Patient leaflet - Cisplatin 1 mg/ml Sterile concentrate
1. What Cisplatin Sterile Concentrate 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 cyostatics.
Cisplatin can destroy cells in your body that may cause certain types of cancer (tumour of testis, tumour of ovary, tumour of the bladder, head and neck epithelial tumour, lung cance
r
and for cervical cancer in combination with radiotherapy).
2. What you need to know before you use Cisplatin Sterile Concentrate
Do not use Cisplatin Sterile Concentrate
- if you are allergic to cisplatin, other platinum containing compounds or any of the other ingredients of this medicine (listed in section 6)
- if you have had hypersensitivity to similar anti-cancer medicines in the past
- if you have severe kidney disease
- if you have hearing difficulties
- if you have very low numbers of blood cells (called ‘myelosuppression’), (your doctor will check this with a blood test)
- if you are dehydrated
- if you are breast-feeding
- if you need to have a vaccine for ‘yellow fever’
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cisplatin Sterile Concentrate:
- if you have any symptoms of nerve damage (peripheral neuropathy) such as pins and needles, numbness or poor sense of touch. You will be examined regularly for these symptoms and treatment may be stopped if necessary.
- if you have had radiation therapy to your head
- Cases of delayed-onset hearing loss have been reported in the paediatric population. Long term follow-up in this population is recommended
Cisplatin is very toxic and treatment is likely to cause some side effects. Cisplatin can affect bone marrow causing changes to blood cell production in the body, tell your doctor if you have unusual bleeding or bruising. Do not take aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) or other medications without telling your doctor. Your doctor will test your blood frequently and check for signs of infection.
Cisplatin may cause hearing problems (ototoxicity). Hearing function will be monitored prior to and during treatment. If you experience hearing problems, you must tell your doctor. Tell your doctor if you intend to have a vaccine during treatment with Cisplatin, live vaccines should be avoided as they can cause serious infections, and your response to other vaccine types (inactivated) may be reduced.
Other medicines and Cisplatin Sterile Concentrate
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, 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. Aminoglycoside antibiotics must not be taken within 2 weeks of treatment with cisplatin.
- 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
- the effectiveness of oral anticoagulants such as coumarins/warfarin may be affected. Your doctor will monitor with blood tests
- use of certain antihistamines, medicines used to prevent nausea and vomiting and medicines to treat psychiatric disorders such as buclizine, cyclizine, loxapine, meclizine, phenothiazines, thioxanthenes or trimethobenzamines. These medicines may hide the symptoms of balance changes (such as dizziness or tinnitus)
- the effectiveness of medicines used for the treatment of convulsions (e.g. phenytoin) may be reduced, so blood levels may need to be checked
- cisplatin may make the side effects of the anti-cancer medicine ifosfamide worse
- antigout medicines such as allopurinol, colchicine, probenecid or sulfinpyrazone reduce the levels of uric acid in the blood. Your doctor may need to change your dose of Cisplatin
Pregnancy, breast-feeding and fertility
Pregnancy
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 using this medicine.
Cisplatin must not be used during pregnancy unless clearly indicated by your doctor.
You must use reliable contraception during and for at least 29 weeks (at least 7 months) after the last dose.
Breast-feeding
You must not use this medicine if you are breast-feeding and for 4 weeks after treatment.
Fertility
Treatment with cisplatin can potentially cause permanent sterility in men.
Men with female partners of childbearing potential should be advised to use effective contraception during treatment with cisplatin and for at least 17 weeks (at least 4 months) after the last dose.
Both men and women should seek advice on fertility preservation before 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 Sterile Concentrate contains sodium
Cisplatin 10 mg/10 ml (1 mg/ ml) Sterile Concentrate contains 35.4 mg of sodium (main component of cooking/table salt) in each 10 ml vial. This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Cisplatin 50 mg/50 ml (1 mg/ml) Sterile Concentrate contains 177 mg of sodium (main component of cooking/table salt) in 50 ml vial. This is equivalent to 8.9% of the recommended maximum daily dietary intake of sodium for an adult.
Cisplatin 100 mg
/100 ml (1 mg/ ml) Sterile C
oncentrate contains 354
mg of sodium (main 7.7% of the
component of cookin recommended maxi
g/table salt) in 100 ml vial. This is equivalent to 1 mum daily dietary intake of sodium for an adult.
This medicine may b into additional consid
e prepared with a solution that contains sodium. eration if you are on a low salt (sodium) diet.
This should be taken
3. How to use
Cisplatin Sterile Concentrate
Dosage and method of administration
Cisplatin should only be given by a specialist in cancer treatment.
The concentrate is diluted with a sodium chloride solution. Cisplatin is only usually given by injection into a vein (an intravenous infusion) over a period of 6 to 8 hours. Cisplatin should not come into contact with any materials that contain aluminium. The recommended dosage of cisplatin depends on your well-being, the anticipated effect of the treatment, and whether or not cisplatin is given on its own (monotherapy) or in combination with other agents (combination chemotherapy).
Cisplatin (monotherapy):
The recommended dose is:
- a single dosage of 50 to 120 mg/m2 body surface area (BSA), 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 BSA or more, once every 3 to 4 weeks.
For treatment of cervical cancer cisplatin is used in combination with radiotherapy or other chemotherapy medicines.
A typical dose is 40 mg/m2 BSA 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 use 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.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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)
- pain or swelling at the injection site during the injection (may be due to the injection not going into the vein properly, which can lead to serious damage to the tissues around the injection site)
stroke
Cisplatin 1 mg/ml
Concentrate The following information is intended for healthcare professionals only
Sterile
Fu
rther to the information included in section 3, practical information on the preparation/ ha
ndling of the medicinal product is provided here.
In
compatibilities
Ci
splatin may interact with metal aluminium to form a black precipitate of platinum. All al
uminium-containing IV sets, needles, catheters and syringes must be avoided.
Th
ere is a total loss of cisplatin in 30 minutes at room temperature when mixed with m
etoclopramide and sodium metabisufite in concentrations equivalent to those that would be fo
und on mixing with a commercial formulation of metoclopramide.
Ci
splatin and sodium metabisulfite have been known to react chemically. Such antioxidants mi
ght inactivate cisplatin before administration if they are present in intravenous fluids.
Sp
ecial precautions for disposal and other handling
Th
e vials are for single use only. Discard any unused contents.
Re
fer to local cytotoxic handling guidelines.
Di Co re
lution prior to administration: An appropriate volume of Cisplatin 1 mg/ml Sterile ncentrate should be diluted in 2 litres of sterile 0.9% sodium chloride injection. Dilution as commended results in clear, colourless solution with no visible particles. llowing dilution in 0.9% sodium chloride injection to a final concentration of 0.15 mg/mL, emical in-use stability has been demonstrated for up to 14 days at 25ºC when stored in n-PVC infusion bags, and for 24 hours when stored at 25°C protected from light when epared in PVC infusion bags. The diluted product should not be refrigerated. From a crobiological point of view, however, the product should be used immediately. If not used mediately, in-use storage times and conditions prior to use are the responsibility of the user d dilution should take place in controlled and validated aseptic conditions. ministration: Should be administered only by or under the direct supervision of a qualified ysician who is experienced in the use of cancer chemotherapeutic agents. e dilution should be administered only intravenously by infusion over a period of 6 to 8 hours. hough cisplatin is usually administered intravenously, the drug has also been given intraperitoneal instillation to patients with intraperitoneal malignancies (e.g., ovarian mours). Steep concentration gradients between intraperitoneal and plasma drug levels can
Fo ch no pr
mi im an Ad ph Th Alt by tu
be achieved by this route of administration.
Preparation (Guidelines): Chemotherapeutic agents should be prepared for administration only by professionals who have been trained in the safe use of preparation. Operations such as dilution and transfer to syringes should be carried out only in the designated area.
The personnel carrying out these procedures should be adequately protected with clothing gloves and eye shield.
,
Pregnant personnel are advised not to handle chemotherapeutic agents. For administration, any device containing aluminium that may come in contact with cisplati (sets for intravenous infusion, needles, catheters, syringes) must be avoided. Contamination: In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to tre the transient stinging of skin. Medical advice should be sought if the eyes are affected. In the event of spillage, operators should put on gloves and mop the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and seal it.
n
at
Disposal: Syringes, containers, absorbent materials, solution and any other contaminated material should be placed in a thick plastic bag or other impervious container and incinerate
d.
- brain dysfunction (confusion, slurred speech, sometimes blindness, memory loss and paralysis)
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) • decrease in blood platelets, which increases 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
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 level of consciousness
- 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 attack
Not known: frequency cannot be estimated from the available data:
- signs of infection such as fever or sore throat
- haemolytic anaemia
- 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 and pain
- 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
- dizziness, light-headedness or fainting on standing up
- 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
- shortness of breath, chest pain particularly upon breathing in, and coughing up blood • problems with your kidneys or urine
- hair loss
rash
extreme tiredness/weakness
injections (see section 2 ‘Cisplatin Sterile Concentrate contains sodium’).
swelling or soreness where the injection was given
What Cisplatin Sterile Concentrate looks like and contents of the pack
cramps or spasms
Cisplatin Sterile Concentrate is a clear, colourless to pale yellow concentrate for solution for infusion (free from visible particles) which comes in glass containers called vials. It may be supplied in packs containing:
- 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.
1 or 10 x 10 mg/10 ml vial
Cisplatin 1 mg/ml Sterile Concentrate
1 or 10 x 50 mg/50 ml vial
1 or 10 x 100 mg/100 ml vial
Reporting of side effects
Not all pack sizes may be marketed
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.
Marketing Authorisation Holder
Hospira UK Limited,
Walton Oaks,
Walton-On-The-Hill,
Dorking Road,
5. How to store Cisplatin Sterile Concentrate
2025-1003871A Cisplatin 1 mg/ml Sterile
Tadworth,
Keep this medici
ne out of the sight and reac
h of children.
Surrey,
KT20 7NS,
Expiry
UK
Do not use this medi
cine after the expiry date which is stated on the v
ial label and carton
after ‘EXP’. The expi
ry date refers to the last day of that month.
Manufacturer
Pfizer Service Company BV,
Storage
Do not store above 2
5°C. Do not refrigerate or freeze. Keep container
in the outer carton
Hermeslaan 11,
in order to protect fro
m light.
1932 Zaventem,
Belgium
Prepared infusions s
hould be used immediately, however, if this is not possible they can be stored for up to 14 days provided they have been prepared in a way to exclude microbial contamination. The prepared infusions should not be refrigerated.
This leaflet was last revised in 11/2025.
Ref: gxCP 20_0
6. Contents of the pack and other information
What Cisplatin Sterile Concentrate contains
The active substance is cisplatin. Each millilitre (ml) of solution contains 1 milligram (mg) of cisplatin.
The other ingredients are mannitol, sodium chloride, dilute hydrochloric acid and water for