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DAPTOMYCIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): DAPTOMYCIN / DAPTOMYCIN

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Package leaflet: Information for the patient

Daptomycin 500 mg powder
for solution for
injection/infusion
daptomycin

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.
- 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 take
Daptomycin
3. How to take Daptomycin
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 powder for
solution for injection/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 in adults to
treat infections in the tissues that line the inside of
the heart (including heart valves) which are caused
by a bacterium called Staphylococcus aureus and
to treat infections in the blood caused by the same
bacterium when associated with skin or 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 take Daptomycin
You should not be given Daptomycin
If you are allergic to daptomycin 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 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 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. Tell a
doctor or a nurse straight away if you experience
symptoms suggestive of allergic reaction, such
as wheezing, difficulty breathing, swelling of the
face, neck and throat, rashes and hives, fever
(see section 4 of this leaflet for more
information).
- 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. rheumathoid 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.

3. How to take Daptomycin
Daptomycin will usually be given to you by a
doctor or a nurse.
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.
Children and adolescents (1 to 17 years of age)
The dose for children and adolescents (1 to 17
years of age) being treated for skin infection will
depend on the age of patient. The recommended
doses based on age are shown in the table below:
Age group

Dosage

12 to 17 years

5 mg/kg once
every 24 hours
infused over
30 minutes
7 mg/kg once
every 24 hours
infused over
30 minutes
9 mg/kg once
every 24 hours
infused over
60 minutes
10 mg/kg once
every 24 hours
infused over
60 minutes

7 to 11 years

2 to 6 years

1 to < 2 years

Duration
of
treatment

Up to 14
days

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.
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.

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:
Very rare serious side effects (may affect up to 1
in 10,000 people)
A hypersensitivity reaction (serious allergic
reaction including anaphylaxis, angioedema, drug
rash with eosinophilia and systemic symptoms
(DRESS)) 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 with blistering, sometimes affecting the
mouth and genitals,
- 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. In very rare cases (reported in less
than 1 in every 10,000 patients), muscle problems
can be serious, including muscle breakdown
(rhabdomyolysis), which can result in kidney
damage.
Serious side effects with frequency not known
(frequency cannot be estimated from the available
data)
A rare but potentially serious lung disorder called
eosinophilic pneumonia has been reported in
patients given Daptomycin, mostly after more than
2 weeks of treatment. The symptoms can include
difficulty breathing, new or worsening cough, or
new or worsening fever. If you experience these
symptoms, tell your doctor or nurse straight away.
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 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.
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).
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 Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. 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 the
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.
After dilution:
Chemical and physical stability of the diluted
solution in infusion bags is established as 12
hours at 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; see
section 6.6) at 25°C must not exceed 12 hours (or
24 at 2°C – 8°C).
For the 2-minute intravenous injection, the storage
time of the reconstituted solution in the vial (see
section 6.6) at 25°C must not exceed 12 hours (or
48 at 2°C – 8°C).
From a microbiological point of view the product
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are
the responsibility of the user and would normally not
be longer than 24 hours at 2°C – 8°C.
Do not use Daptomycin 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).
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6. Contents of the pack and other
information
What Daptomycin contains
The active substance is daptomycin. 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.
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
or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Medichem, S.A.
Fructuós Gelabert 6-8
Sant Joan Despí
(Barcelona) 08970
Spain
Hikma Italia SpA
10 Viale Certosa
Pavia 27100
Italy
This leaflet was last revised in 07/2017.
------------------------------------------------------------------The following information is intended for
healthcare professionals only
Important: Please refer to the Summary of Product
Characteristics before prescribing.
Instructions for use and handling
500 mg presentation:
Daptomycin may be administered intravenously as
an infusion over 30 or 60 minutes or as an
injection over 2 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 can be
achieved by reconstituting the lyophilised product
with 10 ml 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 lyophilised Daptomycin.
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 10 ml 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. Slowly remove the reconstituted liquid (50 mg
daptomycin/ml) from the vial using a sterile
needle that is 21 gauge or smaller in diameter.

6. The reconstituted solution should then be
diluted with sodium chloride 9 mg/ml (0.9%)
(typical volume 50 ml).
7. Invert the vial of the sodium chloride solution in
order to allow the solution to drain towards the
stopper. Using a new 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 the end of the syringe barrel in order to
remove all of the solution from the inverted vial.
8. Replace needle with a new needle for the
intravenous infusion.
9. Expel air, large bubbles, and any excess
solution in order to obtain the required dose.
10. 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
stored under refrigeration at 2°C – 8°C.
Daptomycin given as 2-minute intravenous
injection
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 10 ml 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 injection,
please adhere to the following instructions:
Aseptic technique should be used throughout to
reconstitute lyophilised Daptomycin.
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 10 ml 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 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. Slowly remove the reconstituted liquid (50 mg
daptomycin/ml) from the vial using a sterile
needle that is 21 gauge or smaller in diameter.
6. Invert the vial in order to allow the solution to
drain towards the stopper. Using a new 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 the end of the syringe
barrel in order to remove all of the solution from
the inverted vial.
7. Replace needle with a new needle for the
intravenous injection.
8. Expel air, large bubbles, and any excess
solution in order to obtain the required dose.
9. The reconstituted solution should then be
injected intravenously slowly over 2 minutes.
Chemical and physical in-use stability on the
reconstituted solution in the vial has been
demonstrated for 12 hours at 25°C and up to 48
hours if stored under refrigeration (2°C – 8°C).
From a microbiological point of view the product
should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer than the times stated
above for the chemical and physical in-use
stability.
This medicinal product must not be mixed with
other medicinal products except those mentioned
above.
Daptomycin vials are for single-use only. Any
unused portion remaining in the vial should be
discarded.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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