Daptomycin Dr. Reddy's 500 mg Powder for Solution for Injection/Infusion

• 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.

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

• 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.

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 (see section 4 of this leaflet for more information)
• 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.

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.

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

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.

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.

Daptomycin has no known effects on the ability to drive or use machines.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

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.

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.

• 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 test to make a diagnosis.

If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.

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.

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 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.

The active substance is daptomycin.

Daptomycin 350 mg: One vial of powder 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.

Daptomycin 500 mg: One vial of powder 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.

Daptomycin powder for solution for injection/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.