Micafungin Accord

Package leaflet: Information for the user

Micafungin Accord 50 mg powder for concentrate for solution for

infusion
Micafungin Accord 100 mg powder for concentrate for solution for
infusion
Micafungin
Generic medicine
Please read this leaflet carefully before using 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Micafungin Accord is and what it is used for
  2. What you need to know before using Micafungin Accord
  3. How to use Micafungin Accord
  4. Possible side effects
  5. How to store Micafungin Accord
  6. Contents of the pack and other information

1. What is Micafungin Accord and what is it used for?

Micafungin Accord contains the active substance micafungin. Micafungin Accord is known as an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Accord is used to treat infections caused by fungal or yeast cells called Candida.
Micafungin Accord is effective in treating systemic infections (infections that have spread within the body). It interferes with the production of a component of the fungal cell wall. An intact cell wall is essential for the survival and growth of fungi.
Micafungin Accord causes defects in the fungal cell wall, making the fungus unable to survive and grow.
Your doctor has prescribed Micafungin Accord under the following circumstances, when no other suitable antifungal treatments are available (see section 2):

• To treat adults, adolescents, and children including newborns who have a serious fungal infection called invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents aged 16 years and older who have a fungal infection in the throat (in the oesophagus) for which intravenous (IV) treatment is appropriate.
• To prevent Candida infections in patients undergoing bone marrow transplantation or in patients expected to have neutropenia (low levels of neutrophils, a type of white blood cell) lasting for 10 days or more.

2. What you need to know before taking Micafungin Accord

Do not use Micafungin Accord

• if you are allergic to micafungin, to other echinocandins (Ecalta or Cancidas), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
In rats, long-term treatment with micafungin leads to liver damage and subsequent liver tumours.
The potential risk of tumour development in humans is unknown, and your doctor will evaluate the benefits and risks of treatment with Micafungin Accord before you start taking the medicine.
Inform your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or if you have had abnormal liver function tests. During treatment, your liver function will be monitored more closely.
Ask your doctor or pharmacist before using Micafungin Accord

• if you are allergic to any medicine
• if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis (breakdown of red blood cells)
• if you have kidney problems (e.g. renal failure or abnormal kidney function tests). If this is the case, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause severe inflammation/skin rash and mucosal membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other medicines and Micafungin Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are being treated with deoxycholate amphotericin B or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.
Micafungin Accord with food and drink
Since Micafungin Accord is administered intravenously (into a vein), there are no restrictions on eating or drinking.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Micafungin Accord must not be used during pregnancy unless absolutely necessary.
You must not breastfeed during treatment with Micafungin Accord.
Driving and using machines
It is unlikely that micafungin will affect your ability to drive or use machines.
However, some people may experience dizziness when taking this medicine, and if this happens to you, you must not drive or operate tools or machinery. Inform your doctor if you experience any effect that could cause you problems when driving or using machines.
Micafungin Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Micafungin Accord

Micafungin Accord must be prepared and administered by a doctor or other healthcare professional. Micafungin Accord should be given once daily as a slow intravenous infusion (into a vein). Your doctor will determine the daily dose of Micafungin Accord appropriate for you.
Use in adults, adolescents aged 16 years and older, and elderly patients

• The usual dose for the treatment of invasive Candida infection is 100 mg daily for patients with a body weight above 40 kg and 2 mg/kg daily for patients with a body weight equal to or below 40 kg.
• The usual dose for the treatment of esophageal Candida infection is 150 mg daily for patients with a body weight above 40 kg and 3 mg/kg daily for patients with a body weight equal to or below 40 kg.
• The usual dose for prevention of invasive Candida infections is 50 mg daily for patients with a body weight above 40 kg and 1 mg/kg daily for patients with a body weight equal to or below 40 kg.

Use in children ≥ 4 months of age and adolescents under 16 years of age

• The usual dose for the treatment of invasive Candida infection is 100 mg daily for patients with a body weight above 40 kg and 2 mg/kg daily for patients with a body weight equal to or below 40 kg.
• The usual dose for prevention of invasive Candida infections is 50 mg daily for patients weighing above 40 kg and 1 mg/kg daily for patients weighing equal to or below 40 kg.

Use in children and neonates under 4 months of age

• The usual dose for the treatment of invasive Candida infection is 4–10 mg/kg daily.
• The usual dose for prevention of invasive Candida infections is 2 mg/kg daily.

If you receive more Micafungin Accord than you should
To determine the appropriate dose of Micafungin Accord, your doctor will monitor your response to the medicine and your overall health condition. However, if you are concerned that you have received an excessive dose of Micafungin Accord, speak to your doctor or another healthcare professional immediately.

If you have missed a dose of Micafungin Accord
To determine the necessary treatment regimen with Micafungin Accord, your doctor will monitor your response to the medicine and your overall health condition. However, if you are concerned that a dose of Micafungin Accord has been missed, speak to your doctor or another healthcare professional immediately.

If you have any doubts about how to use Micafungin Accord, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction or a severe skin reaction (for example, blistering and peeling of the skin), contact your doctor or nurse immediately.

Micafungina Accord may cause the following additional side effects:

Common (may affect up to 1 in 10 people)

• changes in blood test values (reduction in white blood cells [leucopenia; neutropenia]); reduction in red blood cells (anaemia)
• decrease in blood potassium (hypokalaemia); decrease in blood magnesium (hypomagnesaemia); decrease in blood calcium (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting (being sick); diarrhoea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increased blood bile pigment (hyperbilirubinaemia)
• rash
• fever
• chills (shivering)

Uncommon (may affect up to 1 in 100 people)

• changes in blood test values (reduction in blood cells [pancytopenia]); reduction in platelets (thrombocytopenia); increase in a certain type of white blood cell called eosinophils; decrease in blood albumin (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decrease in blood sodium (hyponatraemia); increase in blood potassium (hyperkalaemia); decrease in blood phosphate (hypophosphataemia); anorexia (eating disorder)
• insomnia; anxiety; confusion
• drowsiness; tremor; dizziness; taste disturbances
• increased heart rate; increased force of heartbeat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin redness (erythema)
• changes in kidney function tests (increase in blood creatinine; increase in blood urea); worsening of kidney failure
• increase in an enzyme called lactate dehydrogenase
• blood clots at the injection site; inflammation at the injection site; pain at the injection site; fluid accumulation in the body

Rare (may affect up to 1 in 1000 people)

• anaemia caused by destruction of red blood cells (haemolytic anaemia); destruction of red blood cells (haemolysis)

Not known (frequency cannot be estimated from the available data)

• disorders of the blood clotting system
• shock (allergic)
• liver cell damage, including death
• kidney problems; acute kidney failure

Additional side effects in children and adolescents
The following reactions have been reported more frequently in paediatric patients than in adult patients:

Common (may affect up to 1 in 10 people)

• reduction in blood platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increase in bile pigments in the blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased blood urea concentration

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the following link:
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 Micafungin 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 after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the vial in the outer packaging to protect it from light.

Reconstituted concentrate in vials
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 2°C–8°C and at 20°C–25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Diluted infusion solution
Chemical and physical in-use stability has been demonstrated for 96 hours at 2°C–8°C and at 20°C–25°C, protected from light, when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Micafungin Accord does not contain preservatives. From a microbiological point of view, reconstituted and diluted solutions should be used immediately. If not used immediately, the duration and conditions of in-use storage prior to use are the user's responsibility and normally should not exceed 24 hours at a temperature of 2°C to 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Do not use the diluted infusion solution if it appears cloudy or contains precipitate.
The infusion bag containing the diluted infusion solution must be placed inside an opaque bag with closure capability to protect it from light.
The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.

6. Pack contents and other information

What Micafungin Accord contains
The active substance is micafungin (as sodium salt).
One vial contains 50 mg or 100 mg of micafungin (as sodium salt).
The other components are monohydrate lactose, anhydrous citric acid and sodium hydroxide.

Description of the appearance of Micafungin Accord and pack contents
Micafungin Accord 50 mg and 100 mg powder for concentrate for solution for infusion is
a white, compact lyophilised powder in a glass vial with rubber stopper and aluminium seal.
Each vial contains 50 mg or 100 mg of micafungin (as sodium).

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice, Poland
or
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040,
Spain

More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/ .

The following information is intended exclusively for medical or healthcare professionals:
Micafungin Accord must not be mixed or co-infused with other products except those listed below. Micafungin Accord is reconstituted and diluted at room temperature under aseptic conditions as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly inject 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion into each vial, along the inner vial wall and under aseptic conditions (withdrawn from a 100 ml infusion bag/bottle). Even if foam develops in the concentrate, care must be taken to minimize the amount of foam formed. A sufficient number of Micafungin Accord vials must be reconstituted to obtain the required dose in mg (see table below).
3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate must be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be immediately discarded.
4. Immediately after reconstitution, withdraw all the concentrate from each vial and transfer it into the infusion bag/bottle from which the diluent was originally withdrawn. The diluted infusion solution must be used immediately. Chemical and physical in-use stability has been demonstrated for 96 hours at 20–25°C when protected from light and diluted as described above.
5. Gently invert the infusion bag/bottle to promote dispersion of the diluted solution, but DO NOT shake to avoid foaming. The solution must not be used if it is cloudy or contains precipitates.
6. Place the infusion bag/bottle containing the diluted infusion solution into an opaque, closable bag to protect it from light.
7. Use only clear solutions that are practically free from particles.

Preparation of the infusion solution