Daptomicin Reddi

Leaflet attached to the packaging: patient information

Daptomycin Reddy 350 mg powder for solution for injection/infusion

Daptomycin Reddy 500 mg powder for solution for injection/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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
If the patient experiences any side effects, including any side effects 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 Reddy and what is it used for
• 2. Important information before taking Daptomycin Reddy
• 3. How to take Daptomycin Reddy
• 4. Possible side effects
• 5. How to store Daptomycin Reddy
• 6. Contents of the packaging and other information

1. What is Daptomycin Reddy and what is it used for

The active substance of Daptomycin Reddy powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial medicine that can stop the growth of certain bacteria. Daptomycin Reddy is used in adults and children and adolescents (from 1 to 17 years old) to treat skin and soft tissue infections. Daptomycin Reddy is also used to treat blood infections related to skin infections.
Daptomycin Reddy 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 Reddy is also used to treat blood infections caused by the same bacterium that causes heart infections.
Depending on the type of infection, during treatment with Daptomycin Reddy, the doctor may also prescribe other antibacterial medicines.

2. Important information before taking Daptomycin Reddy

When not to use Daptomycin Reddy

• if the patient is allergic to daptomycin or any of the other ingredients of this medicine (listed in section 6).
• the patient should inform the doctor or nurse about any allergy or hypersensitivity. If the patient suspects that they may be allergic to the mentioned substances, they should consult a doctor or nurse.

Warnings and precautions

Before starting treatment with Daptomycin Reddy, the patient should consult a doctor or nurse:
if the patient has or has had kidney problems in the past. The doctor may need to change the dose of Daptomycin Reddy (see section 3 of this leaflet).
in patients receiving Daptomycin Reddy, muscle pain or muscle weakness may occasionally occur. In such a case, the patient should inform the doctor. The doctor will take care of performing a blood test and deciding whether to continue using Daptomycin Reddy. The mentioned symptoms usually disappear within a few days after stopping the use of Daptomycin Reddy.
if the patient has ever experienced a severe skin rash or skin peeling, blistering, or ulcers in the mouth or serious kidney problems after taking daptomycin.
in case of severe obesity. Daptomycin concentrations in the blood may be higher compared to concentrations in people with average body weight, and in such a case, in the event of side effects, careful monitoring of the patient is necessary.
If any of the above points apply to the patient, they should inform the doctor or nurse before starting treatment with Daptomycin Reddy.
The patient should immediately inform the 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. Symptoms may include: wheezing, difficulty breathing, swelling of the face, neck, and throat, rash, and hives or fever.
serious skin disorders have been reported during treatment with daptomycin. Symptoms that may occur in this case include:
the onset or worsening of fever,
red, raised, or fluid-filled bumps on the skin, which may start under the arms or on the chest or in the groin and may spread to a large part 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. If these symptoms occur, the patient should immediately inform the doctor or nurse. The doctor will perform additional tests to make a diagnosis.
tingling or numbness of the hands or feet, loss of sensation, or difficulty moving. If these symptoms occur, the patient should inform the doctor, who will decide whether to discontinue or continue treatment.
diarrhea, especially if it contains blood or mucus, or if the diarrhea becomes acute or persistent.
the 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 patient's lungs and decide whether to continue or discontinue treatment with Daptomycin Reddy.
Daptomycin Reddy may affect the results of laboratory tests that determine blood clotting. Laboratory test results may indicate poor blood clotting when, in fact, blood clotting is normal. It is therefore important for the doctor to take into account the patient's use of Daptomycin Reddy. The patient should inform the doctor about the use of Daptomycin Reddy.
To monitor muscle condition, the doctor may order blood tests before starting treatment, as well as multiple times during treatment with Daptomycin Reddy.

Children and adolescents

Daptomycin Reddy 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, if they do not have kidney disease, can be given the same dose as recommended for adults.

Daptomycin Reddy and other medicines

The patient should tell the 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 (which lower cholesterol levels) or cyclosporine (a medicine used in transplantology to prevent rejection of the transplant or in other conditions, such as rheumatoid arthritis or atopic dermatitis). The use of any of these (or other muscle-acting) medicines during treatment with Daptomycin Reddy may increase the risk of muscle side effects. The doctor will decide whether to discontinue Daptomycin Reddy or temporarily stop the use of other medicines.
painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). They may affect the action of Daptomycin Reddy on the kidneys.
oral anticoagulants (e.g., warfarin), which prevent blood clotting. The doctor may need to monitor blood clotting time.

Pregnancy and breastfeeding

Daptomycin Reddy is not usually given to pregnant women. If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Daptomycin Reddy 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 Reddy affecting the ability to drive or operate machinery.

Daptomycin Reddy contains sodium

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

3. How to take Daptomycin Reddy

Daptomycin Reddy is usually administered by a doctor or nurse.
Adults (18 years and older)
The dose of the medicine 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 infections or blood infections related to skin or heart infections.

In adult patients, the medicine is administered directly into the bloodstream (intravenously) in the form of a 30-minute infusion or a 2-minute injection. The same dose is recommended for people over 65 years old, if they do not have kidney disease.
In patients with kidney function disorders, Daptomycin Reddy may be administered less frequently, e.g., every other day. In patients undergoing dialysis, if the next dose of Daptomycin Reddy falls on a dialysis day, Daptomycin Reddy 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 approximately 30-60 minutes.
Treatment for skin infections usually lasts from 1 to 2 weeks. For blood or heart infections, as well as skin infections, the duration of treatment will be decided by the doctor.
Detailed instructions for the use and preparation of the medicine are provided at the end of this leaflet.
If the patient has any further questions about the use of this medicine, they should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are described below:
Severe side effects with unknown frequency(frequency cannot be determined from available data)

• During treatment with daptomycin, several cases of hypersensitivity reactions (severe allergic reaction, including anaphylaxis and angioedema) have been reported. The occurrence of this severe allergic reaction requires immediate medical attention. The patient should immediately inform the doctor or nurse about the following symptoms: chest pain or tightness, rash or hives, throat swelling, rapid or weak pulse, wheezing, fever, chills or shivering, hot flashes, dizziness, fainting, metallic taste in the mouth.
• If unexplained muscle pain, sensitivity, or weakness occurs, the patient should immediately inform the doctor. Muscle symptoms can be serious. Muscle cell breakdown (rhabdomyolysis) may occur, which can lead to kidney damage. Other severe side effects reported during treatment with Daptomycin Reddy:
• Rare but potentially severe lung disorder called eosinophilic pneumonia has been reported, usually in patients treated for more than 2 weeks. Symptoms may include: difficulty breathing, onset or worsening of cough or onset or worsening of fever.
• Severe skin disorders. Symptoms may include: onset or worsening of fever, red, raised, or fluid-filled bumps on the skin, which may start under the arms or on the chest or in the groin and may spread to a large part of the body, blisters or ulcers in the mouth or on the genitals.
• Severe kidney problems. Symptoms may include: fever and rash. If these symptoms occur, the patient should immediately inform the doctor or nurse. The doctor will perform additional tests to make a diagnosis.

The most commonly reported side effects are described below:
Common side effects(may occur in less than 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,
• gas,
• abdominal bloating or swelling,
• skin rash or itching,
• pain, itching, or redness at the injection site,
• pain in the hands or feet,
• increased liver enzyme activity or creatine phosphokinase (CPK) in the blood.

Other side effects that may occur after taking Daptomycin Reddy are described below:
Uncommon side effects(may occur in less than 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,
• muscle pain, cramps, or weakness, muscle inflammation, joint pain,
• kidney problems,
• vaginal inflammation or irritation,
• general feeling of pain or weakness, fatigue (exhaustion),
• increased blood sugar levels, creatinine in serum, myoglobin, lactate dehydrogenase (LDH) activity, prolonged blood clotting time, or electrolyte imbalance,
• eye itching.

Rare side effects(may occur in less than 1 in 1,000 people)

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

Frequency not known(frequency cannot be determined from available data)
Pseudomembranous colitis associated with antibacterial use, including pseudomembranous colitis [severe or persistent diarrhea with blood and/or mucus, associated with abdominal pain or fever], easy bruising, bleeding from the gums or nose bleeding.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
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 Reddy

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 stated.
Store in a refrigerator (2°C-8°C).
After reconstitution: The chemical and physical stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C-8°C.
The chemical and physical stability of the diluted solution in infusion bags has been established for 12 hours at 25°C or 24 hours at 2°C-8°C.
In the case of a 30-minute intravenous infusion, the total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) at 25°C should not exceed 12 hours (or 24 hours at 2°C-8°C).
In the case of a 2-minute intravenous injection, the storage time of the reconstituted solution in the vial at 25°C should not exceed 12 hours (or 48 hours at 2°C-8°C).
However, from a microbiological point of view, the prepared product should be used immediately.
The product does not contain a preservative or bacteriostatic agent. If the product is not used immediately, the user is responsible for storage, and it is usually not recommended to store it for more than 24 hours at 2°C-8°C, unless reconstitution/dilution was performed under controlled and validated aseptic conditions.
Do not use this medicine if visible signs of spoilage are observed, i.e., the presence of solid particles.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Daptomycin Reddy contains

The active substance is daptomycin.
One vial of powder contains 350 mg of daptomycin.
One ml of solution after reconstitution of the powder in 7 ml of 9 mg/ml (0.9%) sodium chloride injection solution contains 50 mg of daptomycin.
One vial of powder contains 500 mg of daptomycin.
One ml of solution after reconstitution of the powder in 10 ml of 9 mg/ml (0.9%) sodium chloride injection solution contains 50 mg of daptomycin.
The other ingredient is sodium hydroxide to adjust the pH.

What Daptomycin Reddy looks like and contents of the pack

Daptomycin Reddy powder for solution for injection/infusion is a light yellow to light brown disc or powder in glass vials. Before administration, the powder should be mixed with the solvent to form a solution.
Daptomycin Reddy is available in packs containing 1 vial in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Importer/Manufacturer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
SC Rual Laboratories SRL
Splaiul Unirii nr 313, Building H, 1 floor, sector 3
030138 Bucharest
Romania

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

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Note: before prescribing the medicine, the patient should read the Summary of Product Characteristics.
Instructions for use and handling
350 mg powder for solution for injection/infusion
500 mg powder for solution for injection/infusion
Adult patients may be administered daptomycin intravenously in an infusion over 30 minutes or in an injection over 2 minutes. Unlike adults, children and adolescents should not be administered daptomycin in a 2-minute injection. Children and adolescents between 7 and 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 described below.

Daptomycin Reddy administered as an intravenous infusion over 30 or 60 minutes

The concentration of Daptomycin Reddy in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 7 ml (for Daptomycin Reddy 350 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution.
The concentration of Daptomycin Reddy in the infusion solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 10 ml (for Daptomycin Reddy 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution.
Dissolution of the lyophilized product usually 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 Reddy for intravenous infusion, the following instructions should be followed.
During reconstitution or dilution of the lyophilized product, aseptic technique should be maintained at all times.
Reconstitution:

• 1. The polypropylene cap of the vial should be removed to expose the central portion of the rubber stopper. The rubber stopper should be wiped with an alcohol swab or other antiseptic solution and allowed to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile needle (21 G or smaller), or a needleless device, draw up 7 ml (for Daptomycin Reddy 350 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution, then slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the stream of solution against the wall of the vial.
• 1. The polypropylene cap of the vial should be removed to expose the central portion of the rubber stopper. The rubber stopper should be wiped with an alcohol swab or other antiseptic solution and allowed to dry. After cleaning, do not touch the rubber stopper or allow it to come into contact with any other surface. Using a sterile needle (21 G or smaller), or a needleless device, draw up 10 ml (for Daptomycin Reddy 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution, then slowly insert the needle into the center of the rubber stopper and inject the contents of the syringe into the vial, directing the stream of solution against the wall of the vial.
• 2. Then gently rotate the vial to completely wet the lyophilized product and let it stand for 10 minutes.
• 3. Finally, the vial should be gently rotated or shaken in a rotary motion for a few minutes until a clear solution is obtained. Vigorous shaking should be avoided 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 solid particles. The solution of Daptomycin Reddy has a color from light yellow to light brown.

• 5. The reconstituted solution should be diluted with 0.9% sodium chloride injection solution (usually in 50 ml).

Dilution:

• 1. Slowly withdraw the required amount of reconstituted solution (50 mg daptomycin/ml) from the vial using a sterile needle (21 G or smaller) or a needleless device. Invert the vial and, using a new sterile syringe, insert the needle into the inverted vial. Hold the vial with the needle in the stopper, and withdraw the required amount of solution into the syringe. Before withdrawing the needle from the vial, pull the plunger all the way back to withdraw the entire contents of the vial.
• 2. Remove air, large bubbles, and excess solution from the syringe to obtain the desired dose.
• 3. Transfer the desired dose to 50 ml of 9 mg/ml (0.9%) sodium chloride injection solution.
• 4. The reconstituted and diluted solution can then be administered as an intravenous infusion over 30 or 60 minutes.

Daptomycin Reddy is physically and chemically incompatible with solutions containing glucose. The following medicines have been shown to be compatible with daptomycin solution: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.
The total storage time (reconstituted solution in the vial and diluted solution in the infusion bag) should not exceed 12 hours at 25°C or 24 hours at 2°C-8°C.
The stability of the diluted solution in infusion bags is 12 hours at 25°C or 24 hours at 2°C-8°C.

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

Water should not be used to reconstitute Daptomycin Reddy for intravenous injection. Daptomycin Reddy should only be reconstituted with 0.9% sodium chloride injection solution (9 mg/ml).
The concentration of Daptomycin Reddy in the injection solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 7 ml (for Daptomycin Reddy 350 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution.
The concentration of Daptomycin Reddy in the injection solution of 50 mg/ml is achieved by reconstituting the lyophilized product in 10 ml (for Daptomycin Reddy 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injection solution.
The lyophilized product dissolves in 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 Reddy for intravenous injection, the following instructions should be followed.
During reconstitution of the lyophilized product, aseptic technique should be maintained at all times.