Therapeutic Indications

Capecitabine is indicated for:

Breast cancer

Irrespective of gender only Adults (18 years old or older)

Capecitabine is indicated for the treatment of:

  • in combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
  • as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 2500 mg/m² in 2 divided doses daily

Treatment 2: Oral - 2500 mg/m² in 2 divided doses daily

Gastric cancer

Irrespective of gender only Adults (18 years old or older)

Capecitabine is indicated for the treatment of first-line treatment of advanced gastric cancer in combination with a platinum based regimen.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 1250-2000 mg/m² in 2 divided doses daily

Colorectal cancer

Irrespective of gender only Adults (18 years old or older)

Capecitabine is indicated for the treatment of:

  • for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.
  • metastatic colorectal cancer.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 2500 mg/m² in 2 divided doses daily

Treatment 2: Oral - 1250-2000 mg/m² in 2 divided doses daily

Contraindications

Active ingredient Capecitabine is contraindicated in the following cases:

Severe renal impairment (creatinine clearance below 30 ml/min)

No gender/age discrimination

In patients with severe renal impairment (creatinine clearance below 30 ml/min).

Severe hepatic impairment

No gender/age discrimination

In patients with severe hepatic impairment.

Lactation

No gender/age discrimination

It is not known whether capecitabine is excreted in human breast milk. In lactating mice, considerable amounts of capecitabine and its metabolites were found in milk. Breast-feeding should be discontinued while receiving treatment with capecitabine.

Pregnancy

No gender/age discrimination

There are no studies in pregnant women using capecitabine; however, it should be assumed that capecitabine may cause foetal harm if administered to pregnant women. In reproductive toxicity studies in animals, capecitabine administration caused embryolethality and teratogenicity. These findings are expected effects of fluoropyrimidine derivatives. Capecitabine is contraindicated during pregnancy.

Brivudine, sorivudine

No gender/age discrimination

A clinically significant interaction between sorivudine and 5-FU, resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described. This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal. Therefore, capecitabine must not be administered concomitantly with sorivudine or its chemically related analogues, such as brivudine. There must be at least a 4-week waiting period between end of treatment with sorivudine or its chemically related analogues such as brivudine and start of capecitabine therapy.

Dihydropyrimidine dehydrogenase (DPD) deficiency

No gender/age discrimination

Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.

Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil. Although DPD deficiency cannot be precisely defined, it is known that patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus, which can cause complete or near complete absence of DPD enzymatic activity (as determined from laboratory assays), have the highest risk of life-threatening or fatal toxicity and should not be treated with capecitabine. No dose has been proven safe for patients with complete absence of DPD activity.

For patients with partial DPD deficiency (such as those with heterozygous mutations in the DPYD gene) and where the benefits of capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution and frequent monitoring with dose adjusment according to toxicity.There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by specific test.

In patients with unrecognised DPD deficiency treated with capecitabine, life-threatening toxicities manifesting as acute overdose may occur. In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately. Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.

Severe leucopenia, neutropenia, thrombocytopenia

No gender/age discrimination

In patients with severe leucopenia, neutropenia, or thrombocytopenia.