Fluorouracil injection

Fluorouracil injection comes as a solution (liquid) to be given intravenously (into a vein) by a doctor or nurse in a medical facility. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.

Your doctor may need to delay your treatment or change your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with fluorouracil injection.

This medication is usually given by injection into a vein by a health care professional. It may also be given by other methods of injection depending upon your medical condition. The dosage is based on your medical condition, body size, and response to therapy.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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Reviewed on 4/16/2014 References

Fluorouracil is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Fluorouracil is used to treat cancer of the colon, rectum, breast, stomach, or pancreas.

Fluorouracil may also be used for purposes not listed in this medication guide.

You should not receive this medicine if you are allergic to fluorouracil, or if you have:

• bone marrow depression;

• a serious infection; or

• if you are malnourished or are not receiving proper nutrition.

To make sure fluorouracil is safe for you, tell your doctor if you have:

• cancer that has spread to your bone marrow;

• liver disease;

• kidney disease; or

• if you have ever had radiation treatment of your pelvic area.

Tell your doctor about all other cancer medications you have received in the past, especially BiCNU, CeeNU, Cytoxan, DTIC-Dome, Gliadel, Leukeran, Myeleran, Neosar, Temodar, or Zanosar.

Do not use fluorouracil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether fluorouracil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Fluorouracil Injection, USP is supplied as a pharmacy bulk package as a vial containing 2.5 g/50 mL and 5 g/100 mL (50 mg/mL) fluorouracil.

Advise:

• Patients to notify their healthcare provider if they have a known DPD deficiency. Advise patients if they have complete or near complete absence of DPD activity, they are at an increased risk of severe and life-threatening mucositis, diarrhea, neutropenia and neurotoxicity [see Warnings and Precautions (5.1)]. • Patients of the risk of cardiotoxicity. Advise patients to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness [see Warnings and Precautions (5.2)]. • Patients to immediately contact their healthcare provider or go to an emergency room for new onset of confusion, disorientation, or otherwise altered mental status; difficulty with balance or coordination; or visual disturbances [see Warnings and Precautions (5.3, 5.4)]. • Patients to contact their healthcare provider for severe diarrhea or for painful mouth sores with decreased oral intake of food or fluids [see Warnings and Precautions (5.5, 5.8)]. • Patients to contact their healthcare provider for tingling or burning, redness, flaking, swelling, blisters, or sores on the palms of their hands or soles of their feet [see Warnings and Precautions (5.6)]. • Patients of the importance of keeping appointments for blood tests. Instruct patients to monitor their temperature on a daily basis and to immediately contact their healthcare provider for fever or other signs of infection [see Warnings and Precautions (5.7)]. • Patients to notify their healthcare provider of all drugs they are taking, including warfarin or other coumarin-derivative anticoagulants. Advise patients of the importance of keeping appointments for blood tests [see Warnings and Precautions (5.9)]. • Females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months after the last dose of fluorouracil. Instruct female patients to contact their healthcare provider if they become pregnant, if pregnancy occurs during fluorouracil treatment or during the 3 months following the last dose [see Warnings and Precautions (5.10), Use in Specific Populations (8.1 and 8.6), and Nonclinical Toxicology (13.1)]. • Females and males of reproductive potential may have impaired fertility while receiving fluorouracil, based on animal data [see Use in Specific Populations (8.6) and Nonclinical Toxicology (13.1)]. • Nursing mothers to discontinue nursing [see Use in Specific Populations (8.3)].

Manufactured By:

Intas Pharmaceuticals Limited,
Plot No.: 5, 6 & 7, Pharmez, Sarkhej-Bavla,
National Highway No. 8-A, Near Village Matoda,
Tal Sanand, Ahmedabad - 382 213, Gujarat, India

For BluePoint Laboratories

Issued - November, 2016

51 1158 0 711630

Data not available

Administration advice:
-Do not inject the entire contents of the vial directly into patients.
-Individualize the dose and dosing schedule based on tumor type, the specific regimen administered, disease state, response to treatment, and patient risk factors.

General:
-All dosages are based on patient's actual body weight; however, the estimated lean body weight is used if the patient is obese or if there has been a spurious weight gain due to ascites or other forms of abnormal fluid retention.
-Use is contraindicated in patients who are in a poor nutritional status, have depressed bone marrow function, and those with potentially serious infections.
-This drug is highly toxic with a narrow margin of safety.
-It is recommended that patients be hospitalized during treatment.
-This drug is irritating to the skin; avoid contact with the skin and mucous membranes.