Daptomycin Dr. Reddy's

Package leaflet: Information for the patient

Daptomycin Dr. Reddy’s 350 mg powder for solution for injection or infusion

Daptomycin Dr. Reddy’s 500 mg powder for solution for injection or infusion
Please read all of this leaflet carefully before you start using this medicine, as 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 nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:
1. What Daptomycin Dr. Reddy’s is and what it is used for
2. What you need to know before being given Daptomycin Dr. Reddy’s
3. How Daptomycin Dr. Reddy’s is given
4. Possible side effects
5. How to store Daptomycin Dr. Reddy’s
6. Contents of the pack and other information

1. What Daptomycin Dr. Reddy’s is and what it is used for
The active substance of Daptomycin Dr. Reddy’s powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial agent that can stop the growth of certain bacteria.
Daptomycin Dr. Reddy’s is used in adults and in children and adolescents (aged 1 to 17 years) to treat skin and soft tissue infections. It is also used in adults to treat infections of the inner lining of the heart (including heart valves), caused by a bacterium called Staphylococcus aureus, and for the treatment of bloodstream infections caused by the same bacterium when associated with skin and soft tissue infections.
Depending on the type of infection(s) you have, your doctor may also prescribe other antibacterial agents during treatment with Daptomycin Dr. Reddy’s.

2. What you should know before being given Daptomicina Dr. Reddy’s

Do not be given Daptomicina Dr. Reddy’s if:

• You are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor or nurse. If you think you may be allergic, consult your doctor or nurse.

Warnings and precautions
Talk to your doctor or nurse before you are given Daptomicina Dr. Reddy’s:

• If you have or have previously had kidney problems. Your doctor may need to adjust your dose of daptomycin (see section 3 of this leaflet).
• Patients treated with daptomycin have sometimes experienced muscle pain, weakness, or discomfort (see section 4 of this leaflet for more information). If this occurs, inform your doctor. Your doctor will arrange for a blood test and will advise whether you should continue or stop treatment with daptomycin. Symptoms usually resolve within a few days after stopping daptomycin.
• If you are overweight. Daptomycin blood levels may be higher than those observed in people of average weight, so you may need to be monitored more closely for side effects. If any of these apply to you, inform your doctor or nurse before being given Daptomicina Dr. Reddy’s.

Inform your doctor immediately if you develop any of the following symptoms:

• Severe acute allergic reactions have been observed in patients treated with nearly all antibacterial medicines, including daptomycin. Inform your doctor or nurse immediately if you experience symptoms suggesting an allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck, and throat, skin rash, hives, or fever (see section 4 of this leaflet for more information).
• Unusual tingling or numbness in the hands or feet, loss of sensation, or difficulty moving. If this occurs, inform your doctor, who will decide whether treatment should continue.
• Diarrhea, especially if you notice blood or mucus in the stool, or if diarrhea becomes severe or persistent.
• Onset or worsening of fever, cough, or difficulty breathing. These may be signs of a rare but serious lung disease called eosinophilic pneumonia. Your doctor will check your lung condition and decide whether you should continue or stop treatment with daptomycin.

Daptomycin may interfere with laboratory tests used to measure blood coagulation. Test results may suggest a blood clotting problem even when none exists. It is therefore important that your doctor knows you are receiving daptomycin. Inform your doctor that you are being treated with daptomycin.
Your doctor will perform blood tests to monitor your muscle condition both before starting treatment and regularly during treatment with daptomycin.

Children and adolescents
Daptomicina must not be given to children under one year of age, as animal studies have shown that serious adverse effects may occur in this age group.

Use in the elderly
People aged 65 years and older may receive the same dose as adults, provided they have normal kidney function.

Other medicines and Daptomicina Dr. Reddy’s
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines. It is particularly important to inform them if you are taking:

• Medicines called statins or fibrates (used to lower cholesterol) or cyclosporine (a medicine used in organ transplantation to prevent organ rejection or in other conditions such as rheumatoid arthritis or atopic dermatitis). If you take these medicines (and others that may affect muscles) during treatment with daptomycin, the risk of muscle-related side effects may be increased. Your doctor may decide not to prescribe daptomycin or may temporarily discontinue the other medicines.
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). These may interfere with the renal effects of daptomycin.
• Oral anticoagulants (e.g., warfarin), which are medicines that prevent blood from clotting. Your doctor may need to monitor your blood clotting time.

Pregnancy and breastfeeding
Daptomicina is generally not given to pregnant women. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered.
Do not breastfeed while taking daptomycin, as daptomycin passes into breast milk and may therefore affect the baby.

Driving and using machines
Daptomicina has no known effect on the ability to drive or operate machinery.

3. How Daptomycin Dr. Reddy’s is administered

Daptomycin is usually administered by a doctor or a nurse.
The dose given depends on your body weight and the type of infection being treated. In adults, the usual dose is 4 mg per kilogram (kg) of body weight, administered once daily for skin infections, or 6 mg per kg of body weight administered once daily for heart infection or bloodstream infection associated with skin or heart infection. In adult patients, this dose is injected directly into the bloodstream (into a vein), either as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for individuals aged 65 years and older, provided they have normal renal function.

Children and adolescents (from 1 to 17 years of age)
The dose for children and adolescents (from 1 to 17 years of age) used to treat skin infections depends on the patient's age. The recommended doses according to age are shown in the table below:

If you have impaired kidney function, you may receive daptomycin less frequently, e.g. on alternate days. If you are on dialysis and the next dose of daptomycin is to be administered on the same day, daptomycin will usually be given at the end of the dialysis session.
Usually, for skin infections, a course of treatment lasts from 1 to 2 weeks. For bloodstream or heart infections and skin infections, your doctor will decide how long your treatment should continue.
Detailed instructions for use and handling are provided at the end of this leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most serious side effects are described below:
Very rare serious side effects (may affect up to 1 in 10,000 patients)

• In some cases, hypersensitivity reactions have been reported during administration of daptomycin (severe allergic reactions including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)). This severe allergic reaction requires immediate medical intervention. Immediately inform your doctor or nurse if any of the following symptoms occur:
• Chest pain or tightness
• Skin rash with blistering, sometimes affecting the mouth and genitals
• Swelling around the throat
• Rapid or weak heartbeat
• Wheezing
• Fever
• Chills or shivering
• Hot flushes
• Dizziness
• Fainting
• Metallic taste in the mouth

If you notice unexplained muscle pain, tenderness or weakness, inform your doctor immediately. In very rare cases (reported in fewer than 1 in 10,000 patients), muscle problems may be serious, including muscle breakdown (rhabdomyolysis), which may lead to kidney damage.
Serious side effects with unknown frequency (frequency cannot be determined from available data)
A rare but potentially serious lung disease called eosinophilic pneumonia has been reported in patients receiving daptomycin, in most cases after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever. If you experience these symptoms, inform your doctor or nurse immediately.
If you develop raised or fluid-filled skin lesions over a large area of your body, inform your doctor or nurse immediately.
The more frequently reported side effects are described below:
Common side effects (may affect up to 1 in 10 people)

• Fungal infections such as candidiasis,
• Urinary tract infections,
• Decrease in the number of red blood cells in the blood (anaemia),
• Dizziness, anxiety, difficulty sleeping,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhoea, feeling unwell (nausea) or being unwell (vomiting),
• Flatulence,
• Abdominal swelling or tightness,
• Rash or itching,
• Pain, itching or redness at the infusion site,
• Pain in arms or legs,
• Increased levels of liver enzymes or creatine phosphokinase (CPK) shown in blood tests. Other side effects that may occur following treatment with daptomycin are described below:

Uncommon side effects (may affect up to 1 in 100 people)

• Blood abnormalities (e.g. increase in the number of small particles called platelets, which may increase the tendency for blood to clot, or increased levels of certain types of white blood cells),
• Decreased appetite,
• Tingling or numbness in hands and feet, altered taste,
• Tremor,
• Changes in heart rhythm, hot flushes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Rash associated with itching,
• Muscle pain, cramps or weakness, inflammation of muscles (myositis), joint pain,
• Kidney problems,
• Inflammation and irritation of the vagina,
• General pain or weakness, tiredness (fatigue),
• Blood tests showing increased levels of blood sugar, serum creatinine, myoglobin or lactate dehydrogenase (LDH), prolonged bleeding time or electrolyte imbalance,
• Itching of the eyes.

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

• Yellowing of the skin and eyes,
• Prolongation of prothrombin time. Frequency not known (frequency cannot be estimated from available data) Colitis associated with antibiotic use, including pseudomembranous colitis (severe and persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums or nosebleeds.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Daptomycin Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
After reconstitution: The chemical and physical stability in use 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 reconstituted solution in the infusion bag has been established for 12 hours at 25°C or
24 hours at 2°C–8°C.
For a 30-minute intravenous infusion, the total storage period (reconstituted solution in the vial and
diluted solution in the infusion bag; see section 6.6) must not exceed 12 hours at 25°C (24 hours at
2°C–8°C).
For a 2-minute intravenous injection, the storage period of the reconstituted solution in the vial (see
section 6.6) must not exceed 12 hours at 25°C (or 48 hours at 2°C–8°C).
However, from a microbiological standpoint, the medicine should be used immediately.
No preservative or bacteriostatic agent is present in this product. If not used immediately, the user is
responsible for the storage period during use, which should normally not exceed 24 hours at 2°C–8°C,
unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
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 that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daptomicina Dr. Reddy’s contains
The active substance is daptomycin.
One vial of powder contains 350 mg of daptomycin.
After reconstitution with 7 ml of sodium chloride solution 9 mg/ml (0.9%), one ml provides 50 mg of
daptomycin.
One vial of powder contains 500 mg of daptomycin.
After reconstitution with 10 ml of sodium chloride solution 9 mg/ml (0.9%), one ml provides 50 mg of
daptomycin.
The other component is sodium hydroxide.

Description of the appearance of Daptomicina Dr. Reddy’s and contents of the pack
Daptomicina Dr. Reddy’s powder for injectable solution or infusion is supplied as a lyophilized cake or
light yellow to light brown powder in a glass vial. Prior to administration, it is mixed with a solvent to form a liquid.
Daptomicina Dr. Reddy’s is available in packs of 1 vial.

Marketing Authorization Holder
DR. REDDY'S S.R.L.
PIAZZA SANTA MARIA BELTRADE 1, 20123 MILANO

Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd
6 Riverview Road, Beverley, HU17 0LD
United Kingdom
betapharm Arzneimittel GmbH
Kobelweg 95, Augsburg, 86156
Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Germany Daptomycin beta 350 mg, Pulver zur Herstellung einer Injektionslösung
oder einer Infusionslösung
Daptomycin beta 500 mg, Pulver zur Herstellung einer Injektionslösung
oder einer Infusionslösung
Spain Daptomicina Dr. Reddy 350 mg, polvo para solución para perfusión
Daptomicina Dr. Reddy 500 mg, polvo para solución para perfusión
United Kingdom Daptomycin Dr. Reddy's 350 mg Powder For Solution For Injection Or
Infusion
Daptomycin Dr. Reddy's 500 mg Powder For Solution For Injection Or
Infusion
Italy Daptomicina Dr. Reddy's 350 mg powder for injectable solution or for
infusion
Daptomicina Dr. Reddy's 500 mg powder for injectable solution or for
infusion

This patient information leaflet was last updated on

The following information is intended exclusively for healthcare professionals

Important:
Before prescribing, consult the Summary of Product Characteristics
Instructions for use and handling
Daptomycin may be administered intravenously as an infusion lasting 30 or 60 minutes or as an injection lasting 2 minutes. Preparation of the infusion solution requires further dilution, as described below.

Administration of Daptomycin Dr. Reddy’s as a 30- or 60-minute intravenous infusion
A concentration of 50 mg/ml of Daptomycin Dr. Reddy’s for infusion is obtained by reconstituting the lyophilized powder with 7 ml (for Daptomycin Dr. Reddy’s 350 mg powder) or 10 ml (for Daptomycin Dr. Reddy’s 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injectable solution. Approximately 15 minutes are required for complete dissolution of the lyophilized powder. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.

To prepare Daptomycin Dr. Reddy’s for intravenous infusion, follow the instructions below. An aseptic technique must be used throughout the entire reconstitution process of Daptomycin Dr. Reddy’s lyophilized powder.

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Wipe the top of 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 transfer needle of 21 gauge or smaller, or a needle-free device, draw into a syringe 7 ml (for Daptomycin Dr. Reddy’s 350 mg powder) or 10 ml (for Daptomycin Dr. Reddy’s 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injectable solution, and slowly inject it into the vial by inserting the needle into the center of the rubber stopper with the tip directed toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently rotate the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking or agitation to prevent foam formation.
4. Before use, carefully inspect the reconstituted solution to ensure complete dissolution of the product and visually check for absence of particulate matter. The color of the reconstituted Daptomycin Dr. Reddy’s solution may vary from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller and a new syringe, as described in step 6.
6. Invert the vial to allow the solution to flow toward the stopper. Using the new syringe, insert the needle into the inverted vial. While keeping the vial inverted, keep the needle tip at the bottom of the solution while aspirating the solution into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe barrel to aspirate all solution from the inverted vial.
7. The reconstituted solution should then be diluted with 9 mg/ml (0.9%) sodium chloride solution (typical volume 50 ml).
8. For intravenous infusion administered via syringe, replace the needle with a new one.
9. Expel air, large bubbles, and excess solution until the required dose is obtained.
10. The reconstituted and diluted solution should then be administered as an intravenous infusion over 30 or 60 minutes.

The total storage period (reconstituted solution in the vial and diluted solution in the infusion bag) must not exceed 12 hours at 25°C (24 hours if refrigerated).
The stability of the diluted solution in the infusion bag is 12 hours at 25°C or 24 hours if stored refrigerated at 2°C–8°C.

Administration of Daptomycin Dr. Reddy’s as a 2-minute intravenous injection (adults only)
Water must not be used for reconstitution of Daptomycin Dr. Reddy’s for intravenous injection. Daptomycin Dr. Reddy’s must only be reconstituted with 9 mg/ml (0.9%) sodium chloride solution.
A concentration of 50 mg/ml of Daptomycin Dr. Reddy’s for injection is obtained by reconstituting the lyophilized powder with 7 ml (for Daptomycin Dr. Reddy’s 350 mg powder) or 10 ml (for Daptomycin Dr. Reddy’s 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injectable solution. Approximately 15 minutes are required for complete dissolution of the lyophilized powder. The fully reconstituted medicinal product has a clear appearance, and there may be some bubbles or foam around the edges of the vial.

To prepare Daptomycin Dr. Reddy’s for intravenous injection, follow the instructions below. An aseptic technique must be used throughout the entire reconstitution process of Daptomycin Dr. Reddy’s lyophilized powder.

1. Remove the polypropylene flip-off cap to expose the central portion of the rubber stopper. Wipe the top of 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 transfer needle of 21 gauge or smaller, or a needle-free device, draw into a syringe 7 ml (for Daptomycin Dr. Reddy’s 350 mg powder) or 10 ml (for Daptomycin Dr. Reddy’s 500 mg powder) of 9 mg/ml (0.9%) sodium chloride injectable solution, and slowly inject it into the vial by inserting the needle into the center of the rubber stopper with the tip directed toward the vial wall.
2. Gently rotate the vial to ensure the product is completely wetted by the liquid, then allow it to stand for 10 minutes.
3. Finally, gently rotate the vial for a few minutes until a clear reconstituted solution is obtained. Avoid vigorous shaking or agitation to prevent foam formation.
4. Before use, carefully inspect the reconstituted solution to ensure complete dissolution of the product and visually check for absence of particulate matter. The color of the reconstituted Daptomycin Dr. Reddy’s solution may vary from pale yellow to light brown.
5. Slowly withdraw the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle of 21 gauge or smaller and a new syringe, as described in step 6.
6. Invert the vial to allow the solution to flow toward the stopper. Using a new syringe, insert the needle into the inverted vial. While keeping the vial inverted, position the needle tip at the bottom of the solution while aspirating the solution into the syringe. Before removing the needle from the vial, pull back the plunger to the end of the syringe barrel to aspirate all solution from the inverted vial.
7. Replace the needle with a new needle for intravenous injection.
8. Expel air, large bubbles, and excess solution until the required dose is obtained.
9. The reconstituted solution should then be slowly injected intravenously over 2 minutes.

Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if refrigerated (2°C–8°C).
However, from a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the in-use storage period, which under normal circumstances should not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin Dr. Reddy’s is for single use only. Any unused solution remaining in the vial must be discarded.