1 mg / mL concentrate for infusion solution
cisplatin
What Cisplatin Pfizer is and what it is used for
Cisplatin belongs to a group of medicines called cytostatics. Treatment with chemotherapy is sometimes called chemotherapy.
Cisplatin is used in the treatment of certain types of cancer, such as ovarian cancer, testicular cancer, bladder cancer, lung cancer, cancer of the head and neck area, and in cervical cancer in combination with other chemotherapy. Cisplatin can be used as the only drug but it is often used in combination with other chemotherapy drugs. Your doctor can give you more information.
Cisplatin contained in Cisplatin Pfizer may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Cisplatin Pfizer
Do not use Cisplatin Pfizer
- if you are allergic to cisplatin or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to any other medicine that contains platinum
- if you have impaired kidney function
- if you suffer from dehydration
- if you have severe bone marrow dysfunction
- if you have a hearing impairment
- if you are breast-feeding
- together with live vaccines including vaccines against yellow fever.
Warnings and cautions
- Treatment with Cisplatin Pfizer should be performed under the careful supervision of a physician with extensive experience in the treatment of anticancer medicines.
- Cisplatin Pfizer can have harmful effects on the kidneys. Your doctor will therefore examine your kidney function and take regular blood tests to assess your blood count, determine your sodium, potassium, calcium, and magnesium levels in the blood and also examine your liver function.
- Cisplatin Pfizer can cause nerve damage. Your doctor will therefore perform neurological examinations regularly.
- Cisplatin can cause hearing loss such as tinnitus and/or hearing loss. Your hearing will be checked before each cycle of treatment with Cisplatin Pfizer.
- Allergic reactions and injection site reactions may occur during treatment with Cisplatin Pfizer, see section 4 Possible side effects.
- Cisplatin Pfizer may affect fertility. If you are planning to have a baby, talk to your doctor before taking Cisplatin Pfizer (see Pregnancy, breast-feeding, and fertility ).
Other medicines and Cisplatin Pfizer
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
You should not take so-called live vaccines, such as yellow fever vaccines when you are being treated with cisplatin (see also the section Do not use Cisplatin Pfizer).
Talk to your doctor if you are taking any of the medicines listed below:
- Certain types of antibiotics such as cephalosporins, aminoglycosides, and/or amphotericin B.
- A contrast agent (can be given in connection with X-ray examination).
- Some other chemotherapy drugs (eg bleomycin, methotrexate, ifosfamide, and paclitaxel).
- Loop diuretics ( diuretic and antihypertensive drugs).
- Anticoagulants (blood thinners).
- Medicines for hypersensitivity so-called antihistamines such as bulletin, cyclizine, meclozine, and phenothiazines. The first signs of hearing loss (dizziness and/or tinnitus ) may be hidden if you are given these medicines at the same time as cisplatin treatment.
- Drugs for epilepsy such as phenytoin. Cisplatin may reduce the effect of these medicines.
- Pyridoxine (used for vitamin B 6 deficiency ).
- Lithium (used in the treatment of bipolar disorder ).
- Some medicines for mental illness, such as loxapine, thioxanthenes, or trimethobenzamide. The first signs of hearing loss (dizziness and/or tinnitus ) may be hidden if you are given these medicines at the same time as cisplatin treatment.
Pregnancy, breastfeeding, 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 using this medicine.
Cisplatin can affect the fetus when given to a pregnant woman. Cisplatin Pfizer should only be given on the doctor’s explicit prescription after the mother’s needs have been weighed against the risks to the fetus.
Cisplatin passes into breast milk in such quantities that there is a risk of affecting the baby. Cisplatin Pfizer should not be used during breast-feeding.
Both female and male patients of childbearing potential should use effective contraception to avoid pregnancy during and at least 6 months after stopping treatment with Cisplatin Pfizer.
Genetic consultation is recommended if the patient wishes to have children after the end of treatment.
Treatment with cisplatin may cause irreversible ( irreversible ) infertility. It is recommended that men who wish to become fathers in the future seek advice regarding freezing storage of semen before treatment.
Driving and using machines
Due to its side effect, Cisplatin Pfizer can affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cisplatin Pfizer contains sodium and latex
This medicine contains 3.5 mg sodium per milliliter. This should be considered by patients on a low-salt diet.
The rubber stopper of the vial contains latex which may cause severe allergic reactions.
3. How to use Cisplatin Pfizer
Cisplatin Pfizer will be given to you by healthcare professionals.
Your doctor will calculate the correct dose of cisplatin for you and how often it should be given. Dose one will depend on your disease and your body size.
Cisplatin is usually given as a single dose every three to four weeks or as a daily dose for five days every three to four weeks.
This medicine will be diluted before it is given to you. It will then be given as an infusion (drip) into a vein for 1 to 8 hours.
If you use more Cisplatin Pfizer than you should
Your doctor will make sure you get the right dose. Should overdose occur, side effects may increase? Your doctor may treat these side effects symptomatically.
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.
If you get side effects, it is important that you tell your doctor before taking the next treatment.
Serious side effects are
Contact your doctor immediately if you get any of the following:
- You have severe pain or swelling in one of your legs, chest pain, or difficulty breathing (may indicate harmful blood clots in a blood vessel) (common: may affect up to 1 in 10 people).
- Pain, swelling, redness at the injection site during infusion. This may be because the infusion does not enter the blood vessel properly, which can lead to inflammation and severe damage to the skin around the injection site (common).
- Swelling of the face, wheezing, difficulty breathing, palpitations, and/or low blood pressure. This may be a symptom of a severe allergic reaction (anaphylactoid reaction) (uncommon).
- Severe chest pain that may radiate to the jaw or arm with sweating, shortness of breath, and nausea. This may be a sign of a heart attack (rare).
These side effects are serious and you may need emergency care.
Other side effects that may occur:
Very common (may affect more than 1 user in 10):
- reduced production of blood cells; decreased number of platelets and/or white blood cells in the blood, anemia
- decreased amount of sodium in the blood
- hearing damage that often manifests as hearing loss or tinnitus ( tinnitus )
- nausea, vomiting, loss of appetite, diarrhea
- fever
Common (may affect up to 1 in 10 people):
- blood poisoning
- decreased ability to hear a normal conversation
- irregular heartbeat, slow heart rate, fast heart rate
- loss of appetite
- kidney disease (tubular necrosis )
- weakness, malaise
Uncommon (may affect up to 1 in 100 people):
- decreased amount of magnesium in the blood
- effects on the nervous system (tremors, muscle weakness, loss of taste, spinal cord disease, optic neuritis)
- changed color vision
- liver effects
- disorders in the formation of sperm
Rare (may affect up to 1 in 1,000 people):
- blood cancer ( acute leukemia )
- convulsions, tingling and numbness, diseases of the brain (leukoencephalopathy), including symptoms such as confusion and difficulty concentrating (signs of a condition called RPLS (reversible posterior leukoencephalopathy syndrome), stroke
- different degrees of vision loss
- dizziness (vestibular toxicity )
- inflammation of the oral mucosa ( stomatitis )
Very rare (may affect up to 1 in 10,000 people)
- cardiac arrest
Has been reported (occurs in an unknown number of users):
- the infection you (which can lead to death)
- anemia due to increased degradation of red blood cells (hemolytic anemia )
- decreased number of white blood cells in the blood ( neutropenia )
- hot flashes, redness
- increased or abnormal amount of certain enzymes (amylase) and hormones ( ADH ) in the blood
- dehydration, decreased amount of potassium, phosphate, and/or calcium in the blood, increased amount of uric acid in the blood, tetanus
- diseases of the blood vessels of the brain including inflammation, loss of taste, sudden cutting pain from the neck down to the back and legs during forwarding bending (Lhermitte’s symptoms), nerve damage (autonomic neuropathy )
- swelling of the eye (papilloedema), blurred vision, color blindness, loss of vision, inflammation of the optic nerve, pigmentation of the retina
- deafness
- heart disease
- impaired blood flow, e.g. in the brain, but also in fingers and toes (Raynaud’s phenomenon), vascular disease (thrombotic microangiopathy, hemolytic uremic syndrome )
- hiccup
- increased amount of liver enzymes, increased amount of bilirubin in the blood
- a blood clot in the lungs ( pulmonary embolism )
- skin rash, hair loss
- muscle spasm
- renal impairment including renal failure
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cisplatin Pfizer
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store in a cold place.
Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not use this medicine if the solution is cloudy or contains particles.
A reconstituted infusion solution should be used immediately. Other shelf life and storage times are the responsibility of the user and should not normally be longer than 24 hours at a maximum of 25 ° C unless dilution has taken place under controlled and validated aseptic conditions. The diluted product should not be stored in the refrigerator. When stored for more than 6 hours, the infusion should be protected from light.
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. Contents of the packaging and other information
Content declaration
The active substance is cisplatin. Each ml of concentrate for solution for infusion contains 1 mg cisplatin.
A vial with:
- 10 ml concentrate for solution for infusion contains 10 mg cisplatin
- 50 ml concentrate for solution for infusion contains 50 mg cisplatin
- 100 ml concentrate for solution for infusion contains 100 mg cisplatin
- The other ingredients are mannitol, sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.
The vial of the vial contains latex, see section Cisplatin Pfizer contains sodium and latex.
What the medicine looks like and the contents of the pack
The clear solution, colorless to pale yellow.
Pack sizes: 10 ml, 50 ml, and 100 ml in a brown glass bottle.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK
or
Pfizer Service Company BVBA
High Way 10
1930 Zaventem
Belgium