Safdola^® 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.

Safdola^® belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections.

Safdola^® prevents normal development of fungal cell walls. In the presence of Safdola^®, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.

Do not use Safdola^®

• 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 Safdola^®.

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 Safdola^®. 

• 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

Safdola^® should not be given to patients under 1 month of age.

Other medicines and Safdola^®

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, Safdola^® 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 Safdola^®.

The effect of anidulafungin in breast-feeding women is not known. Ask your doctor or pharmacist for advice before taking Safdola^® while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicines.

Safdola^® contains fructose

This medicine contains 102.5 mg fructose (a type of sugar). 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.

Safdola^®contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

Safdola^® 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).

Safdola^® 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 

Safdola^® 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.

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.

If you receive more Safdola^® than you should

If you are concerned that you may have been given too much Safdola^®, tell your doctor or another healthcare professional immediately.

If you forgot to use Safdola^®

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 Safdola^®

You should not experience any effects from Safdola^® if your doctor stops Safdola^® treatment.

Your doctor may prescribe another medicine following your treatment with Safdola^® 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.

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 doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 data 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 (do not freeze) and should be administered at  25°C (room temperature) within 48 hours. 

• Do not throw away any medicines via wastewater or household waste.