Anidulafungin Accord
Italy
Table of Contents
Package leaflet: Information for the user
Anidulafungin Accord 100 mg powder for concentrate for solution for infusion
Generic medicine
Please read all of this leaflet carefully before you or your child use this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What Anidulafungin Accord is and what it is used for
- What you need to know before you or your child use Anidulafungin Accord
- How to use Anidulafungin Accord
- Possible side effects
- How to store Anidulafungin Accord
- Contents of the pack and other information
1. What Anidulafungina Accord is and what it is used for
Anidulafungina Accord contains the active substance anidulafungin and is used in adults and pediatric patients aged 1 month to less than 18 years to treat a type of fungal infection in the blood or other internal organs called invasive candidiasis.
The infection is caused by cells of a type of fungus (yeast) called Candida.
Anidulafungina Accord belongs to a group of medicines called echinocandins.
These medicines are used to treat serious fungal infections.
Anidulafungina Accord prevents the normal development of fungal cell walls. In the presence of Anidulafungina Accord, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
2. What you need to know before you or your child use Anidulafungin Accord
Do not use Anidulafungin Accord
- if you are allergic to anidulafungin, to other echinocandins (e.g. caspofungin acetate), or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Anidulafungin Accord.
Your doctor may decide to monitor you
- more closely for liver function if you develop liver problems during treatment.
- for signs of an allergic reaction such as itching, wheezing, skin rash
- for signs of an infusion-related reaction which may include rash, urticaria, itching, redness
- for shortness of breath/respiratory difficulties, dizziness, or confusion
Children and adolescents
Anidulafungin Accord must not be administered to patients under 1 month of age.
Other medicines and Anidulafungin Accord
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
It is unknown whether Anidulafungin Accord has an effect in pregnant women. Therefore, the use of Anidulafungin Accord is not recommended during pregnancy. Women of childbearing age must use an adequate method of contraception. Contact your doctor immediately if you become pregnant during treatment with Anidulafungin Accord.
It is unknown whether Anidulafungin Accord has an effect in breastfeeding women. Ask your doctor or pharmacist for advice before using Anidulafungin Accord while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Anidulafungin Accord contains fructose
This medicine contains 102.5 mg of fructose (a type of sugar) per vial. If your doctor has told you that you have an intolerance to certain sugars, contact him or her before using this medicine.
If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not take this medicine. Patients with HFI are unable to metabolize the fructose contained in this medicine, which may therefore cause serious adverse effects.
Inform your doctor before taking this medicine if you or your child have HFI, or if the child can no longer consume sweet foods or drinks because they cause discomfort, vomiting, or unpleasant symptoms such as bloating, stomach cramps, or diarrhoea.
Anidulafungin Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
3. How to use Anidulafungin Accord
Anidulafungin Accord will always be prepared and administered for you or your child by a doctor or healthcare professional (further information on the preparation of this medicine for medical and healthcare staff can be found at the end of this leaflet in the section dedicated to physicians and healthcare providers).
For use in children and adolescents (aged 1 month to less than 18 years), treatment begins with a loading dose of 3.0 mg/kg (maximum dose 200 mg) on the first day, followed by a daily maintenance dose of 1.5 mg/kg (maximum dose 100 mg). The dose administered depends on the patient's body weight.
For use in adults, treatment begins with a loading dose of 200 mg on the first day, followed by a daily maintenance dose of 100 mg.
Anidulafungin Accord must be administered once daily by slow intravenous infusion (over at least 1.5 hours for the maintenance dose and at least 3 hours for the loading dose in adults). For children and adolescents, the infusion duration may be shorter depending on the patient's body weight.
Your doctor will determine the duration of treatment and the daily amount of Anidulafungin Accord you will receive, and will monitor your response to treatment and your clinical condition.
In general, treatment should continue for at least 14 days after the last day that Candida was detected in the blood.
If you receive more Anidulafungin Accord than you should
If you are concerned that you may have received an excessive dose of Anidulafungin Accord, inform your doctor or another healthcare professional immediately.
If you forget to use Anidulafungin Accord
Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, inform your doctor or pharmacist if you think a dose has been missed.
Do not receive a double dose from your doctor.
If you stop treatment with Anidulafungin Accord
If your doctor stops treatment with Anidulafungin Accord, no adverse effects are expected.
Your doctor may prescribe another medicine after treatment with Anidulafungin Accord to continue treating the fungal infection or to prevent its recurrence.
If the original symptoms of infection return, inform your doctor or another healthcare professional immediately.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects will be monitored by your doctor while assessing your response and condition.
Life-threatening allergic reactions have been reported rarely during administration of Anidulafungin Accord,
including breathing difficulties with wheezing or worsening of pre-existing rashes.
Serious side effects – inform your doctor or another healthcare professional immediately if you experience any of the following:
- Seizures (convulsive fits)
- Flushing
- Rash, itching
- Hot flushes
- Hives (urticaria)
- Sudden contraction of the airway muscles causing wheezing or coughing fits
- Breathing difficulties
Other side effects
Very common side effects (may affect more than 1 in 10 people) are:
- Low blood potassium levels (hypokalaemia)
- Diarrhoea
- Nausea
Common side effects (may affect up to 1 in 10 people) are:
- Seizures (convulsive fits)
- Headache
- Vomiting
- Changes in liver function tests
- Rash, itching
- Changes in kidney function tests
- Impairment of bile flow from the gallbladder to the intestine (cholestasis)
- High blood sugar levels
- High blood pressure
- Low blood pressure
- Sudden contraction of the airway muscles causing wheezing or coughing fits
- Breathing difficulties
Uncommon side effects (may affect up to 1 in 100 people) are:
- Bleeding disorders
- Flushing
- Hot flushes
- Stomach ache
- Hives (urticaria)
- Pain at the injection site
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- Life-threatening allergic reactions
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Anidulafungin Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C).
The reconstituted solution can be stored at up to 25°C for a maximum of 24 hours.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
The infusion solution can be stored at 25°C (room temperature) for up to 48 hours (do not refrigerate) and must be administered at 25°C (room temperature) within 48 hours.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user; normally, storage should not exceed 24 hours at temperatures between 2°C and 8°C, unless reconstitution/dilution has taken place under controlled, validated aseptic conditions.
Do not dispose of any medicine via wastewater or household waste.
6. Package contents and other information
What Anidulafungin Accord contains
- The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin. The reconstituted solution contains 3.33 mg/ml of anidulafungin and the diluted solution contains 0.77 mg/ml of anidulafungin.
The other components are: fructose (see section 2 “Anidulafungin Accord contains fructose”), mannitol, polysorbate 80, lactic acid, sodium hydroxide (for pH adjustment) (see section 2 “Anidulafungin Accord contains sodium”), hydrochloric acid (for pH adjustment).
Description of the appearance of Anidulafungin Accord and contents of the pack
Anidulafungin Accord is available in a pack containing 1 vial of 100 mg powder for concentrate for solution for infusion.
The solid or powder is white to off-white in colour.
Pack size: 1 vial
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona, Spain
Manufacturer
PharmIdea SIA
4 Rupnica St. Olaine, 2114 Latvia
Lyocontract GmbH
Pulverwiese 1, 38871 Ilsenburg, Germany
and
LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82,
Alcalá de Henares, 28802
Madrid, Spain
The following information is intended exclusively for physicians or healthcare professionals and applies only to the Anidulafungin Accord 100 mg powder for concentrate for solution for infusion pack containing a single vial.
The contents of the vial must be reconstituted with water for injections and subsequently diluted ONLY with sodium chloride for infusion 9 mg/ml (0.9%) or glucose for infusion 50 mg/ml (5%). Compatibility of reconstituted Anidulafungin Accord with other intravenous substances, additives or medicinal products different from sodium chloride for infusion 9 mg/ml (0.9%) or glucose for infusion 50 mg/ml (5%) has not been established. The infusion solution must not be frozen.
Reconstitution
Each vial must be reconstituted aseptically by adding 30 ml of water for injections and gently shaken until a concentration of 3.33 mg/ml is achieved. Reconstitution may take up to 5 minutes. After subsequent dilution, the solution must be discarded if particles or discoloration are observed. The reconstituted solution may be stored at up to 25°C for a maximum of 24 hours prior to further dilution. From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.
Dilution and infusion
Whenever solution and container permit, parenteral medicinal products should be inspected visually prior to administration for the presence of particles and discoloration. If particles or discoloration are observed, the solution must be discarded.
Adult patients
The contents of the reconstituted vial must be transferred aseptically into an intravenous infusion bag (or bottle) containing sodium chloride for infusion 9 mg/ml (0.9%) or glucose for infusion 50 mg/ml (5%) to achieve 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 administration of Anidulafungin Accord
| Dose | Number of vials of powder | Volume reconstituted (ml) | Total infusion volume (ml) | Total volume of infusion B (ml) | Infusion rate | Minimum duration | |----------|-------------------------------|-------------------------------|--------------------------------|-------------------------------------|-------------------|----------------------| | 100 mg | 1 | 30 | 100 | 130 | 1.4 ml/min or 84 ml/hour | 90 min | | 200 mg | 2 | 60 | 200 | 260 | 1.4 ml/min or 84 ml/hour | 180 min |
Sodium chloride for infusion 9 mg/ml (0.9%) or glucose for infusion 50 mg/ml (5%)
The concentration of the infusion solution is 0.77 mg/ml.
The infusion rate must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour when reconstituted and diluted as instructed).
Paediatric patients
For paediatric patients aged 1 month to < 18 years, the volume of infusion solution required to deliver the dose varies according to patient weight. The reconstituted solution must be further diluted to a concentration of 0.77 mg/ml for the final infusion solution. Use of a programmable syringe or infusion pump is recommended. The infusion rate must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour when reconstituted and diluted as instructed).
- Calculate the patient's dose and reconstitute the required number of vials according to reconstitution instructions to obtain a concentration of 3.33 mg/ml.
- Calculate the volume (ml) of reconstituted anidulafungin required:
- Volume of anidulafungin (ml) = Dose of anidulafungin (mg) ÷ 3.33 mg/ml
- Calculate the total volume of dosing solution (ml) required to achieve a final concentration of 0.77 mg/ml:
- Total volume of dosing solution (ml) = Dose of anidulafungin (mg) ÷ 0.77 mg/ml
- 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)
- Aseptically transfer the required volumes (ml) of reconstituted anidulafungin and 5% dextrose injection, USP or 0.9% sodium chloride injection, USP (normal saline) into an infusion syringe or intravenous infusion bag as needed for administration. For single use only. Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.