CARBOPLATIN 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: CARBOPLATIN

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Package leaflet: Information for the user
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
carboplatin
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 Carboplatin is and what it is used for
2.
What you need to know before you are given Carboplatin
3.
How you are given Carboplatin
4.
Possible side effects
5.
How to store Carboplatin
6.
Contents of the pack and other information

1.

What Carboplatin is and what it is used for

Carboplatin concentrate contains the active ingredient carboplatin which belongs to a
group of medicines known as platinum coordination compounds, which is used to
treat cancer.
Carboplatin is used against advanced cancer of the ovary and small cell cancer of the
lung.

2.

What you need to know before you are given Carboplatin

Do not use Carboplatin:
if you are allergic to carboplatin or any of the other ingredients of this
medicine (listed in section 6).
if you are allergic to another drug that belongs to the group of platinum
containing compound.
if you are breast feeding.
if you have severe problems with your kidney (creatinine clearance below 30
ml/min) and/or liver fuinction.
if you have an imbalance of your blood cells (severe myelosuppression).
if you have a tumour that bleeds.
If you plan to receive a yellow fever vaccination or have just received one.
If any of these apply to you and you have not already discussed this with your doctor
or nurse, it is recommended to inform the doctor or nurse as soon as possible and
before receiving Carboplatin.

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Carboplatin is usually given to patients in hospital. Normally you must not handle this
medicine. Your doctor or nurse will administer the medicine and will carefully and
frequently monitor you during and after treatment. You will normally have blood tests
before each administration.
Warnings and precautions
Talk to your doctor or nurse before using Carboplatin:
If you are pregnant or there is a chance you may be pregnant.
If you are breast-feeding.
If you are likely to drink alcohol whilst treated with this medicine.
If you are on radiotherapy.
If you have had or are due to have any vaccination including a live or live-attenuated
vaccination.
If your kidneys are not working properly the effects of carboplatin on the blood
(haematopoietic system) are increased and prolonged compared to patients with
normal kidney function.
In patients with abnormal kidney function visual disturbances, including reversible
loss of vision has been reported if carboplatin is used in dose higher than that
recommended. The vision may recover totally or to a significant extent upon
discontinuation of this medicine.
Your doctor will want to monitor you more regularly if your kidneys are not working
properly.
Older people are more likely to experience side effect of the carboplatin on the blood
count and nervous system.
If any of these apply to you and you have not already discussed this with your doctor
or nurse, it is recommended to inform the doctor or nurse as soon as possible and
before receiving the medicine.
This medicine may be diluted with another solution before it is administered. You
must discuss this with your doctor and make sure that it is suitable for you.
Talk to your doctor or nurse before being given Carboplatin.
Other medicines and Carboplatin
Tell your doctor or nurse if you are using, have recently used or might use any other
medicines.
You should tell your doctor if you are taking any of the following medicines as they
may interact with Carboplatin:
yellow fever vaccine and other live vaccines
other medicines that are known to affect blood cell formation in the bone marrow
other medicines that are known to be toxic to your kidney (e.g. aminoglycosides
antibiotics, loop diuretics, vancomycin, capreomycin)

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other medicines that are known to damage the hearing or balance functions of the
ear (e.g. aminoglycosides antibiotics, furosemide (loop diuretics), [used to treat
heart failure and edema], vancomycin, capreomycin)
other medicines which decrease the activity of the immune system (e.g
cyclosporine, tacrolimus, sirolimus and other anticancer medicine)
blood thinning medicines e.g. warfarin
phenytoin and fosphenytoin (used to treat various types of convulsions and
seizures)
chelating agents (substances binding to carboplatin thereby decreasing the effect of
carboplatin).
Carboplatin with alcohol
There is no known interaction between carboplatin and alcohol. However you must
check with your doctor as carboplatin may affect the liver’s ability to cope with
alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
If any of these apply to you and you have not already discussed this with your doctor
or nurse, it is recommended to inform your doctor or nurse as soon as possible and
before receiving this medicine.
Pregnancy
This medicine must not be used during pregnancy other than in the most exceptional
circumstances in the treatment of cancer; where the potential benefit to the mother is
considered to be greater than the risk to the unborn baby.
Breast-feeding
If treatment becomes necessary during the lactation period, breastfeeding must be
stopped.
Fertility
Carboplatin can cause genetic damage. Women are advised to avoid becoming
pregnant by using effective contraception before and during treatment. For women
who are pregnant or become pregnant during therapy, genetic counselling should be
provided.
Men treated with carboplatin are advised not to father a child during, and up to 6
months after treatment. Advice on conservation of sperm should be sought prior to
treatment because of the possibility of irreversible infertility.
Ask your doctor or nurse for advice before using any medicine.
Driving and using machines
Carboplatin does not affect your ability to drive and use machines. However you
should take extra care when you are given carboplatin especially if you are feeling
and/or being sick, experiencing visual and hearing disturbances or feeling unsure of
yourself.
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3.

How to use Carboplatin

Carboplatin will always be administered by a nurse or doctor experienced in the use
of cancer treatment. It is usually given in a drip by slow injection into a vein and will
usually take between 15 and 60 minutes to be administered.
Dose
Your dose is dependent on your height and weight, function of your blood
(haemetopoietic) system and your kidney function. Your doctor will choose the best
dose for you. Carboplatin will be diluted before use.
Adults
The usual dose is 400 mg/m2 of your body surface area (calculated from your height
and weight).
Older people
For elderly patients (over 65 years old), the dosage may need adjusting depending on
your physical condition and laboratory evaluation.
Kidney problems
The amount given may vary, according to how well your kidneys are working. If you
suffer from kidney problems, your doctor may reduce the dose and may perform
frequent blood tests as well as monitoring your kidney function.
Use in children and adolescents
There has not been enough usage of carboplatin in children to allow the
recommendation of specific dose.
You may feel sick while you are being treated with carboplatin. Your doctor may give
you another medicine to reduce these effects before you are treated with this
medicine.
There will be a usual gap of 4 weeks between each dose of carboplatin. Your doctor
will want to perform some blood tests each week after giving you this medicine so
he/she can decide on the correct next dosage for you.
If you take more Carboplatin than you should
It is unlikely that you will be given too much carboplatin. However in the event that
this occurs you may have some problems with your kidneys. If you are worried that
too much has been administered or you have any questions about the dose being
given, you should talk to the doctor administering your medicine.
If you forget to take Carboplatin
It is very unlikely that you will miss a dose of your medicines, as your doctor will
have instructions on when to give you your medicine. If you think you have missed
your dose please talk to your doctor.
If you stop taking Carboplatin

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Tell your doctor immediately if you notice any of the following:
Abnormal bruising, bleeding, or signs of infection such as a sore throat and high
temperature.
Severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue
and/or throat, which may cause difficulty in swallowing or breathing (angiooedema).
Stomatitis/mucositis (e.g. sore lips or mouth ulcers).
Very common side effects (may affect more than 1 in 10 people):
Changes in your red and white blood cells and platelets (myelosuppression). Your
doctor may want to monitor you
Anaemia (a condition in which there is a decreased number of red blood cells
which leads to tiredness)
Increase in the level of urea and enzymes in your blood. Your doctor may want to
monitor you
Slight loss of hearing
Abnormal liver function test results. Your doctor may want to monitor you
Increased uric acid levels in your blood which may lead to gout
Feeling or being sick
Abdominal pain or cramp
Unusual feelings of tiredness or weakness
Decrease in the level of salts in your blood. Your doctor may want to monitor you
Damage to the kidneys (renal toxicity).
Common side effects (may affect up to 1 in 10 people):
Unusual bruising or bleeding (haemorrhagic complications)
Reduced function of your kidneys
Diarrhoea, constipation, sore lips or mouth ulcers (mucositis)
Allergic reactions including rash, urticaria, skin reddening, itching, high
temperature
Ringing in the ears (tinnitus), hearing impairment and hearing loss
Pins and needles (peripheral neuropathy)
Hair loss
Feeling unwell
Decreased serum levels of calcium
Flu-like syndrome
Loss or lack of body strength
Fever
Interstitial lung disease (a group of lung disorders in which the deep lung tissues
become inflamed)

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Decrease bone and tendon reflux.
.
Uncommon (may affect up to 1 in 100 people)
Secondary malignancies
Central nervous symptoms often associated with medicine you may be taking to
stop you from feeling or being sick
Fever and chills without evidence of infection
Redness, swelling and pain or dead skin around the injection site (injection site
reaction)
Infection
Unusual weight loss
Change in blood pressure (hyper or hypotension).
Rare (may affect up to 1 in 10,000 people)
Feeling unwell with a high temperature due to low levels of white blood cells
(febrile neutropenia)
Life threatening infections and bleeding
Taste alteration
Loss of appetite (anorexia)
Severely impaired liver function, damage or death of liver cells. Your doctor may
want to monitor you.
Temporary visual disturbances including temporary sight loss
Inflammation of the optic nerve that may cause a complete or partial loss of
vision (optic neuritis)
Haemolytic-uraemic syndrome (a disease characterised by acute renal failure)
Decreased number of red blood cells (microangiopathic haemolytic anaemia) and
a low platelet count)
Severe allergic reactions (anaphylaxis/anaphylactic reactions)
Symptoms of a severe allergic reaction include sudden wheeziness or tightness of
chest, swelling of the eyelids, face or lips, facial flushing, hypotension,
tachycardia, urticaria, dyspnoea, dizziness and anaphylactic shock.
Very rare (may affect up to 1 in 10,000 people)
Heart failure, blockage in blood vessels of your heart, high blood pressure
Bleeding in the brain, which may result in a stroke or loss of consciousness
Scarring of the lungs which causes shortness of breath and/or cough (pulmonary
fibrosis).
If you get any side effects, talk to your doctor or nurse. This includes any side effects
not listed in this leaflet.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
side effects not listed in this leaflet. You can also report side effects directly via
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 Carboplatin
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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 vial and carton
after {EXP}. The expiry date refers to the last day of that month.
Unopened vial: Store below 30°C. Keep the vial in the outer carton in order to protect
from light.
Diluted product: Chemical and physical in-use stability has been demonstrated after
dilution for 24 hours at 2 to 8oC.
From a microbiological point of view however, the product should be used
immediately.
If not used immediately, in-use storage times and conditions are the responsibility of
the user and would normally not be longer than 24 hours at 2 – 8oC, unless dilution
has taken place in controlled and validated aseptic conditions.

6.

Contents of the pack and other information

What Carboplatin contains
-

The active substance is carboplatin.
One vial of 5 ml contains 50 mg carboplatin.
One vial of 15 ml contains 150 mg carboplatin.
One vial of 45 ml contains 450 mg carboplatin.
One vial of 60 ml contains 600 mg carboplatin.
One vial of 100 ml contains 1000 mg carboplatin.

-

The other ingredient is water for injection.

What Carboplatin looks like and contents of the pack
Carboplatin is a clear, colourless to pale yellow solution free from particles.
Carboplatin is supplied in type I transparent, flint moulded glass vial containing either
5 ml, 15 ml, 45 ml, 60 ml or 100 ml concentrate for solution for infusion. Vials are
closed with grey rubber stoppers and white/blue (60 ml vial only) flip-off aluminium
seals.
Pack size:
1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
7

Sandwich, Kent, CT13 9NJ
UK
Manufacturer
Pfizer Service Company BVBA
Hoge Wei 10, B-1930 Zaventem
Belgium
This leaflet was last revised in {07/2013}.

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-------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
This product is for single use only. Any unused infusion solution should be discarded.
Handling and use
The preparation and administration of injectable solutions of cytotoxic agents must be
carried out by trained specialist personnel with knowledge of the medicines used, in
conditions that guarantee the protection of the environment and, in particular, the
protection of the personnel handling the medicines. It requires a preparation area
reserved for this purpose. It is forbidden to smoke, eat or drink in this area.
Personnel must be provided with appropriate handling materials, notably long sleeved
gowns, protection masks, caps, protective goggles, sterile single-use gloves,
protective covers for the work area and collection bags for waste.
Syringes and infusion sets should be assembled carefully to avoid leakage (use of
Luer lock fittings is recommended).
Spills and leakages must be wiped up, wearing protective gloves.
Precautions should be taken to avoid exposing staff during pregnancy.
On completion, any exposed surface should be thoroughly cleaned and hands and face
washed.
Guidelines for the safe handling of anti-neoplastic agents:
Carboplatin should be prepared for administration only by professionals who
have been trained in the safe use of chemotherapeutic agents
This should be performed in a designated area.
Adequate protective gloves, face mask and protective clothes should be worn.
Precautions should be taken to avoid the drug accidentally coming into contact
with the eyes. In the event of contact with the eyes, wash with water and/or
saline.
The cytotoxic preparation should not be handled by pregnant staff.
Adequate care and precautions should be taken in the disposal of items
(syringes, needles, etc...) used to reconstitute cytotoxic drugs. Excess material
and body waste may be disposed of by placing in double sealed polyethylene
bags and incinerating at a temperature of 1,000oC.
The work surface should be covered with disposable plastic-backed absorbent
paper.
Use Luer-Lock fittings on all syringes and sets. Large bore needles are
recommended to minimise pressure and the possible formation of aerosols.
The latter may also be reduced by the use of a venting needle.
Preparation of the solution for infusion
The product must be diluted before use, with glucose solution 50 mg/ml or sodium
chloride solution 9 mg/ml, to concentration as low as 0.5 mg/ml. The carboplatin in
the vial prior to dilution is at strength 10 mg/ml. The dilutions should be used within

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24 hours once diluted with glucose solution 50 mg/ml or sodium chloride solution 9
mg/ml and stored at 2°C to 8°C.
The solution is to be inspected visually for particulate matter and discoloration prior
to administration. The solution should only be used if the solution is clear and free
from particles.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

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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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