Description
Gemcitabine is used to treat non-muscle invasive bladder cancer (NMIBC) that has not spread to other parts of the body (carcinoma in situ) with or without papillary tumors in patients who did not respond to Bacillus Calmette-Guérin (BCG) treatment.
This medicine is to be used only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Implant
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of gemcitabine in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemcitabine in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Azathioprine
- Cedazuridine
- Cholera Vaccine
- Ebola Zaire Vaccine, Live
- Hexaminolevulinate
- Influenza Virus Vaccine, Live
- Levoketoconazole
- Mercaptopurine
- Methotrexate
- Rotavirus Vaccine, Live
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Perforation (hole or tear) of the bladder—Should not be used in patients with this condition.
Proper Use
A doctor or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given into your bladder through a tube called a urinary catheter. It is given once every 3 weeks for up to 6 months (8 doses) and once every 12 weeks for up to 18 months (6 doses).
This medicine is removed after 3 weeks of being inserted.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Your doctor may give you other medicines (eg, antibiotics) before receiving or after removal of this medicine.
Do not empty your bladder before receiving this medicine.
After receiving this medicine:
- Drink about 6 to 7 cups (1500 mL) of fluids per day during treatment with this medicine to make sure you have enough urine to be released into the bladder.
- You can urinate normally. There is no need to hold your urine.
- Avoid skin contact with your urine.
- Male and female patients should sit on the toilet while urinating and flush after using.
- Wash your hands well with soap and water and wash your genital area with water after you urinate.
- Wash clothing soiled with urine right away and separately from any other clothing.
Avoid skin contact with your urine for at least 24 hours after this medicine is removed.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check you closely to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Your doctor will give you an MRI safety information card. This card contains important information in case you need to have an MRI. Keep the card and show it to all of your healthcare professionals before you have an MRI.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Bladder pain
- bloody or cloudy urine
- decrease in urine volume
- difficult, burning, or painful urination
- loss of bladder control
- lower back or side pain
- passing urine more often
- waking to urinate at night
Some side effects 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
- Diarrhea
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008512
