Daptomycin fosun pharma

Package leaflet: Information for the patient

Daptomycin Fosun Pharma, 350 mg, powder for solution for injection/infusion
Daptomycinum
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents

1. What Daptomycin Fosun Pharma is and what it is 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. Contents of the pack and other information

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

The active substance in 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 in children and adolescents (aged 1 to 17 years) for the treatment of skin and soft tissue infections. Daptomycin Fosun Pharma is also used in the treatment of bloodstream infections associated with skin infections.
Daptomycin Fosun Pharma is also used in adults for the treatment of infections of the inner lining of the heart cavity (including heart valves), caused by a bacterium called Staphylococcus aureus. Daptomycin Fosun Pharma is also used in the treatment of bloodstream infections caused by the same bacterium, associated with heart infection.
Depending on the type of infection(s), during treatment with Daptomycin Fosun Pharma, your doctor may also prescribe other antibacterial medicines.

2. Important information before using Daptomycin Fosun Pharma

When not to use Daptomycin Fosun Pharma:

• if the patient is allergic to daptomycin, sodium hydroxide, or any of the other ingredients of this medicine (listed in section 6);
• inform your doctor or nurse if you have any allergies. If you suspect you may be allergic to any of the substances mentioned, consult your doctor or nurse for advice.

Warnings and precautions
Before starting treatment with Daptomycin Fosun Pharma, discuss with your doctor or
nurse if:

• the patient has or has previously had kidney problems. The doctor may decide to reduce the dose of Daptomycin Fosun Pharma (see section 3 of the leaflet);
• muscle pain, tenderness, or weakness may occasionally occur in patients receiving Daptomycin Fosun Pharma (see section 4 of the leaflet for more information). In such cases, inform your doctor. The doctor will arrange for blood tests and decide whether treatment with Daptomycin Fosun Pharma should continue. These symptoms usually resolve within a few days after stopping Daptomycin Fosun Pharma;
• the patient has ever experienced severe skin rash, skin peeling, blisters, and/or mouth ulcers, or serious kidney problems after receiving daptomycin;
• the patient is significantly overweight. Blood concentrations of Daptomycin Fosun Pharma may be higher than in individuals with normal body weight, and careful monitoring is required if adverse reactions occur;
• the patient develops superinfection, as the use of antibacterial agents may promote overgrowth of resistant microorganisms. Appropriate measures should be taken.

If any of the above points apply to the patient, inform the doctor or nurse before starting
treatment with Daptomycin Fosun Pharma.
Immediately inform your doctor or nurse if any of the following symptoms occur:

• Severe, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Daptomycin Fosun Pharma. Inform your doctor or nurse immediately if symptoms of an allergic reaction occur, such as wheezing, difficulty breathing, swelling of the face, neck, or throat, rash, hives, or fever (see section 4 of the leaflet for more information).
• Serious skin reactions have been reported during treatment with daptomycin. Symptoms may include:
• onset or worsening of fever,
• red, raised, or fluid-filled skin lesions, which may start under the arms, on the chest, or in the groin area and may spread over large areas of the body,
• blisters or ulcers in the mouth or on the genitals.
• Serious kidney problems have been reported during treatment with daptomycin. Symptoms may include fever and rash.
• Any unusual tingling or numbness in hands or feet, loss of sensation, or difficulty moving. If any of these symptoms occur, inform your doctor, who will decide whether to discontinue or continue treatment.
• Diarrhea, especially if blood or mucus is present, or if diarrhea becomes severe or persistent.
• Onset or worsening of fever, cough, or difficulty breathing. These may be symptoms of a rare but serious lung disorder called eosinophilic pneumonia. The doctor will examine the lungs and decide whether to continue or discontinue treatment with Daptomycin Fosun Pharma.

Daptomycin Fosun Pharma may affect laboratory test results used to measure blood clotting. Laboratory results may indicate poor blood clotting even when clotting function is actually normal. It is therefore important that the doctor takes into account that the patient is receiving Daptomycin Fosun Pharma. Inform your doctor that you are being treated with Daptomycin Fosun Pharma.
To monitor muscle function, your doctor may order blood tests both before and repeatedly during treatment with Daptomycin Fosun Pharma.

Children and adolescents
Daptomycin Fosun Pharma must not be given to children under one year of age, as animal studies have shown that severe adverse reactions may occur in this age group.

Use in elderly patients
Patients aged 65 years and older may receive the same dose as recommended for adults, provided no kidney disease is present.

Daptomycin Fosun Pharma and other medicines
Inform your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. It is especially important to inform the doctor about:

• Medicines called statins or fibrates (cholesterol-lowering agents), or cyclosporine (a medicine used in transplantation to prevent graft rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). Using any of these (or other muscle-affecting) medicines during treatment with Daptomycin Fosun Pharma may increase the risk of muscle-related adverse effects. The doctor will decide whether to discontinue Daptomycin Fosun Pharma or temporarily suspend the other medicines.
• Pain-relieving medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Daptomycin Fosun Pharma is generally not given to pregnant women. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Breastfeeding
Daptomycin Fosun Pharma must not be used during breastfeeding, as it may pass into human milk and harm the baby.

Driving and using machines
There are no known effects of Daptomycin Fosun Pharma on the ability to drive or operate machinery.

Daptomycin Fosun Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning it is considered "sodium-free".

3. How to use Daptomycin Fosun Pharma

Daptomycin Fosun Pharma is usually administered by a doctor or nurse.
Adults (aged 18 years and above)
The dose depends on body weight and the type of infection being treated. The usual dose for adults is 4 mg per kilogram (kg) of body weight once daily for skin infections, or 6 mg per kilogram of body weight once daily for heart infections or bloodstream infections associated with skin or heart infections. In adult patients, this dose is administered directly into the bloodstream (intravenously) as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for individuals over 65 years of age, provided their kidneys are functioning properly.
If kidney function is impaired, Daptomycin Fosun Pharma may be administered less frequently, for example every other day. In dialysis patients, if the next dose of Daptomycin Fosun Pharma falls on a dialysis day, the drug is usually administered after completion of dialysis.
Children and adolescents (aged 1 to 17 years)
The dose for children and adolescents (aged 1 to 17 years) will depend on the patient's age and the type of infection being treated. The dose is administered directly into the bloodstream (intravenously) by infusion lasting approximately 30–60 minutes.
Treatment usually lasts from 1 to 2 weeks for skin infections. For bloodstream or heart infections, as well as for skin infections, the duration of treatment will be determined by the physician.
Detailed instructions for the preparation and administration of the medicinal product are provided at the end of this leaflet.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The most serious adverse reactions are described below:

• Serious adverse reactions with unknown frequency (frequency cannot be estimated from the available data). Cases of hypersensitivity reactions (severe allergic reactions including symptoms such as anaphylaxis, angioedema) have been reported during administration of Daptomycin Fosun Pharma. This severe allergic reaction requires immediate medical attention. You should immediately inform your doctor or nurse if you experience any of the following symptoms:
• chest pain or chest tightness,
• rash or hives,
• swelling of the throat,
• rapid or weak pulse,
• wheezing,
• fever,
• chills or shivering,
• hot flushes,
• dizziness,
• fainting,
• metallic taste in the mouth.

If unexplained muscle pain, tenderness or weakness occurs, you should inform your doctor immediately.
Muscle-related symptoms may be serious and may include breakdown of muscle cells (so-called rhabdomyolysis), which may lead to kidney damage.
Other serious adverse reactions reported include:

• Rare but potentially serious lung disorder called eosinophilic pneumonia, most commonly occurring when treatment lasts longer than 2 weeks. Symptoms include difficulty breathing, new or worsening cough, new or worsening fever.
• Severe skin reactions [acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)]. Symptoms may include:
• new or worsening fever,
• red, raised or fluid-filled blisters on the skin, which may start under the arms, on the chest or in the groin area and may spread to large areas of the body,
• blisters or ulcers in the mouth or on the genitals.
• Serious kidney problems. Symptoms may include fever and rash.

If such symptoms occur, you must immediately inform your doctor or nurse.
Your doctor will order additional tests to establish a diagnosis.
The most commonly reported adverse reactions are described below:
Common adverse reactions (may affect up to 1 in 10 people)

• fungal infections, such as candidiasis,
• urinary tract infection,
• decreased number of red blood cells (anaemia),
• dizziness, restlessness, difficulty sleeping,
• headache,
• fever, weakness (asthenia),
• increased or decreased blood pressure,
• constipation, abdominal pain,
• diarrhoea, nausea or vomiting,
• flatulence,
• abdominal swelling or bloating,
• skin rash or itching,
• pain, itching or redness around the infusion site,
• pain in hands or feet,
• increased levels of liver enzymes or creatine phosphokinase (CPK) in blood.

Other adverse reactions that may occur after administration of Daptomycin Fosun Pharma are described below:
Uncommon adverse reactions (may affect up to 1 in 100 people)

• blood disorders (e.g. increased number of small blood cells called platelets, which may increase blood clotting, or increased number of certain types of white blood cells),
• decreased appetite,
• tingling or numbness in hands or feet, taste disturbances,
• tremor,
• changes in heart rhythm, sudden flushing of the face,
• indigestion (dyspepsia), inflammation of the tongue,
• itchy skin rash,
• muscle pain, cramps or weakness, muscle inflammation, joint pain,
• kidney problems,
• inflammation or irritation of the vagina,
• general feeling of pain or weakness, fatigue (tiredness),
• increased blood glucose, serum creatinine, myoglobin, lactate dehydrogenase (LDH) activity, prolonged blood clotting time or electrolyte imbalance,
• eye itching.

Rare adverse reactions (may affect up to 1 in 1000 people)

• yellowing of the skin and eyes,
• prolonged prothrombin time.

Unknown frequency (frequency cannot be estimated from the available data)
Colitis associated with antibacterial effect, including pseudomembranous colitis (severe or persistent diarrhoea with blood and (or) mucus, associated with abdominal pain or fever), bruising, bleeding gums or nosebleeds.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Daptomycin Fosun Pharma

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

6. Contents of the pack and other information

What Daptomycin Fosun Pharma contains

• The active substance is daptomycin. One vial of powder contains 350 mg of daptomycin.
• Other ingredient: sodium hydroxide (for pH adjustment).

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 brownish cake or powder in glass vials. Before administration, the powder
must be reconstituted with a solvent to form a solution.
Daptomycin Fosun Pharma is available in packs containing 1 vial.

Marketing Authorisation Holder and Importer
Fosun Pharma Sp. z o.o.
ul. Zajęcza 15,
00-351 Warsaw
Tel.: +48 22 244 11 05

This medicinal product is authorised in the European Economic Area member states 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

Information intended exclusively for healthcare professionals:

Warning: Before prescribing the medicinal product, read the Summary of Product Characteristics.
Instructions for use and handling of the 350 mg vial
Daptomycin may be administered intravenously as a 30-minute infusion or as a 2-minute injection in adults. In contrast to adult patients, daptomycin should not be administered as a 2-minute injection in children and adolescents. In children and adolescents aged 7 to 17 years, daptomycin should be administered as a 30-minute infusion. In children under 7 years of age receiving a dose of 9–12 mg/kg body weight, daptomycin should be administered over 60 minutes. Preparation of the infusion solution requires an additional dilution step, as specified below.

Daptomycin Fosun Pharma medicinal product administered as a 30- or 60-minute intravenous infusion

The concentration of Daptomycin Fosun Pharma 350 mg powder for solution for infusion, resulting in 50 mg/mL, is achieved by reconstituting the lyophilized product with 7 mL of 0.9% (9 mg/mL) sodium chloride solution for injection.
Dissolution of the lyophilized product usually takes 15 minutes. The fully reconstituted solution 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.
Throughout the reconstitution and dilution process of the lyophilized Daptomycin Fosun Pharma medicinal product, aseptic techniques must be strictly maintained.

Reconstitution:

1. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21G needle or smaller, or a needle-free device, draw up 7 mL of 0.9% (9 mg/mL) sodium chloride solution for injection into a syringe. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilized material and leave it for 10 minutes.
3. Finally, gently rotate or invert the vial several times for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the medicinal product is completely dissolved and free from particulate matter. The reconstituted solution of Daptomycin Fosun Pharma ranges in color from yellowish to light brown.
5. Dilute the reconstituted solution with 0.9% sodium chloride solution (9 mg/mL), typically in 50 mL.

Dilution:

1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/mL) from the vial using a new sterile 21G needle or smaller by inverting the vial so that the solution flows toward the stopper. Using a syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deeply as possible into the solution during withdrawal. Before removing the needle from the vial, pull back the syringe plunger fully to withdraw the required volume from the inverted vial.
2. Remove air, large bubbles, and excess solution from the syringe to obtain the required dose.
3. Transfer the required volume of the reconstituted dose into 50 mL of 0.9% (9 mg/mL) sodium chloride solution.
4. The reconstituted and diluted solution may then be administered as an intravenous infusion over 30 or 60 minutes (in accordance with section 4.2 of the Summary of Product Characteristics).

The following medicinal products have shown no incompatibility when added to the infusion solution of Daptomycin Fosun Pharma: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
After reconstitution: the chemical and physical stability of the reconstituted solution in the vial is 12 hours at 25°C or up to 48 hours when stored refrigerated at 2°C–8°C. The chemical and physical stability of the diluted solution in an infusion bag is 12 hours at 25°C or 24 hours when stored refrigerated at 2°C–8°C.
The stability of the diluted solution in infusion bags has been established as 12 hours at 25°C or 24 hours when stored refrigerated at 2°C–8°C.
However, from a microbiological standpoint, the product prepared for use should be administered immediately. If not used immediately, the responsibility for storage duration lies with the user. Generally, storage should not exceed 24 hours at 2°C–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.

Daptomycin Fosun Pharma medicinal product administered as a 2-minute intravenous injection (adults only)

Do not use water for reconstitution of Daptomycin Fosun Pharma for intravenous injection. Daptomycin Fosun Pharma must be reconstituted exclusively with 0.9% sodium chloride solution (9 mg/mL).
The concentration of Daptomycin Fosun Pharma 350 mg powder for solution for injection, resulting in 50 mg/mL, is achieved by reconstituting the lyophilized product with 7 mL of 0.9% (9 mg/mL) sodium chloride solution for injection.
The lyophilized product dissolves in approximately 15 minutes. The fully dissolved medicinal product becomes clear and may contain a few small bubbles or foam at the edge of the vial.
To prepare Daptomycin Fosun Pharma for intravenous injection, follow the instructions below.
Throughout the reconstitution of the lyophilized Daptomycin Fosun Pharma medicinal product, aseptic techniques must be strictly maintained.

1. Remove the polypropylene cap from the vial to expose the central area of the rubber stopper. Wipe the rubber stopper with an alcohol-impregnated swab or other antiseptic solution and allow it to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile 21G needle or smaller, or a needle-free device, draw up 7 mL of 0.9% (9 mg/mL) sodium chloride solution for injection into a syringe. Then slowly pierce the center of the rubber stopper with the needle and inject the syringe contents, directing the needle against the vial wall.
2. Gently rotate the vial to completely wet the lyophilized material and leave it for 10 minutes.
3. Finally, gently rotate or invert the vial several times for a few minutes until a clear solution is obtained. Avoid vigorous shaking to prevent foaming.
4. Inspect the reconstituted solution carefully before use to ensure that the medicinal product is completely dissolved and free from particulate matter. The reconstituted solution of Daptomycin Fosun Pharma ranges in color from yellowish to light brown.
5. Slowly withdraw the reconstituted solution (50 mg daptomycin/mL) from the vial using a sterile 21G needle or smaller.
6. Invert the vial so that the solution flows toward the stopper. Using a new syringe, insert the needle into the inverted vial. While holding the vial upside down, place the needle tip as deeply as possible into the solution during withdrawal. Before removing the needle from the vial, pull back the syringe plunger fully to withdraw the entire solution from the inverted vial.
7. Change the needle to a new one suitable 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 administered slowly into the vein over 2 minutes (in accordance with 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 up to 48 hours when stored refrigerated at 2°C–8°C.
However, from a microbiological standpoint, the product prepared for use should be used immediately. If not used immediately, the responsibility for storage duration lies with the user. Generally, storage should not exceed 24 hours at 2°C–8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.
The medicinal product must not be mixed with other medicinal products except those listed above.
Vials containing Daptomycin Fosun Pharma are for single use only.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.