Description
Fluorouracil injection is used to treat breast, colon, rectum, gastric, and pancreatic adenocarcinoma. Your doctor will perform a test to check for the DPYD gene before you receive this medicine.
Fluorouracil injection belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by the medicine, other side effects may also occur. Some of these may be serious and must be reported to your doctor.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
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 fluorouracil injection 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 fluorouracil injection 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 taking 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
- Brivudine
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Tegafur
- 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.
- Acenocoumarol
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Allopurinol
- Azanidazole
- Benznidazole
- Cholera Vaccine
- Cimetidine
- Ebola Zaire Vaccine, Live
- Fosphenytoin
- Influenza Virus Vaccine, Live
- Isoconazole
- Leucovorin
- Levoleucovorin
- Methotrexate
- Metronidazole
- Nimorazole
- Ornidazole
- Oxypurinol
- Phenindione
- Phenprocoumon
- Phenytoin
- Rotavirus Vaccine, Live
- Secnidazole
- Tamoxifen
- Tinidazole
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Levamisole
- Rolapitant
- Thiamine
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:
- DPD deficiency (genetic problem), homozygous or heterozygous or
- Heart disease (eg, heart attack) or
- Heart failure—Use with caution. May make these conditions worse.
- Infection—May decrease your body's ability to fight infection.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins.
Precautions
It is very important that your doctor checks your progress at regular visits to make sure that this medicine is working properly. Blood 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 starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after your last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause heart problems. Check with your doctor right away if you have chest pain, discomfort, or tightness, decreased urine output, dilated neck veins, dizziness, fainting, fast, slow, or irregular heartbeat, nausea, pain or discomfort in the arms, jaw, back, or neck, swelling of the face, fingers, feet, or lower legs, sweating, trouble breathing, vomiting, or weight gain.
Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, low body temperature, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
This medicine may cause brain or nerve problems. Check with your doctor right away if you have blurred or loss of vision, confusion about identity, place, and time, double vision, halos around lights, night blindness, shakiness and unsteady walk, tunnel vision, unsteadiness, trembling, or other problems with muscle control or coordination.
This medicine may cause diarrhea, and in some cases it can be severe. Take medicine to treat diarrhea or drink more water. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
This medicine may cause a serious skin problem called palmar plantar erythrodysesthesia syndrome. Check with your doctor if you have a rash that does not go away or redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
Fluorouracil can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may cause mouth sores or ulcers. Check with your doctor right away if you have cracked lips, diarrhea, difficulty in swallowing, heartburn, sore throat, sores, ulcers, or white spots on the lips, tongue, or mouth, or swelling or inflammation of the mouth.
This medicine may increase your risk of bleeding while using this medicine. Check with your doctor right away if you have back pain, blood in the eyes, blood in the urine, black, tarry stools, bruising or purple areas on the skin, coughing up blood, dizziness, headache, joint pain or swelling, or nosebleeds.
Some men and women 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
Incidence not known
- Bleeding gums
- blood in urine or stools
- bloody, black, or tarry stools
- blurred or loss of vision
- changes in mental status
- changes in skin color
- chest pain, discomfort, or tightness
- chills
- confusion about identity, place, and time
- cough
- cracked lips
- decreased urine output
- diarrhea
- difficulty swallowing
- dilated neck veins
- dizziness
- false or unusual sense of well-being
- fast heartbeat
- fever
- halos around lights
- heartburn
- hives, itching, skin rash
- low body temperature
- lower back or side pain
- nausea
- night blindness
- pain, tenderness, or swelling of the foot or leg
- pain or discomfort in the arms, jaw, back, or neck
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness, swelling, pain of the skin
- scaling of the skin on hands and feet
- shakiness and unsteady walk
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- swelling of the face, fingers, feet, or lower legs
- swelling or inflammation of the mouth
- swollen glands
- tingling of the hands and feet
- trouble breathing
- tunnel vision
- ulceration of the skin
- uncontrolled eye movements
- unexplained bleeding or bruising
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feelings of sluggishness
- unusual tiredness or weakness
- weight gain
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:
Incidence not known
- Bloody nose
- constipation
- difficulty seeing at night
- increased sensitivity of skin to sunlight
- indigestion
- loss of nails
- redness or other discoloration of skin
- severe sunburn
- stomach pain, cramping, or burning
- vomiting of blood or material that looks like coffee grounds
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-20063861
