In the U.S.—

In Canada—

• Antineoplastic

Gemcitabine (jem-SITE-a-been ) belongs to the group of medicines called antimetabolites. It is used to treat cancer of the breast,pancreas and lung. It may also be used to treat other kinds of cancer, as determined by your doctor.

Gemcitabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with gemcitabine has been stopped.

This medicine is available only with your doctor's prescription, 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 gemcitabine, the following should be considered:

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

Pregnancy—Tell your doctor if you are pregnant. Studies in mice and rabbits have shown that gemcitabine causes birth defects and death of the fetus, as well as problems in the mother.

Be sure that you have discussed this with your doctor before starting treatment with this medicine. It is best to use birth control while you are receiving gemcitabine. Also, tell your doctor right away if you think you have become pregnant during treatment.

Breast-feeding—It is not known whether gemcitabine passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—There is no specific information comparing use of gemcitabine in children with use in other age groups.

Older adults—Gemcitabine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, seriously low blood counts tend to occur more often in elderly patients.

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 taking gemcitabine, 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., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or other cancer medicines—The risk of developing seriously low blood counts may be increased. Also, gemcitabine can cause problems, sometimes serious, in areas treated by radiation

• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Corticosteroids (cortisone-like medicine) or
• Cyclosporine (e.g., Sandimmune) or
• Mercaptopurine (e.g., Purinethol) or
• Muromonab-CD3 (monoclonal antibody) (e.g., Orthoclone OKT3) or
• Tacrolimus (e.g., Prograf)—There may be an increased risk of infection because gemcitabine decreases your body's ability to fight it

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

• Infection—Gemcitabine can decrease your body's ability to fight infection

• Kidney disease or
• Liver disease, severe—These conditions sometimes increase the effects of medicines by causing them to be removed from the body more slowly

Gemcitabine often causes nausea and vomiting. It can also cause flu-like symptoms such as chills, fever, general feeling of illness, headache, muscle pain, and weakness. It is very important that you continue to receive the medicine even if it makes you feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of gemcitabine will be different for different patients. The dose that is used may depend on a number of things, including the type of cancer being treated, the patient's size, and whether or not other treatments are also being given. If you are receiving gemcitabine at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of gemcitabine, 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. Blood tests will be needed to check for unwanted effects.

While you are being treated with gemcitabine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Gemcitabine may lower your body's resistance, and there is a chance you might get the infection that 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 past 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.

Check with your doctor immediately if shortness of breath occurs or worsens while you are being treated with gemcitabine.

Gemcitabine 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 needed 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. Also, 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.

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
  • Shortness of breath 
  
  

• Less common
  • Cough or hoarseness (accompanied by fever or chills);  fever or chills;  headache (sudden and severe);  lower back or side pain (accompanied by fever or chills);  painful or difficult urination (accompanied by fever or chills);  pain in chest, arm, or back;  pressure or squeezing in chest;  slurred speech or inability to speak;  troubled breathing, tightness in chest, and/or wheezing;  weakness in arm and/or leg on one side of the body (sudden and severe) 
  
  

• Rare
  • Coughing;  noisy or rattling breathing  
  
  

The following side effects may mean that you are having a serious allergic reaction to this medicine, especially if they occur together with breathing problems. Check with your doctor immediately if any of them occur:

• Rare
  • Change in skin color of the face;  skin rash, hives, and/or itching;  swelling or puffiness of the face, especially the eyelids or area around the eyes 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Black, tarry stools;  blood in urine or stools;  cloudy urine;  fever;  pinpoint red spots on skin;  skin rash, with or without itching;  swelling of fingers, feet, or lower legs;  unusual bleeding or bruising ;  unusual tiredness or weakness 
  
  

• Less common
  • Fast or irregular heartbeat;  high blood pressure 
  
  

• Rare
  • Increased or decreased urination;  yellow eyes or skin 
  
  

Some of the above side effects may occur, or continue to occur, after treatment with gemcitabine has ended. Check with your doctor if you notice any of them after you stop receiving the medicine.

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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  diarrhea;  general feeling of illness;  loss of appetite;  muscle pain;  nausea and vomiting;  runny nose;  sweating;  trouble in sleeping 
  
  

• Less common
  • Drowsiness (severe);  irritation, pain, or redness at place of injection;  numbness or tingling of hands or feet;  sores, ulcers, or white spots on lips and in mouth 
  
  

Gemcitabine may also cause a temporary loss of hair in some people. After treatment with gemcitabine has ended, normal hair growth should return.

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 this use is not included in product labeling, gemcitabine is used in certain patients with the following medical conditions:

• Bladder cancer
• Cancer of the lymph system
• Epithelial ovarian cancer
• Cancer of the bile ducts
• Cancer of the gallbladder
• Germ cell tumors of the ovaries and testes (cancer of the egg- and sperm-producing cells)

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