Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The active substance in daptomycin powder for solution for injection or infusion 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.
You should not be given Daptomycin 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, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.
Warnings and precautions Talk to your doctor or nurse before you are given daptomycin.
• If you have or have previously had kidney problems. Your doctor may need to change the dose of daptomycin (see section 3 of this leaflet).
• Occasionally, patients receiving daptomycin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with daptomycin. The symptoms generally go away within a few days of stopping daptomycin.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores, or serious kidney problems after taking daptomycin.
• If you are very overweight. There is a possibility that your blood levels of daptomycin could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
If any of these applies to you, tell your doctor or nurse before you are given daptomycin.
Tell your doctor or nurse straight away if you develop any of the following symptoms:
• Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including daptomycin. The symptoms can include wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, or fever.
• Serious skin disorders have been reported with the use of daptomycin. The symptoms that occur with these skin disorders 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 has been reported with the use of daptomycin. The symptoms can include fever and rash.
• Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.
• Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.
• New or worsening fever, cough or difficulty breathing. These may be signs of a rare but serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not you should continue daptomycin treatment.
Daptomycin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore it is important that your doctor takes into account that you are receiving daptomycin. Please inform your doctor that you are on treatment with daptomycin.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with daptomycin.
Children and adolescents Daptomycin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Use in elderly People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Other medicines and Daptomycin Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention the following:
• Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with daptomycin. Your doctor may decide not to give you daptomycin or to stop the other medicine for a while.
• Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of daptomycin in the kidney.
• Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It may be necessary for your doctor to monitor your blood clotting times.
Pregnancy and breast-feeding Daptomycin is not usually given to pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Do not breast-feed if you are receiving daptomycin, because it may pass into your breast milk and could affect the baby.
Driving and using machines Daptomycin has no known effects on the ability to drive or use machines.
Daptomycin contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Daptomycin will usually be given to you by a doctor or a nurse.
Adults (18 years of age and above) The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.
If your kidneys do not work well, you may receive daptomycin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of daptomycin is due on a dialysis day, you will be usually given daptomycin after the dialysis session.
Children and adolescents (1 to 17 years of age) The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated. This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Detailed instructions for use and handling are given at the end of the leaflet.
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 daptomycin. 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 at www.mhra.gov.uk/yellowcard 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.
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 the month.
Store in a refrigerator (2°C – 8°C).
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.
What Daptomycin contains The active substance is daptomycin. One vial of powder contains 500 mg daptomycin.
The other ingredient is sodium hydroxide.
What Daptomycin looks like and contents of the pack Daptomycin powder for solution for injection or infusion is supplied as a pale yellow to light brown cake or 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 Istituto Biochimico Italiano Giovanni Lorenzini S.p.A.
Via Fossignano 2
04011 Aprilia (LT)
Italy
Manufacturer Laboratorios Normon S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos (Madrid)
Spain
This leaflet was last revised in 01/2024
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Daptomycin 500mg Powder for solution for injection/infusion vials comes as powder containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Daptomycin 500mg Powder for solution for injection/infusion vials is daptomycin.
Medicines with the same active substance include: Cubicin 350 mg powder for solution for injection or infusion, Cubicin 500 mg powder for solution for injection or infusion, Daptomycin 350 mg Powder for Solution for Injection or Infusion, Daptomycin 350 mg Powder for solution for infusion vial, Daptomycin 350 mg powder for solution for injection or infusion, Daptomycin 350 mg powder for solution for injection/infusion. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Daptomycin 500mg Powder for solution for injection/infusion vials, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
• Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
• Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. See sections 4.4 and 5.1.
• Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Daptomycin is active against Gram positive bacteria only (see section 5.1). In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co- administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Clinical studies in patients employed infusion of daptomycin over at least 30 minutes. There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes. This mode of administration was only studied in healthy subjects. However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see sections 4.8 and 5.2).
Posology
Adults
• cSSTI without concurrent SAB: Daptomycin 4 mg/kg is administered once every 24 hours for 7-14 days or until the infection is resolved (see section 5.1).
• cSSTI with concurrent SAB: Daptomycin 6 mg/kg is administered once every 24 hours. See below for dose adjustments in patients with renal impairment. The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
• Known or suspected RIE due to Staphylococcus aureus: Daptomycin 6 mg/kg is administered once every 24 hours. See below for dose adjustments in patients with renal impairment. The duration of therapy should be in accordance with available official recommendations.
Daptomycin is administered intravenously in 0.9% sodium chloride (see section 6.6). Daptomycin should not be used more frequently than once a day.
Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Renal impairment
Daptomycin is eliminated primarily by the kidney.
Due to limited clinical experience (see table and footnotes below) daptomycin should only be used in adult patients with any degree of renal impairment (CrCl < 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment, renal function and creatine phosphokinase (CPK) levels should be closely monitored in all patients with any degree of renal impairment (see sections 4.4 and 5.2). The dosage regimen for daptomycin in paediatric patients with renal impairment has not been established.
Dose adjustments in adult patients with renal impairment by indication and creatinine clearance:
| Indication for use | Creatinine clearance | Dose recommendation | Comments |
| cSSTI without SAB | ≥ 30 ml/min | 4 mg/kg once daily | See section 5.1 |
| < 30 ml/min | 4 mg/kg every 48 hours | (1, 2) | |
| RIE or cSSTI associated with SAB | ≥ 30 ml/min | 6 mg/kg once daily | See section 5.1 |
| < 30 ml/min | 6 mg/kg every 48 hours | (1, 2) | |
| cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia. (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic studies and modelling results (see sections 4.4 and 5.2). (2) The same dose adjustments, which are based on pharmacokinetic data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD). Whenever possible, daptomycin should be administered following the completion of dialysis on dialysis days (see section 5.2). | |||
Hepatic impairment
No dose adjustment is necessary when administering daptomycin to patients with mild or moderate hepatic impairment (Child-Pugh Class B) (see section 5.2). No data are available in patients with severe hepatic impairment (Child-Pugh Class C). Therefore caution should be exercised if daptomycin is given to such patients.
Elderly patients
The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4).
Paediatric population (1 to 17 years of age)
The recommended dosage regimens for paediatric patients based on age and indication are shown below.
| Age Group | Indication | |||
| cSSTI without SAB | cSSTI associated with SAB | |||
| Dosage Regimen | Duration of Therapy | Dosage Regimen | Duration of Therapy | |
| 12 to 17 years | 5 mg/kg once every 24 hours infused over 30 minutes | Up to 14 days | 7 mg/kg once every 24 hours infused over 30 minutes | (1) |
| 7 to 11 years | 7 mg/kg once every 24 hours infused over 30 minutes | 9 mg/kg once every 24 hours infused over 30 minutes | ||
| 2 to 6 years | 9 mg/kg once every 24 hours infused over 60 minutes | 12 mg/kg once every 24 hours infused over 60 minutes | ||
| 1 to < 2 years | 10 mg/kg once every 24 hours infused over 60 minutes | 12 mg/kg once every 24 hours infused over 60 minutes | ||
| cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Daptomycin for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient. The duration of daptomycin may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient. In the paediatric SAB study, the mean duration of IV Daptomycin was 12 days, with a range of 1 to 44 days. The duration of therapy should be in accordance with available official recommendations. | ||||
Daptomycin is administered intravenously in 0.9 % sodium chloride (see section 6.6). Daptomycin should not be used more frequently than once a day.
Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Paediatric patients below the age of one year should not be given daptomycin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Method of administration
In adults, daptomycin is given by intravenous infusion (see section 6.6) and administered over a 30- minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
In paediatric patients aged 7 to 17 years, daptomycin is given by intravenous infusion over a 30-minute period (see section 6.6). In paediatric patients aged 1 to 6 years, daptomycin is given by intravenous infusion over a 60-minute period (see section 6.6).
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Daptomycin undergoes little to no cytochrome P450 (CYP450)-mediated metabolism. It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Interaction studies for daptomycin were performed with aztreonam, tobramycin, warfarin and probenecid. Daptomycin had no effect on the pharmacokinetics of warfarin or probenecid, nor did these medicinal products alter the pharmacokinetics of daptomycin. The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Although small changes in the pharmacokinetics of daptomycin and tobramycin were observed during coadministration by intravenous infusion over a 30-minute period using a daptomycin dose of 2 mg/kg, the changes were not statistically significant. The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown. Caution is warranted when daptomycin is co-administered with tobramycin.
Experience with the concomitant administration of daptomycin and warfarin is limited. Studies of daptomycin with anticoagulants other than warfarin have not been conducted. Anticoagulant activity in patients receiving daptomycin and warfarin should be monitored for the first several days after therapy with daptomycin is initiated.
There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors). However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in adult patients taking one of these medicinal products at the same time as daptomycin. It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with daptomycin unless the benefits of concomitant administration outweigh the risk. If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy. See sections 4.4, 4.8 and 5.3.
Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co- administration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors). In addition, there is a potential for a pharmacodynamic interaction to occur during co- administration due to additive renal effects. Therefore, caution is advised when daptomycin is co- administered with any other medicinal product known to reduce renal filtration.
During post–marketing surveillance, cases of interference between daptomycin and particular reagents used in some assays of prothrombin time/international normalised ratio (PT/INR) have been reported. This interference led to a false prolongation of PT and elevation of INR. If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test. The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section 4.4).
Pregnancy
No clinical data on pregnancies are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Daptomycin should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Breast-feeding
In a single human case study, daptomycin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24- hour period on day 27. The highest measured concentration of daptomycin in the breast milk was 0.045 µg/ml, which is a low concentration. Therefore, until more experience is gained, breast-feeding should be discontinued when daptomycin is administered to nursing women.
Fertility
No clinical data on fertility are available for daptomycin. Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
No studies on the effects on the ability to drive and use machines have been performed.
On the basis of reported adverse drug reactions, daptomycin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
In the event of overdose, supportive care is advised. Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
Ask anything about Daptomycin 500mg Powder for solution for injection/infusion vials. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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