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.
Important
Information
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).
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.
Before taking
this medicine
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.
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 (urine, feces, vomit). 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. Caregivers should wear rubber gloves while
cleaning up a patient's 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.
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 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:
1000 mg/m2 IV
one time over 30 minutes.
-Weeks 1 through 8: Weekly dosing for the first 7 weeks, followed by one week
of rest. If toxicity occurs, a dose should be held.
-After week 8: Weekly dosing on Days 1, 8, and 15 of 28 day cycles
Comments:
-Patients should be monitored prior to each dose with a complete blood count
(CBC), including differential and platelet count.
-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.
-Dose modifications due to hematological toxicity in subsequent cycles, for all
indications:
The gemcitabine dose should be reduced to 75% of the original cycle initiation
dose, in the case of the following hematological toxicities:
1) Absolute granulocyte count less than 500,000,000/L for more than 5 days
2) Absolute granulocyte count less than 100,000,000/L more than 3 days
3) Febrile neutropenia
4) Platelets less than 25,000,000,000/L
5) Cycle delay of more than 1 week due to toxicity
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4)
nonhematological toxicity until resolved. No dose modifications are recommended
for alopecia, nausea, or vomiting.
Use: Pancreatic cancer (as
first-line treatment for patients with locally advanced (nonresectable Stage II
or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. This
drug is indicated for patients previously treated with 5-FU).
Usual Adult Dose
for Non-Small Cell Lung Cancer:
Four week
schedule: 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in combination
with cisplatintherapy
Three week schedule: 1250 mg/m2 IV over 30 minutes on days 1 and 8 in
combination with cisplatin therapy
Comments:
-Patients should be monitored prior to each dose with a complete blood count
(CBC), including differential and platelet count.
-Dose modifications due to hematological toxicity in subsequent cycles, for all
indications:
The gemcitabine dose should be reduced to 75% of the original cycle initiation
dose, in the case of the following hematological toxicities:
1) Absolute granulocyte count less than 500,000,000/L for more than 5 days
2) Absolute granulocyte count less than 100,000,000/L more than 3 days
3) Febrile neutropenia
4) Platelets less than 25,000,000,000/L
5) Cycle delay of more than 1 week due to toxicity
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4)
non-hematological toxicity until resolved. No dose modifications are
recommended for alopecia, nausea, or vomiting.
Use: 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.
Usual Adult Dose
for Breast Cancer:
1250 mg/m2 IV
over 30 minutes on days 1 and 8 of each 21 day cycle that includes paclitaxel.
Paclitaxel should be administered at 175 mg/m2 IV on day 1 as a 3 hour IV
infusion before gemcitabine administration
Dose reduction with each cycle or within a cycle may be applied based upon the
grade of toxicity experienced by the patient. Patients should have an absolute
granulocyte count of at least 1,500,000,000/L prior to initiation of
gemcitabine plus paclitaxel combination.
Comments:
-Patients should be monitored prior to each dose with a complete blood count
(CBC), including differential and platelet count.
-Doses may need to be adjusted, based upon the degree of hematologic toxicity
experienced by the patient. -Dose Modifications for Non-Hematologic Adverse
Reactions
Permanently discontinue therapy for any of the following:
1) Unexplained dyspnea or other evidence of severe pulmonary
toxicity
2) Severe hepatic toxicity
3) Hemolytic-Uremic Syndrome
4) Capillary Leak Syndrome
5) Posterior reversible encephalopathy syndrome
-Withhold therapy or reduce dose by 50% for other severe (Grade 3 or 4)
non-hematological toxicity until resolved. No dose modifications are
recommended for alopecia, nausea, or vomiting.
Use: For breast cancer (in combination with paclitaxel
for the first-line treatment of patients with metastatic breast cancer after
failure of prior anthracycline-containing adjuvant chemotherapy, unless
anthracyclines were clinically contraindicated)
Usual Adult Dose
for Ovarian Cancer:
1000 mg/m2 IV
over 30 minutes on days 1 and 8 of each 21 day cycle. Carboplatin should
be administered IV on day 1 of each 21 day cycle after gemcitabine
administration.
Comments:
-Patients should be monitored prior to each dose with a complete blood count,
including differential counts.
-Guidelines for dose modification vary in different regions. Consult the
manufacturer
Use: 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.
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.
