Class: Chemotherapy

Generic Name: Gemcitabine (jem-SIGH-ta-been)
Trade Name: Gemzar®

For which conditions is this drug approved? Gemcitabine is FDA-approved for the treatment of locally advanced or metastatic pancreatic cancer, either as initial therapy or following treatment with the chemotherapy agent fluorouracil; the treatment of locally advanced or metastatic non-small cell lung cancer, in combination with the chemotherapy agent cisplatin (Platinol®); for the treatment of recurrent ovarian cancer in combination with the chemotherapy agent carboplatin (Paraplatin®) in patients whose cancer has progressed at least 6 months following prior therapy, and metastatic breast cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Gemcitabine belongs to a group of drugs called antimetabolites. Antimetabolites produce their anti-cancer effects by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death.

How is gemcitabine typically given (administered)? Gemcitabine is administered intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with gemcitabine.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Liver and kidney function will be assessed prior to and during treatment. Pulmonary function will be assessed, as lung damage may occur as a side effect of treatment with gemcitabine. Kidney function will be monitored as hemolytic uremia syndrome and/or renal failure are rare but serious side effects of treatment with gemcitabine.

What are the common (occur in 30% or more of patients) side effects of treatment with gemcitabine?

• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia or blood transfusions
• Low platelet levels – increases risk of bleeding
• Fever
• Muscle pain
• Generalized fatigue
• Nausea and vomiting
• Rash
• Abnormalities in liver function level tests as determined by blood tests
• Blood or protein in the urine – indicating kidney abnormalities

What are the less common (occur in 10% to 29% of patients) side effects of treatment with gemcitabine?

• Flu-like symptoms (fever, weakness, lack of appetite, headache, chills, cough, muscle ache, fatigue, difficulty sleeping)
• Diarrhea
• Constipation
• Weakness
• Hair loss
• Mouth sores
• Drowsiness
• Difficulty breathing
• Swelling (edema)
• Numbness or tingling of hands or feet

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Difficulty breathing
• Chest pain
• Swelling of the ankles, feet, hands or face
• Little or no urine output
• Change in color of urine
• Yellowing of skin or eyes
• Persistent or severe nausea and vomiting
• Persistent or severe diarrhea
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect Last updated 11/15.

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