Capecitabine

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What is Capecitabine?



What are the uses of this medicine?

This medicine is used to treat people with:

  • cancer of the colon that has spread to lymph nodes in the area close to the colon (Dukes' C stage), after they have surgery.
  • cancer of the colon or rectum (colorectal) that has spread to other parts of the body (metastatic), as your first treatment of your cancer at this stage.
  • breast cancer that has spread to other parts of the body (metastatic) together with another medicine called docetaxel after treatment with certain other anti-cancer medicines have not worked.
  • breast cancer that spread to other parts of the body and has not improved after treatment with paclitaxel and certain other anti-cancer medicines, or who cannot receive any more treatment with certain anti-cancer medicines.

How does this medicine work?

  • Capecitabine (kap" e sye' ta been) is a pyrimidine analogue (pentyloxycarbonyl-deoxy-fluorocytidine) that has antineoplastic action against several solid tumors, including breast and colon cancers.
  • Capecitabine is a prodrug of 5-fluorouracil (5-FU) and is converted to this active metabolite intracellularly, where it acts by interfering with DNA, RNA and protein synthesis and inhibiting cell division.
  • Unlike 5-FU, capecitabine can be given by mouth.
  • Furthermore, capecitabine is converted to 5-FU in a three step process, the first of which takes place in the liver and the last two predominantly in tumor cells, which may account for why it is better tolerated than 5-FU.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

  • have severe kidney problems
  • are allergic to capecitabine, 5-fluorouracil, or any of the ingredients in XELODA.

What drug interactions can this medicine cause?

  • Altered coagulation parameters and/or bleeding have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Monitor anticoagulant response (INR or prothrombin time) frequently in order to adjust the anticoagulant dose as needed.
  • The level of phenytoin should be carefully monitored in patients taking XELODA and phenytoin dose may need to be reduced.
  • The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin.
  • Care should be exercised when XELODA is coadministered with CYP2C9 substrates.
  • Avoid the use of allopurinol during treatment with XELODA.
  • Food reduced both the rate and extent of absorption of capecitabine. It is recommended that XELODA be administered with food.

Is this medicine FDA approved?

  • Initial U.S. Approval: 1998

How should this medicine be used?

Recommended Dosage: Monotherapy: 1250 mg/m2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles.

  • Adjuvant treatment is recommended for a total of 6 months (8 cycles).
  • In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1-hour IV infusion every 3 weeks.
  • XELODA dosage may need to be individualized to optimize patient management.
  • Reduce the dose of XELODA by 25% in patients with moderate renal impairment.

Administration

  • Take XELODA exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much XELODA to take and when to take it.
  • Take XELODA 2 times a day, 1 time in the morning and 1 time in the evening.
  • Take XELODA within 30 minutes after finishing a meal.
  • Swallow XELODA tablets whole with water. Do not crush or cut XELODA tablets. If you cannot swallow XELODA tablets whole, tell your healthcare provider.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with XELODA if you develop side effects.
  • If you take too much XELODA, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • As Tablets: 150 mg and 500 mg

This medicine is available in fallowing brand namesː

  • XELODA

What side effects can this medication cause?

The most common side effects of this medicine include:

XELODA can cause serious side effects including:

What special precautions should I follow?

  • Coagulopathy may occur. May result in bleeding, death. Monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly.
  • XELODA can induce diarrhea, sometimes severe. May be severe. Interrupt XELODA treatment immediately until diarrhea resolves or decreases to grade 1. Recommend standard antidiarrheal treatments.
  • The cardiotoxicity observed with XELODA includes myocardial infarction/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. Common in patients with a prior history of coronary artery disease.
  • Patients with partial DPD (Dihydropyrimidine Dehydrogenase Deficiency)activity may also have increased risk of severe, life-threatening, or fatal adverse reactions caused by XELODA. Withhold or permanently discontinue XELODA in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity. No XELODA dose has been proven safe in patients with absent DPD activity.
  • Dehydration has been observed and may cause acute renal failure which can be fatal. Patients with pre-existing compromised renal function or who are receiving concomitant XELODA with known nephrotoxic agents are at higher risk. Interrupt XELODA treatment until dehydration is corrected. Potential risk of acute renal failure secondary to dehydration. Monitor and correct dehydration.
  • XELODA Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • Severe mucocutaneous reactions, Steven-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. XELODA should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. XELODA may induce hand-and-foot syndrome. Persistent or severe hand-and-foot syndrome can lead to loss of fingerprints which could impact patient identification. Interrupt XELODA treatment until the hand-and-foot syndrome event resolves or decreases in intensity.
  • Hyperbilirubinemia may occur. Interrupt XELODA treatment immediately until the hyperbilirubinemia resolves or decreases in intensity.


What to do in case of emergency/overdose?

Symptoms of overdosage may include:

Management of overdosage:

  • management of overdose should include customary supportive medical interventions aimed at correcting the presenting clinical manifestations.
  • Although no clinical experience using dialysis as a treatment for XELODA overdose has been reported, dialysis may be of benefit in reducing circulating concentrations.

Can this medicine be used in pregnancy?

  • XELODA can cause fetal harm when administered to a pregnant woman.
  • Limited available human data are not sufficient to inform the drug-associated risk during pregnancy.

Can this medicine be used in children?

  • The safety and effectiveness of XELODA in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

  • Active ingredient: capecitabine
  • Inactive ingredients: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.

Who manufactures and distributes this medicine?

  • Distributed by:

Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco XELODA® is a registered trademark of Hoffmann-La Roche.

What should I know about storage and disposal of this medication?

  • Store XELODA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep XELODA in a tightly closed container.
  • Ask your healthcare provider or pharmacist how to safely throw away any unused XELODA.
  • Keep XELODA and all medicines out of the reach of children.

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