The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0705.
Anidulafungin 100 mg powder for concentrate for solution for infusion
Anidulafungin 100 mg Powder for concentrate for solution for infusion
(Referred to as Anidulafungin in the remainder of the leaflet)
1. What Anidulafungin is and what it is used 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
Anidulafungin contains the active substance Anidulafungin and is prescribed in adults 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.
Talk to your doctor or pharmacist or nurse before using Anidulafungin. Your doctor may decide to monitor you.
Anidulafungin should not be given to patients under 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
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 will always be prepared and given to you 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).
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. This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
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 are concerned that you may have been given too much Anidulafungin, tell your doctor or another healthcare professional immediately.
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.
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.
Very common side effects (may affect more than 1 in 10 people) are:
Common side effects (may affect up to 1 in 10 people) are:
Uncommon side effects (may affect up to 1 in 100 people) are:
Not known (frequency cannot be estimated from the available data) are:
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.
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.
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.
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Anidulafungin 100 mg powder for concentrate for solution for infusion PL 29831/0705
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This leaflet was last revised in 01/2023.