DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Patient leaflet - DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Daptomycin 350 mg

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

1. What Daptomycin is and what it is used for
2. What you need to know before you are given Daptomycin
3. How Daptomycin is given
4. Possible side effects
5. How to store Daptomycin
6. Contents of the pack and other information

1. what daptomycin is and what it is used for

The active substance in Daptomycin is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Daptomycin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used to treat infections in the blood when associated with skin infection.

Daptomycin is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus. It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.

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

2. what you need to know before you are given daptomycin

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Daptomycin 350 mg

Important: Please refer to the Summary of Product Characteristics before prescribing.

Instructions for use and handling

350 mg & 500 mg presentation:

In adults, daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes. Unlike in adults, daptomycin should not be administered by injection over a 2 minute period in paediatric patients.

Paediatric patients 7 to 17 years old should receive daptomycin infused over 30 minutes. In paediatric patients under 7 years old receiving a 9–12 mg/kg dose, daptomycin should be administered over 60 minutes. Preparation of the solution for infusion requires an additional dilution step as detailed below:

Daptomycin given as an intravenous infusion over 30 or 60 minutes

A 50 mg/ml concentration of Daptomycin for infusion can be achieved by reconstituting the lyophilised product with 7 ml for the 350 mg strength (or 10 ml for the 500 mg strength) of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Daptomycin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be used throughout to reconstitute or dilute lyophilised Daptomycin.

For Reconstitution:

1. The flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface. Draw 7 ml for the 350 mg strength (or 10 ml for the 500 mg strength) of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
2. The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
3. Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/ agitation should be avoided to prevent foaming of the product.
4. The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Daptomycin range in colour from pale yellow to light brown.
5. The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).

For Dilution:

1. Slowly remove the appropriate reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle that is 21 gauge or smaller in diameter by inverting the vial in order to allow the solution to drain towards the stopper. Using a syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to end of the syringe barrel in order to remove the required solution from the inverted vial.
2. Expel air, large bubbles, and any excess solution in order to obtain the required dose.
3. Transfer the required reconstituted dose into 50 ml sodium chloride 9 mg/ml (0.9%).
4. The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.

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

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

Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if

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:

Serious side effects with frequency not known (frequency cannot be estimated from the available data)

A hypersensitivity reaction (serious allergic reaction including anaphylaxis and angioedema) has been reported, in some cases during administration of Cubicin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:
Chest pain or tightness,
Rash or hives,
Swelling around throat,
Rapid or weak pulse,
Wheezing,
Fever,
Shivering or trembling,
Hot flushes,
Dizziness,
Fainting,
Metallic taste.
Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. Muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.

Other serious side effects that have been reported with the use of Daptomycin are:

A rare but potentially serious lung disorder called eosinophilic pneumonia, mostly after more than 2 weeks of treatment. The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Serious skin disorders. The symptoms can include:
a new or worsening fever,
red raised or fluid-filled skin spots which may start in your armpits or on your chest or groin areas and which can spread over a large area of your body,
blisters or sores in your mouth or on your genitals.
A serious kidney problem. The symptoms can include fever and rash.

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

The most frequently reported side effects are described below:

Common side effects (may affect up to 1 in 10 people)

Fungal infections such as thrush,
Urinary tract infection,
Decreased number of red blood cells (anaemia),
Dizziness, anxiety, difficulty in sleeping,
Headache,
Fever, weakness (asthenia),
High or low blood pressure,
Constipation, abdominal pain,
Diarrhoea, feeling sick (nausea) or being sick (vomiting),
Flatulence,
Abdominal swelling or bloating,
Skin rash or itching,
Pain, itchiness or redness at the site of infusion,
Pain in arms or legs,
Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Other side effects which may occur following Daptomycin treatment are described below:

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

Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells),
Decreased appetite,
Tingling or numbness of the hands or feet, taste disturbance,
Trembling,
Changes in heart rhythm, flushes
Indigestion (dyspepsia), inflammation of the tongue,
Itchy rash of skin,
Muscle pain, cramping or weakness, inflammation of the muscles (myositis), joint pain,
Kidney problems,
Inflammation and irritation of the vagina,
General pain or weakness, tiredness (fatigue),
Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts.
Itchy eyes.

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

Yellowing of the skin and eyes,
Prothrombin time prolonged.

Frequency not known (frequency cannot be estimated from the available data)

Antibacterial-associated colitis, including pseudomembranous colitis (severe or 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store daptomycin

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

After reconstitution: 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 at 2°C- 8°C. Chemical and physical stability of the diluted solution in infusion bags is established at 12 hours, 25°C or 24 hours at 2°C – 8°C.

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

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

However, from a microbiological point of view the product should be used immediately. No preservative or bacteriostatic agent is present in this product. If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2°C – 8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.

Do not use this medicine if you notice any change in the aspect of the product (signs of humidity or presence of particles with a different colour in the powder, or presence of particles, turbidity or precipitate when the solution is reconstituted).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other

INFORMATION

What Daptomycin contains

The active substance is daptomycin.

Each vial contains 350 mg daptomycin.

One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.

Each vial contains 500 mg daptomycin.

One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ ml (0.9%) solution.

The other ingredient is sodium hydroxide (for pH-adjustment) (see also section 2).

What Daptomycin looks like and contents of the pack

Daptomycin is supplied as a pale yellow to light brown powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Daptomycin is available in packs containing 1 vial.

Marketing Authorisation Holder Hikma Farmaceutica (Portugal), S.A.

Estrada do Rio da Mo n° 8, 8A e 8B,

Fervenga

2705–906 Terrugem SNT

Portugal

Manufacturer

Laboratori Fundacio Dau

C/ De la letra C, 12–14,

Poligono Industrial de la Zona Franca 08040 Barcelona

Spain

Distributed by:

Consilient Health (UK) Ltd.,

No.1 Church Road, Richmond upon Thames, Surrey, TW9 2QE, UK

This leaflet was last revised in September 2021.

P1279

stored under refrigeration at 2°C – 8°C.

Daptomycin given as 2-minute intravenous injection (adult patient only)

Water should not be used for reconstitution of Daptomycin for intravenous injection. Daptomycin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).

A 50 mg/ml concentration of Daptomycin for injection is obtained by reconstituting the lyophilised product with 7 ml for the 350 mg strength (or 10 ml for the 500 mg strength) of sodium chloride 9 mg/ ml (0.9%) solution for injection.