DBL FLUOROURACIL INJECTION BP 50MG/ML [SIN05050P]

Product Info

DBL FLUOROURACIL INJECTION BP 50MG/ML

[SIN05050P]

4.1 Therapeutic indications

Fluorouracil is indicated alone or in combination for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas.

Fluorouracil should only be used when other proven measures have failed or are considered impractical.

4.2 Dose and method of administration

Dosage

The dosage being based on the patient’s actual weight. Ideal weight is used only if the patient is obese or if there has been a spurious weight gain due to oedema, ascites or other forms of abnormal fluid retention. Prior to treatment each patient is to be carefully evaluated in order to estimate the optimum initial dosage of fluorouracil.

The total daily dose of fluorouracil should not exceed 1 gram.

The following regimens have been recommended for use of fluorouracil as a single agent in adults:

Intravenous infusion

15 mg/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500 mL of 5% glucose given over a period of 4 hours. Infusion may be continued daily until the first gastrointestinal side effects occur, i.e., stomatitis, diarrhoea, leucopenia and thrombocytopenia, treatment must be discontinued until the side effects have receded (until the white blood cell (WBC) count has risen to 3,000 to 4,000 per mm³ or platelet count to 80,000 to 100,000 per mm³), the patient may then be placed on a maintenance therapy program.

Intravenous injection

12 mg/kg bodyweight daily for 3 consecutive days.

If toxic effects do not appear, the patient may then be given 6 mg/kg intravenously on the 5^th, 7^th and 9^th days. If there are still no signs of toxicity, the patient may be placed on maintenance therapy, otherwise regression of toxic side effects must be awaited before continuing therapy.

Maintenance therapy

5 to 10 mg/kg bodyweight by intravenous injection once a week. Toxic symptoms seldom occur during maintenance therapy. If, however, they do appear, therapy must be discontinued until the symptoms resolve.

Dosage adjustments

The initial recommended doses should be reduced by one third to a half if any of the following conditions are present:

1. poor nutritional state;

2. after major surgery (within previous 30 days);

3. inadequate bone marrow function (WBC count less than 5,000 per mm³; platelet count less than 100,000 per mm³);

4. impaired hepatic and/or renal function.

Method of administration

DBL Fluorouracil Injection BP may be administered by intravenous infusion or intravenous injection.

Fluorouracil may be used in combination with other cytotoxic agents or with radiotherapy. In such cases doses should be correspondingly reduced. DBL Fluorouracil Injection BP may also be administered as a 24-hour intra-arterial continuous drip infusion (5 to 7.5 mg/kg bodyweight daily).

4.3 Contraindications

Fluorouracil is contraindicated in patients

• who have any known hypersensitivity to fluorouracil or its excipients,

• who are debilitated,

• who are suffering from poor nutritional state,

• who are suffering from bone marrow depression following radiotherapy or therapy with other antineoplastic agents (leucocyte count less than 5,000/mm³, platelet count less than 100,000/mm³),

• who are suffering from a potentially serious infection,

• who are pregnant, and

• with known complete dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Fluorouracil must not be taken within 4 weeks of treatment with brivudine, sorivudine or their chemically related analogues. Brivudine, sorivudine and their analogues are potent inhibitors of the enzyme dihydropyrimidine dehydrogenase (DPD), which degrades fluorouracil (see section 4.5 Interactions with other medicines and other forms of interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).