Pronunciation:

jem-SYE-ta-been

Brand Names:

• Gemzar
• Infugem

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Gemcitabine injection is used together with other medicines (eg, carboplatin) to treat patients with advanced ovarian cancer that has come back at least 6 months after treatment with other cancer medicines (platinum-based).

Gemcitabine injection is also used together with other medicines (eg, paclitaxel) to treat metastatic (cancer that has spread) breast cancer in patients who have received other treatments (eg, anthracycline medicine) that did not work well.

It is also used together with other medicines (eg, cisplatin) to treat non-small cell lung cancer that has advanced, spread, or cannot be treated with surgery.

Gemcitabine injection is also used to treat pancreas cancer that has advanced or spread to the other parts of the body in patients who have been previously treated with fluorouracil.

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 to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of gemcitabine injection in the pediatric population. However, because of this medication's toxicity, it should be used with caution, after less toxic alternatives have been considered or found ineffective. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemcitabine injection in the elderly. However, elderly women patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

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.

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 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
• Bacillus of Calmette and Guerin Vaccine, Live
• Cedazuridine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Hexaminolevulinate
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Methotrexate
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Warfarin
• Yellow Fever Vaccine

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)—Use with caution. May increase risk of the 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—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Lung or breathing problems—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle should stay in place for at least 30 minutes.

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 doctor or pharmacist for ways to lessen these effects.

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 and urine tests will be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

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 the 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 may cause lung problems (eg, interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, adult respiratory distress syndrome), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have new or worsening cough, fever, chest tightness, or trouble breathing.

This medicine may cause kidney problems, including hemolytic uremic syndrome, thrombotic microangiopathy, and kidney failure. Check with your doctor right away if you have stomach pain, blood in the urine, fever, increased or decreased urination, pinpoint red spots on the skin, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

If you plan to have children, talk with your doctor before receiving this medicine. Some men using this medicine have become infertile (unable to have children).

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 may need medical attention.

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

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

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

chest pain

chills

cloudy urine

confusion

cough

coughing up blood

diarrhea

difficult or labored breathing

difficulty in moving

difficulty in swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

general feeling of discomfort or illness

headache

hoarseness

increased menstrual flow or vaginal bleeding

joint pain

lack or loss of strength

loss of appetite

lower back or side pain

muscle ache, cramps, pain, or stiffness

nausea

nosebleeds

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

rapid weight gain

red or black, tarry stools

red or dark brown urine

runny nose

shivering

sores, ulcers, or white spots on the lips or in the mouth

sore throat

sweating

swelling of the hands, ankles, feet, or lower legs

swelling or inflammation of the mouth

swollen glands

swollen joints

tightness in the chest

trouble sleeping

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Chest discomfort

fast, slow, or irregular heartbeat

headache (sudden and severe)

hives, itching, skin rash

inability to speak

nervousness

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

slurred speech

temporary blindness

weakness in the arm or leg or on one side of the body (sudden and severe)

Rare

Rapid, shallow breathing

Incidence not known

Blue lips and fingernails

cloudy urine

coughing that sometimes produces a pink frothy sputum

dark urine

decrease or increase in the amount of urine

decreased urine output

difficult, fast, noisy breathing

dilated neck veins

extreme tiredness or weakness

fast, slow, or irregular heartbeat

general feeling of tiredness or weakness

increased sweating

irregular breathing

itching, pain, redness, swelling, tenderness, or warmth on the skin

light-colored stools

sores on the skin, especially on the thighs, breasts, penis, or buttocks

sores, welts, or blisters

stomach pain, continuing

sudden weakness in the arms or legs

sudden, severe chest pain

swelling of the face, fingers, feet, or lower legs

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:

More common

Difficulty having a bowel movement

hair loss

sleepiness or unusual drowsiness

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 the injection 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.