Patient Information Leaflet

Daptomycin Dr. Reddys 350 mg Powder for Injection and Infusion EFG

daptomycin

Read this leaflet carefully before you start 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 questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

The active ingredient ofDaptomicina Dr. Reddysis daptomycin. Daptomycin is an antibacterial capable of stopping the growth of certain bacteria.

Daptomicina Dr. Reddysis used in adults and in children and adolescents (ages 1 to 17 years) to treat skin and underlying tissue infections. It is also used to treat blood infections when associated with a skin infection. Daptomicina Dr. Reddys is also used in adults to treat tissue infections that cover the interior of the heart (including heart valves), caused by a type of bacteria calledStaphylococcus aureus.It is also usedto treat blood infections caused by the same type of bacteria when associated with heart infection.

Depending on the type of infection(s) you have, your doctor may also prescribe other antibacterials while receiving treatment with Daptomicina Dr. Reddys.

You should not receive Daptomicina Dr. Reddys

• if you are allergic to daptomycin or sodium hydroxide or any of the other components of this medication (listed in section 6).

Inform your doctor or nurse if this is the case. If you think you may be allergic, consult your doctor or nurse.

Warnings and precautions

Consult your doctor or nurse before receiving Daptomicina Dr. Reddys:

• If you have or have had kidney problems. Your doctor may need to change the dose of daptomycin (see section 3 of this leaflet).
• Occasionally, patients receiving daptomycin tend to develop muscle pain or weakness (see section 4 of this leaflet for more information). Inform your doctor if this happens. Your doctor will ensure that you have a blood test and advise whether it is recommended to continue using daptomycin. Symptoms usually disappear within a few days after stopping treatment with daptomycin.
• If you have ever developed severe skin rash or skin peeling, blisters, and/or mouth sores or severe kidney problems after taking daptomycin.
• If you have significant overweight, there is a possibility that your blood levels of daptomycin may be higher than those found in people of average weight, and that you may therefore need closer monitoring in cases of adverse effects.

If any of the above cases apply to you, inform your doctor or nurse before receiving Daptomicina.

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

• Severe allergic reactions have been observed in patients treated with almost all antibacterial agents, including daptomycin. Symptoms may include shortness of breath, difficulty breathing, facial, neck, and throat swelling, skin rash, and urticaria, fever.
• Severe skin disorders have been reported with the use of daptomycin. Symptoms that occur with these skin disorders may include:
• new or worsening fever,
• red skin patches raised or filled with fluid that may start in the armpits or chest or groin and may spread to a large part of your body,
• mouth sores or genital sores.
• Severe kidney problems have been reported with the use of daptomycin. Symptoms may include fever and rash.
• Any unusual tingling or numbness in your hands or feet, loss of sensation, or difficulty moving. If this happens, inform your doctor, who will decide whether you should continue treatment.
• Diarrhea, especially if you notice blood or mucus in your stool or if diarrhea becomes severe or persistent.
• Appearance of fever or worsening of the same, cough, or difficulty breathing. These may be signs of a rare but serious lung function deterioration called eosinophilic pneumonia. Your doctor will check your lung function and decide whether you should continue treatment with daptomycin.

Daptomycin may interfere with laboratory tests that measure your blood's clotting ability. Results may appear to suggest poor clotting, despite no actual problem. Therefore, it is essential that your doctor is aware that you are receiving daptomycin. Inform your doctor that you are on daptomycin treatment.

Your doctor will perform blood tests to monitor your muscle health before starting treatment and frequently during treatment with daptomycin.

Children and adolescents

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

Use in elderly patients

Elderly patients over 65 years of age may receive the same dose as other adults, provided their kidneys function correctly.

Use of Daptomicina Dr. Reddys with other medications

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

It is particularly important to mention the following:

• Medications called statins or fibrates (to lower cholesterol) or cyclosporine (a medication used in transplants to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis). It may increase the risk of muscle adverse effects if you take any of these medications (and other that may affect muscles) during treatment with daptomycin. Your doctor may decide not to administer daptomycin or temporarily interrupt treatment with the other medication.
• Pain-relieving medications called nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g., celecoxib). These may interfere with the elimination of daptomycin by the kidney.
• Oral anticoagulants (e.g., warfarin), which are medications that prevent blood clotting. Your doctor may need to monitor your blood clotting times.

Pregnancy and breastfeeding

Daptomycin is usually not administered to pregnant women. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before receiving this medication.

Do not breastfeed while receiving daptomycin, as it may pass into breast milk and affect the baby.

Driving and operating machinery

Daptomycin has no known effects on the ability to drive or operate machinery.

Daptomycin Dr. Reddys contains sodium hydroxide as an excipient

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially "sodium-free".

Daptomicina Dr. Reddys will be administered by your doctor or nurse.

Adults (18 years of age and older)

The dose will depend on your weight and the type of infection being treated. The usual dose for adults is 4 mg per kilogram 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 associated with skin or heart infections. In adult patients, this dose is administered directly into your bloodstream (in a vein), either as an infusion lasting approximately 30 minutes or as an injection lasting approximately 2 minutes. The same dose is recommended for people over 65 years old, provided their kidneys function properly.

If your kidneys do not function well, you may receive daptomicina less frequently, for example, once every other day. If you are undergoing dialysis and your next dose of daptomicina is due on a day of dialysis, you will usually receive daptomicina after the dialysis session.

Children and adolescents (1 to 17 years of age)

The recommended doses in children and adolescents (1 to 17 years) being treated for skin infections will depend on the patient's age and the type of infection being treated. This dose is administered directly into the bloodstream (in a vein), as an infusion lasting approximately 30-60 minutes.

A complete treatment for skin infections usually lasts between 1 and 2 weeks. Your doctor will decide the duration of your treatment for blood or heart infections and for skin infections.

Instructions for use and handling are provided in detail at the end of the prospectus.

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

The following are the most serious side effects:

Severe side effects with unknown frequency (frequency cannot be estimated from available data)

During daptomycin administration, some cases of hypersensitivity reactions (severe allergic reactions including anaphylaxis, angioedema, drug-induced skin eruption with eosinophilia, and systemic symptoms (DRESS)) have been reported. These severe allergic reactions require immediate medical attention. Inform your doctor or nurse immediately if you experience any of the following symptoms:

• Chest pain or pressure,
• Rash or urticaria,
• Swelling around the throat,
• Fast or weak pulse,
• Labored breathing,
• Fever,
• Chills or tremors,
• Headache,
• Dizziness,
• Fainting,
• Metals taste.

Inform your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. Muscle problems can be severe, including muscle breakdown (rhabdomyolysis), which can cause kidney damage.

Other severe side effects reported with the use of daptomycin are:

•A rare but potentially life-threatening lung disorder called eosinophilic pneumonia, mainly after more than 2 weeks of treatment. Symptoms may include difficulty breathing, new or worsening cough, or new or worsening fever.

•Severe skin disorders. Symptoms may include:

-New or worsening fever,

-Red skin patches that are raised or filled with fluid, which may start in the armpits, chest, or groin and spread to a large part of the body,

-Blisters or sores in the mouth or genitals.

•A severe kidney problem. Symptoms may include fever and rash.

If you experience these symptoms, inform your doctor or nurse immediately. Your doctor will perform additional tests to make a diagnosis.

The following are the side effects reported most frequently:

Frequent side effects(may affect up to 1 in 10 patients)

• Infections such as mouth ulcers (aphthous ulcers),
• Urinary tract infection,
• Anemia (decreased red blood cell count),
• Dizziness, anxiety, difficulty falling asleep,
• Headache,
• Fever, weakness (asthenia),
• High or low blood pressure,
• Constipation, abdominal pain,
• Diarrhea, nausea or vomiting,
• Flatulence,
• Abdominal swelling or distension,
• Rash or itching,
• Pain, itching, or redness at the infusion site,
• Pain in arms or legs,
• Elevated liver enzymes or creatine phosphokinase (CPK) levels in blood tests.

The following are other side effects that may occur after treatment with daptomycin:

Rare side effects(may affect up to 1 in 100 patients)

• Alterations in blood counts (e.g., increased platelet count, which may increase the risk of developing blood clots, or increased counts of certain types of white blood cells),

• Loss of appetite,
• Tickling or numbness in the hands or feet, changes in taste,
• Tremors,
• Changes in heart rhythm, hot flashes,
• Indigestion (dyspepsia), inflammation of the tongue,
• Rash with itching,
• Muscle pain, cramps, or weakness, muscle inflammation (myositis), joint pain,
• Kidney problems,
• Vaginal inflammation and irritation,
• Generalized pain or weakness, fatigue,
• Elevated blood sugar, creatinine, myoglobin, or lactate dehydrogenase (LDH) levels, prolonged blood clotting time, or electrolyte imbalance in blood tests,
• Eye itching.

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

-Yellowing of the skin and eyes (jaundice),

• Prolonged prothrombin time.

Unknown frequency(cannot be estimated from available data)

Antibiotic-associated colitis, including pseudomembranous colitis (severe or persistent diarrhea with blood and/or mucus, associated with abdominal pain or fever),easy bruising, bleeding gums, or nosebleeds.

Reporting of side effects

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

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

Store in refrigerator (between 2°C and 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 is 12 hours at 25°C or 24 hours between 2°C - 8°C.

For 30-minute intravenous infusion, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C should not exceed 12 hours (or 24 hours between 2°C - 8°C).

For 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C should not exceed 12 hours (or 48 hours between 2°C - 8°C).

However, from a microbiological point of view, the product should be used immediately. The product does not contain preservatives or bacteriostatic agents. If not used immediately, the storage time is the responsibility of the user and is normally not more than 24 hours at 2°C - 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

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

Do not use this medication if you notice visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of medications that are no longer needed. These measures will help protect the environment.

Composition of Daptomycin Dr. Reddys

The active ingredient is daptomycin

The active ingredient is daptomycin. A vial of powder contains 350 mg of daptomycin.

One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride solution (0.9%).

The other component is sodium hydroxide.

Appearance of the product and contents of the package

Daptomycin Dr. Reddys 350 mg powder for injectable solution for infusion EFG is presented in a glass vial as a powder or cake of pale yellow to light brown color. It is mixed with a solvent to form a solution before administration.

Daptomycin Dr. Reddys is presented in packages containing 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reddy Pharma Iberia, S.A.

Avenida Josep Tarradellas, nº 38

08029 Barcelona-Spain

Tel.: +34 93 355 49 16

Fax: +34 93 355 49 61

Responsible for manufacturing

Dr. Reddy's Laboratories (UK) Ltd.

6, Riverview Road, Beverley,

East Yorkshire,HU17 0LD

United Kingdom

Fax: +44 1482872042

Phone: +44 1482860228

or

Betapharm Arzneimittel GmbH

Kobelweg 95,

86156 Augsburg, Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Denmark:Daptomycin beta 350 mg Powder for the preparation of an injection/infusion solution

Spain:Daptomicina Dr. Reddys 350 mg, powder for injectable solution and for infusion EFG

United Kingdom:Daptomycin Dr. Reddy's 350 mg Powder For Solution For Injection/Infusion

Italy:Daptomicina Dr. Reddy's 350 mg, Powder for injectable solution or for infusion

France:Daptomycine Dr. Reddy's 350 mg, powder for injectable solution or for perfusion

Last review date of this leaflet: December 2021

This information is intended solely for healthcare professionals:

Important: Please refer to the Technical Data Sheet or Summary of Product Characteristics before prescribing.

Instructions for use and handling

350 mg presentation:

In adults, daptomycin can be administered intravenously as a 30-minute infusion or as a 2-minute injection. Unlike adults, daptomycin should not be administered to pediatric patients as a 2-minute injection. Pediatric patients aged 7 to 17 years should receive daptomycin as a 30-minute infusion. Pediatric patients under 7 years old who receive doses of 9-12 mg/kg should be administered daptomycin as a 60-minute infusion. The preparation of the infusion solution requires an additional dilution phase, as described below.

Daptomycin Dr. Reddys administered as intravenous infusion for 30 or 60 minutes

Reconstituting the lyophilized product with 7 ml of a 9 mg/ml sodium chloride solution (0.9%) can obtain a concentration of 50 mg/ml of Daptomycin Dr. Reddys for infusion.

The lyophilized product takes approximately 15 minutes to dissolve. The completely reconstituted product has a transparent appearance and may present small bubbles or foam around the edge of the vial.

To prepare Daptomycin Dr. Reddys for intravenous infusion, follow the instructions below:

To reconstitute or dilute Daptomycin Dr. Reddys lyophilized, a sterile technique must be used throughout the process.

For reconstitution:

1. . The polypropylene flip-off cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper, nor allow it to touch any other surface. Remove 7 ml of a 9 mg/ml sodium chloride solution (0.9%) for Daptomycin Dr. Reddys 350 mg powder for injectable solution for infusion EFG using a sterile transfer needle of caliber 21 or less, or a device without a needle, and inject slowly through the center of the rubber stopper into the vial, pointing the needle towards the vial wall.
2. The vial must be gently rotated to ensure that the product is completely moistened, and then left to stand for 10 minutes.
3. Finally, the vial must be gently shaken for a few minutes to obtain a transparent reconstituted solution. Vigorous shaking should be avoided to prevent foam formation.
4. The reconstituted solution must be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomycin Dr. Reddys may vary from pale yellow to light brown.
5. The reconstituted solution must be diluted with 9 mg/ml sodium chloride solution (0.9%) (typical volume of 50 ml).

For Dilution:

1.Remove the reconstituted solution (50 mg daptomycin/ml) from the vial using a new sterile needle of caliber 21 or less, while inverting the vial to allow the solution to flow towards the rubber stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle in the lowest part of the solution in the vial while it is being drawn into the syringe. Before removing the needle from the vial, push the plunger back to the end of the syringe barrel to remove all the required solution from the inverted vial.

2.Expel the air, large bubbles, and any excess solution to obtain the required dose.

3.Transfer the reconstituted dose required to 50 ml of 9 mg/ml sodium chloride solution (0.9%).

4.The reconstituted and diluted solution must be infused intravenously for 30 or 60 minutes.

Daptomycin Dr. Reddys is not physically or chemically compatible with solutions containing glucose. The following drugs have been shown to be compatible when added to infusion solutions containing daptomycin: aztreonam, ceftazidima, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.

The combined storage time (reconstituted solution in the vial and diluted solution in infusion bags) at 25°C should not exceed 12 hours (24 hours if refrigerated).

The stability of the diluted solution in infusion bags has been established for 12 hours at 25°C or 24 hours if refrigerated at 2°C - 8°C.

Daptomycin Dr. Reddys administered as intravenous injection for 2 minutes (only for adult patients)

Water should not be used for reconstituting Daptomycin Dr. Reddys for intravenous injection. Daptomycin Dr. Reddys must be reconstituted only with 9 mg/ml sodium chloride solution (0.9%).

Reconstituting the lyophilized product with 7 ml of a 9 mg/ml sodium chloride solution (0.9%) for intravenous injection can obtain a concentration of 50 mg/ml of Daptomycin Dr. Reddys for injectable solution.

The lyophilized product takes approximately 15 minutes to dissolve. The completely reconstituted product has a transparent appearance and may present small bubbles or foam around the edge of the vial.

To prepare Daptomycin Dr. Reddys for intravenous injection, follow the instructions below:

To reconstitute Daptomycin Dr. Reddys lyophilized, a sterile technique must be used throughout the process.

1. The polypropylene flip-off cap must be removed to expose the central part of the rubber stopper. Clean the top of the rubber stopper with an alcohol swab or other antiseptic solution and let it dry. After cleaning, do not touch the rubber stopper, nor allow it to touch any other surface. Remove 7 ml of a 9 mg/ml sodium chloride solution (0.9%) using a sterile transfer needle of caliber 21 or less, or a device without a needle, and inject slowly through the center of the rubber stopper into the vial, pointing the needle towards the vial wall.
2. The vial must be gently rotated to ensure that the product is completely moistened, and then left to stand for 10 minutes.
3. Finally, the vial must be gently shaken for a few minutes to obtain a transparent reconstituted solution. Vigorous shaking should be avoided to prevent foam formation.
4. The reconstituted solution must be carefully inspected before use to ensure that the substance is dissolved and to verify the absence of particles in suspension. The color of the reconstituted solution of Daptomycin Dr. Reddys may vary from pale yellow to light brown.
5. Remove the reconstituted solution (50 mg daptomycin/ml) from the vial using a sterile needle of caliber 21 or less.
6. Invert the vial to allow the solution to flow towards the rubber stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, place the tip of the needle in the lowest part of the solution in the vial while it is being drawn into the syringe. Before removing the needle from the vial, push the plunger back to the end of the syringe barrel to remove all the solution from the inverted vial.
7. Replace the needle with a new one for intravenous injection.
8. Expel the air, large bubbles, and any excess solution to obtain the required dose.
9. The reconstituted solution must be injected slowly intravenously for 2 minutes.

The physical and chemical stability during the use of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to a maximum of 48 hours if refrigerated (2°C - 8°C).

However, from a microbiological point of view, the product should be used immediately. If not used immediately, the storage time during use is the responsibility of the user and, normally, should not exceed 24 hours at 2°C - 8°C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

This medicine should not be mixed with other medications that are not mentioned above.

The vials of Daptomycin Dr. Reddys are exclusively for single use. Any remaining vial that has not been used must be discarded.