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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.
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.
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.
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.
Call your doctor for instructions if you miss an appointment for your gemcitabine injection.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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 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.
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.
Other drugs may affect gemcitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Gemcitabine Hcl (www.drugs.com/mtm/gemcitabine.html).
More frequently reported side effects include: signs and symptoms of injection site. See below for a comprehensive list of adverse effects.
Applies to gemcitabine: intravenous powder for solution, intravenous solution
Along with its needed effects, gemcitabine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking gemcitabine:
More common
Less common
Rare
Incidence not known
Some side effects of gemcitabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about 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
Less common
Applies to gemcitabine: intravenous powder for injection, intravenous solution
Very common (10% or more): Anemia (68%), neutropenia (63%), leucopenia (62%), thrombocytopenia (24%), petechiae (16%), hemorrhage (17%), bone marrow suppression (usually mild to moderate)
Common (1% to 10%): Febrile neutropenia
Very rare (less than 0.01%): Thrombocytosis
Postmarketing reports: Capillary leak syndrome (CLS)
Myelosuppression is the major dose-limiting factor associated with gemcitabine therapy.
Dosage adjustments for hematologic toxicity are frequently necessary. Less than 1% of patients have had to discontinue therapy for either anemia, leukopenia, or thrombocytopenia. Grade 3/4 thrombocytopenia was more common in the elderly, especially older women.
The risk for thrombotic thrombocytopenic purpura increases as the cumulative dose of gemcitabine approaches 20,000 mg/m2.
Very common (10% or more): Nausea/vomiting (69%), diarrhea (19%), stomatitis (11%), stomatitis and ulceration of the mouth (11%)
Common (1% to 10%): Constipation
Very rare (less than 0.01%): Ischemic colitis, anal pruritus
If the patient is not vomiting due to their disease state, nausea can generally be prevented by administration of prochlorperazine or low-dose oral serotonin antagonists and glucocorticoid therapy. One study of 790 patients found the rate of WHO grade 3 nausea and vomiting at a frequency of 22% in patients under 65 years of age, and 12% in patients 65 years of age or older.
No evidence of increased hepatic toxicity has been reported with longer duration or greater total cumulative dose.
Very common (10% or more): Increased ALT (68%), increased AST (67%), increased alkaline phosphatase (55%), hyperbilirubinemia (13%)
Common (1% to 10%):
Uncommon (0.1% to 1%): Serious hepatotoxicity (including liver failure and death), increased gamma-glutamyl transferase (GGT)
Postmarketing reports: Hepatic veno-occlusive disease
Renal failure may not be reversible, even upon discontinuation of therapy.
Very common (10% or more): Proteinuria (45%), hematuria (35%), increased BUN (16%)
Common (1% to 10%): Increased creatinine (8%)
Uncommon (0.1% to 1%): Renal failure, hemolytic-uremic syndrome
The flu-like symptoms usually take place a few hours after drug administration. The symptoms are usually self-limiting and recovery is generally within 24 to 48 hours. Less than 1% of patients discontinued use due to flu-like symptoms. Some patients get relief from nonsteroidal anti-inflammatory drugs or acetaminophen.
Out of the five reported cases of distal ischemic changes, four of those case related to combination chemotherapy with cisplatin and gemcitabine, while one case was of gemcitabine as a single agent in first-line therapy.
Very common (10% or more): Fever (41%), asthenia, chills
Common (1% to 10%): Paresthesia
Rare (less than 0.1%): Radiation toxicity, radiation recall
Frequency not reported: Cough, chills, pattern of tissue injury typically associated with radiation toxicity
Rash was generally a macular or finely granular maculopapular pruritic eruption, mild to moderate in severity, involving the trunk and extremities. Alopecia is usually minimal.
Very common (10% or more): Allergic skin rash frequently associated with pruritus (30%), alopecia (15%)
Common (1% to 10%): Itching, sweating
Rare (0.01% to 0.1%): Severe skin reactions (including desquamation and bullous skin eruptions), ulceration, vesicle and sore formation, scaling
Very rare (less than 0.01%): Lyell's syndrome (toxic epidermal necrolysis, Stevens Johnson Syndrome
Postmarketing reports: Cellulitis
Very common (10% or more): Dyspnea (23%)
Common (1% to 10%): Cough, rhinitis
Uncommon (0.1% to 1%): Interstitial pneumonitis, bronchospasm
Rare (0.01% to 0.1%): Pulmonary edema, adult respiratory distress syndrome (ARDS)
Very rare (less than 0.01%): Respiratory failure/death
Frequency not reported: Pulmonary fibrosis, pulmonary edema
Some of the dyspnea reported may have been due to underlying disease. Forty percent of the study population consisted of lung cancer patients, while some of the other study patients had pulmonary manifestations of other malignancies.
Different patterns of lung injury may be related to gemcitabine. A rapid response following the administration of corticosteroids would mean the respiratory problem was probably due to a hypersensitivity reaction.
Common (1% to 10%): Headache, insomnia, somnolence, paraesthesia
Uncommon (0.1% to 1%): Cerebrovascular accident
Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)
Less than 1% of the paresthesias have been severe.
Very common (10% or more): Injection site reactions (mainly mild)
Rare (less than 0.1%): Hypersensibility
Many of the patients that suffered cardiovascular effects had a prior history of cardiovascular disease. Two percent of patients discontinued therapy due to these effects. Less than 1% of patients discontinued due to edema.
Uncommon (0.1% to 1%): Arrhythmias (predominantly supraventricular), heart failure
Rare (less than 0.1%): Hypotension, hypertension, myocardial infarction, atrial fibrillation
Very rare (less than 0.01%): Congestive heart failure
Postmarketing reports: Supraventricular arrhythmias
Very common (10% or more): Infection (16%), influenza-like symptoms
Rare (less than 0.1%): Anaphylactoid reaction
Frequency not reported: Scleroderma-like reaction
Very common (10% or more): Edema/peripheral edema-including facial edema (usually reversible after stopping treatment)
Common (1% to 10%): Anorexia
Common (1% to 10%): Back pain, myalgia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Gemcitabine Hcl (www.drugs.com/mtm/gemcitabine.html).
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