Micafungin Teva

Package leaflet: Information for the user

MICAFUNGINA TEVA 50 mg powder for concentrate for solution for infusion, 100 mg powder for concentrate for solution for infusion

micafungin
Read all of this leaflet carefully before you start 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Micafungina Teva is and what it is used for
2. What you need to know before using Micafungina Teva
3. How to use Micafungina Teva
4. Possible side effects
5. How to store Micafungina Teva
6. Contents of the pack and other information

1. What Micafungin Teva is and what it is used for

Micafungin Teva contains the active substance micafungin. Micafungin Teva is known as an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Teva is used to treat infections caused by fungal or yeast cells called Candida.
Micafungin Teva 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 Teva causes defects in the fungal cell wall, rendering the fungus unable to survive and grow.
Your doctor has prescribed Micafungin Teva under the following circumstances, in the absence of other suitable antifungal treatments (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 experience neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

2. What you need to know before using Micafungin Teva

Do not use Micafungin Teva

• 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 tumors.
The potential risk of tumor development in humans is unknown, and your doctor will evaluate the benefits and risks of treatment with Micafungin Teva before you start taking the medicine.
Inform your doctor if you have severe liver problems (e.g. hepatic impairment or hepatitis) or have had abnormal liver function tests. During treatment, your liver function will be monitored more closely.
Talk to your doctor or pharmacist before using Micafungin Teva

• if you are allergic to any medicine
• if you suffer from hemolytic anemia (anemia due to destruction of red blood cells) or hemolysis (breakdown of red blood cells)
• if you have kidney problems (e.g. renal impairment and abnormal kidney function tests). If this occurs, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause a serious inflammation/rash of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other medicines and Micafungin Teva
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 amphotericin B deoxycholate 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 Teva with food and drink
Since Micafungin Teva is administered intravenously (into a vein), there are no restrictions on eating or drinking.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Micafungin Teva should not be used during pregnancy unless strictly necessary. You must not breastfeed during treatment with Micafungin Teva.
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 should not drive or operate tools or machinery. Inform your doctor if you experience any effect that could cause you problems while driving or using machines.
Micafungin Teva contains sodium
Micafungin Teva contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially “sodium-free”.

3. How to use Micafungin Teva

Micafungin Teva must be prepared and administered by a doctor or other healthcare professional.
Micafungin Teva must be given once daily by slow intravenous infusion (into a vein). Your doctor will determine the daily dose of Micafungin Teva required for you.

Use in adults, adolescents aged 16 years and older, and elderly patients

• The usual dose used to treat an invasive Candida infection is 100 mg daily for patients with a body weight greater than 40 kg and 2 mg/kg daily for patients with a body weight equal to or less than 40 kg.
• The usual dose used to treat Candida esophageal infection is 150 mg daily for patients with a body weight greater than 40 kg and 3 mg/kg daily for patients with a body weight equal to or less than 40 kg.
• The usual dose used to prevent invasive Candida infections is 50 mg daily for patients with a body weight greater than 40 kg and 1 mg/kg daily for patients with a body weight equal to or less than 40 kg.

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

• The usual dose used to treat an invasive Candida infection is 100 mg daily for patients with a body weight greater than 40 kg and 2 mg/kg daily for patients with a body weight equal to or less than 40 kg.
• The usual dose used to prevent invasive Candida infections is 50 mg daily for patients with a body weight greater than 40 kg and 1 mg/kg daily for patients with a body weight equal to or less than 40 kg.

Use in children and newborns under 4 months of age

• The usual dose used to treat an invasive Candida infection is 4–10 mg/kg daily.
• The usual dose used to prevent invasive Candida infections is 2 mg/kg daily.

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

If you miss a dose of Micafungin Teva
Your doctor will monitor your response to the medicine and your overall health to determine the appropriate treatment regimen with Micafungin Teva. However, if you are concerned that you have not received a dose of Micafungin Teva, speak to your doctor or another healthcare professional immediately.

If you have any doubts about how to use this medicine, 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), inform your doctor or nurse immediately.
Micafungin Teva may cause the following additional side effects:

Common (may affect up to 1 in 10 people)

• Blood test abnormalities (decrease in white blood cells [leucopenia; neutropenia]); decrease 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)
• Increase in bile pigment in the blood (hyperbilirubinaemia)
• Rash
• Fever
• Chills (shivering)

Uncommon (may affect up to 1 in 100 people)

• Blood test abnormalities (decrease in number of blood cells [pancytopenia]); decrease in platelets (thrombocytopenia); increase in a certain type of white blood cells called eosinophils; decrease in blood albumin (hypoalbuminaemia)
• Hypersensitivity
• Increased sweating
• Decrease in blood sodium (hyponatraemia); increase in blood potassium (hyperkalaemia); decrease in blood phosphates (hypophosphataemia); anorexia (eating disorder)
• Insomnia (difficulty sleeping); 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-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); decreased bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• Itchy rash (urticaria); itching; skin redness (erythema)
• Abnormal kidney function tests (increase in blood creatinine; increase in blood urea levels); worsening of kidney failure
• Increase in an enzyme called lactate dehydrogenase
• Blood clots at injection site; inflammation at injection site; pain at injection site; fluid accumulation in the body

Rare (may affect up to 1 in 1,000 people)

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

Frequency not known (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)

• Decrease 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; increase in 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 national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Micafungin Teva

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 vial and the outer carton after
"Exp". The expiry date refers to the last day of that month.
The unopened vial does not require any special storage conditions.

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

Diluted infusion solution
Chemical and physical in-use stability has been demonstrated for up to 96 hours at 25°C when stored
protected from light and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or with
glucose 50 mg/ml (5%) solution for infusion.
From a microbiological standpoint, diluted and reconstituted solutions should be used immediately.
If not used immediately, the storage times and conditions prior to use are the responsibility of the user
and must not exceed 24 hours at 2–8°C, unless reconstitution and dilution have taken place under
controlled and validated aseptic conditions.

This medicine must be prepared for use only by a healthcare professional who has read the instructions thoroughly.
Do not use the diluted infusion solution if it is cloudy or contains precipitate.
The infusion vial/bag containing the diluted infusion solution must be placed in an opaque, closable bag to protect it from light.
The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Micafungin Teva contains

• The active substance is micafungin (as sodium salt). One vial contains sodium micafungin equivalent to 50 mg or 100 mg of micafungin.
• The other components are sucrose, citric acid, and sodium hydroxide.

Description of the appearance of Micafungin Teva and the contents of the pack
Micafungin Teva 50 mg and 100 mg powder for concentrate for solution for infusion is a white to off-white powder.
Micafungin Teva is supplied in packs of 1 vial.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TEVA B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
S.C. SINDAN-PHARMA S.R.L.,
11 Ion Mihalache Ave., the 1st district
011171 Bucharest - Romania

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

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly inject, along the inner wall and under aseptic conditions, 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (withdrawn from a 100 ml bottle/bag) into each vial. Even though foam may form in the concentrate, utmost care must be taken to minimize the amount of foam generated. A sufficient number of Micafungin Teva 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. Aspirate the entire reconstituted concentrate from each vial and transfer it into the infusion bottle/bag from which the diluent was originally withdrawn. The diluted infusion solution must be used immediately. Chemical and physical in-use stability of the solution has been demonstrated for 96 hours at 25°C when stored protected from light and diluted as described above.
5. Gently invert the infusion bottle/bag to facilitate dispersion of the diluted solution, but DO NOT shake to avoid foaming. The solution must not be used if it appears cloudy or if precipitation has occurred.
6. Place the infusion bottle/bag containing the diluted infusion solution into an opaque bag with closure possibility to protect it from light.

Preparation of the infusion solution

After reconstitution and dilution, the solution must be administered by intravenous infusion over approximately 1 hour.