Leaflet: information for the user

Micafungina Accord50 mg powder for concentrate for solution for infusion EFG

micafungina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains the active ingredient micafungin.Micafunginis an antifungal medication as it is used to treat infections caused by fungal cells.

Micafungin is used to treat fungal infections caused by fungal cells or yeasts called Candida.Micafungin is effective in the treatment of systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall.

When no other antifungal treatment is available, your doctor will prescribe Micafungin in the following circumstances (see section 2):

• To treat a severe fungal infection in adults, adolescents, and children, including newborns, called invasive candidiasis (infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years with a fungal infection in the esophagus in which it is appropriate to apply the treatment intravenously.
• To prevent Candida infection in patients undergoing a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

No use Micafungina Accord

-if you are allergic to micafungina, to other echinocandins (anidulafungina or caspofungina) or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use micafungina.

• if you are allergic to any medication
• if you have hemolytic anemia (anemia caused by the rupture of red blood cells) or hemolysis (rupture of red blood cells).
• if you have kidney problems (renal failure or abnormal renal function tests). In this case, your doctor may decide to monitor your renal function more closely.

Micafungina may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medications and Micafungina Accord

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

It is especially important to inform your doctor if you are using amphotericin B desoxicolate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (a calcium channel blocker used to treat hypertension). Your doctor may decide to adjust the dose of these medications.

Use of Micafungina Accord with food and drinks

Since micafungina is administered intravenously (in the vein), there are no restrictions related to food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Micafungina should not be used during pregnancy except when clearly necessary. If you use micafungina, do not breastfeed.

Driving and operating machinery

It is unlikely that micafungina will affect your ability to drive or operate machinery. However, some people may feel dizzy when taking this medication, and if this happens to you, do not drive or operate any machinery or tools. Please inform your doctor if you experience any effects that may cause you problems driving or operating machinery.

Micafungina Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Micafungina must be prepared and administered by a doctor or other healthcare professional.

Micafungina must be administered by slow intravenous infusion (into a vein), once a day. Your doctor will determine the daily dose of micafungina you will receive.

Use in adults, adolescents ≥ 16 years, and elderly patients

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing more than 40 kg, and 2 mg/kg per day for patients weighing 40 kg or less.
• The dose to treat esophageal Candida infection is 150 mg for patients weighing more than 40 kg, and 3 mg/kg per day for patients weighing 40 kg or less.
• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg, and 1 mg/kg per day for patients weighing 40 kg or less.

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

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing more than 40 kg, and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg, and 1 mg/kg per day for patients weighing 40 kg or less.

Use in children and newborns <4 months of age

• The usual dose to treat invasive Candida infection is 4-10 mg/kg per day.
• The usual dose to prevent invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungina Accord than you should

Your doctor will monitor your response and the state of your disease to determine the necessary dose of micafungina. However, if you are concerned that you have received too much micafungina, contact your doctor or another healthcare professional immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount received.

If you miss your dose of Micafungina Accord

Your doctor will monitor your response and the state of your disease to determine the appropriate treatment with micafungina. However, if you are concerned that you have missed a dose of micafungina, contact your doctor or another healthcare professional immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic attack, or a severe skin reaction (e.g. blistering of the skin and peeling of the skin), you must inform your doctor or nurse immediately.

Micafungina may cause these other side effects:

Frequent (may affect up to 1 in 10 people)

• Abnormal results in blood tests (reduction in the number of white blood cells [leucopenia; neutropenia]); reduction in the number of red blood cells (anemia)

[leucopenia; neutropenia]; anemia

• Reduction of potassium in the blood (hypokalemia); reduction of magnesium in the blood (hypomagnesemia); reduction of calcium in the blood (hypocalcemia)
• Headache
• Inflammation in the venous wall (at the injection site)
• Nausea (discomfort); vomiting; diarrhea, abdominal pain
• Abnormal results in liver tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• Increased bilirubin in the blood (hyperbilirubinemia)
• Rash
• Fever
• Chills

Rare (may affect up to 1 in 100 people)

• Abnormal results in blood tests (reduction in the number of blood cells [pancytopenia]); reduction in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cell; called eosinophils; reduction of albumin in the blood (hypoalbuminemia)
• Hypersensitivity
• Increased sweating
• Reduction of sodium in the blood (hyponatremia); increase of potassium in the blood (hyperkalemia); reduction of phosphates in the blood (hypophosphatemia); anorexia (eating disorder)
• Insomnia (difficulty sleeping); anxiety; confusion
• Somnolence (drowsiness); tremors, dizziness; alteration of the sense of taste
• Increased heart rate; stronger heartbeat; irregular heartbeat
• High or low blood pressure; redness
• Shortness of breath
• Indigestion; constipation
• Liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (the skin or the white part of the eyes turns yellow due to liver or blood problems); reduction of the amount of bile that reaches the intestine (cholestasis); enlargement of the liver; inflammation of the liver
• Rash with itching (urticaria); pruritus; redness (erythema)
• Abnormal results of renal function tests (increase in creatinine in the blood; increase in urea in the blood); worsening of renal failure
• Increased activity of an enzyme called lactate dehydrogenase
• Formation of blood clots at the injection site; inflammation at the injection site; pain at the injection site; accumulation of fluid in the body

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

• Anemia caused by the rupture of red blood cells (hemolytic anemia), rupture of red blood cells (hemolysis)

Unknown (the frequency cannot be estimated from the available data)

• Blood clotting disorders
• Shock (allergic)
• Liver cell damage including death
• Renal alterations; acute renal failure

Other side effects in children and adolescents

The following reactions have been described more frequently in pediatric patients than in adults:

Frequent (may affect up to 1 in 10 people)

• Reduction of platelets in the blood (thrombocytopenia)
• Increased heart rate (tachycardia)
• High or low blood pressure
• Increased bilirubin in the blood (hyperbilirubinemia); enlargement of the liver
• Acute renal failure; increase of urea in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the packaging. The expiration date is the last day of the month indicated.

The intact vial (not opened) does not require special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as it does not contain preservatives to prevent bacterial contamination. Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

Do not use the diluted solution for infusion if you observe that it is cloudy or if a precipitate has formed.

To protect the diluted solution for infusion from light, the bottle/bag containing it must be introduced into an opaque bag with a seal.

The vial has a single use. Therefore, the unused reconstituted concentrate must be discarded immediately.

Composition of Micafungina Accord

• The active ingredient is micafungin (as sodium salt). 1 vial contains 50 mg of micafungin (as sodium salt).
• The other components are lactose monohydrate, citric acid and sodium hydroxide.

Appearance of the product and contents of the pack

Micafungina Accord 50 mg powder for concentrate for solution for infusion is a compact white or off-white powder.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6ª planta 08039 - Barcelona

Spain

Responsible Person

PharmIdea SIA

Rupnicu Street 4, Olaine 2114,

Latvia

Or

Lyocontract GmbH

Pulverwiese 1, 38871 Ilsenburg,

Germany

Or

Accord Healthcare Polska Sp. Z.o.o.

Ul. Tasmowa 7, Entrance B, 6th floor

Marynarska Business Park, Warsaw,

Poland

Or

Accord Healthcare B.V.

Winthontlaan 200, Utrecht,

Netherlands

Last review date of this leaflet: March 2024

____________________________________________________________________________

This information is intended solely for medical professionals or healthcare professionals:

Micafungin should not be mixed or infused simultaneously with other medications except those mentioned below. Micafungin is reconstituted and diluted, using aseptic techniques at room temperature, as indicated below:

1. The plastic cap should be removed from the vial and the stopper should be disinfected with alcohol.
2. 5 ml of sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion (taken from a 100 ml bottle/bag) should be slowly and aseptically injected into each vial along the inner wall.
3. The vial should be gently rotated. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use. Therefore, the unused reconstituted concentrate should be discarded immediately.
4. All the reconstituted concentrate should be removed from each vial and returned to the infusion bag from which it was taken initially. The diluted infusion solution should be used immediately. It has been proven that the chemical and physical stability allows the use of the medication for 96 hours, when kept at 25°C, provided it is protected from light, and the dilution is carried out as described above.
5. The infusion bag should be carefully inverted to disperse the diluted solution but should NOT be shaken, to avoid foam formation. The solution should not be used if it is turbid or if a precipitate has formed.
6. The infusion bag containing the diluted infusion solution should be introduced into an opaque bag with a seal to protect it from light.

Preparation of the infusion solution