What are the possible side effects of Kapecitabin Zentiva?
Get emergency medical help if you have signs of an allergic reaction to Kapecitabin Zentiva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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fever above 100.5 degrees;
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nausea, loss of appetite, eating much less than usual, vomiting (more than once in 24 hours);
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severe diarrhea (more than 4 times per day, or during the night);
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blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
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pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
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dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
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heart problems - chest pain or pressure, uneven heartbeats, shortness of breath (even with mild exertion), swelling or rapid weight gain;
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kidney problems - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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low blood cell counts - fever or other flu symptoms, cough, skin sores, pale skin, easy bruising, unusual bleeding, feeling light-headed, rapid heart rate; or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Kapecitabin Zentiva side effects may include:
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stomach pain or upset, constipation;
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tired feeling;
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mild skin rash; or
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numbness or tingling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Kapecitabin Zentiva in details
Clinical Trials: Adverse drug reactions (ADRs) considered by the investigator to be possibly, probably, or remotely related to the administration of Kapecitabin Zentiva have been obtained from clinical studies conducted with Kapecitabin Zentiva monotherapy (in adjuvant therapy of colon cancer, in metastatic colorectal cancer and metastatic breast cancer), and clinical studies conducted with Kapecitabin Zentiva in combination with different chemotherapy regimens for multiple indications. ADRs are added to the appropriate category in the tables below according to the highest incidence from the pooled analysis of seven clinical trials. Within each frequency grouping ADRs are listed in descending order of seriousness. Frequencies are defined as very common ≥1/10, common ≥5/100 to <1/10 and uncommon ≥1/1000 to <1/100.
Kapecitabin Zentiva Monotherapy: Safety data of Kapecitabin Zentiva monotherapy were reported for patients who received adjuvant treatment for colon cancer and for patients who received treatment for metastatic breast cancer or metastatic colorectal cancer. The safety information includes data from a phase III trial in adjuvant colon cancer (995 patients treated with Kapecitabin Zentiva and 974 treated with i.v. 5-FU/LV) and from 4 phase II trials in female patients with breast cancer (N=319) and 3 trials (1 phase II and 2 phase III trials) in male and female patients with colorectal cancer (N=630). The safety profile of Kapecitabin Zentiva monotherapy is comparable in patients who received adjuvant treatment for colon cancer and in those who received treatment for metastatic breast cancer or metastatic colorectal cancer. The intensity of ADRs was graded according to the toxicity categories of the NCIC CTC Grading System.
Skin fissures were reported to be at least remotely related to Kapecitabin Zentiva in less than 2% of the patients in seven completed clinical trials (N=949).
The following ADRs represent known toxicities with fluoropyrimidine therapy and were reported to be at least remotely related to Kapecitabin Zentiva in less than 5% of patients in seven completed clinical trials (N=949): Gastrointestinal Disorders: Dry mouth, flatulence, ADRs related to inflammation/ulceration of mucous membranes such as esophagitis, gastritis, duodenitis, colitis, gastrointestinal hemorrhage.
Cardiac Disorders: Edema lower limb, cardiac chest pain including angina, cardiomyopathy, myocardial ischemia/infarction, cardiac failure, sudden death, tachycardia, atrial arrhythmias including atrial fibrillation, and ventricular extrasystoles.
Nervous System Disorders: Taste disturbance, insomnia, confusion, encephalopathy, and cerebellar signs such as ataxia, dysarthria, impaired balance, abnormal coordination.
Infections and Infestations: ADRs related to bone marrow depression, immune system compromise, and/or disruption of mucous membranes, such as local and fatal systemic infections (including bacterial, viral, fungal etiologies) and sepsis.
Blood and Lymphatic System Disorders: Anemia, bone marrow depression/pancytopenia.
Skin and Subcutaneous Tissue Disorders: Pruritus, localized exfoliation, skin hyperpigmentation, nail disorders, photosensitivity reactions, radiation recall syndrome.
General Disorders and Administration Site Conditions: Pain in limb, chest pain (non-cardiac).
Eye: Eye Irritation.
Respiratory: Dyspnoea, cough.
Musculoskeletal: Back pain, myalgia, arthralgia.
Psychiatric Disorders: Depression.
Hepatic failure and cholestatic hepatitis have been reported during clinical trials and post-marketing exposure. A causal relationship with Kapecitabin Zentiva treatment has not been established.
Kapecitabin Zentiva in Combination Therapy: Table 9 lists ADRs associated with the use of Kapecitabin Zentiva in combination therapy with different chemotherapy regimens in multiple indications and occurred in addition to those seen with monotherapy and/or at a higher frequency grouping. The safety profile was similar across all indications and combination regimens. These reactions occurred in ≥5% of patients treated with Kapecitabin Zentiva in combination with other chemotherapies. Adverse drug reactions are added to the appropriate category in Table 9 according to the highest incidence seen in any of the major clinical trials. Some of the adverse reactions are reactions commonly seen with chemotherapy (e.g. peripheral sensory neuropathy with docetaxel or oxaliplatin) or with bevacizumab (e.g. hypertension); however, an exacerbation by Kapecitabin Zentiva therapy cannot be excluded.
Hypersensitivity reactions (2%) and cardiac ischaemia/infarction (3%) have been reported commonly for Kapecitabin Zentiva in combination with other chemotherapy but in less than 5% of patients.
Rare or uncommon ADRs reported for Kapecitabin Zentiva in combination with other chemotherapy are consistent with the ADRs reported for Kapecitabin Zentiva monotherapy or the combination product monotherapy.
Laboratory Abnormalities: Table 10 displays laboratory abnormalities observed in 995 patients (adjuvant colon cancer) and 949 patients (metastatic breast and colorectal cancer), regardless of relationship to treatment with Kapecitabin Zentiva.
Post-Marketing: The following ADRs have been identified during post-marketing exposure:
Laboratory Abnormalities: No text.
What is the most important information I should know about Kapecitabin Zentiva?
- Kapecitabin Zentiva may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Kapecitabin Zentiva may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Kapecitabin Zentiva. Vaccinations may be less effective.
- Diarrhea is common with Kapecitabin Zentiva. Some cases of diarrhea may cause dehydration and kidney problems that can sometimes be deadly. Do not try to treat diarrhea without first checking with your doctor. Call your doctor right away if the number of bowel movements you have in a day increases by 4 or more than is normal for you. Call your doctor right away if you have bloody diarrhea, severe stomach pain, and fever.
- Dehydration has happened in people taking Kapecitabin Zentiva. Dehydration may cause serious kidney problems that can be fatal. The risk may be increased in people who already have kidney problems or who are taking medicines that can cause kidney problems. The risk may also be increased in people who have loss of appetite, nausea, vomiting, diarrhea, or weakness. Discuss any questions or concerns with your doctor.
- If you have nausea, vomiting, diarrhea, or loss of appetite, talk with your doctor. There may be ways to lower these side effects.
- Very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. They can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Heart problems (eg, heart attack, heart failure, irregular heartbeat) and sudden death have happened with Kapecitabin Zentiva. These effects may be more common in people who have a history of heart disease. Discuss any questions or concerns with your doctor,
- Tell your doctor or dentist that you take Kapecitabin Zentiva before you receive any medical or dental care, emergency care, or surgery.
- Lab tests may be performed while you take Kapecitabin Zentiva. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Talk with your doctor about using an effective method of birth control while taking Kapecitabin Zentiva.
- Use Kapecitabin Zentiva with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Kapecitabin Zentiva has been shown to cause harm to the fetus. Do not become pregnant while you are taking it. Talk with your doctor about using effective methods of birth control while taking Kapecitabin Zentiva. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Kapecitabin Zentiva while you are pregnant. It is not known if Kapecitabin Zentiva is excreted in breast milk. Do not breast-feed while taking Kapecitabin Zentiva.
Kapecitabin Zentiva contraindications
You should not take this medication if you are allergic to Kapecitabin Zentiva or fluorouracil (Adrucil), or if you have severe kidney disease or a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.
Before you take Kapecitabin Zentiva, 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 Kapecitabin Zentiva, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment.
Kapecitabin Zentiva 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.
References
- DailyMed. "CAPECITABINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "5'-Deoxy-5-fluoro-N-((pentyloxy)carbonyl)cytidine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "CAPECITABINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Kapecitabin Zentiva are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Kapecitabin Zentiva. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
