITT] population) were included in the primary analysis of global response at the end of IV therapy. A successful global response required clinical improvement and microbiological eradication. Patients were followed for six weeks beyond the end of all therapy.
Two hundred and fifty-six patients (aged 16 to 91 years) were randomised to treatment and received at least one dose of study medication. The median duration of IV therapy was 14 and 11 days in the Eraxis and fluconazole arms, respectively. For those who received oral fluconazole, the median duration of oral therapy was 7 days for the Eraxis arm and 5 days for the fluconazole arm.
Two hundred and forty-five patients (127 Eraxis, 118 fluconazole) met the criteria for inclusion in the MITT population. Of these, 219 patients (116 Eraxis (91.3%), 103 fluconazole (87.3%)) had candidaemia only; 5.5% patients in the anidulafungin arm and 9.3% patients in the fluconazole arm had infections at other normally sterile sites; finally 3.1% patients in the Eraxis arm and 3.4% patients in the fluconazole arm had both (candidaemia and infections at other normally sterile sites). Of these, 219 patients (116 Eraxis, 103 fluconazole) had candidaemia only.
Risk factors for candidaemia among patients in both treatment arms in this study were: presence of a central venous catheter (78%), receipt of broad-spectrum antibiotics (69%), recent surgery (42%), recent hyperalimentation (25%), and underlying malignancy (22%). The most frequent species isolated at baseline was C. albicans (61.6%), followed by C. glabrata (20.4%), C. parapsilosis (11.8%) and C. tropicalis (10.6%). The majority (97%) of patients were non-neutropenic (ANC > 500) and 81% had APACHE II scores less than or equal to 20.
At the end of therapy, Eraxis was superior to fluconazole in the treatment of patients with candidaemia and/or other forms of invasive candidiasis. In the Eraxis arm, 96 patients (75.6%) had global success versus 71 patients (60.2%) in the fluconazole arm. The between group difference in global success rate (Eraxis global success rate minus fluconazole global success rate) was 15.4% (95% CI: 3.9, 27.0).
Global success rates in patients with candidaemia and other Candida infections are summarised in Table 3. Table 4 presents outcome and mortality data for the MITT population.

Candida infections in neutropenic patients.

The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm3, WBC ≤ 500 cells/mm3 or classified by the investigator as neutropenic at baseline) with microbiologically confirmed invasive candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative versus caspofungin and 4 open-label, non-comparative). Patients were treated for at least 14 days. In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin. A total of 46 patients were included in the analysis. The majority of patients had candidaemia only (84.8%; 39/46). The most common pathogens isolated at baseline were C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.2%; 7/46), and C. glabrata (15.2%; 7/46). The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%). All-cause mortality up to the end of the study (6 Week Follow-up Visit) was 21/46 (45.7%).
The efficacy of anidulafungin in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomised, controlled trial. Eligible patients received either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or caspofungin (70 mg intravenous loading dose followed by 50 mg intravenous daily) (2:1 randomisation). Patients were treated for at least 14 days. In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment. A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin). The majority of patients had candidaemia only. The most common pathogens isolated at baseline were C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), and C. ciferrii (2 anidulafungin, 0 caspofungin). The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3). All-cause mortality up to the 6 Week Follow-Up visit for anidulafungin (MITT population) was 4/11 (36.4%) and 2/3 (66.7%) for caspofungin.
Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, non-comparative studies. The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) was assessed in 35 adult neutropenic patients defined as absolute neutrophil count ≤ 500 cells/mm3 or WBC ≤ 500 cells/mm3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients. All patients were treated for at least 14 days. In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin. The majority of patients had candidaemia only (85.7%). The most common pathogens isolated at baseline were C. tropicalis (12 patients), C. albicans (7 patients), C. glabrata (7 patients), C. krusei (7 patients), and C. parapsilosis (6 patients). The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 18/35 (51.4%) and 16/35 (45.7%) at the End of All Treatment. All-cause mortality by Day 28 was 10/35 (28.6%). The successful global response rate at End of Intravenous Treatment and End of All Treatment were both 7/13 (53.8%) in the 13 patients with neutropenia assessed by investigators at baseline.

Deep tissue infections.

The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult patients with microbiologically confirmed deep tissue candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative and 4 open-label). Patients were treated for at least 14 days. In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin. A total of 129 patients were included in the analysis. Twenty one (16.3%) had concomitant candidaemia. The mean APACHE II score was 14.9 (range, 2 - 44). The most common sites of infection included the peritoneal cavity (54.3%; 70 of 129), hepatobiliary tract (7.0%; 9 of 129), pleural cavity (5.4%; 7 of 129) and kidney (3.1%; 4 of 129). The most common pathogens isolated from a deep tissue site at baseline were C. albicans (64.3%; 83 of 129), C. glabrata (31.0%; 40 of 129), C. tropicalis (11.6%; 15 of 129), and C. krusei (5.4%; 7 of 129). The successful global response rate at the end of intravenous treatment (primary endpoint) and end of all treatment and all-cause mortality up to the 6 week follow-up visit is shown in Table 5.

Paediatric population.

A prospective, open-label, non-comparative, multi-national study assessed the safety and efficacy of anidulafungin in 68 paediatric patients aged 1 month to < 18 years with invasive candidiasis including candidaemia (ICC). Patients were stratified by age (1 month to < 2 years, 2 to < 5 years, and 5 to < 18 years) and received once daily intravenous anidulafungin (3.0 mg/kg loading dose on Day 1, and 1.5 mg/kg daily maintenance dose thereafter) for up to 35 days followed by an optional switch to oral fluconazole (6-12 mg/kg/day, maximum 800 mg/day). Patients were followed at 2 and 6 weeks after end of all treatment (EOT).
Among 68 patients who received anidulafungin, 64 had microbiologically confirmed Candida infection and were evaluated for efficacy in the modified intent-to-treat (MITT) population. Overall, 61 patients (92.2%) had Candida isolated from blood only. The most commonly isolated pathogens were C. albicans (25 [39.1%] patients), followed by C. parapsilosis (17 [26.6%] patients), and C. tropicalis (9 [14.1%] patients). A successful global response was defined as having both a clinical response of success (cure or improvement) and a microbiological response of success (eradication or presumed eradication). The overall rates of successful global response in the MITT population are presented in Table 6.

5.2 Pharmacokinetic Properties

General pharmacokinetic characteristics.

The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients. A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed. The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose).

Distribution.

The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution of 30-50 L that is similar to total body fluid volume. Anidulafungin is extensively bound (> 99%) to human plasma proteins.

Metabolism.

Hepatic metabolism of anidulafungin has not been observed. Anidulafungin is not a clinically relevant substrate, inducer or inhibitor of cytochrome P450 isoenzymes. It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ring-opened peptide that lacks antifungal activity. The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours. In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.

Excretion.

The clearance of anidulafungin is about 1 L/h. Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterises the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
In a single-dose clinical study, radiolabeled (14C) anidulafungin (~ 88 mg) was administered to healthy subjects. Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug. Less than 1% of the administered radioactive dose was excreted in the urine. Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose. Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.

Linearity.

Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).

Special populations.

Patients with fungal infections.

The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses. With the 200/100 mg daily dose regimen at an infusion rate of 1.0 mg/min, the steady state Cmax and trough concentrations (Cmin) could reach approximately 7 and 3 mg/L, respectively, with an average steady state AUC of approximately 110 mg.h/L.

Weight.

Although weight was identified as a source of variability in clearance in the population pharmacokinetic analysis, weight has little clinical relevance on the pharmacokinetics of anidulafungin.

Gender.

Plasma concentrations of anidulafungin in healthy men and women were similar. In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.

Elderly.

The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 L/h) and the non-elderly group (patients < 65, median CL = 1.22 L/h), however the range of clearance was similar.

Ethnicity.

Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.

HIV status.

Dosage adjustments are not required based on HIV status, irrespective of concomitant anti-retroviral therapy.

Impairment of hepatic function.

Anidulafungin is not hepatically metabolised. Anidulafungin pharmacokinetics were examined in a single dose study in subjects with Child-Pugh class A, B or C hepatic insufficiency. Anidulafungin concentrations were not increased in subjects with any degree of hepatic insufficiency. Although a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, the decrease was within the range of population estimates noted for healthy subjects.

Impairment of renal function.

Anidulafungin has negligible renal clearance (< 1%). In a single dose clinical study of subjects with mild, moderate, severe or end stage (dialysis-dependent) renal insufficiency, anidulafungin pharmacokinetics were similar to those observed in subjects with normal renal function. Anidulafungin is not dialysable and may be administered without regard to the timing of hemodialysis.

Paediatric.

The pharmacokinetics of anidulafungin after daily doses were investigated in immunocompromised paediatric (2 through 11 years) and adolescent (12 through 17 years) patients with neutropenia. The steady state was achieved on the first day after administration of the loading dose (twice the maintenance dose), and the Cmax and AUCss increased in a dose-proportional manner. Concentrations and exposures following administration of maintenance doses of 0.75 and 1.5 mg/kg/day in this population were similar to those observed in adults following maintenance doses of 50 and 100 mg/day, respectively, as shown in Table 5 (see Section 4.2 Dose and Method of Administration).
The pharmacokinetics of anidulafungin was investigated in 66 paediatric patients (1 month to < 18 years) with ICC in a prospective, open-label, non-comparative paediatric study following administration of 3.0 mg/kg loading dose and 1.5 mg/kg/day maintenance dose (see Section 5.1). Based on population pharmacokinetic analysis of combined data from adult and paediatric patients with ICC, the mean exposure parameters (AUC0-24,ss and Cmin,ss) at steady state in the overall paediatric patients across age groups (1 month to < 2 years, 2 to < 5 years, and 5 to < 18 years) were comparable to those in adults receiving 200 mg loading dose and 100 mg/day maintenance dose. Body weight adjusted CL (L/h/kg) and volume of distribution at steady state (L/kg) were similar across the age groups. See Table 7.

5.3 Preclinical Safety Data

Genotoxicity.

Anidulafungin was not genotoxic in the following in vitro studies: bacterial reverse mutation assays, a chromosome aberration assay with Chinese hamster ovary cells, and a forward gene mutation assay with mouse lymphoma cells. Anidulafungin was not genotoxic in mice using the in vivo micronucleus assay.

Carcinogenicity.

Long-term animal carcinogenicity studies of anidulafungin have not been conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Fructose, mannitol, polysorbate 80 (250 mg/vial), tartaric acid, hydrochloric acid, sodium hydroxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Reconstituted solution.

Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilised for up to 24 hours when stored at 25°C.

Infusion solution.

Do not freeze.
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, following good aseptic practices, the infusion solution can be utilised for up to 48 hours from preparation when stored at 25°C.

6.4 Special Precautions for Storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Excursions for up to 96 hours at temperatures up to 25°C are permitted, and the powder can be returned to refrigerated storage.

6.5 Nature and Contents of Container

100 mg lyophile in a 30 mL type 1 glass vial with an elastomeric stopper and aluminium seal with flip-off cap.
Anidulafungin is supplied as a pack containing 1 vial of powder.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Eraxis (anidulafungin) is a semi-synthetic lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol.

Chemical structure.


Chemical name: 1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine] echinocandin B.
ATC code: J02AX06.
The empirical formula of anidulafungin is C58H73N7O17 and the formula weight is 1140.3.

CAS number.

166663-25-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes