Gemcitabine (Intravenous Route)

It is used alone or in combination with other medicines to treat cancer of the breast, ovary, 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.

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)

This product is available in the following dosage forms:

• Powder for 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

Gemcitabine has been tested in a limited number of children and was not found to cause different side effects in children than it does in adults. However, side effects specific to children can not be ruled out because appropriate studies have not been done .

Geriatric

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.

Pregnancy

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

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.

• Rotavirus 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.

• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• 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.

• 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:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)a€”Risk of severe disease spreading to other parts of the body

• Infectiona€”Gemcitabine can decrease your body`s ability to fight infection

• Kidney disease or


• Liver disease, severea€”These conditions sometimes increase the effects of medicines by causing them to be removed from the body more slowly .

Proper Use

Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed into one of your veins .

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 this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

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.


• This medicine can cause harm to your unborn baby . Make sure your doctor knows if you are pregnant before taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away .

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

• Bleeding gums


• Blood in urine or stools


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain


• Cloudy urine


• Coughing up blood


• Cough or hoarseness


• Diarrhea


• Difficult or labored breathing


• Difficulty in moving


• Difficulty in swallowing


• Dizziness


• Fever or chills


• General feeling of discomfort or illness


• Headache


• Increased menstrual flow or vaginal bleeding


• Joint pain


• Lack or loss of strength


• Loss of appetite


• Lower back or side pain


• Muscle aching or cramping


• Muscle pains or stiffness


• Nausea


• Nosebleeds


• Painful or difficult urination


• Pale skin


• Paralysis


• Pinpoint red spots on skin


• Prolonged bleeding from cuts


• Red or black, tarry stools


• Red or dark brown urine


• Runny nose


• Shivering


• Shortness of breath


• Sores, ulcers, or white spots on lips or in mouth


• Sore throat


• Sweating


• Swelling of hands, ankles, feet, or lower legs


• Swollen glands


• Swollen joints


• Tightness in chest


• Troubled breathing with exertion


• Trouble sleeping


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Vomiting


• Weight loss


• Wheezing

Less common

• Blurred vision


• Chest discomfort


• Fainting


• Fast, slow, or irregular heartbeat


• Headache (sudden and severe)


• Inability to speak


• Nervousness


• Noisy breathing


• Pain or discomfort in arms, jaw, back or neck


• Pounding in the ears


• Seizures


• Slurred speech


• Temporary blindness


• Weakness in arm and/or leg on one side of the body (sudden and severe)

Rare

• Confusion


• Lightheadedness


• Rapid, shallow breathing

Incidence not determined

• Hives


• Itching


• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue


• Skin rash

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:

More common

• Difficulty having a bowel movement (stool)


• Hair loss


• Pain


• Sleepiness or unusual drowsiness


• Swelling or inflammation of the mouth


• Thinning of hair

Less common

• 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 site

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.