Micafungin Hikma

Package leaflet: Information for the user

Micafungin Hikma 50 mg powder for concentrate for solution for infusion, 100 mg powder for concentrate for solution for infusion

micafungin
Generic medicine
Please 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 side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Micafungin Hikma contains the active substance micafungin. Micafungin Hikma is known as an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Hikma is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin Hikma is effective in the treatment of 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 Hikma causes defects in the fungal cell wall, making the fungus unable to survive and grow.
Your doctor has prescribed Micafungin Hikma under the following circumstances, when no other suitable antifungal treatments are available (see section 2):

• To treat adults, adolescents, and children including newborns with 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 (oesophagus) for which intravenous (IV) treatment is appropriate.
• To prevent Candida infections in patients undergoing bone marrow transplantation or in patients expected to develop neutropenia (low levels of neutrophils, a type of white blood cell) lasting for 10 days or more.

2. What you need to know before using Micafungin Hikma

Do not use Micafungin Hikma

• 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 developing liver tumors in humans is unknown, and your doctor will assess the benefits and risks of treatment with Micafungin Hikma before you start taking the medicine. Inform your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests. During treatment, your liver function will be monitored more closely.

Ask your doctor or pharmacist before using Micafungin Hikma

• 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 failure or abnormal kidney function tests). If this occurs, your doctor may decide to monitor your kidney function more closely. Micafungin may also cause a severe inflammation/rash of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis). Other medicines and Micafungin Hikma 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 Hikma with food and drink Since Micafungin Hikma 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 if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Micafungin Hikma must not be used during pregnancy unless clearly necessary. If you are taking Micafungin Hikma, you must not breastfeed.

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 side effect that could cause you problems when driving or using machines.
Micafungin Hikma 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 Hikma

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

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

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

Use in children and neonates under 4 months of age

• The usual dose used to treat 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 receive more Micafungin Hikma than you should

Your doctor will monitor your response to the medicine and your health condition to determine the required dose of Micafungin Hikma. However, if you are concerned that you have received an excessive dose of Micafungin Hikma, speak to your doctor or another healthcare professional immediately.

If a dose of Micafungin Hikma has not been administered

Your doctor will monitor your response to the medicine and your health condition to determine the required treatment with Micafungin Hikma. However, if you are concerned that you have not received a dose of Micafungin Hikma, speak to your doctor or another healthcare professional immediately.

If you have any doubts about how to use Micafungin Hikma, 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 Hikma may cause the following additional side effects:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (decrease in blood cells [pancytopenia]); decrease in platelet count (thrombocytopenia); increase in a type of white blood cell called eosinophils; low albumin levels in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• low sodium levels in the blood (hyponatraemia); high potassium levels in the blood (hyperkalaemia); low phosphate levels in the blood (hypophosphataemia); loss of appetite (anorexia)
• insomnia (difficulty sleeping); anxiety; confusion
• feeling lethargic (drowsiness); tremors; dizziness; taste disturbances
• increased heart rate; increased force of heart beat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood problems); reduced bile flow to the intestines (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin redness (erythema)
• changes in kidney function tests (increased blood creatinine; increased blood urea levels); worsening of kidney failure
• increased levels of 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 1,000 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)

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

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 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 Hikma

Keep Micafungin Hikma out of the sight and reach of children.
Do not use Micafungin Hikma after the expiry date stated on the vial and
the outer carton. The expiry date refers to the last day of the 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.
Micafungin Hikma does not contain preservatives. From a microbiological standpoint, reconstituted and diluted solutions should be used immediately. If not used immediately, the in-use 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 medicinal product must be prepared for use only by a healthcare professional who has thoroughly read the instructions.
Do not use the diluted infusion solution if it appears cloudy or contains precipitate.
The vial or infusion bag containing the diluted infusion solution should 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.

6. Package contents and other information

What Micafungin Hikma contains

• The active substance is micafungin (as sodium salt). Micafungin Hikma 50 mg 1 vial contains sodium micafunginate equivalent to 50 mg of micafungin. Micafungin Hikma 100 mg 1 vial contains sodium micafunginate equivalent to 100 mg of micafungin.
• The other components are lactose monohydrate, anhydrous citric acid and sodium hydroxide.

Description of the appearance of Micafungin Hikma and contents of the pack
Micafungin Hikma 50 mg or 100 mg powder for concentrate for solution for infusion is a white, compact lyophilised powder.
Micafungin Hikma is supplied in packs of 1 vial and 10 vials.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A, 8B, Fervença
2705-906 Terrugem SNT
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Micafungin Hikma 50 mg Powder for a concentrate for solution for infusion
Micafungin Hikma 100 mg Powder for a concentrate for solution for infusion
France MICAFUNGIN HIKMA 50 mg, powder for solution for dilution for perfusion
MICAFUNGIN HIKMA 100 mg, powder for solution for dilution for perfusion
Germany Micafungin Hikma 50 mg Powder for a concentrate for solution for infusion
Micafungin Hikma 100 mg Powder for a concentrate for solution for infusion
Italy Micafungina Hikma powder for concentrate for solution for infusion
Netherlands Micafungine Hikma 50 mg, powder for concentrate for infusion solution

Portugal Micafungina Hikma
Spain Micafungina Hikma 50 mg powder for concentrate for solution for infusion
EFG
Micafungina Hikma 100 mg powder for concentrate for solution for
infusion EFG
United Kingdom Micafungin 50 mg and 100 mg Powder for concentrate for solution for infusion

The following information is intended exclusively for medical professionals or healthcare
providers:
Micafungina Hikma must not be mixed or infused together with other products except those indicated below.
Micafungina Hikma is reconstituted and diluted as follows, using aseptic conditions at room temperature:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Under aseptic conditions, slowly inject 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion along the inner wall of each vial (withdrawn from a 100 ml infusion bottle/bag). Although foam may form in the concentrate, care must be taken to minimize the amount of foam generated. A sufficient number of Micafungina Hikma 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 (approximately 0.2 ml volume).
4. Withdraw 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 protected from light and diluted as described above.
5. Gently invert the infusion bottle/bag to disperse the diluted solution, but DO NOT SHAKE to avoid foaming. The solution must not be used if it appears cloudy or if precipitation occurs.
6. Place the infusion bottle/bag containing the diluted infusion solution into an opaque, closable bag to protect from light.

Preparation of the infusion solution