Infugem (Intravenous)

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

Gemcitabine injection is also used with other medicines (for example, paclitaxel) to treat metastatic breast cancer in patients who have had other treatments (for example, anthracycline medicine) that did not work well.

It is also used with other medicines (for example, 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 pancreatic cancer that has advanced or spread to other parts of the body in patients who have been treated before with fluorouracil.

Gemcitabine interferes with the growth of cancer cells, leading to their eventual destruction. Normal cells may also be affected by the medicine, resulting in other effects. Some of these effects may be serious and should be reported to your doctor. Other effects, such as hair loss, may not be serious but could be concerning. Some effects may appear after treatment with gemcitabine has stopped.

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

It is very important for your doctor to check your progress at regular visits to ensure 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).

In deciding to use a medicine, you and your doctor need to think about the risks and benefits of the medicine. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care provider about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how gemcitabine injection affects children. Because this medication can be toxic, it should be used carefully after considering other less toxic options or if those have not worked. Safety and effectiveness have not been proven.

Geriatric

Research has not found any specific problems in older adults that would limit the use of gemcitabine injection. However, older women may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants from using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together, even if there may be an interaction. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 needed in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Use with caution. This may increase the risk of the disease spreading to other areas of the body.

• Infection—Gemcitabine can lower your body’s ability to fight infections.

• Kidney disease or
• Severe liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Lung or breathing problems—Use with caution. This may worsen your condition.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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. Your health care professional may also know 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.

In the U.S.

• Gemzar
• Infugem

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

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.

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