In the U.S.—

In Canada—

• Antineoplastic

Cisplatin ( sis-PLA-tin) belongs to the group of medicines known as alkylating agents. It is used to treat cancer of the bladder, ovaries, and testicles. It may also be used to treat other kinds of cancer, as determined by your doctor.

Cisplatin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cisplatin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with cisplatin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Cisplatin is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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 cisplatin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cisplatin.

Pregnancy—There is a chance that this medicine may cause birth defects if either the male or female is taking it at the time of conception or if it is taken during pregnancy. Cisplatin causes toxic or harmful effects in the fetus in humans and birth defects in mice. In addition, many cancer medicines may cause sterility which could be permanent. Although sterility has not been reported with this medicine, the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving cisplatin. Tell your doctor right away if you think you have become pregnant while receiving cisplatin.

Breast-feeding—Because cisplatin may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Hearing problems and loss of balance are more likely to occur in children, who are usually more sensitive to the effects of cisplatin.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cisplatin in the elderly with use in other age groups.

Other medicines—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 cisplatin, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Introl A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Cisplatin may increase the effects of these medicines or radiation therapy on the blood

• Anti-infectives by mouth or by injection (medicine for infection) or
• Chloroquine (e.g., Aralen) or
• Combination pain medicine containing acetaminophen and aspirin (e.g., Excedrin) or other salicylates (with large amounts taken regularly) or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Inflammation or pain medicine, except narcotics or
• Lithium (e.g., Lithane) or
• Penicillamine (e.g., Cuprimine) or
• Plicamycin (e.g., Mithracin) or
• Quinine (e.g., Quinamm) or
• Tiopronin (e.g., Thiola)—Risk of ear and kidney problems caused by cisplatin is increased

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Cisplatin may raise the amount of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not work as well in patients receiving cisplatin

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones (history of)—Cisplatin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Hearing problems—May be worsened by cisplatin

• Infection—Cisplatin decreases your body's ability to fight infection

• Kidney disease—Effects of cisplatin may be increased because of slower removal from the body

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 usually causes nausea and vomiting that may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects, especially if they are severe.

Dosing—

The dose of cisplatin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving cisplatin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of cisplatin, ask your doctor.

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

While you are being treated with cisplatin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Cisplatin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

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.

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.

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

Also, because of the way cancer medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

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

• Less common
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness accompanied by fever or chills;  dizziness or faintness (during or shortly after a dose);  fast heartbeat (during or shortly after a dose);  fever or chills;  lower back or side pain accompanied by fever or chills;  painful or difficult urination accompanied by fever or chills;  pain or redness at place of injection;  pinpoint red spots on skin;  swelling of face (during or shortly after a dose);  unusual bleeding or bruising ;  wheezing (during or shortly after a dose) 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Joint pain;  loss of balance;  ringing in ears;  swelling of feet or lower legs;  trouble in hearing;  unusual tiredness or weakness 
  
  

• Less common
  • Convulsions (seizures);  loss of reflexes ;  loss of taste;  numbness or tingling in fingers or toes;  trouble in walking  
  
  

• Rare
  • Agitation or confusion;  blurred vision ;  change in ability to see colors (especially blue or yellow);  muscle cramps;  sores in mouth and on lips 
  
  

Other 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:

• More common
  • Nausea and vomiting (severe) 
  
  

• Less common
  • Loss of appetite 
  
  

After you stop receiving cisplatin, it may still produce some side effects that need attention. During this period of time check with your doctor if you notice any of the following side effects:

• Black, tarry stools;  blood in urine or stools;  convulsions (seizures);  cough or hoarseness;  decrease in urination;  fever or chills;  loss of balance;  loss of reflexes;  loss of taste;  lower back or side pain;  numbness or tingling in fingers or toes;  painful or difficult urination;  pinpoint red spots on skin;  ringing in ears;  swelling of feet or lower legs;  trouble in hearing;  trouble in walking;  unusual bleeding or bruising  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cisplatin is used in certain patients with the following medical conditions:

• Cancer of the outside layer of the adrenal gland
• Cancer of the breast
• Cancer of the cervix
• Cancer of the endometrium
• Cancer of the fallopian tube or lining of the abdomen (spreading from the ovary)
• Cancer of the esophagus
• Cancer of the stomach
• Cancer of the lung
• Neuroblastoma (a certain type of cancer in nerve tissues that occurs in children)
• Cancer of the prostate
• Cancers of the head and neck
• Cancer of the liver
• Cancer of the thyroid
• Cancer of the anus
• Cancer of the vulva
• Cancer of the bile duct
• Cancer of the skin, including types that spread to other parts of the body
• Cancer of unknown primary site
• Cancer of the lymph system
• Hepatoblastoma (a certain type of liver cancer that occurs in children)
• Thymoma (a cancer of the thymus, which is a small organ that lies under the breastbone)
• Tumors in the ovaries
• Gestational trophoblastic tumors (tumors in the uterus or womb)
• Wilms' tumor (a cancer of the kidneys occurring mainly in children)
• Retinoblastoma (a cancer of the eye occurring mainly in children)
• Cancer of the bones (in children)
• Cancer of the muscles, connective tissues (tendons), vessels that carry blood or lymph, joints, and fat.
• Autoimmune deficiency syndrome (AIDS)–associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.