NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CUBICIN®
(pronounced Q-bi-sin)
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 pharmacist.
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 and children to treat blood infections.It is also used in adults to treat infections of the tissues that line the inside of the heart (including heart valves) – that are caused by Staphylococcus aureus bacteria.
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 infection.
Ask your doctor if you have any questions about why Cubicin has been prescribed for you.
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.
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 food shop.
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
Cubicin 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.For adults, the dose will depend on how much you weigh and the type of infection being treated.
For children (1 to 17 years of age), the dose will depend on the age of the patient, how much the child weighs,and the type of infection being treated.
Your doctor will decide on the dose and how long you will receive Cubicin.
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.
How it is given
Adults: Cubicin is given directly into your blood stream by intravenous injection over about 2 minutes or by infusion (drip) over about 30 minutes.
Children ( 7-17 years of age): Cubicin is given directly into the blood stream by infusion (drip) over 30 minutes.
Children (1-6 years of age): Cubicin is given directly into your blood stream by infusion (drip) over 60 minutes.
If you are given too much (overdose)
Since Cubicin is usually given to you in hospital under the supervision of your doctor, 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.
Pleasecontact the Poisons Information Centre (telephone 13 11 26, for advice on overdose management.
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 doctor.
If you develop itching with swelling or skin rash or difficulty breathing while you are being given Cubicin tellyour 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 in moving.
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 or discharge.
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 fungi.
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 soon after being given Cubicin, tell your doctor.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being givenCubicin.
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 being given Cubicin.
Tell any other doctors, dentists, and pharmacists who treat you that you are being givenCubicin.
Things you must not do
Do not stop receiving Cubicin because you are feeling better, unless advised by your doctor.
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.
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.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are taking Cubicin.
Cubicin helps most people with certain 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 of them.
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)
fungal infections
pain, itchiness or redness at the site of administration
general pain, weakness or tiredness (fatigue)
trembling
decreased appetite
dizziness
spinning sensation (vertigo)
headache
flushes
mild stomach upsets such as indigestion (dyspepsia), feeling sick (nausea), being sick (vomiting) or stomach pain
abdominal pain, swelling or bloating
flatulence
constipation or mild diarrhoea
taste disturbance
eye irritation
difficulty in sleeping (insomnia)
pain in the arms or legs, or joint pain
anxiety
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 breathing
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, weakness or cramps
tingling, burning or numbness of arms and hands or legs and feet (paraesthesia)
loss or difficulty movingthe arms and/or legs
changes in heart rhythm
yellowing of the skin and eyes (jaundice)
kidney problems, including kidney failure
diarrhoea, especially bloody diarrhoea
fainting
unusual bleeding in the skin and bruising
hypersensitivity reactions (serious allergic reactions) such as:
pus filled bumps that can spread over the body, sometimes with a fever
shivering or chills
flushed appearance
blistering rash (vesiculobullous rash)
swelling of the face, neck and throat
fainting
cough.
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 given Cubicin.
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
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.
Storage
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.
Product description
What it looks like
Cubicin comes in a 10 mL glass vial containing a pale yellow to light brown powder.
Ingredients
Each vial contains daptomycin 350 mg or 500 mg as the active ingredient.
It also contains the following inactive ingredient:
sodium hydroxide
Cubicin does not contain preservatives or bacteriostatic agents.
Sponsor
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 April 2020.
Australian Registration Numbers:
AUST R 143574 (350 mg vial)
AUST R 143586 (500 mg vial)
® = Registered trademark
Based on PI dated14 April 2020.
Source: Read Full Article