Daptomicin Fosun Pharma

PATIENT INFORMATION LEAFLETLeaflet accompanying the packaging: patient information

Daptomycin Fosun Pharma, 350 mg, powder for solution for injection/infusion

for infusion
Daptomycin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Daptomycin Fosun Pharma and what is it used for
• 2. Important information before using Daptomycin Fosun Pharma
• 3. How to use Daptomycin Fosun Pharma
• 4. Possible side effects
• 5. How to store Daptomycin Fosun Pharma
• 6. Package contents and other information

1. What is Daptomycin Fosun Pharma and what is it used for

The active substance of Daptomycin Fosun Pharma powder for solution for injection/infusion is daptomycin. Daptomycin is an antibacterial medicine that can stop the growth of certain bacteria. Daptomycin Fosun Pharma is used in adults and children and adolescents (from 1 to 17 years old) to treat skin and soft tissue infections. Daptomycin Fosun Pharma is also used to treat blood infections related to skin infections.
Daptomycin Fosun Pharma is also used in adults to treat infections of the tissue lining the heart from the inside (including heart valves), caused by a bacterium called Staphylococcus aureus. Daptomycin Fosun Pharma is also used to treat blood infections caused by this bacterium, related to heart infections.
Depending on the type of infection, during treatment with Daptomycin Fosun Pharma, the doctor may also prescribe other antibacterial medicines.

2. Important information before using Daptomycin Fosun Pharma

When not to use Daptomycin Fosun Pharma:

• the patient should inform their doctor or nurse about any allergy. If the patient suspects that they may be allergic to the mentioned substances, they should consult their doctor or nurse for advice.

Warnings and precautions

Before starting treatment with Daptomycin Fosun Pharma, the patient should discuss with their doctor or nurse if:

• the patient has or has had kidney problems in the past. The doctor may decide to reduce the dose of Daptomycin Fosun Pharma (see section 3 of the leaflet);
• in patients receiving Daptomycin Fosun Pharma, muscle pain or muscle sensitivity, or muscle weakness may occasionally occur (more information, see section 4 of the leaflet). In such a case, the patient should inform their doctor. The doctor will take care of blood tests and decide whether to continue using Daptomycin Fosun Pharma. The mentioned symptoms usually disappear within a few days after discontinuing Daptomycin Fosun Pharma;
• the patient has ever had a severe skin rash or skin peeling, blisters, or ulcers in the mouth or serious kidney problems after taking daptomycin;
• the patient is significantly overweight. The levels of Daptomycin Fosun Pharma in the blood may be higher compared to people with average body weight, and in such a case, if side effects occur, careful monitoring of the patient is necessary;
• if the patient develops a superinfection during treatment, as the use of antibacterial medicines can promote the overgrowth of resistant microorganisms. Appropriate measures should be taken.

If any of the above points apply to the patient, they should tell their doctor or nurse before starting treatment with Daptomycin Fosun Pharma.

The patient should immediately inform their doctor or nurse if they experience any of the following symptoms:

• Severe, acute allergic reactions have been observed in patients treated with almost all antibacterial medicines, including Daptomycin Fosun Pharma. The patient should immediately tell their doctor or nurse if they experience symptoms of an allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, and hives or fever (more information, see section 4 of the leaflet).
• Severe skin reactions have been reported during treatment with daptomycin. The symptoms of these reactions may include:
• the onset or worsening of fever,
• red, raised, or fluid-filled skin patches that may start under the arms, on the chest, or in the groin area and may spread to a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney problems have been reported during treatment with daptomycin. The symptoms may include fever and rash.
• Any unusual tingling or numbness of the hands or feet, loss of sensation, or difficulty moving. If the patient experiences any of the above symptoms, they should inform their doctor, who will decide whether to stop or continue treatment.
• Diarrhea, especially if it contains blood or mucus, or if the diarrhea becomes severe or persistent.
• The onset or worsening of fever, cough, or difficulty breathing. These may be symptoms of a rare but serious lung condition called eosinophilic pneumonia. The doctor will examine the patient's lungs and decide whether to continue or stop treatment with Daptomycin Fosun Pharma.

Daptomycin Fosun Pharma may affect the results of laboratory tests that determine blood clotting. The laboratory test results may indicate poor blood clotting when, in fact, the blood clotting is normal. Therefore, it is essential for the doctor to consider that the patient is taking Daptomycin Fosun Pharma. The patient should inform their doctor about taking Daptomycin Fosun Pharma.
To monitor muscle condition, the doctor may order blood tests, both before and during treatment with Daptomycin Fosun Pharma.

Children and adolescents

Daptomycin Fosun Pharma should not be given to children under one year of age, as animal studies have shown that this age group may experience severe side effects.

Use in elderly patients

Patients over 65 years old can be given the same dose as the recommended dose for adults, if they do not have kidney disease.

Daptomycin Fosun Pharma and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the doctor about:

• Medicines called statins or fibrates (cholesterol-lowering medicines) or cyclosporine (a medicine used in transplantology to prevent rejection of the transplant or in other conditions, such as rheumatoid arthritis or atopic dermatitis). Taking any of these (or other muscle-affecting) medicines during treatment with Daptomycin Fosun Pharma may increase the risk of muscle side effects. The doctor will decide whether to stop Daptomycin Fosun Pharma or temporarily discontinue the use of other medicines.
• Pain relievers, called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). They may affect the effect of Daptomycin Fosun Pharma on the kidneys.
• Oral anticoagulants (e.g., warfarin), which prevent blood clotting. The doctor may need to monitor blood clotting time.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Normally, Daptomycin Fosun Pharma is not given to pregnant women. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Breastfeeding
Daptomycin Fosun Pharma should not be used during breastfeeding, as it may pass into breast milk and harm the baby.

Driving and using machines

There are no known cases of Daptomycin Fosun Pharma affecting the ability to drive or use machines.

Daptomycin Fosun Pharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Daptomycin Fosun Pharma

Daptomycin Fosun Pharma is usually administered by a doctor or nurse.

Adults (18 years and older)

The dose depends on body weight and the type of infection being treated. The usual dose of the medicine for adults is 4 mg per kilogram (kg) of body weight once a day for skin infections or 6 mg per kilogram of body weight once a day for heart or blood infections related to skin or heart infections. In adult patients, this dose is administered directly into the bloodstream (intravenously) in an infusion lasting about 30 minutes or an injection lasting about 2 minutes.
The same dose is recommended for people over 65 years old, provided their kidneys are working properly.
If the kidneys are not working properly, Daptomycin Fosun Pharma may be administered less frequently, e.g., every other day. In patients undergoing dialysis, if the next dose of Daptomycin Fosun Pharma is scheduled on a dialysis day, Daptomycin Fosun Pharma is usually administered after dialysis.

Children and adolescents (from 1 to 17 years old)

The dose for children and adolescents (from 1 to 17 years old) will depend on the patient's age and the type of infection being treated. The dose is administered directly into the bloodstream (intravenously) in an infusion lasting about 30-60 minutes.
Treatment usually lasts from 1 to 2 weeks for skin infections. For blood or heart infections, as well as skin infections, the duration of treatment will be decided by the doctor.
Detailed instructions for preparing and administering the medicine are provided at the end of this leaflet.

4. Possible side effects

Like all medicines, Daptomycin Fosun Pharma can cause side effects, although not everybody gets them.

The most serious side effects are described below:

• Severe side effects, the frequency of which is unknown(the frequency cannot be determined based on available data). Cases of hypersensitivity reactions (severe allergic reactions, including symptoms such as anaphylaxis, angioedema) have been reported in patients treated with Daptomycin Fosun Pharma. The occurrence of this severe allergic reaction requires immediate medical attention. The patient should immediately inform their doctor or nurse about the following symptoms:
• chest pain or tightness in the chest,
• rash or hives,
• swelling of the throat,
• rapid or weak pulse,
• wheezing,
• fever,
• chills or shivering,
• hot flashes,
• dizziness,
• fainting,
• metallic taste in the mouth.

If the patient experiences unexplained muscle pain, sensitivity, or weakness, they should immediately inform their doctor. Muscle symptoms can be severe and may include muscle cell breakdown (so-called rhabdomyolysis), which can lead to kidney damage.

Other severe side effects that have been reported include:

• A rare but potentially severe lung condition called eosinophilic pneumonia, which occurs most often with treatment lasting more than 2 weeks. Its symptoms include difficulty breathing, onset or worsening of cough, onset or worsening of fever.
• Severe skin disorders [acute generalized exanthematous pustulosis (AGEP), drug reactions with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), or toxic epidermal necrolysis (TEN)]. The symptoms may include:
• new or worsening fever,
• red, raised, or fluid-filled skin patches that may start under the arms or on the chest or in the groin area and may spread to a large area of the body,
• blisters or ulcers in the mouth or on the genitals.
• Severe kidney problems. The symptoms may include fever and rash.

If the patient experiences any of these symptoms, they should immediately inform their doctor or nurse. The doctor will order additional tests to make a diagnosis.

The most common side effects are described below:
Common side effects(may affect up to 1 in 10 people)

• fungal infections, such as thrush,
• urinary tract infections,
• decreased red blood cell count (anemia),
• dizziness, anxiety, sleep disturbances,
• headache,
• fever, weakness (asthenia),
• increased or decreased blood pressure,
• constipation, abdominal pain,
• diarrhea, nausea, or vomiting,
• bloating,
• abdominal swelling or bloating,
• skin rash or itching,
• pain, itching, or redness at the injection site,
• pain in the hands or feet,
• increased levels of liver enzymes or creatine phosphokinase (CPK) in the blood.

Other side effects that may occur after using Daptomycin Fosun Pharma are described below:
Uncommon side effects(may affect up to 1 in 100 people)

• blood disorders (e.g., increased platelet count, which may increase blood clotting, or increased white blood cell count),
• decreased appetite,
• tingling or numbness of the hands or feet, taste disturbances,
• tremors,
• heart rhythm changes, sudden flushing of the face,
• indigestion (dyspepsia), tongue inflammation,
• itchy skin rash,
• pain, cramps, or weakness of the muscles, muscle inflammation, joint pain,
• kidney problems,
• vaginal inflammation or irritation,
• general feeling of pain or weakness, fatigue (exhaustion),
• increased blood sugar levels, serum creatinine, myoglobin, lactate dehydrogenase (LDH) activity, prolonged blood clotting time, or electrolyte imbalance,
• eye itching.

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

• jaundice,
• prolonged prothrombin time.

Unknown(the frequency cannot be determined based on available data)
Colitis associated with antibacterial use, including pseudomembranous colitis (severe or persistent diarrhea with blood and/or mucus, associated with abdominal pain or fever), bruising, gum bleeding, or nosebleeds.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Daptomycin Fosun Pharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C – 8°C).

6. Package contents and other information

What Daptomycin Fosun Pharma contains

• The active substance of the medicine is daptomycin. One vial of powder contains 350 mg of daptomycin.
• The other ingredient is: sodium hydroxide (to adjust pH).

What Daptomycin Fosun Pharma looks like and contents of the pack

Daptomycin Fosun Pharma powder for solution for injection/infusion is available as a yellowish to light brown disc or powder in glass vials. Before administration, the powder should be mixed with a solvent to form a solution.
Daptomycin Fosun Pharma is available in packs containing 1 vial.

Marketing authorization holder and importer

Fosun Pharma Sp. z o. o.
ul. Zajęcza 15,
00-351 Warsaw
Phone: +48 22 244 11 05

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Daptomycin Fosun Pharma
Germany: Daptomycin Fosun Pharma 350 mg powder for solution for injection/infusion
Spain: Daptomycin Fosun Pharma
France: Daptomycin Fosun Pharma
Italy: Daptomicina Fosun Pharma
Poland: Daptomycin Fosun Pharma

Date of last revision of the leaflet:

------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Note: before prescribing the medicine, read the Summary of Product Characteristics.
Instructions for use and handling of the 350 mg vial
Adult patients may be administered daptomycin intravenously in an infusion over 30 minutes or by injection over 2 minutes. Unlike adult patients, children and adolescents should not be administered daptomycin by 2-minute injection. Children and adolescents from 7 to 17 years old should be administered daptomycin in an infusion over 30 minutes. Children under 7 years old receiving a dose of 9-12 mg/kg body weight should be administered daptomycin over 60 minutes. Preparation of the infusion solution requires an additional dilution step, which is detailed below.

Daptomycin Fosun Pharma administered as an intravenous infusion over 30 or 60 minutes

The concentration of Daptomycin Fosun Pharma 350 mg, powder for solution for infusion, of 50 mg/mL is achieved by reconstituting the lyophilized product in 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Dissolution of the lyophilized product takes about 15 minutes. The completely reconstituted product is clear and may contain a few small air bubbles or foam at the edge of the vial.
To prepare Daptomycin Fosun Pharma for intravenous infusion, follow the instructions below.
During reconstitution or dilution of the lyophilized product, the principles of asepsis should be observed at all times.

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile needle, 21G or smaller, or a needleless device, draw up 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection into a syringe. Then slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle toward the wall of the vial.
• 2. Gently rotate the vial to ensure that the lyophilized product is completely moistened and let it stand for 10 minutes.
• 3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming of the solution.
• 4. The reconstituted solution should be inspected visually before use to ensure that the product is completely dissolved and does not contain any particulate matter. The reconstituted solution of Daptomycin Fosun Pharma has a yellowish to light brown color.
• 5. The solution should be diluted to 50 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.

Dilution:

• 1. Slowly withdraw the required volume of reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile needle, 21G or smaller. Invert the vial and, using a new syringe, insert the needle into the inverted vial. Hold the vial upside down and position the needle so that the tip is at the bottom of the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end to withdraw all the solution from the inverted vial.
• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the required dose.
• 3. Transfer the required dose to 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
• 4. The reconstituted and diluted solution can then be administered as an intravenous infusion over 30 or 60 minutes (as specified in section 4.2 of the Summary of Product Characteristics).

The chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or 48 hours when stored in a refrigerator (2°C – 8°C).
However, from a microbiological point of view, the prepared solution should be used immediately. If not used immediately, the storage time is the responsibility of the user, usually no more than 24 hours at 2°C – 8°C, unless reconstitution and dilution are performed under controlled and validated aseptic conditions.

Daptomycin Fosun Pharma administered as a 2-minute intravenous injection (only for adult patients)

Water should not be used to reconstitute Daptomycin Fosun Pharma for intravenous injection. Daptomycin Fosun Pharma should be reconstituted only with sodium chloride 9 mg/mL (0.9%) solution for injection.
The concentration of Daptomycin Fosun Pharma 350 mg, powder for solution for injection, of 50 mg/mL is achieved by reconstituting the lyophilized product in 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
The lyophilized product dissolves in about 15 minutes. The completely dissolved product becomes clear and may contain a few small air bubbles or foam at the edge of the vial.
To prepare Daptomycin Fosun Pharma for intravenous injection, follow the instructions below.
During reconstitution of the lyophilized product, the principles of asepsis should be observed at all times.

• 1. Remove the polypropylene cap from the vial to expose the central portion of the rubber stopper. Wipe the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile needle, 21G or smaller, or a needleless device, draw up 7 mL of sodium chloride 9 mg/mL (0.9%) solution for injection into a syringe. Then slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the needle toward the wall of the vial.

2. Gently rotate the vial to ensure that the lyophilized product is completely moistened and let it stand for 10 minutes.

• 3. Finally, gently rotate or swirl the vial for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming of the solution.
• 4. The reconstituted solution should be inspected visually before use to ensure that the product is completely dissolved and does not contain any particulate matter. The reconstituted solution of Daptomycin Fosun Pharma has a yellowish to light brown color.
• 5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile needle, 21G or smaller.
• 6. Invert the vial and, using a new syringe, insert the needle into the inverted vial. Hold the vial upside down and position the needle so that the tip is at the bottom of the solution in the vial while withdrawing the solution into the syringe. Before removing the needle from the vial, pull the plunger to the end to withdraw all the solution from the inverted vial.
• 7. Change the needle to a new one intended for intravenous injection.
• 8. Remove air, large bubbles, and excess solution from the syringe to obtain the required dose.
• 9. The reconstituted solution should be injected slowly into a vein over 2 minutes (as specified in section 4.2 of the Summary of Product Characteristics).

The chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or 48 hours when stored in a refrigerator (2°C – 8°C).
However, from a microbiological point of view, the prepared solution should be used immediately. If not used immediately, the storage time is the responsibility of the user, usually no more than 24 hours at 2°C – 8°C, unless reconstitution is performed under controlled and validated aseptic conditions.
The medicine should not be mixed with other medicines, except those listed above.
The vials containing Daptomycin Fosun Pharma are intended for single use only.
Any unused product or waste material should be disposed of in accordance with local regulations.