What you need to know before you take Capecitabine Do not use Capecitabine: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine.

Talk to your doctor or pharmacist or nurse before taking capecitabine. DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.

If you have an unrecognised DPD deficiency and take capecitabine, you may experience severe forms of the side effects listed under section 4 Possible side effects. Contact your doctor immediately if you are concerned about any of the side effects or if you notice any additional side effects not listed in the leaflet see section 4 Possible side effects.

Children and adolescents Capecitabine is not indicated in children and adolescents. What is capecitabine Xeloda? Capecitabine is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body Capecitabine is used to treat breast cancer and colon or rectum cancer that has spread to other parts of the body.

Capecitabine may also be used for purposes not listed in this medication guide. What are the possible side effects of capecitabine Xeloda? Get emergency medical help if you have any of these signs of an allergic reaction: Call your doctor at once if you have a serious side effect such as: Other common side effects may include: This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the most important information I should know about capecitabine Xeloda? You should not take this medication if you are allergic to capecitabine or fluorouracil Adrucil , or if you have severe kidney disease or a metabolic disorder called DPD dihydropyrimidine dehydrogenase deficiency.

Before you take capecitabine, tell your doctor if you have liver or kidney disease, a history of coronary artery disease, or if you are also taking folic acid contained in many vitamin and mineral supplements , leucovorin Wellcovorin , phenytoin Dilantin , or a blood thinner warfarin, Coumadin.

Do not use this medication without telling your doctor if you are pregnant or breast-feeding a baby. Use effective birth control while you are taking capecitabine, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment.

Capecitabine can have long lasting effects on your body. You may need frequent medical tests while you are using this medication and for a short time after your treatment ends. Call your doctor at once if you have a serious side effect such as severe vomiting or diarrhea, fever or flu symptoms, pain or redness of your hands or feet, jaundice yellowing of the skin or eyes , chest pain, sudden numbness or weakness, or fainting.

You should not take this medication if you are allergic to capecitabine or fluorouracil Adrucil , or if you have: To make sure capecitabine is safe for you, tell your doctor if you have any of these conditions: FDA pregnancy category D. Dose modifications applied should be applied for the precipitating adverse event as necessary see section 4. Hand-foot syndrome also known as hand-foot skin reaction or palmar-plantar erythrodysesthesia or chemotherapy induced acral erythema.

Persistent or severe hand-foot syndrome Grade 2 and above can eventually lead to loss of fingerprints which could impact patient identification. If grade 2 or 3 hand-foot syndrome occurs, administration of capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1.

Following grade 3 hand-foot syndrome, subsequent doses of capecitabine should be decreased. When capecitabine and cisplatin are used in combination, the use of vitamin B6 pyridoxine is not advised for symptomatic or secondary prophylactic treatment of hand—foot syndrome, because of published reports that it may decrease the efficacy of cisplatin.

There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Xeloda. Cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes including very rare cases of QT prolongation.

These adverse reactions may be more common in patients with a prior history of coronary artery disease. Cardiac arrhythmias including ventricular fibrillation, torsade de pointes, and bradycardia , angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving capecitabine.

Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris see section 4. Hypo- or hypercalcaemia has been reported during capecitabine treatment. Caution must be exercised in patients with pre-existing hypo- or hypercalcaemia see section 4. Central or peripheral nervous system disease. Caution must be exercised in patients with central or peripheral nervous system disease, e.

Diabetes mellitus or electrolyte disturbances. Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during capecitabine treatment. These results suggest an interaction, probably due to an inhibition of the cytochrome P 2C9 isoenzyme system by capecitabine.

Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response INR or prothrombin time monitored closely and the anticoagulant dose adjusted accordingly see section 4.

In the absence of safety and efficacy data in patients with hepatic impairment, Capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis.

Dihydropyrimidine dehydrogenase DPD deficiency: Rarely, unexpected, severe toxicity e. 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 e.

No dose has been proven safe for patients with complete absence of DPD activity. Genotyping for these alleles is recommended to identify patients at increased risk for severe toxicity.

It cannot be excluded that other rare variants may also be associated with an increased risk of severe toxicity. For patients with partial DPD deficiency such as those with heterozygous mutations in the DPYD gene and where the benefits of Xeloda 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.

A reduction of the starting dose in these patients may be considered to avoid serious toxicity. There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by specific test. The consequences of a reduced dose for efficacy are currently uncertain.

Therefore, in the absence of serious toxicity the dose could be increased while carefully monitoring the patient. The patients who are tested negative for the above-mentioned alleles may still have a risk of severe adverse events. In patients with unrecognised DPD deficiency treated with capecitabine as well as in those patients who test negative for specific DPYD variations, life-threatening toxicities manifesting as acute overdose may occur see section 4.

Xeloda 150mg and 500mg Film-coated Tablets

Get plenty of rest. In the US - Call your doctor for medical advice about side effects. Of the patients with grade 3 or 4 hyperbilirubinemia, Persistent or severe hand-foot syndrome Grade 2 and above can eventually lead to loss of fingerprints which could impact patient identification. The first trial was conducted in 22 pediatric patients median age 8 years, range years with newly diagnosed non-disseminated intrinsic diffuse brainstem gliomas and high grade gliomas. Caution must be exercised in patients with diabetes mellitus or electrolyte disturbances, as these may be aggravated during capecitabine treatment, xeloda 500 mg capecitabine. These adverse reactions may be more common in patients with a prior history of coronary artery disease. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Capecitabine filmcoated tablets contains mg or mg capecitabine, which generic for xanax mylan is not a cytostatic agent. Fertility There is no data on Xeloda and impact on fertility. Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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