Carboplatin 10 Mg/Ml Concentrate For Solution For Infusion
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PATIENT INFORMATION LEAFLET
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
Carboplatin
Read all of this leaflet carefully before you starts using this medicine. Keep this leaflet. You may need to read it again.
Ifyou havefurtherquestions, pleaseaskyourdoctorornurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctor or nurse.
Jnthis leaflet:
H. What Carboplatin Infusion is and what it is used for Before you are given Carboplatin Infusion How you are given Carboplatin Infusion 4. Possible side effects |5. How to store Carboplatin Infusion Further information
1. What Carboplatin Infusion is and what it is used for
The name of your medicine is 'Carboplatin 10mg/ml concentrate for solution for infusion' but in the rest of the leaflet it will be called ^Carboplatin Infusion'.
Iwhat Carboplatin Infusion is
.Carboplatin Infusion contains carboplatin, which belongs to a group lof medicines known as platinum coordination compounds, which are ^sed to treat cancer.
What Carboplatin Infusion is used for
|Carboplatin Infusion is used against advanced cancer of the ovary and small cell cancerof the lung.
2. Before you are given Carboplatin Infusion
not use Carboplatin Infusion
If you are allergic (hypersensitive) to Carboplatin or to any of the ingredients of Carboplatin Infusion
If you are allergic to another drug that belongs to the group of platinum containing compound.
If you have severe problems with your kidneys (creatinine clearance at or below 20 ml/min)
If you have an imbalance of your blood cells (sever myelosuppression)
Ifyou have tumourthat bleeds Ifyou are pregnant orbreastfeeding
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the following information is intended for medical or healthcare professional only:
nstructions for use Cytotoxic
Carboplatin should be used by the intravenous route only. The Recommended dosage of Carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine clearance > 60 ml/min is 400 mg/m2 as a single short term IV dose administered by a n5 to 60 minutes infusion. Alternatively, the Calvert formula shown below may be used to determine dosage:
Dose (mg) = target AUC (mg/ml x min)x[GFR ml/min + 25]
bose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
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Target AUC |
Planned chemotherapy |
Patient treatment status |
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5-7 mg/ml .min |
single agent Carboplatin |
Previously untreated |
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4-6 mg/ml .min |
single agent Carboplatin |
Previously untreated |
|
4-6 mg/ml .min |
Carboplatin plus cyclophosphamide |
Previously untreated |
If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before receiving Infusion.
Carboplatin is usually given to patients in hospital. Normally you should 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
Take special care while receiving carboplatin Infusion
Ifyou are pregnant or if there is a chance you may be pregnant Ifyou are breastfeeding
Ifyou are likely to drink any alcohol whilst being treated with this Infusion
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. Your doctor will want to monitor you more regularly if yourkidneys are notworking properly.
If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before receiving Infusion.
Your Infusion may be diluted with another solution before it is administered. You should discuss this with your doctor and make sure that it suitable for you.
Using other medicines:
You should tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without prescription You should tell your doctor if you are taking any of the following medicines as they may interact with Carboplatin.
• Other medicines that are known to affect blood cell formation in the bone marrow
• Other medicines that are known to be toxic to your kidneys (e.g. aminoglycosides antibiotics)
• Other medicines that are known to damage the hearing or balance functions of the ear (e.g. aminoglycosides antibiotics; furosemide [used to treat heart failure and edema])
• Chelating agents (substances binding to carboplatin thereby decreasing the effect of carboplatin)
• Phenytoin (used to treat various types of convulsions and seizures)
• Warfarin (used to prevent the formation of blood clots)
Using with food and drink
There is no known interaction between Carboplatin and alcohol. However you should check with yourdoctoras Carboplatin may affect the liver's ability to cope with alcohol.
Pregnancy and breast-feeding
Tell yourdoctor if you are trying to become pregnant, are already pregnant, or are breast-feeding before being treated with Carboplatin Infusion.
If any of these this applies to you and you have not already discussed this with your doctor or nurse, you should do as soon as possible and before receiving the Infusion.
Note: With the Calvert formula, the total dose of Carboplatin is calculated in mg, not mg/m2. Calvert's formula should not be used in patients who have received extensive pretreatment**
“Patients are considered heavily pretreated if they have received any of the following:
• Mitomycin C
• Nitrosourea
• Combination therapy with doxorubicin/ cyclophosphamide/cisplatin,
• Combination therapy with 5 or more agents,
• Radiotherapy 4500 rad, focused on a 20 x 20 cm field or on more than one field of therapy.
Therapy with carboplatin should be discontinued in the case of an unresponsive tumour, progressive disease and/or occurrence of not tolerable side effects.
Therapy should not be repeated until four weeks after the previous Carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Reduction of the initial dosage by 20-25% is recommended for those patients who present with risk factors such as prior myelosuppressive treatment and low performance status (ECOG-Zubrod 2-4 or Karnofsky below 80). Determination of the haematological nadir by weekly blood counts during the initial courses of treatment with Carboplatin Infusion is recommended for future dosage adjustment.
Pregnancy
You must not be treated with carboplatin infusion during pregnancy unless clearly indicated by your doctor. Animal studies have shown a| possible risk of abnormalities in the developing fetus. Ifyou are being treated with carboplatin whilst pregnant, you should discuss with yourdoctorthe possible risk of effects on your unborn child.
Women of child bearing potential must use an effective method of. contraception both before and during treatment with carboplatin) Since carboplatin can cause genetic damage, if pregnancy occurs, during treatment with carboplatin, genetic counseling isl recommended. Genetic counseling is also recommended for. patients wishing to have children after treatment with Carboplatin Infusion
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Breast feeding
It is not known whether carboplatin is excreted into the breast milk.| Therefore, during treatment with carboplatin infusion you should discontinue breast-feeding.
Fertility
Carboplatin can cause genetic damage. Women of childbearing potential should be advised avoid becoming pregnant by using, effective contraception during treatment. For women who are pregnant or become pregnant during therapy, genetic counseling, 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 sperml should be sought prior to treatment because of the possibility of irreversible infertility.
Askyourdoctoror pharmacist for advice before using any medicine | Driving and using machines
Carboplatin does not affect your ability to drive and use machines.1 However you should take extra care when you are first given thei Infusion, especially ifyou feel dizzy or unsure of yourself. 1
3. How you are given Carboplatin Infusion
Your Infusion will always be administered by nurse or doctor. It isl usually given in a drip by slow injection into a vein and will usually take between 15 and 60 minutes to be administered. If you require any further information, askyourdoctorornurse who will be or who has administered the Infusion
Your dose will be 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. The Infusion will normally be diluted before use
Adult
The usual dose is 400 mg/m2 of your body surface area (calculated1 fromyourheightand weight). |
Elderly .
The usual adult doses may be used although the doctor may choosel to use a different dose.
Impaired renal function:
Patients with creatinine clearance values of less than 60 ml/min are at greater risk to develop myelosuppression.
The optimal use of Carboplatin in patients presenting with impaired renal function requires adequate dosage adjustments and frequent monitoring of both haematological nadirs and renal function.
In case of a glomerular filtration rate of < 20 ml/min, carboplatin should not be administered at all. |
Combination Therapy:
The optimal use of Carboplatin Infusion in combination with otherl myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.
Use in children: |
As no sufficient experience of carboplatin use in children is available;, nospecificdosagerecommendationscan begiven. I
Elderly:
Dosage adjustment, initially or subsequently, may be necessary, dependent on the physical condition of the patient.
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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. The Infusion will be given by a doctor experienced in the use of cancer treatment.
^Children
iThere has not been enough usage of carboplatin in children to allow ihe recommendation of specific dose.
iYou may feel sick while you are being treated with Carboplatin Infusion. Your doctor may give you another medicine to reduce these effects before you are treated with Carboplatin Infusion.
(There will be usual gap of 4 weeks between each dose of Carboplatin Infusion. Your doctor will want to perform some blood tests each week after giving you Carboplatin Infusion. So he/she can decide on the correct next dosage for you
If you receive more Carboplatin Infusion than you should
|lt is unlikely that you will be given too much carboplatin. However in the event that this occurs you may have some problems with your jddneys. 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 doctoradministering your medicine.
Jf you miss a dose of Carboplatin Infusion
Itisvery unlikely that you will miss a dose of your medicines, as yours
Doctor will have instructions on when to give you your medicine. If ou thinkyou have missed dose please talkto yourdoctor.
[f you stop using Carboplatin Infusion
If you have any further question on the use of this product ask your |doctorornurse.
4. Possible side effects
Like all medicines, Carboplatin can have 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 soar 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 (angio-oedema).
• Stomatitis/mucositis (e.g. sore lips ormouth ulcers).
|Very common side effects (occurring in more than 1 in 10 patients):
Changes in your red and white blood cells and platelets (myelosuppression) your doctor may wants to monitor you. Anaemia (a condition in which there is a decreased number of red blood cells which lead to tiredness)
Increase in the level of the creatinine and urea in your blood. Your doctor may want to monitor you
C Slight loss of hearing
Abnormal liver enzyme levels. Your doctor may want to monitor you
Increased uric acid levels in the blood which may lead to gout
• Feeling or being sick
• Abdominal pain and cramp
• Unusual feelings of tiredness or weakness
• Decrease in the level of salts in your blood. Your doctor may want to monitoryou
• Damage to the kidneys (renal toxicity)
• Nausea and vomiting
Common side effects (occurring in more than 1 in 100 and less than 1 in
10 patients):
• Unusual bruising orbleeding (haemorrhagiccomplications)
• Reduced function of your kidneys.
• Diarrhoea, constipation, sore lips ormouth ulcers (mucositis)
• Allergic reaction including rash, urticaria, skin reddening, itching, high temperature
• Ringing in the ears (tinnitus), hearing impairment and hearing loss
• Pins and needles (peripheral neuropathy)
• Hairloss
• Feeling unwell
• Decreased serum levels of calcium
• Flu-like syndrome
• Lossorlackof bodily strength
• Fever
Uncommon side effects (occurring in more than 1 in 1000 and less than
1 in 100 patients):
• 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
Rare side effects (occurring in less than 1 in 1000 patients):
• 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. You 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 characterized by acute renal failure, decreased number of red blood cells [microangiopathic haemolytic anaemia] and a low platelet count).
• Severe allergic reactions (anaphylaxis/anaphylactoid 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 side effects (occurring in less than 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctoror nurse.
5: Howto store Carboplatin
Keep out of reach and sight of children. .
Do not use carboplatin infusion after expiry date, which is stated onl the label.
The expiry date refers to the last day of that month.
Store below 25°C. Do not refrigerate or freeze. Keep vial in the outer| carton in order to protect from light.
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In use: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 30 hours at 2-I 8C.
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 2-8°C, unless dilution has. taken place in controlled and validated aseptic condition
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. Further information
What Carboplatin Infusion contains
The active ingredient in Carboplatin infusion is carboplatin.
The other ingredient is waterfor injections 1
What Carboplatin Infusion looks like and content of the pack
Carboplatin infusion is a clear, colourless to slightly pale yellow, solution.
Each 1ml of concentrate for solution for infusion contain 10mg oil carboplatin
Each 5 ml vial contains 50 mg of carboplatin Each 15ml vial contains 150 mg of carboplatin Each 45 ml vial contains 450 mg of carboplatin Each 60 ml vial contains 600 mg of carboplatin
Not all pack size may be marketed.
Marketing Authorization holderand manufacturer: .
North Harrow, Middlesex, HA1 4HF,
United Kingdom
The leaflet was last approved in 06/2011.
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Dilution and Reconstitution:
.The product must be diluted prior to infusion, with 5 % dextrose Isolution or 0.9 % sodium chloride solution, to concentrates as low as 0.5 mg/ml.
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Incompatibilities
Needles or intravenous sets containing aluminium parts that may come into contact with Carboplatin Infusion should not be used for preparation or administration of Carboplatin Infusion. iThis medicinal product must not be mixed with other medicinal product except 5 % dextrose solution or 0.9 % sodium chloride solution.
Carboplatin may interact with aluminium to form a black precipitate. Reedies, syringes, catheters or intravenous sets containing aluminium parts that may come into contact with carboplatin should ot be used for preparation or administration of carboplatin.
helf life and storage
Carboplatin Infusion is intended for single use only.
before opening
Store below 25°C. Do not refrigerate or freeze. Keep vial in the outer |carton in order to protect from light.
After dilution
In use: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 30 hours at 2-8C.
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 2-8°C, unless dilution has taken place in controlled and validated aseptic condition
INSTRUCTIONS FOR USE/HANDLING, PREPARATION AND DISPOSAL GUIDE FOR USE WITH CARBOPLATIN
Handling of Carboplatin
As with other antineoplastic agents, Carboplatin must be prepared and handled with caution.
The following protective measures should be taken when handling Carboplatin
Personnel should be trained in appropriate techniques for reconstitution and handling
1. Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents. Personnel handling Carboplatin Infusion should wear protective clothing: goggles, gowns and disposable gloves and masks.
A designated area should be defined for syringe preparation! (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper All items used for reconstitution, administration or cleaning (including gloves) should be placed in high-risk, waste-disposal bags for high temperature incineration.
Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by! soaking, and then water. All contaminated and cleaning materials should be placed in high-risk, waste- disposal bags for| incineration. Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade! the skin by using a scrub brush. Medical attention should be sought. Always wash hands after removing gloves.
Preparation of infusion solution
The product must be diluted before use. It may be diluted with dextrose or Sodium Chloride, to concentrations as low as 0.5 mg/ml (500 micrograms/ml). '
Disposal I
Medicines should not be disposed of via wastewater or household waste. All material used for preparation, administration or otherwise! coming into contact with carboplatin should undergo disposal according to local guidelines for the handling of cytotoxic compounds, j