Patient Medication Information: uses, side effects, how to take - Fluorouracil Injection USP (Accord Healthcare)
Serious warnings and precautions box
Serious side effects of Fluorouracil Injection USP include:
- Severe skin reactions: this includes Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Some cases have been fatal.
- Severe toxicity, including death, in patients who do not have an enzyme called dihydropyrimidine dehydrogenase (DPD). If you lack this enzyme, you should not take Fluorouracil Injection USP. Your healthcare professional might check to see if you have this enzyme before you can take Fluorouracil Injection USP.
See the Serious side effects and what to do about them table, below, for more information.
What Fluorouracil Injection USP is used for:
Fluorouracil Injection USP is used in adults for the palliative treatment of the following cancers: colon and rectum, breast, stomach, pancreas, prostate, ovary, bladder, head and neck.
- It can be used alone or together with other treatments, such as radiation or other cancer medicines.
- Palliative treatment helps relieve your symptoms but will not cure your disease.
- Fluorouracil Injection USP is used in adults after other treatments to help prevent colorectal and breast cancer from coming back.
How Fluorouracil Injection USP works:
Fluorouracil Injection USP is an antineoplastic agent that contains the medicinal ingredient fluorouracil (5- fluorouracil). These medications interfere with the growth of cells that rapidly divide in the body, including cancer cells. It prevents the growth of cancer cells and kills them.
The ingredients in Fluorouracil Injection USP are:
Medicinal ingredient: fluorouracil (5-fluorouracil)
Non-medicinal ingredients: hydrochloric acid, sodium hydroxide, water for injection
Fluorouracil Injection USP comes in the following dosage forms:
Solution; 50 mg / mL
Do not use Fluorouracil Injection USP if you:
- are pregnant
- are in a poor nutritional state
- have severely suppressed bone marrow function
- have a serious infection
- are allergic to Fluorouracil Injection USP, fluorouracil (5-fluorouracil) or any of the non-medicinal ingredients in Fluorouracil Injection USP.
- are being treated now, or have been treated in the last 4 weeks, with brivudine, sorivudine or a similar medicine, used to treat the viral infection herpes zoster (chickenpox or shingles)
- have been told that you do not have an enzyme called dihydropyrimidine dehydrogenase (DPD)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Fluorouracil Injection USP. Talk about any health conditions or problems you may have, including if you:
- have recently had a major surgery
- have had high dose radiation treatment to areas that contain bone marrow, such as your pelvis, spine, ribs, etc.
- have been treated with other medicines that suppress your bone marrow
- have tumours in your bone marrow that have spread from other locations in your body (metastasized)
- have kidney or liver problems
- plan to become pregnant
- are breastfeeding or planning to breastfeed
Other warnings you should know about:
Fertility: Fluorouracil Injection USP can impair fertility in both male and female patients.
Female patients:
- You should not become pregnant while you are taking Fluorouracil Injection USP. This is because it can harm your unborn child.
- Before you start taking Fluorouracil Injection USP it is recommended that you take a pregnancy test to make sure you are not pregnant.
- You must use effective birth control while you are taking Fluorouracil Injection USP and for six months after you stop taking it. Talk to your healthcare professional about effective methods of birth control.
- You should not breastfeed while you are taking Fluorouracil Injection USP. It is not known if it passes into breastmilk. Talk to your healthcare professional about ways to feed your baby during treatment.
Male patients:
- You should not father a child while you are taking Fluorouracil Injection USP.
- If your female partner is of childbearing age, you must use effective birth control while you are taking Fluorouracil Injection USP and for 3 months after you stop taking it. Talk to your healthcare professional about effective methods of birth control for you and your partner.
Blood tests and monitoring:
- Fluorouracil Injection USP can affect your blood cell counts, specifically your level of white blood cells. It can also cause toxicity and related side effects. Because of this, your healthcare professional will do frequent blood tests, especially when you first start taking Fluorouracil Injection USP, and monitor you for other side effects. They might change, reduce or stop your dose for a period of time based on your blood tests results or if other side effects appear.
- Fluorouracil Injection USP can affect the results of certain urine tests. If you are going to have urine tests, tell the healthcare professional doing the test that you are taking Fluorouracil Injection USP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Fluorouracil Injection USP:
- medicines used to treat certain viral infections like chickenpox or shingles, such as brivudine, sorivudine
- leucovorin (folinic acid), a medicine used to prevent the harmful effects of cancer chemotherapy medication
- other medicines used to treat cancer, such as methotrexate, cyclophosphamide, cisplatin, vincristine, mitomycin, adriamycin, levamisole, interferon alpha 2a
- cimetidine, used to treat heartburn and acid indigestion
- metronidazole, an antibiotic and antiprotozoal medicine used to treat infections
- blood thinner medicine, such as warfarin and other coumarin medicines
How to take Fluorouracil Injection USP:
- Fluorouracil Injection USP will be given to you in a healthcare setting.
- Fluorouracil Injection USP will be given to you directly into a vein (intravenously) by a healthcare professional experienced in the use of cancer medicines.
Usual dose:
Your healthcare professional will decide on the dose and length of treatment that is right for you based on your weight or body surface area and the condition being treated.
Overdose:
The main symptoms of overdose are:
- nausea
- vomiting
- diarrhea
- inflammation of the mouth, tongue and throat (stomatitis)
- inflammation of the esophagus
- ulcers and bleeding from the GI tract (vomiting blood or blood in the stool)
- unusual bleeding from anywhere in the body (hemorrhage)
- bone marrow suppression (very low levels of white and red blood cells and platelets).
If you think you, or a person you are caring for, have been given too much Fluorouracil Injection USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canda’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
Talk to your healthcare professional if you have missed a dose.
Possible side effects from using Fluorouracil Injection USP:
These are not all the possible side effects you may have when taking Fluorouracil Injection USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- loss of appetite
- hair loss
- skin rash, irritation
- dry skin
- eye irritation, vision problems
- nail changes, including nail loss
- headache
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| Very common | ||||||
| Diarrhea | √ | |||||
| Nausea | √ | |||||
| Vomiting | √ | |||||
Leukopenia / neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains, flu-like symptoms | √ | |||||
| Common | ||||||
Stomatitis (inflammation of the mouth, throat and tongue): sores, ulcers, redness, pain or swelling of the mouth including inside, the tongue or the throat, problems eating | √ | |||||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | √ | |||||
Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes | √ | |||||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches, swollen glands | ||||||
| Rare | ||||||
| Bone marrow suppression (a large decrease in the production of red blood cells, white blood cells and platelets by the bone marrow): bleeding, bruising, nose bleeds, chills, fatigue, fever, infections, weakness, shortness of breath or other signs of infection | √ | |||||
| Infection: cough, fever, chills, pain during urination, sore throat | √ | |||||
| Heart problems: chest pain, abnormal heart rate, fainting, heart skipping a beat, shortness of breath, swelling of ankles or legs, weakness | √ | |||||
| Gastrointestinal bleeding: stomach pain, vomiting blood, blood in the stool, black/tar coloured stool | √ | |||||
| Liver problems: abdominal pain, dark urine, fatigue, light-coloured stool, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice) | √ | |||||
| Nervous system toxicity: lack of coordination or balance, tremor, trouble speaking, disorientation, headache, confusion, weakness, rapid, uncontrolled eye movements, loss of vision, personality or mood changes | √ | |||||
| Hand-foot syndrome: tingling, numbness, pain, swelling, redness or blisters of the palms of the hands or soles of the feet | √ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Fluorouracil Injection USP will be stored by your healthcare professional.
Keep out of reach and sight of children.
If you want more information about Fluorouracil Injection USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.accordhealth.ca; or by calling 1-866-296-0354.
3535 Boul. St-Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada