Adrucil injection

Fluorouracil is also sometimes used to treat cancer of the cervix (opening of the uterus) and esophagus, head and neck cancer (including cancer of the mouth, lip, cheek, tongue, palate, throat, tonsils, and sinuses), ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), and renal cell cancer (RCC, a type of cancer that begins in the kidney). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving fluorouracil,

• tell your doctor and pharmacist if you are allergic to fluorouracil or any of the ingredients in fluorouracil injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain chemotherapy medications such as bendamustine (Treanda), busulfan (Myerlan, Busulfex), carmustine (BiCNU, Gliadel Wafer), cyclophosphamide (Cytoxan), chlorambucil (Leukeran), ifosfamide (Ifex), lomustine (CeeNU), melphalan (Alkeran), procarbazine (Mutalane), or temozolomide (Temodar); medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an infection. Your doctor may not want you to receive fluorouracil injection.
• tell your doctor if you have previously received radiation (x-ray) therapy or treatment with other chemotherapy medications or if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breast-feed while you are receiving fluorouracil injection. If you become pregnant while receiving fluorouracil injection, call your doctor. Fluorouracil may harm the fetus.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Fluorouracil may make your skin sensitive to sunlight.

• 5-Fluorouracil
• 5-FU

You should not use this medicine if you have bone marrow depression, a serious infection, or if you are malnourished or are not receiving proper nutrition.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using fluorouracil, 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.

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.

Applies to fluorouracil: injectable, solution

Along with its needed effects, fluorouracil (the active ingredient contained in Adrucil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking fluorouracil:

• Diarrhea
• heartburn
• sores in mouth and on lips

• Black, tarry stools
• cough or hoarseness, accompanied by fever or chills
• fever or chills
• lower back or side pain, accompanied by fever or chills
• nausea and vomiting (severe)
• painful or difficult urination, accompanied by fever or chills
• stomach cramps

• Blood in urine or stools
• pinpoint red spots on skin
• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur while taking fluorouracil:

• Chest pain
• cough
• shortness of breath
• tingling of hands and feet, followed by pain, redness, and swelling
• trouble with balance

Some side effects of fluorouracil 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:

• Loss of appetite
• nausea and vomiting
• skin rash and itching
• weakness

• Dry or cracked skin

This medicine often causes a temporary loss of hair. After treatment with fluorouracil has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness, accompanied by fever or chills
• fever or chills
• lower back or side pain, accompanied by fever or chills
• painful or difficult urination, accompanied by fever or chills
• pinpoint red spots on skin
• unusual bleeding or bruising

Applies to fluorouracil: compounding powder, intravenous solution

Cardiovascular

Very common (10% or more): Ischemic ECG abnormalities
Common (1% to 10%): Angina pectoris-like chest pain
Uncommon (0.1% to 1%): Arrhythmia, myocardial infarction, myocardial ischemia myocarditis, heart insufficiency, dilative cardiomyopathy, cardiac shock, hypotension
Rare (0.01% to 0.1%): Cerebral, intestinal and peripheral ischemia, Raynaud's syndrome, thromboembolism
Very rare (less than 0.01%): Cardiac arrest, sudden cardiac death
Frequency not reported: Tachycardia[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), alopecia
Uncommon (0.1% to 1%): Dermatitis, skin alterations (e.g., dry skin, fissure erosion, erythema, pruritic maculopapular rash), exanthema, urticaria, photosensitivity, hyperpigmentation, streaky hyperpigmentation or depigmentation near the veins, changes in nails (e.g., diffuse superficial blue pigmentation, hyperpigmentation, nail dystrophy, pain and thickening of the nail bed, paronychia), onycholysis[Ref]

Endocrine

Rare (less than 0.1%): Total thyroxin (T4) increased, total triiodothyronine (T3) increased[Ref]

Gastrointestinal

Very common (10% or more): Mucositis (stomatitis, esophagitis, pharyngitis, proctitis), anorexia, watery diarrhea, nausea, vomiting
Uncommon (0.1% to 1%): Dehydration, GI ulceration, GI bleeding, GI sloughing
Frequency not reported: Dysphagia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Spermatogenesis, ovulation disorder
Frequency not reported: Urinary tract infection[Ref]

Hematologic

Very common (10% or more): Myelosuppression, neutropenia, thrombocytopenia, leucopenia, agranulocytosis, anemia, pancytopenia
Rare (less than 0.1%): Thrombophlebitis/vein tracking[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver cell damage
Very rare (less than 0.01%): Liver necrosis, biliary sclerosis, cholecystitis[Ref]

Hypersensitivity

Rare (less than 0.1%): Generalized allergic reactions, anaphylaxis, anaphylactic shock[Ref]

Immunologic

Very common (10% or more): Immunosuppression with an increased risk of infection
Frequency not reported: Sepsis, septic shock, neutropenic sepsis, super infection, cellulitis[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, dizziness, Parkinson's disease like symptoms, pyramidal signs
Very rare (less than 0.01%): Symptoms of leukoencephalopathy (including ataxia, acute cerebellar syndrome, dysarthria, confusion, disorientation, myasthenia, aphasia, convulsion, or coma in patients receiving high doses and in patients with dihydropyrimidine dehydrogenase deficiency)
Frequency not reported: Peripheral neuropathy, acute cerebellar syndrome[Ref]

Ocular

Uncommon (0.1% to 1%): Nystagmus, excessive lacrimation, blurred vision, eye movement disturbance, optic neuritis, diplopia, decrease in visual acuity, photophobia, conjunctivitis, blepharitis, ectropion, dacryostenosis[Ref]

Renal

Very rare (less than 0.01%): Kidney failure[Ref]

Psychiatric

Uncommon (0.1% to 1%): Euphoria, somnolence
Rare (0.01% to 0.1%): Confusion
Very rare (less than 0.01%): Disorientation[Ref]

Respiratory

Very common (10% or more): Bronchospasm, epistaxis
Frequency not reported: Breathlessness, pneumonia, pharyngitis[Ref]

Some side effects of Adrucil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Substance Name

Fluorouracil

CAS Registry Number

51-21-8

Drug Class

Antimetabolites

Antineoplastic Agents

Antimetabolites, Antineoplastic

Immunosuppressive Agents