Fluorouracil

5-Fluorouracil "EBEVE" concentrate is intended for the treatment of:

• malignant neoplasms of progressive colorectal cancer;
• progressive stomach cancer;
• progressive pancreatic cancer;
• progressive and / or metastatic breast cancer;
• progressive tumors in the head and neck.

Structure

Active ingredient: fluorouracil (fluorouracil);

1 ml of concentrate contains 50 mg of fluorouracil;

Excipients: sodium hydroxide, water for injection.

Contraindications

• Sensitivity to fluorouracil or to any of the components of the drug.
• Significant deviations in the number of formed elements in the blood.
• Suppression of bone marrow function, especially after radiation therapy or treatment with other antitumor drugs.
• Bleeding.
• Severe impairment of liver and / or kidney function.
• Severe infectious diseases (such as shingles, chickenpox).
• Stomatitis, ulcers of the oral mucosa and gastrointestinal tract.
• Pseudomembranous enterocolitis.
• Myelosuppression
• Severe diarrhea.
• Severe exhaustion (cachexia).
• Plasma bilirubin> 85 μmol / L.
• During treatment with fluorouracil, vaccination with live vaccines should be avoided.
• During pregnancy and breastfeeding.

Fluorouracil cannot be used simultaneously with brivudine, sorivudine, or their analogues. Brivudin, Sorivudine and analogues are powerful inhibitors of the enzyme dihydropyrimidine dehydrogenase (DPD), which destroys fluorouracil.

Mode of application

Doses and treatment regimen are determined individually depending on the condition of the patient and the type of cancer, and also depending on whether 5-fluorouracil Ebeve is used as monotherapy or in combination with other types of treatment. The exact dosage must be recognized from therapeutic protocols that have proven effective in treating a particular disease.

It is necessary to begin treatment with 5-fluorouracil “Ebeve” in a hospital setting. The total daily dose should not exceed 1 g.

Usually, doses should be determined for adults based on 1 kg of the patient’s actual body weight, but for patients with excess body weight, edema, ascites, and other forms of pathological fluid retention in the body, doses should be determined based on 1 kg of ideal body weight.

5-fluorouracil "Ebeve" is administered by intravenous injection, infusion.

Initial therapy with daily use:

• as an intravenous (iv) infusion of 15 mg / kg, or 600 mg / m2, for 4 hours daily before the onset of side effects.
• as an iv injection: slow iv (from 2 to 3 minutes) administration of 12 mg / kg, or 480 mg / m2, on days 1, 2 and 3;

If signs of toxicity are not observed, apply 6 mg / kg, or 240 mg / m2, on days 5, 7, and 9.

Initial therapy on a weekly basis: slow intravenous administration of 15 mg / kg, or 600 mg / m2, once a week.

Maintenance therapy

As soon as remission is achieved, or after a decrease in side effects, namely with a further increase in the number of leukocytes to 3000 - 4000 / μl, platelets to 80,000 - 100000 / μl: 5-10 mg / kg or 200-400 mg / m2 iv once a week.

The maximum daily dose should not exceed 1 g. All doses are used for patients with normal body weight, that is, for patients with obesity, ascites or edema, a dose adjustment is necessary.

When fluorouracil is combined with other cytostatics with a similar side effect profile or radiation therapy, the dose should be accordingly reduced. In this case, the drug is used in the form of a 24-hour continuous drip infusion.

Route of administration

Fluorouracil should be used strictly by intravenous infusion. The drug should be administered by injection or injection after dilution in a 0.9% sodium chloride solution or 5% glucose solution.

Extravascular applications should be avoided.

Application features

Pregnancy

5-fluorouracil "Ebeve" should not be used during pregnancy.

Breastfeeding.The drug can not be used during lactation.

Fertility. Fluorouracil can have a negative effect on the reproductive system. Men who receive fluorouracil therapy are not recommended to start a child during treatment, as well as within 6 months after the end of treatment. Men should be advised to consult with specialists about semen cryopreservation before starting treatment, since the use of fluorouracil can lead to irreversible infertility.

Drivers

Fluorouracil can cause nausea and vomiting, thus impairing the ability to drive vehicles and mechanisms. Patients should refrain from driving and from working with mechanisms if they receive fluorouracil treatment.

Overdose

Symptoms Acute psychotic reactions, drowsiness, increased effects of sedatives, increased toxic effects of alcohol.

Treatment. The specific antidote of fluorouracil is unknown. For prophylactic purposes, use transfusions of leukocyte or platelet concentrates. It is necessary to ensure adequate hydration and diuresis, as well as correct imbalance in electrolytes. In hemodialysis, it is usually not required. The patient should be under medical supervision to quickly identify hematological and late gastrointestinal complications. Further treatment is symptomatic.

Adverse reactions

The most common and serious adverse reactions with fluorouracil are toxic effects from the bone marrow and disorders of the gastrointestinal tract.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C. Do not refrigerate or refrigerate. Keep out of the reach of children.

Shelf life is 2 years.