Gemcitabine

Generic name: gemcitabine (jem SYE ta been)
Brand name: Gemzar, Infugem
Dosage forms: intravenous powder for injection (1 g; 2 g; 200 mg); intravenous solution (10 mg/mL-NaCl 0.9%; 100 mg/mL; 38 mg/mL)
Drug class: Antimetabolites

Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast.

Gemcitabine is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working.

Gemcitabine may also be used for purposes not listed in this medication guide.

Warnings

Gemcitabine can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, tiredness, bruising or bleeding, pale skin).

Gemcitabine can also affect your liver, kidneys, or lungs. Tell your doctor if you have stomach pain, dark urine, yellow skin or eyes, little or no urinating, swelling, rapid weight gain, severe shortness of breath, wheezing, or cough with foamy mucus.

If you receive gemcitabine during or after radiation treatment, tell your doctor right away if you have severe skin redness, swelling, oozing, or peeling.

Before taking this medicine

You should not use gemcitabine if you are allergic to it.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease (especially cirrhosis);
• alcoholism; or
• radiation treatment.

Both men and women using gemcitabine should use effective birth control to prevent pregnancy. Gemcitabine can harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, do not use gemcitabine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using gemcitabine.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby.

You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose.

How is gemcitabine used?

Gemcitabine is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when gemcitabine is injected.

If any of this medicine accidentally gets on your skin, wash the area thoroughly with soap and warm water.

Gemcitabine can increase your risk of bleeding or infection. You will need frequent medical tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your gemcitabine injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using gemcitabine?

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.

Do not receive a "live" vaccine while using gemcitabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Gemcitabine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also call your doctor at once if you have:

• headache, confusion, change in mental status, vision loss, seizure (convulsions);
• blisters or ulcers in your mouth, trouble eating or swallowing;
• severe skin redness, swelling, oozing, or peeling during or after radiation treatment;
• liver problems--loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts--fever, chills, tiredness, skin sores, cold hands and feet, feeling light-headed;
• fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold, clammy skin, anxiety, rapid heartbeats; or
• signs of damaged red blood cells--unusual bruising or bleeding, pale skin, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• fever;
• nausea, vomiting;
• low blood cell counts;
• abnormal blood or urine tests;
• shortness of breath;
• swelling in your hands or feet;
• rash; or
• red or pink urine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.