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gemcitabine

Pronunciation

Generic Name: gemcitabine (jem SYE ta been)
Brand Name: Gemzar

What is gemcitabine?

Gemcitabine is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

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

What is the most important information I should know about gemcitabine?

Gemcitabine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Slideshow: Flashback: FDA Drug Approvals 2013

Gemcitabine can 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.

What should I discuss with my healthcare provider before receiving gemcitabine?

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

To make sure gemcitabine is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease (especially cirrhosis);

  • a history of alcoholism; or

  • if you are receiving radiation treatment.

FDA pregnancy category D. Do not use gemcitabine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether gemcitabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using gemcitabine.

How is gemcitabine used?

Gemcitabine is injected into a vein through an IV. A healthcare provider will give you this injection.

Gemcitabine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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

What happens if I miss a dose?

Contact your doctor if you miss a miss an appointment to receive your gemcitabine infusion.

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. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

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), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Gemcitabine side effects

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

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

A rare but serious side effect of gemcitabine is called capillary leak syndrome. Call your doctor right away if you have signs of this condition, which may include: stuffy or runny nose followed by weakness or tired feeling, and sudden swelling in your arms, legs and other parts of the body.

Also call your doctor at once if you have:

  • fever, chills, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums);

  • blisters or ulcers in your mouth, red or swollen gums, trouble eating or swallowing;

  • severe headache, blurred vision, buzzing in your ears, confusion, seizure (convulsions);

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of damaged red blood cells--bloody diarrhea, stomach pain with vomiting, blood in your urine, pale skin;

  • signs of a kidney problem--little or no urinating, painful or difficult urination, swelling in your feet or ankles; or

  • symptoms of a lung problem--sudden chest pain or discomfort, anxiety, sweating, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, severe dizziness.

Common side effects may include:

  • nausea, vomiting;

  • fever, unusual bleeding;

  • abnormal blood or urine tests;

  • trouble breathing;

  • swelling in your hands or feet;

  • mild 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.

See also: Side effects (in more detail)

Gemcitabine dosing information

Usual Adult Dose for Pancreatic Cancer:

For the first-line treatment of patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. (Gemcitabine is indicated for patients previously treated with 5-FU.)

1000 mg/m² intravenously one time over 30 minutes. May repeat at weekly intervals for up to 7 weeks, followed by one week of rest. If toxicity occurs, a dose should be held. Subsequent cycles should consist of weekly cycles for 3 consecutive weeks, out of every 4 weeks.

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000 give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000, then hold the dose.

Dosage Modifications, Increases: Patients who complete an entire seven week initial cycle of therapy or subsequent three week cycle at a dose of 1000 mg/m² may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) > 1,500,000,000/L, platelet nadirs > 1,000,000,000,000 and nonhematologic toxicity has not been > WHO Grade 1. If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500,000,000/L and 100,000,000,000/L, respectively, and that nonhematologic toxicity has not been greater than WHO grade 1.

Usual Adult Dose for Non-Small Cell Lung Cancer:

In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer:

Two schedules have been investigated and the optimum schedule has not been determined. With the 4 week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on days 1, 8, and 15 of each 28 day cycle. With the 3 week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on days 1 and 8 of each 21 day cycle.

Dose Modifications: Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines below:

Dosage Modifications, Decreases: Doses may need to be adjusted, based upon the degree of hematologic toxicity experienced by the patient. If marrow suppression is detected, therapy should be modified or suspended according to the following guidelines: Absolute granulocyte count 500,000,000-999,000,000/L or Platelet count 50,000,000,000-99,000,000,000/L give 75% of the full dose. Absolute granulocyte count < 500,000,000 or Platelet count < 50,000,000,000/L, then hold the dose.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored.

Usual Adult Dose for Breast Cancer:

In combination with paclitaxel as first-line therapy in the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (unless anthracyclines were clinically contraindicated):

Gemcitabine 1250 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Gemcitabine is given in combination with paclitaxel. Paclitaxel should be administered at 175 mg/m2 on day 1 as a 3 hour intravenous infusion before gemcitabine administration.

Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dosage adjustments for hematologic toxicity are based on the granulocyte and platelet counts taken on day 8 of therapy. If marrow suppression is detected, the dosage of gemcitabine should be modified as follows:

If the absolute granulocyte count is greater than or equal to 1,200,000,000/L and the platelet count is greater than 75,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,199,000,000/L or the platelet count is between 50,000,000,000/L and 75,000,000,000/L, than give 75% of the full dose.

If the absolute granulocyte count is between 700,000,000/L and 999,000,000/L and the platelet count is greater than or equal to 50,000,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 700,000,000/L or the platelet count is less than 50,000,000,000/L, than the dose should be held.

In general, for severe (grade 3 or 4) nonhematologic toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician.

Usual Adult Dose for Ovarian Cancer:

In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy:

1000 mg/m2 intravenously over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should be administered intravenously on day 1 after gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count greater than or equal to 1,500,000,000/L and a platelet count greater than or equal to 100,000,000,000/L prior to each cycle.

Dose Modifications: Gemcitabine dosage adjustments for hematologic toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on day 8 of therapy.

If marrow suppression is detected, gemcitabine dosage should be modified according to guidelines below.

Dosage Reduction Guidelines for Gemcitabine in Combination with Carboplatin:

If the absolute granulocyte count is greater than or equal to 1,500,000,000/L and the platelet count is greater than 100,000,000,000/L, than give 100% of the full dose.

If the absolute granulocyte count is between 1,000,000,000/L and 1,499,000,000/L and/or the platelet count is between 75,000,000,000/L and 99,999,000,000/L, than give 50% of the full dose.

If the absolute granulocyte count is less than 1,000,000,000/L and/or the platelet count is less than 75,000,000,000/L, than the dose should be held.

In general, for severe (Grade 3 or 4) nonhematologic toxicity, except nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician.

Dose adjustment for gemcitabine in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine in subsequent cycles should be reduced to 800 mg/m2 on days 1 and 8 in case of any of the following hematologic toxicities:
Absolute granulocyte count less than 500,000,000/L for more than five days
Absolute granulocyte count less than 100,000,000/L for more than three days
Febrile neutropenia
Platelets less than 25,000,000,000/L
Cycle delay of more than one week due to toxicity

If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine should be given on day 1 only at 800 mg/m2.

Gemcitabine may be administered on an outpatient basis.

What other drugs will affect gemcitabine?

Other drugs may interact with gemcitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about gemcitabine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2014-03-31, 6:06:19 PM.

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