Powder for solution for injection
daptomycin (pronounced DAP-toe-MY-sin)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Cubicin. It does not contain all
the available information. It does not take the place of talking to your doctor or
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine.
Those updates may contain important information about the medicine and its use of
which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
this medicine against the benefits they expect it will provide.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Cubicin is used for
What it is used for
Cubicin is used in adults and children (1 to 17 years of age) to treat complicated
infections of the skin and the tissues under the skin.
It is also used in adults to treat blood infections or infections of the tissues that
line the inside of the heart (including heart valves) - that are caused by Staphylococcus
Cubicin will not work against infections that cause pneumonia (a serious infection
or inflammation in the lung tissue).
How Cubicin works
Cubicin is an antibiotic that belongs to a group of medicines called cyclic lipopeptides.
These antibiotics work by killing the Gram-positive bacteria that are causing your
Ask your doctor if you have any questions about why Cubicin has been prescribed for
Your doctor may have prescribed it for another purpose.
This medicine is available only with a doctor's prescription.
Cubicin is not addictive.
Before you have Cubicin
When you must not have it
You must not have Cubicin if you are allergic (hypersensitive) to daptomycin, the
active ingredient, or to any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.
You must not have this medicine after the expiry date printed on the pack or if the
packaging is torn or shows signs of tampering.
In that case, it should be returned to your pharmacist.
Before you are given it
Cubicin should not be administered to children below the age of 1 year due to possible
side effects on muscles and nerves that were observed in animal studies.
Tell your doctor if you:
are allergic to any other medicines, foods, dyes or preservatives
have or have had any kidney problems. Your doctor may need to change the dose of Cubicin
are suffering from diarrhoea
are pregnant, or intend to become pregnant
Like most medicines, Cubicin is not recommended in pregnancy. Your doctor will discuss
with you the risks and benefits of having Cubicin during pregnancy.
are breastfeeding or plan to breastfeed.
You should not breast-feed your child during your treatment with Cubicin.
Taking other medicines
Tell your doctor if you are taking, or have recently taken, any other medicines, including
medicines that you buy without a prescription from a pharmacy, supermarket or health
Some medicines and Cubicin may interfere with each other.
Tell your doctor if you are taking:
Warfarin (a medicine used to prevent blood clots).
Statins or fibrates (medicines used to lower cholesterol)
Cyclosporin (a medicine used to help prevent organ transplant rejection or to treat
certain problems with the immune system)
Non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors, e.g. celecoxib
(medicines used to relieve pain, swelling or other symptoms of inflammation)
Tobramycin, another antibiotic used to treat various types of bacterial infections.
These medicines may be affected by Cubicin, or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/her before you
are given this medicine.
How Cubicin is given
Your medicine will be given to you by a doctor or a nurse as it needs to be given
as an injection or infusion into a vein.
How much is given
Your doctor will decide what dose and how long you will receive Cubicin. The dose
will depend on how much you weigh and the type of infection being treated.
The usual adult dose is 4 mg/kg daily for skin infections and 6mg/kg daily for blood
or heart infections.
If you are over 65 years of age, you will be given the same dose as other adults,
provided your kidneys are working well.
Children and adolescents (1-17 of age)
The dose for children and adolescent patients (1 to 17 years of age) being treated
for skin infection will depend on the age of patient. The usual dose given to children
1-6 years of age is 9-10 mg/kg daily. The usual dose given to children aged 7 to 11
years is 7 mg/kg daily. The recommended dose given to adolescents 12 to 17 years of
age is 5 mg/kg daily.
How it is given
In adult patients Cubicin is given directly into your blood stream by intravenous
injection over about 2 minutes or by infusion (drip) over about 30 minutes.
In patients 7-12 years of age Cubicin is given directly into the blood stream by infusion
(drip) over 30 minutes.
In children aged 1-6 years Cubicin is given directly into your blood stream by infusion
(drip) over 60 minutes.
When it is given
Your doctor will determine when you are given Cubicin.
How long it is given for
A course of treatment usually lasts for 7 to 14 days for skin infections and 2 to
6 weeks for blood or heart infections. Your doctor will decide how long you should
If you have kidney problems, you may receive Cubicin less often, e.g. every other
day. If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis
day, you will usually be given Cubicin after the dialysis session.
If you miss a dose
If you think that you have missed a dose of treatment, tell a doctor or nurse or pharmacist
Since Cubicin is given by a doctor or nurse, once a day, it is very unlikely that
you will miss a dose.
If you are given too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13
11 26) or go to Accident and Emergency at your nearest hospital, if you think that
you may have been given too much Cubicin. Do this even if there are no signs of discomfort
Since Cubicin is given by a doctor or nurse, once a day, it is very unlikely that
you will be given too much of the medicine. Your doctor, nurse or pharmacist will
be monitoring your progress and checking the medicine that you are given.
While you are being given Cubicin
Things you must do
If the symptoms of your infection do not improve, or if they become worse, tell your
If you develop itching with swelling or skin rash or difficulty breathing while you
are being given Cubicin contact your doctor immediately.
Tell your doctor immediately if you develop any of the following symptoms:
Tender or aching muscles or muscle weakness.
Your doctor will make sure that you have a blood test and will decide whether or not
you should continue Cubicin treatment. The symptoms generally go away within a few
days of stopping Cubicin.
Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties
Your doctor will decide whether or not you should continue treatment.
Diarrhoea, especially if you notice blood.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care. Do not take any diarrhoea medicine without first checking
with your doctor.
New or worsening fever, cough or difficulty breathing.
These may be the signs of a rare, but serious lung disorder called eosinophilic pneumonia.
If you experience these symptoms, tell your doctor. Your doctor will check the condition
of your lungs and will decide whether or not you should continue Cubicin treatment.
Your doctor will perform blood tests to monitor the health of your muscles both before
you start treatment and frequently during the course of treatment with Cubicin.
Your doctor will monitor your kidney function and the health of your muscles more
frequently during Cubicin treatment if you have kidney problems.
If you get a sore white mouth or tongue while you are being given Cubicin or soon
after stopping it, tell your doctor. Also tell your doctor if you get vaginal itching
This may mean you have a fungal infection called thrush. Sometimes the use of Cubicin
allows fungi to grow and the above symptoms to occur. Cubicin does not work against
You should tell your doctor that you are being treated with Cubicin if you are about
to have a blood clotting test or any other blood tests.
It may interfere with the results of some tests.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
It may affect other medicines used during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Cubicin.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
Things you must not do
Do not stop receiving Cubicin because you are feeling better, unless advised by your
If you do not complete the full course prescribed by your doctor, all of the bacteria
causing your infection may not be killed. These bacteria may continue to grow and
multiply so that your infection may not clear completely or it may return.
Do not give this medicine to anyone else, even if their condition seems similar to
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Cubicin affects you.
Cubicin generally does not cause any problems with your ability to drive a car or
operate machinery. However, as with many other medicines, Cubicin may cause dizziness
or tiredness in some people.
Tell your doctor or nurse as soon as possible if you do not feel well while you are
Cubicin helps most people with infections, but it may have unwanted side-effects in
a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or nurse if you notice any of the following and they worry you:
oral thrush (symptoms include a white, furry, sore tongue and mouth)
vaginal thrush (symptoms include sore and itchy vagina and/or discharge)
inflammation and irritation of the vagina (vaginitis)
pain, itchiness or redness at the site of administration
general pain, weakness or tiredness (fatigue)
spinning sensation (vertigo)
mild stomach upsets such as indigestion (dyspepsia), feeling sick (nausea), being
sick (vomiting) or stomach pain
abdominal pain, swelling or bloating
constipation or mild diarrhoea
difficulty in sleeping (insomnia)
pain in the arms or legs, or joint pain
urinary tract infection
high or low blood pressure
Tell your doctor or nurse immediately if you notice any of the following:
anaphylaxis, a sudden life-threatening allergic reaction with the symptoms: sudden
signs of allergy such as rash, itching or hives on the skin, swelling of the face,
lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
difficulty breathing, new or worsening cough, new or worsening fever (these may be
the signs of a rare, but serious lung disorder called eosinophilic pneumonia)
unexplained muscle pain, tenderness or weakness
tingling or numbness of the hands or feet (paraesthesia)
burning sensations in the arms and/or legs
changes in heart rhythm
yellowing of the skin and eyes (jaundice)
kidney problems or function disorders, including kidney failure
diarrhoea, especially bloody diarrhoea
pus-filled bumps that can spread over the body, sometimes with a fever
hypersensitivity reactions (serious allergic reactions) such as:
chest pain or tightness
blistering, rash (vesiculobullous rash)
swelling of the face, neck and throat
Hypersensitivity reactions (serious allergic reactions including anaphylaxis, angioedema,
drug rash with eosinophilia and systemic symptoms (DRESS) and pulmonary eosinophilia);
and a serious lung disorder called eosinophilic pneumonia have been reported in patients
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet.
After you are given Cubicin
Each Cubicin vial is to be used for one injection or infusion only. Any unused portion
remaining in the vial should be discarded.
Tell your doctor immediately if you develop diarrhoea, especially bloody diarrhoea,
after your treatment has stopped.
Diarrhoea is a common problem that happens when taking antibiotics. It usually stops
when the antibiotic is stopped.
Other medicines of the same class as Cubicin may also cause diarrhoea.
Do not take any diarrhoea medicine without first checking with your doctor.
It is unlikely you will have to store Cubicin powder at home.
If you do have to store it:
Keep it in a refrigerator (2°C to 8°C).
Keep the vial in the outer carton in order to protect it from light.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on a window sill.
Heat and dampness can destroy some medicines.
Keep the medicine where children cannot reach it.
What it looks like
Cubicin is available in a 10 mL glass vial containing a pale yellow to light brown
Each vial contains daptomycin 350 mg or 500 mg as the active ingredient.
It also contains the following inactive ingredient:
Cubicin does not contain preservatives or bacteriostatic agents.
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A
26 Talavera Road
Macquarie Park, NSW 2113
Date of preparation
This leaflet was prepared in May 2017.
Australian Registration Numbers:
AUST R 143574 (350 mg vial)
AUST R 143586 (500 mg vial)
® = Registered trademark
Based on PI dated 4 May 2017.