Brand Name

    US Brand Name

    Platinol-AQ

    Canadian Brand Name

    CISplatin


    Description

    Cisplatin injection is used to treat advanced cancer of the bladder, ovaries, or testicles.

    Cisplatin is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

    This medicine is to be given only by or under the direct supervision of a doctor.

    This product is available in the following dosage forms:

    • Powder for Solution
    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of cisplatin injection in the pediatric population. Safety and efficacy have not been established. This medicine may increase the risk for serious ear or hearing problems in children younger that 5 years of age.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cisplatin injection in the elderly. However, elderly patients are more likely to have age-related kidney disease or unwanted effects (eg, nerve problems, blood or bone marrow problems), which may require caution and an adjustment in the dose for patients receiving this medicine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Measles Virus Vaccine, Live
    • Mumps Virus Vaccine, Live
    • Rotavirus Vaccine, Live
    • Rubella Virus Vaccine, Live
    • Varicella Virus Vaccine, Live
    • Zoster Vaccine, Live

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adenovirus Vaccine Type 4, Live
    • Adenovirus Vaccine Type 7, Live
    • Aspirin
    • Bacillus of Calmette and Guerin Vaccine, Live
    • Cholera Vaccine, Live
    • Dengue Tetravalent Vaccine, Live
    • Doxorubicin
    • Doxorubicin Hydrochloride Liposome
    • Ebola Zaire Vaccine, Live
    • Furosemide
    • Influenza Virus Vaccine, Live
    • Melphalan
    • Paclitaxel
    • Poliovirus Vaccine, Live
    • Rituximab
    • Smallpox Monkeypox Vaccine, Live Non-Replicating
    • Smallpox Vaccine
    • Tacrolimus
    • Thioctic Acid
    • Trilaciclib
    • Typhoid Vaccine, Live
    • Valproic Acid
    • Vinorelbine
    • Yellow Fever Vaccine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Aldesleukin
    • Docetaxel
    • Fosphenytoin
    • Lithium
    • Phenytoin
    • Tobramycin
    • Warfarin

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Blood or bone marrow problems or
    • Ear or hearing problems or
    • Kidney disease or
    • Nerve problems—Use with caution. May make these conditions worse.

    Proper Use

    Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

    You will receive this medicine while you are in a medical facility. A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for 6 to 8 hours.

    If any of this medicine gets on your skin or in your eyes, nose, or mouth, tell your doctor or nurse right away.

    This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

    This medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

    While you are receiving this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

    This medicine often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. Other medicines may be given to you to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

    Missed Dose

    This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    Receiving this medicine while you are pregnant can harm your unborn baby. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 14 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 11 months after the last dose. If you think a pregnancy has occurred while receiving this medicine, tell your doctor right away.

    This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, diarrhea, a fever or chills, hives, hoarseness, itching, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.

    Cisplatin may cause serious kidney problems. Tell you doctor right away if you have blood in urine, change in frequency of urination or amount of urine, difficulty in breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness.

    Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy. These symptoms may occur 3 to 8 weeks after the last dose of this medicine.

    Cisplatin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

    • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
    • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
    • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
    • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
    • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
    • Avoid contact sports or other situations where bruising or injury could occur.

    Check with your doctor right away if you have dizziness, loss of balance, loss of hearing, ringing or buzzing in the ears, or troubled hearing. These could be symptoms of hearing or ear problems.

    Call your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. These could be symptoms of eye problems (eg, optical neuritis, papilledema, cortical blindness).

    This medicine may increase your risk for other cancers, including leukemia. Tell your doctor right away if you have bone or joint pain, fever, pale skin, unusual bleeding or bruising, unusual tiredness or weakness, weight loss, or swollen lymph glands in the neck, armpit, groin, or stomach.

    If cisplatin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

    Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Black, tarry stools
    • blood in urine or stools
    • burning, numbness, tingling, or painful sensations
    • change in frequency of urination or amount of urine
    • cough or hoarseness
    • difficulty in breathing
    • dizziness
    • drowsiness
    • feeling of fullness in the ears
    • fever or chills
    • increased thirst
    • loss of appetite
    • loss of balance
    • loss of hearing
    • lower back or side pain
    • nausea or vomiting
    • painful or difficult urination
    • pinpoint red spots on skin
    • ringing or buzzing in the ears
    • swelling of the feet or lower legs
    • trouble in hearing
    • unsteadiness or awkwardness
    • unusual bleeding or bruising
    • weakness in the arms, hands, legs, or feet

    Incidence not known

    • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
    • bleeding gums
    • blindness
    • blue-yellow color blindness
    • blurred vision
    • chest pain or discomfort
    • decreased vision
    • eye pain
    • fast heartbeat
    • general body swelling
    • headache
    • leg pain
    • nosebleeds
    • pain or discomfort in the arms, jaw, back or neck
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • pale skin
    • sweating
    • unusual tiredness or weakness
    • weight loss
    • yellow eyes or skin

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Bloating
    • constipation
    • diarrhea
    • hair loss or thinning
    • indigestion
    • loss of appetite
    • muscle cramps
    • rash
    • swelling or inflammation of the mouth

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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