GEMCITABINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Gemzar

In Canada?

• Gemzar

Category

• Antineoplastic

Description

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 beused to treat other kinds of cancer, as determined by your doctor.

Gemcitabine interferes with the growth of cancer cells, which are eventuallydestroyed. 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 reportedto your doctor. Other effects, like hair loss, may not be serious but maycause concern. Some effects may occur after treatment with gemcitabine hasbeen stopped.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to gemcitabine.

Pregnancy?Tell your doctor if you are pregnant. Studies inmice and rabbits have shown that gemcitabine causes birth defects and deathof the fetus, as well as problems in the mother.

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

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

Children?Gemcitabine has been tested in a limited number ofchildren and was not found to cause different side effects in children thanit does in adults. However, side effects specific to children can not be ruledout because appropriate studies have not been done.

Older adults?Gemcitabine has been tested in elderly patients andhas not been shown to cause different side effects or problems in older peoplethan it does in younger adults. However, seriously low blood counts tend tooccur more often in elderly patients.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinggemcitabine, it is especially important that your health care professionalknow 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?Therisk of developing seriously low blood counts may be increased. Also, gemcitabinecan 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 ofinfection because gemcitabine decreases your body's ability to fight it

Other medical problems?The presence of other medicalproblems may affect the use of gemcitabine. Make sure you tell your doctorif you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease spreading toother parts of the body

• Infection?Gemcitabine can decrease your body's ability to fightinfection

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

Proper Use of This Medicine

Gemcitabineoften causes nausea and vomiting. It can also cause flu-like symptoms suchas chills, fever, general feeling of illness, headache, muscle pain, and weakness.It is very important that you continue to receive the medicine even if itmakes you feel ill. Ask your health care professional for ways to lessen theseeffects.

Dosing?The dose of gemcitabine will be different fordifferent 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 whetheror not other treatments are also being given. If youare receiving gemcitabine at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of gemcitabine,ask your doctor.

Precautions While Using This Medicine

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

While you are being treated with gemcitabine, and after you stop treatmentwith 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 ismeant to prevent. In addition, other persons living in your household shouldnot take oral polio vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe past several months. Do not get close to them and do not stay in the sameroom with them for very long. If you cannot take these precautions, you shouldconsider wearing a protective face mask that covers the nose and mouth.

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

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

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Also, check with your medical doctor before having any dentalwork done.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

Side Effects of This Medicine

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 mayneed medical attention.

Check with your doctorimmediately 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 andsevere); lower back or side pain (accompanied byfever 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 followingside effects may mean that you are having a serious allergic reaction to thismedicine, 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; skinrash, hives, and/or itching; swelling or puffinessof the face, especially the eyelids or area around the eyes

Also, checkwith your doctor as soon as possible if any of the following side effectsoccur:

More common

Black, tarry stools; blood in urineor 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 bloodpressure

Rare

Increased or decreased urination; yellow eyes or skin

Some of the above sideeffects may occur, or continue to occur, after treatment with gemcitabinehas ended. Check with your doctor if you notice any of them after you stopreceiving the medicine.

Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:

More common

Constipation; diarrhea; general feeling of illness; loss ofappetite; 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 tinglingof hands or feet; sores, ulcers, or white spots onlips and in mouth

Gemcitabinemay also cause a temporary loss of hair in some people. After treatment withgemcitabine has ended, normal hair growth should return.

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

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor 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- andsperm-producing cells)

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