Patient leaflet - Cisplatin 1 mg / ml concentrate for solution for infusion
1. What Cisplatin Injection is and what it is used for
Cisplatin forms part of a group of medicines called cytostatics, which are used in the treatment of cancer. Cisplatin can be used alone but more commonly cisplatin is used in combination with other cytostatics.
Cisplatin can destroy cells in your body that may cause certain types of cancer (tumour of the testis, tumour of the ovary, tumour of the bladder, head and neck epithelial tumour, lung cancer and for cervical cancer in combination with radiotherapy).
Your doctor will be able to provide you with more information.
You must talk to a doctor if you do not feel better or you feel worse.
2. What you need to know before you use Cisplatin Injection
Do not use Cisplatin Injection if:
- you are allergic to cisplatin or similar anti-cancer medicines or to any of the other ingredients of this medicine (listed in section 6)
- you have very low numbers of blood cells (called ‘myelosuppression’), (your doctor will check this with a blood test)
- you are pregnant or breast-feeding
- you have severe kidney disease
- you have hearing difficulties
- you are dehydrated
- you need to have a vaccine for “yellow fever”
Tell your doctor if the above applies to you before this medicine is used.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cisplatin Injection:
- if you have any symptoms or nerve damage (peripheral neuropathy) such as pins and needles, numbness or poor sense of touch
- if you have had radiation therapy to your head
Cisplatin may cause hearing problems (ototoxicity) and kidney problems (nephrotoxicity). Renal function and hearing will be monitored prior to and during treatment. Cisplatin may also cause decreased levels of blood cells (myelosuppression), which will be monitored.
Other medicines and Cisplatin Injection
Talk to your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine, for example:
- some antibiotics, such as cephalosporins, aminoglycosides and amphotericin B, and some substances used in medical imaging may make the side effects of cisplatin worse, particularly kidney problems
- some water tablets called loop diuretics, antibiotics called aminoglycosides and an anti- cancer medicine called ifosfamide may make the hearing loss side effect of cisplatin worse
- bleomycin (anti-cancer medicine), methotrexate (used to treat cancer or arthritis) and paclitaxel (anti-cancer medicine) may produce more side effects if cisplatin is also being used
- cisplatin may reduce the effectiveness of anticonvulsants (used to treat epilepsy), phenytoin blood levels may need to be checked
- the effectiveness of oral anticoagulants (e.g. warfarin) may be affected, your doctor will monitor with blood tests
- buclizine, cyclizine and meclozone (antihistamine medicines), loxapine, phenothiazines and thioxanthenes (medicines used to treat psychiatric disorders) or trimethobenzamines (medicines used to prevent nausea and vomiting) may hide the symptoms of balance changes (such as dizziness or tinnitus)
- cisplatin may make the side effects of the anti-cancer medicine ifosfamide worse
- pyroxidine (vitamin B6) and altretamine (anti-cancer medicine) used in combination with cisplatin for the treatment of advanced ovarian cancer may reduce the time spent in recovery. Your doctor will discuss this with you
- bleomycin and etoposide anti-cancer medicines) used in combination with cisplatin and lithium (used to treat mental illness) may reduce the levels of lithium in the blood. It is recommended to monitor the lithium values
- yellow fever vaccine must not be used at the same time as treatment with cisplatin due to the risk of death resulting from the vaccination. It is recommended to use an inactive vaccine.
Cisplatin Injection with food and drink
There are no special recommendations concerning the use of this medicine with food and drink.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Cisplatin must not be used during pregnancy unless clearly indicated by your doctor. It may cause birth defects, so it is important to tell your doctor if you think you are pregnant. Ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
Do not use this medicine if you are breast-feeding.
Fertility
Both men and women should seek advice on fertility preservation before treatment. If you are sexually active, you are advised to use effective birth control to prevent pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment with cisplatin and for at least 7 months after the last dose.
Males should use effective contraception during treatment and for at least 4 months after the last dose. Male patients treated with cisplatin are advised not to father a child during treatment and up to 6 months after treatment. Treatment with cisplatin can potentially cause permanent sterility in men. It is recommended that men who wish to become fathers in the future, seek advice regarding frozen storage (cryo-conservation (freezing)) of their sperm prior to treatment.
Driving and using machines
Do not drive or use machines if you experience any side effect which may lessen your ability to do so.
Cisplatin injection contains sodium
This medicine contains 3.5 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 38.3% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to use Cisplatin Injection
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Dosage and method of administration
Cisplatin Injection should only be given by a specialist in cancer treatment.
The concentrate is diluted with a sodium chloride solution. Cisplatin is only given by injection into a vein (an intravenous infusion).
Cisplatin should not come into contact with any materials that contain aluminium.
Supportive equipment should be available to control anaphylactic reactions.
The recommended dosage of cisplatin depends on your well-being, the anticipated effects of the treatment, and whether or not cisplatin is given on its own (monotherapy) or in combination with other agents (combination chemotherapy).
Recommended dose
Cisplatin (monotherapy):
The following dosages are recommended:
- A single dosage of 50 to 120 mg/m² body surface, every 3 to 4 weeks.
- 15 to 20 mg/m² per day over a 5-day period, every 3 to 4 weeks
Cisplatin in combination with other chemotherapeutical agents (combination chemotherapy):
- 20 mg/m² or more, once every 3 to 4 weeks.
For treatment of cervical cancer cisplatin is used in combination with radiotherapy:
- A typical dose is 40 mg/m² weekly for 6 weeks.
In order to avoid, or reduce, kidney problems, you are advised to drink copious amounts of water for a period of 24 hours following treatment with cisplatin.
If you take more cisplatin than you should
Your doctor will ensure that the correct dose for your condition is given. In case of overdose, you may experience increased side effects. Your doctor may give you symptomatic treatment for these side effects. If you think you received too much cisplatin, immediately contact your doctor.
If you forget to use Cisplatin
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
- severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), flushing and you may feel you are going to faint
- severe chest pains possibly radiating to the jaw or arm with sweating, breathlessness and nausea (heart attack)
- fainting or fitting
- hearing problems – you may experience ringing in the ears or hearing loss (ototoxicity)
- kidney and urine problems
- excessive tiredness and general feeling of being unwell, which could be symptoms of decreased levels of blood cells (myelosuppression). This would be confirmed with a blood test.
These are serious side effects. You may need urgent medical attention.
Very common: may affect more than 1 in 10 people
- decrease in bone marrow function (which can affect the production of blood cells)
- decrease in white blood cells which makes infections more likely (leukopenia)
decease in blood platelets, which increase the risk of bruising and bleeding
(thrombocytopenia)
- reduction of red blood cells which can cause weakness and your skin to look pale (anaemia)
- reduced level of sodium in the blood
- high temperature
- damage to the ear (ototoxicity)
- loss of appetite, anorexia
- feeling or being sick
- diarrhoea
- problems with your kidneys or urine
- high level of uric acid in the blood
Common: may affect up to 1 in 10 people
- severe pain or swelling in either of your legs, chest pain, or difficulty breathing (possibly indicating harmful blood clots in a vein)
- fast, irregular or slow heart beats
- sepsis (blood poisoning)
Uncommon: may affect up to 1 in 100 people
- severe allergic reaction (see above)
- damage to the ear (ototoxicity)
- reduced level of magnesium in the blood
- abnormal sperm production
Rare: may affect up to 1 in 1,000 people
- increased risk of acute leukaemia
- seizures (fits)
- fainting, headache, confusion and loss of vision
- loss of certain types of brain function, including brain dysfunction characterised by spasms and reduced levels of consciousness
- brain dysfunction (confusion, slurred speech, sometimes blindness, memory loss, and paralysis)
- heart attack
- inflammation of mucous membranes of the mouth (stomatitis)
- peripheral neuropathy of the sensory nerves, characterised by tickling, itching or tingling without cause and sometimes with loss of taste, touch, sight, sudden shooting pains from the neck through the back and into the legs when bending forward
Very rare: may affect up to 1 in 10,000 people
- heart arrest
Not known: frequency cannot be estimated from the available data
- signs of infection such as fever or sore throat
- haemolytic anaemia
- neutropenia (an abnormally low count of a type of white blood cell called neutrophils)
- inappropriate release of vasopressin hormone (ADH) which may lead to low sodium in the blood and water retention
- blood amylase (enzyme) increased
- dehydration
- reduced level of calcium, phosphate, potassium in the blood
- high level of uric acid in the blood
- muscle cramping
- spinal disease which may cause a sensation of electric shocks passing into your limbs
- loss of taste
- problems with your eyesight (blurred vision, odd colours, loss of vision or eye pain)
- ringing in the ears or deafness
- heart problems
- unusually cold or white hands and feet
- tingling, numbness or tremor in your hands, feet, arms or legs
- persistent headache
- feeling or being sick
- loss of appetite, anorexia
- hiccups
- diarrhoea
- liver enzymes increased, bilirubin increased
- difficulty breathing
- problems with your kidneys or urine
- hair loss
- rash
- extreme tiredness/weakness
- swelling or soreness where the injection was given
- cramps or spasms
- burning or prickling sensation
- unexpected bruising or bleeding
- haemolytic uremic syndrome which may cause changes to the kidneys and blood
Cisplatin may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems and to monitor electrolytes.
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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cisplatin injection
Keep this medicine out of the sight and reach of children.
Concentrate for solution for infusion 1 mg/ml
Keep container in the outer carton in order to protect from light. Do not refrigerate or freeze.
If a crystal or precipitate has formed as a result of exposure to low temperatures, redissolve by keeping the vials at room temperature until a clear solution is obtained. The product should be discarded if the solution doesn’t become clear after vigorous shaking.
Do not use this medicine after the expiry date which is stated on the carton and the vial after ‘EXP’. The expiry date refers to the last day of that month. Do not use this medicine if you notice visible signs of deterioration.
Do not store above 25 °C. Do not refrigerate or freeze. Keep container in the outer carton in order to protect from light.
After dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C, protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user, dilution should take place in controlled and validated aseptic conditions.
Do not store diluted solutions in the refrigerator or freezer.
If you find the solution cloudy or a deposit that does not dissolve is noticed, the bottle should be discarded.
All materials that have been used for the preparation and administration, or which have been in contact with cisplatin in any way, must be disposed of according to local cytotoxic guidelines.
6. Contents of the pack and other information
What Cisplatin Injection contains
Cisplatin Injection contains the active ingredient cisplatin.
Each millilitre (ml) of solution contains 1 milligram (mg) of cisplatin.
The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
What Cisplatin Injection looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion.
Cisplatin is a clear, colourless to pale yellow solution in an amber glass vial, which is practically free from particles.
For 10 ml
10 ml type I amber glass vial with a 20 mm Rubber stoppers (Teflon coated), sealed with a 20 mm flip off tear off aluminium seal.
For 50 ml
50 ml type I amber glass vial with a 20 mm Rubber stoppers (Teflon coated), sealed with a 20 mm flip off tear off aluminium seal.
For 100 ml
100 ml type I amber glass vial with a 20 mm Rubber stoppers (Teflon coated), sealed with an 20 mm flip off tear off aluminium seal.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Dawa Ltd
5 Sandridge Close, Harrow,
Middlesex, HA1 1XD
United Kingdom
Manufacturer
S&D Pharma CZ, spol. s r.o Theodor 28,
Pchery (Pharmos a.s. facility) 27308, Czech Republic
Cipla (EU) Limited
Dixcart House, Addlestone Road, Bourne Business Park,
Addlestone, Surrey,
KT15 2LE
United Kingdom
Cipla Europe NV
De Keyserlei 58-60,
Bus 19, 2018
Antwerp, Belgium
This leaflet was last revised in 07/2025
Blind or partially sighted? Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.
0140/L-3 (Please note this is a Prescriber Information Leaflet NOT the SmPC. For full details regarding this product please refer to the SmPC.)
The following information is intended for medical or healthcare professionals only: Preparation and handling of the product
Like with all anti-neoplastic products caution is needed with the processing of cisplatin. Dilution should take place under aseptic conditions by trained personnel in an area specifically intended for this. Protective gloves should be worn for this. Precautions should be taken to avoid contact with the skin and mucous membranes. If skin contact did occur anyway, the skin should be washed with soap and water immediately. With skin contact tingling, burns and redness have been observed. In case of contact with the mucous membranes they should be copiously rinsed with water. After inhalation dyspnoea, pain in the chest, throat irritation and nausea have been reported.
Pregnant women must avoid contact with cytostatic drugs. Cisplatin should not be used during pregnancy unless the clinician considers the risk in an individual patient to be clinically justified.
Bodily waste matter and vomit should be disposed with care.
If the solution is cloudy or a deposit that does not dissolve is noticed, the bottle should be discarded. A damaged bottle must be regarded and treated with the same precautions as contaminated waste.
Contaminated waste must be stored in waste containers specifically marked for this. See section “Disposal”.
Preparation of the intravenous administration
Take the quantity of the solution that is needed from the bottle and dilute with at least 1 litre of the following solutions:
- 1. Normal Saline
- 2. 5% Dextrose in Normal saline
- 3. 5% Dextrose in 1/2 Normal saline containing 37.5 g of Mannitol.
Always look at the injection before use. Only a clear solution, free from particles should be administered.
If precipitate or crystal observed inside the vial, keep vial at room temperature (20 - 25°C) until a clear solution is obtained. Protect unopened container from light. The product should be discarded if the solution doesn’t become clear after vigorous shaking.
DO NOT bring in contact with injection material that contains aluminium. DO NOT administer undiluted.
With respect to microbiological, chemical and physical stability with use of the undiluted solutions, see below “Special precautions for storage”.
Disposal
All materials that have been used for the preparation and administration, or which have been in contact with cisplatin in any way, must be disposed of according to local cytotoxic guidelines. 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.
Incompatibilities
Do not bring in contact with aluminium. Cisplatin may interact with metal aluminium to form a black precipitate of platinum. All aluminium-containing IV sets, needles, catheters and syringes should be avoided.
Cisplatin decomposes with solution in media with low chloride content; the chloride concentration should at least be equivalent to 0.45% of sodium chloride.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Antioxidants (such as sodium metabisulphite), bicarbonates (sodium bicarbonate), sulfates, fluorouracil and paclitaxel may inactivate cisplatin in infusion systems.
Special precautions for storage
Medicinal product as packaged for sale:
Concentrate for solution for infusion 1 mg/ml
Undiluted solution: “Do not store above 25°C. Keep container in the outer carton in order to protect from light. Do not refrigerate or freeze. If the solution is not clear or an undissolvable precipitate is formed the solution must not be used.
Diluted solution: Chemical and physical in-use stability has been demonstrated after dilution with infusion fluids described in section “Preparation and handling of the product” for 24 hours at 25°C, protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not store diluted solutions in the refrigerator or freezer.