DACARBAZINE 100 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: DACARBAZINE

View full screen / Print PDF » Download PDF ⇩

Transcript


Package leaflet: Information for the user

l100 mg

Powder for solution for injection or infusion
Dacarbazine
Read all of this leaflet carefully before you start having this
medicine.
–– Keep this leaflet. You may need to read it again.
–– f you have any further questions, ask your doctor, nurse
I
or pharmacist.
––  his medicine has been prescribed for you. Do not pass
T
it on to others. It may harm them, even if their symptoms
are the same as yours.
–– f any of the side effects gets serious, or if you notice any
I
side effects not listed in this leaflet, please tell your doctor,
nurse or pharmacist.
In this leaflet:
1. What Dacarbazine is and what it is used for
2. Before you have Dacarbazine
3. How you have Dacarbazine
4. Possible side effects
5. How to store Dacarbazine
6. Further information

1.  HAT DACARBAZINE IS AND WHAT IT IS
W
USED FOR
What Dacarbazine is
Dacarbazine belongs to a group of medicines called
“cytotoxic drugs”, often called chemotherapy. Treatment
with Dacarbazine should only be carried out by doctors who
specialise in the treatment of cancer (oncologists) or blood
problems (haematologists).
What Dacarbazine is used for
Dacarbazine is used to treat a type of skin cancer called
“metastatic malignant melanoma”. This is a type of skin
cancer which has spread to another part of your body.
Dacarbazine is also used together with other medicines for:
––  dvanced cancer of a part of your immune system called
A
the “lymphatic system”. This type of cancer is often called
“Hodgkin’s disease”.
––  dvanced soft tissue sarcoma in adults (exceptions:
A
mesothelioma, Kaposi sarcoma). Soft tissue sarcomas
are malignant tumours which arise from the soft tissues of
the body. Tumours may be found in many places such as
around your nerves, muscles or blood vessels.
How Dacarbazine works
Dacarbazine helps to stop your cancer cells growing and
multiplying.

2. BEFORE YOU HAVE DACARBAZINE
Do not have Dacarbazine if:
––  ou are allergic (hypersensitive) to dacarbazine or any of
Y
the other ingredients of this medicine (listed in Section 6)
––  ou are pregnant or are breastfeeding your child
Y
––  ou have a low number of white blood cells (leukopenia)
Y
or a low number of platelets (thrombocytopenia)
–– You have severe liver or kidney problems
–– In combination with yellow fever vaccine
Do not have Dacarbazine if any of the above apply to you.
If you are not sure, talk to your doctor, nurse or pharmacist
before using Dacarbazine.
Take special care with Dacarbazine
Your doctor will need to ensure appropriate administration
of dacarbazine in order to prevent tissue damage and pain.
Extravasation (injection of the solution into the tissue around
the vein) can lead to tissue damage and severe pain.

Tests:
During your treatment the following things will be checked:
––  iver size and how well your liver is working (through
L
blood tests). This is to check that the veins in your liver
are not being blocked. If your liver is affected, treatment
will be stopped.
––  mount of red, white and platelet blood cells in your blood
A
(through blood tests). This is to check that your bone
marrow is working properly to help create blood cells. If
your bone marrow is affected, treatment may be stopped
for a while or stopped completely.
Men who are being treated with dacarbazine are advised
to take contraceptive measures during therapy and for 6
months after the end of therapy.
Using other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines.
This is because Dacarbazine can affect the way some other
medicines work. Also some other medicines can affect the
way Dacarbazine works.
In particular, do not have this medicine and tell your doctor,
nurse or pharmacist if you are using any of the following:
–– Phenytoin – for fits (seizures)
–– Other medicines which might damage your liver.
Do not use Dacarbazine if any of the above apply to you. If
you are not sure, talk to your doctor, nurse or pharmacist
before having Dacarbazine.
Tell your doctor, nurse or pharmacist if you are using any of
the following:
––  adiation treatment or other medicines to reduce tumour
R
growth (chemotherapy). Using these medicines with
Dacarbazine can increase the damage to your bone
marrow.
––  ther medicines that are metabolized by a system of liver
O
enzymes called cytochrome P450.
––  ethoxypsoralen – for skin problems such as psoriasis and
M
eczema. Having Dacarbazine with Methoxypsoralen can
make you more sensitive to sunlight (photosensitisation).
––  otemustine – You should not use dacarbazine earlier
F
than one week after fotemustine administration to avoid
damage to your lungs.
––  yclosporin or tacrolimus: these medicines may reduce
C
the function of your immune system.
If any of the above apply to you (or you are not sure),
please tell your doctor, nurse or pharmacist before having
Dacarbazine.
Your doctor will decide whether use of medicines to improve
the blood flow should be given to you and will check your
clotting tendency of the blood.
Using vaccines
There is different advice for different types of vaccines:
––  ellow-fever – You must not have a yellow-fever vaccine if
Y
you are having Dacarbazine.
––  ive vaccines – You should not have a “live” vaccine if you
L
are having Dacarbazine. This is because Dacarbazine
may weaken your immune system and make you more
likely to catch a serious infection.
––  illed vaccines – You may have a “killed” or inactivated
K
vaccine if you are having Dacarbazine.
Having Dacarbazine with food and drink
––  o not eat just before having Dacarbazine. This could
D
make you feel less sick or be less sick.
–– Do not drink alcohol during your treatment.
Pregnancy and breast-feeding
––  o not have Dacarbazine if you are pregnant or planning
D
to become pregnant. This is because the medicine can
damage your unborn child.
––  uring treatment men and women need to use a reliable
D
method of contraception. If you become pregnant, tell
your doctor straight away.
––  en who are being treated with Dacarbazine also need to
M
use a reliable method of contraception for 6 months after
the end of therapy.
––  o not breast-feed during your treatment with
D
Dacarbazine.

Driving and using machines
You may feel sleepy, confused or having impaired vision
while having Dacarbazine. You may also feel or be sick.
If any of these happen, do not drive or use any tools or
machines.

3. HOW YOU HAVE DACARBAZINE
Your doctor will decide how long your treatment should last.
This will depend upon:
–– The type of cancer you have and how advanced it is
––  hich treatment you are being given and how well you
W
are responding to it
–– Whether you are having any side effects
How much you will be given
The amount you are given is worked out depending on your
size (m2 body surface area).

Skin cancer that has spread (metastatic malignant
melanoma)
––  he usual dose is 200 – 250 mg per m2 body surface
T
area, once a day.
––  ou are given this 5 days in a row, every 3 weeks. You
Y
then have a break.
–– t will be given as a fast injection into your vein or as
I
a slow infusion into your vein lasting 15 to 30 minutes.
––  lternatively, you can be given one larger dose of 850
A
mg per m2 body surface area, every 3 weeks. This will be
given as a slow infusion into your vein.
Cancer of your lymphatic system (Hodgkin’s disease)
––  he usual dose is 375 mg per m2 body surface area,
T
every 15 days.
––  ou will also be given medicines called doxorubicin,
Y
bleomycin and vinblastin (this combination is called the
ABVD regimen).
––  ou will usually do this 6 times.
Y
–– t will be given as a slow infusion into the vein.
I
Cancer of the tissues that join your body togeher (soft
tissue sarcoma)
––  he usual dose is 250 mg per m2 body surface area, once
T
a day.
––  ou will also be given a medicine called doxorubicin (this
Y
combination is called the ADIC regimen).
––  ou are given this 5 days in a row, every 3 weeks. You
Y
then have a break.
–– t will be given as a slow infusion into the vein lasting
I
15 – 30 minutes.
Patients with kidney or liver problems
If you have either mild or moderate kidney or liver problems,
you do not usually need to have less of this medicine. If you
have both kidney and liver problems, your body will take
longer to use the medicine and remove it from your system.
Your doctor may give you less of this medicine.
Elderly people
There are no special instructions for the use of Dacarbazine
in elderly people.
Children
Until further data become available, no special
recommendations for the use of Dacarbazine in children can
be given.
If you have more Dacarbazine than you should
If you think that you have been given too much Dacarbazine,
tell your doctor or nurse straight away.
–– f an overdose is suspected, the numbers of your blood
I
cells will be checked and supportive meaures such as
transfusions may be required.
––  n overdose would cause severe damage to your bone
A
marrow (bone marrow toxicity). This can lead to a
complete loss of function of your bone marrow (bone
marrow aplasia). This can be delayed by up to 2 weeks.

If you have any further questions on the use of this product,
ask your doctor, nurse or pharmacist.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor,
nurse or pharmacist.
Common (affects 1 to 10 users in 100)
––  oss of appetite (anorexia), feeling sick or being sick.
L
If anyone helps to clean up your sick, they must wear
gloves. This is because some of the medicine may pass
into their skin.
––  lood problems. These are dependent on how strong
B
your dose is and are most likely after 3 to 4 weeks. You
may feel tired, look pale, bruise more easily than usual or
get more infections than usual. They are shown by blood
tests:
· anaemia (decreased red blood cells)
· leukopenia (decreased white blood cells)
· thrombocytopenia (decreased platelets)
·  one marrow suppression (decreased formation of all
b
blood cells in the bone marrow)
Uncommon (affects 1 to 10 users in 1,000)
––  lu-like symptoms such as tiredness, chills, fever or
F
muscle pain. These are more likely in the first few days of
each treatment cycle
––  bnormal kidney function or increased liver enzymes
A
(shown in tests)
––  iver damage (hepatotoxicity)
L
––  lockage of a vein in your liver (also called Budd-chiari
B
syndrome)
––  iver tissue damage (necrosis) due to blockage of a
L
vein in your liver. The signs include fever, stomach pain,
yellow eyes and skin (jaundice). Your doctor would also
be able to see that your liver was larger and you would
have changes in the numbers of your blood cells. This is
most likely in your second cycle.
––  ark patches on your skin (hyperpigmentation)
D
–– ncreased sensitivity of your skin to sunlight
I
(photosensitivity)
––  air loss (alopecia)
H
––  eeling confused
F
––  lushed face
F
––  ransient rash
T
––  lurred vision
B
Rare (affects 1 to 10 users in 10,000)
–– njection site reactions such as vein irritation
I
––  ed skin (erythema), a rash with spots and blisters
R
(maculopapular exanthema) or a nettle rash (urticaria)
––  kin reactions where the medicine is injected
S
––  welling of the face, lips, mouth and throat with difficulty
S
breathing (anaphylactic reaction)
––  eeling sleepy, having impaired vision
F
––  eadache
H
––  its (seizures)
F
––  ins and needles sensation in the face
P
––  iarrhoea. If anyone helps to clean up your diarrhoea,
D
they must wear gloves. This is because some of the
medicine may pass into their skin.
––  lood problems. These are dependent on how strong your
B
dose is and are most likely after 3 to 4 weeks. You may
feel tired, look pale, bruise more easily than usual or get
more infections than usual. They are shown by blood tests
· pancytopenia (all blood cells decreased)
·  granulocytosis (marked decrease in one type of white
a
blood cell called a “granulocyte”)
If the medicine is accidentally injected into the tissue around
your vein, it will be painful and there will be tissue damage.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor,
nurse or pharmacist.

5. HOW TO STORE DACARBAZINE
Keep out of the reach and sight of children.
Do not have Dacarbazine after the expiry date which is stated
on the carton and bottle after EXP. The expiry date refers to
the last day of that month.

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.
Do not store above 25 °C.
Store in the original package in order to protect from light.

Shelf life of the reconstituted solution
Chemical and physical in-use stability has been
demonstrated for 1 hour at 25 °C and for 24 hours at 4 °C
and protected from light.
Shelf life of diluted solution for infusion
Chemical and physical in-use stability has been
demonstrated for 30 minutes at 25 °C and for 8 hours at
4 °C and protected from light.

6. FURTHER INFORMATION
What Dacarbazine contains
––  he active substance is dacarbazine (100 mg per vial).
T
––  he other ingredients are citric acid monohydrate and
T
mannitol (E 421).
What Dacarbazine looks like and contents of the pack
Dacarbazine is a white powder that is made up into a clear
liquid for injection or infusion. It is packed in cartons each
containing 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lipomed GmbH
Hegenheimer Strasse 2
D 79576 Weil / Rhein
Germany
Telephone number: +49-7621-1693 472
Fax number: +49-7621-1693 474
E-Mail: lipomed@lipomed.com
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria: Dacarbazin Lipomed 100 mg Pulver zur Herstellung
einer Injektions- oder Infusionslösung
Germany: Dacarbazin Lipomed 100 mg Pulver zur
Herstellung einer Injektions- bzw. Infusionslösung
Spain: Dacarbazina Lipomed 100 mg polvo para solución
inyectable o para solución para perfusión
France: Dacarbazine Lipomed 100 mg poudre pour solution
pour injection ou pour perfusion
Italy: Dacarbazina Lipomed 100 mg polvere per soluzione
iniettabile o per soluzione per infusione
United Kingdom: Dacarbazine 100 mg powder for solution
for injection or infusion
This leaflet was last approved in 01/2010.
The following information is intended only for doctors and/
or medical personnel
It is recommended that the patency of the vein is tested with
5 to 10 ml of isotonic sodium chloride solution or glucose
5%. The same solution will be used to rinse the remaining
medicine out of the infusion tube.

Administration of the injection/infusion
After reconstitution (preparation of the solution) with water
for injection and without further dilution with isotonic sodium
chloride solution or glucose 5%, Dacarbazin preparations
are hypo-osmolar (ca. 100 mOsmol/kg) which means that
the solutions contain a lower concentration of dissolved
substances than blood; it should therefore be given by slow
intravenous injection, e.g., over 1 minute and not as an i.v.
bolus injection (fast injection) over a few seconds.
Dacarbazine is sensitive to light. Reconstituted solutions
must therefore be protected from light, including during the
infusion (light-resistant infusion set).

The solution must be administered carefully to avoid
extravasation (injection of the solution into the tissue around
the vein), as this can cause local pain and tissue damage.
If extravasation occurs the injection must be immediately
interrupted and the remaining dose administered in a
different vein.

Notes on safe handling
Dacarbazine is an antineoplastic agent (it reduces the
growth of cancer cells). Before preparing a solution, local
cytotoxic (cell damaging) guidelines should be referred to
regarding handling of cytotoxic agents. Dacarbazine should
only be opened by trained staff. As with all cytotoxic agents,
precautions should be taken to avoid exposing staff. Handling
of cytotoxic drugs should be generally avoided during
pregnancy. Preparation of the solution for administration
should be carried out in a designated handling area and
working over a washable tray or disposable plastic-backed
absorbent paper. It is recommended that suitable eye
protection, disposable gloves, face mask and a disposable
apron are worn. Syringes and infusion sets should be
assembled carefully to avoid leaks (use of Luer lock fittings
is recommended). Once completed, any exposed surface
should be thoroughly cleaned and the hands and face
washed. In the event of spillage, operators should put on
gloves, face masks, eye-protection and a disposable apron
and mop up the spilled material with an absorbent material
laid out in the area for that purpose. The area should then
be cleaned and all contaminated material transferred to a
cytotoxic spillage bag or bin or sealed for incineration.
Preparation of the solution for intravenous dosing
(administration into a vein)
Dacarbazine solutions should be prepared immediately
before use. Dacarbazine is sensitive to light. During the
treatment the infusion container and infusion set has to be
protected from light, for example by using a light-resistant
PVC infusion set. Other infusion sets should, for example, be
wrapped in light resistant aluminium foil.
Preparation and administration of the solution for injection/
infusion
Dacarbazine 100 mg powder for solution for injection
or infusion will be reconstituted with 9.9 ml of water for
injections, that means the powder will be completely
dissolved. The resulting solution contains 10 mg/ml
dacarbazine. The solution will be given as a slow injection –
it will be injected slowly into a vein. At higher doses, the
reconstituted solution will be diluted with 200 ml glucose 5%
or sodium chloride solution 0.9% and infused intravenously
over 15 to 30 minutes (given slowly into a vein).
Dacarbazine is for single use only.
Dacarbazine solution is chemically incompatible with the
medicinal products heparin, hydrocortisone, L-cysteine and
sodium hydrogen carbonate; this means that dacarbazine
solution should not be mixed with medicines that contain
these substances. This medicinal product must not be mixed
with other medicinal products except those mentioned
above.

Shelf life of the reconstituted solution
Chemical and physical in-use stability has been
demonstrated for 1 hour at 25 °C and for 24 hours at 4 °C
and protected from light.
From a microbiological point of view, the reconstituted
solution should be used immediately.
If the reconstituted solution is not used immediately, the
duration and conditions of storage are the responsibility
of the user. The reconstituted solution should not be stored
for longer than 24 hours in the refrigerator (2 to 8 °C) and
protected from light, unless reconstitution has taken place in
controlled and validated aseptic conditions.
Shelf life of diluted solution for infusion
Chemical and physical in-use stability has been
demonstrated for 30 minutes at 25 °C and for 8 hours at
4 °C and protected from light.
From a microbiological point of view, the diluted solution
should be used immediately.
If the diluted solution for infusion is not used immediately,
the duration and conditions of storage are the responsibility
of the user. The diluted solution for infusion should not be
stored for longer than 8 hours in the refrigerator (2 to 8 °C)
and protected from light, unless reconstituion has been taken
place in controlled and validated aseptic conditions.

201002

Like all medicines, Dacarbazine can cause side effects,
although not everybody gets them.

Do not have Dacarbazine if the solution is cloudy or has bits
floating in it.

DAC-553.L.100.010.UK10

4. POSSIBLE SIDE EFFECTS

Expand view ⇕

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.

Advanced Breast Cancer: Learn about treatments to improve quality of life. Click Here

Close
Hide
(web5)