Information Sheet
Xeloda ® (Capecitabine)
Capecitabine (marketed under the name Xeloda®) is a tablet that works by attacking cancer cells alone without causing the discomfort and danger of conventional intravenous therapy.
How Does Capecitabine Work?
The patient took capecitabine tablets after breakfast and after dinner for two weeks and then there was a one week rest period. After this rest period the patient took capecitabine again.
Capecitabine has a unique 3 step activation mechanism. Capecitabine is inactive when swallowed, then absorbed into the intestine and into the bloodstream.
The first two steps of the activation process take place in the liver, when capecitabine begins to be converted into a 'cancer cell killing agent' which remains non-toxic (non-toxic). The final step of activation takes place within the cancer cell itself where capecitabine is activated into 5-FU by an enzyme that is found more frequently in cancer cells than in healthy cells. With this 'active on tumor cells' mechanism, more 5-FU will be produced in cancer cells than in healthy cells.
Capecitabine then poisons the cancer cells with 5-FU which attacks the DNA of the cancer cells.[1- 2]
How Do We Know Capecitabine is Effective?
Capecitabine was compared to 5-FU/LV (5-FU plus leucovorin) given by injection (bolus injection – Mayo regimen) in two international phase III studies involving more than 1,200 patients with metastatic colorectal cancer.[3-4]
This study showed that one in 4 patients treated with capecitabine (26%) showed a significant reduction in cancer compared with patients treated intravenously (17% or 1 in 6 patients). This suggests that capecitabine is more effective in shrinking cancer than conventional 5-FU/LV therapy given intravenously. Furthermore, cancer stopped growing in 48% of patients taking capecitabine. Thus, and 7 out of 10 patients benefited from treatment with capecitabine with either significant cancer reduction or suppression of cancer growth. The time required for the development of the disease to metastasize and the life expectancy in the two groups are relatively the same.[5]
More Efficacious and More Comfortable For Patients
Capecitabine has a much better toxicity profile compared to standard chemotherapy. Overall, capecitabine reduces the risk of diarrhea, mouth sores, hair loss, nausea, neutropenia (low white blood cells) and reduces hospital stays.
Before capecitabine was developed, patients with metastatic colorectal cancer who wanted to get the best treatment for their disease had no choice but regular infusion chemotherapy with 5-FU/LV administered into a vein, pumped through a catheter permanently implanted under the skin.
Along with the discomfort of the catheter – and the surgery required to implant it – patients are also at risk for infection, blood clots and bruising and must make regular visits to the hospital for chemotherapy.
The availability of capecitabine tablets allows patients to undergo chemotherapy at home, which of course has better effectiveness.
Two studies [6-7] that tested patient choice found that patients prefer to take chemotherapy tablets over injections/infusions, as long as the tablets are as effective as infusions, and capecitabine has the desired action.
Side Effects, Safety and Tolerability
The most common side effects encountered in 5-FU therapy are diarrhea, nausea, stomatitis and hair loss. The incidence rate in patients taking capecitabine was significantly lower compared to 5-FU/LV infusion.
In patients who use capecitabine, redness of the palms and feet is found or commonly called hand-foot syndrome, but this can be overcome by temporarily stopping therapy and adjusting the dose. This syndrome is not life threatening.
The decrease in the number of white blood cells (neutropenia) in capecitabine users is also much less, thereby reducing the risk of infection and hospitalization.
About Xeloda ®
Xeloda® is a drug in the treatment of cancer. Xeloda® is packaged in tablet form and has different activity from other chemotherapy drugs. Xeloda® is FDA and BPOM approved for the treatment of breast and colorectal cancer either alone or in combination. Each patient is different in terms of needs, treatment reactions, and your medical team is the first point of reference where you can get detailed information about your disease or about Xeloda® treatment. If you still have questions about your medication and illness, don't hesitate to ask your medical team.
What is Xeloda ® and how does it work?
Xeloda® has a unique mechanism of action in which Xeloda® produces 5-FU, which is cancer-killing, only in cancer cells. Xeloda® has been registered with BPOM and is available for ASKES patients starting January 1, 2005. How is Xeloda ®
different from other chemotherapy?
Most chemotherapy is given by injection/infusion which requires the patient to come to the hospital (RS) or clinic. Xeloda® is a drug that is consumed in tablet form. You don't need to come to a hospital or clinic to receive Xeloda® but just take it at home or on the go.
Important information that you should know before you consume Xeloda®
It is important to know about conditions under which you should not consume Xeloda®, including:
How Does Capecitabine Work?
The patient took capecitabine tablets after breakfast and after dinner for two weeks and then there was a one week rest period. After this rest period the patient took capecitabine again.
Capecitabine has a unique 3 step activation mechanism. Capecitabine is inactive when swallowed, then absorbed into the intestine and into the bloodstream.
The first two steps of the activation process take place in the liver, when capecitabine begins to be converted into a 'cancer cell killing agent' which remains non-toxic (non-toxic). The final step of activation takes place within the cancer cell itself where capecitabine is activated into 5-FU by an enzyme that is found more frequently in cancer cells than in healthy cells. With this 'active on tumor cells' mechanism, more 5-FU will be produced in cancer cells than in healthy cells.
Capecitabine then poisons the cancer cells with 5-FU which attacks the DNA of the cancer cells.[1- 2]
How Do We Know Capecitabine is Effective?
Capecitabine was compared to 5-FU/LV (5-FU plus leucovorin) given by injection (bolus injection – Mayo regimen) in two international phase III studies involving more than 1,200 patients with metastatic colorectal cancer.[3-4]
This study showed that one in 4 patients treated with capecitabine (26%) showed a significant reduction in cancer compared with patients treated intravenously (17% or 1 in 6 patients). This suggests that capecitabine is more effective in shrinking cancer than conventional 5-FU/LV therapy given intravenously. Furthermore, cancer stopped growing in 48% of patients taking capecitabine. Thus, and 7 out of 10 patients benefited from treatment with capecitabine with either significant cancer reduction or suppression of cancer growth. The time required for the development of the disease to metastasize and the life expectancy in the two groups are relatively the same.[5]
More Efficacious and More Comfortable For Patients
Capecitabine has a much better toxicity profile compared to standard chemotherapy. Overall, capecitabine reduces the risk of diarrhea, mouth sores, hair loss, nausea, neutropenia (low white blood cells) and reduces hospital stays.
Before capecitabine was developed, patients with metastatic colorectal cancer who wanted to get the best treatment for their disease had no choice but regular infusion chemotherapy with 5-FU/LV administered into a vein, pumped through a catheter permanently implanted under the skin.
Along with the discomfort of the catheter – and the surgery required to implant it – patients are also at risk for infection, blood clots and bruising and must make regular visits to the hospital for chemotherapy.
The availability of capecitabine tablets allows patients to undergo chemotherapy at home, which of course has better effectiveness.
Two studies [6-7] that tested patient choice found that patients prefer to take chemotherapy tablets over injections/infusions, as long as the tablets are as effective as infusions, and capecitabine has the desired action.
Side Effects, Safety and Tolerability
The most common side effects encountered in 5-FU therapy are diarrhea, nausea, stomatitis and hair loss. The incidence rate in patients taking capecitabine was significantly lower compared to 5-FU/LV infusion.
In patients who use capecitabine, redness of the palms and feet is found or commonly called hand-foot syndrome, but this can be overcome by temporarily stopping therapy and adjusting the dose. This syndrome is not life threatening.
The decrease in the number of white blood cells (neutropenia) in capecitabine users is also much less, thereby reducing the risk of infection and hospitalization.
About Xeloda ®
Xeloda® is a drug in the treatment of cancer. Xeloda® is packaged in tablet form and has different activity from other chemotherapy drugs. Xeloda® is FDA and BPOM approved for the treatment of breast and colorectal cancer either alone or in combination. Each patient is different in terms of needs, treatment reactions, and your medical team is the first point of reference where you can get detailed information about your disease or about Xeloda® treatment. If you still have questions about your medication and illness, don't hesitate to ask your medical team.
What is Xeloda ® and how does it work?
Xeloda® has a unique mechanism of action in which Xeloda® produces 5-FU, which is cancer-killing, only in cancer cells. Xeloda® has been registered with BPOM and is available for ASKES patients starting January 1, 2005. How is Xeloda ®
different from other chemotherapy?
Most chemotherapy is given by injection/infusion which requires the patient to come to the hospital (RS) or clinic. Xeloda® is a drug that is consumed in tablet form. You don't need to come to a hospital or clinic to receive Xeloda® but just take it at home or on the go.
Important information that you should know before you consume Xeloda®
It is important to know about conditions under which you should not consume Xeloda®, including:
- You have an allergic reaction or intolerance to Xeloda® or 5-FU.
- (5-Flouroracil), or any other medicine you received during your treatment.
- You are pregnant or about to become pregnant.
- You are currently breastfeeding or planning to breastfeed.
- You have severe spinal cord depression.
- You have serious liver disease or serious kidney problems.
- Heart disease
- Kidney illness
- Liver disease
- Other serious illness
Like other cancer drugs, Xeloda® also has side effects. The doctor will tell you the symptoms that arise if these side effects appear. If you are concerned about the side effects that you may experience during treatment, you should tell your doctor.
What side effects often occur when using Xeloda® ?
Possible side effects of Xeloda®:
- Digestive system: Diarrhoea, nausea, vomiting, stomatitis, and abdominal pain.
- Skin: Hand-foot syndrome (palms and feet feel itchy, sore, swollen and reddish), spots on the skin, dry and itchy skin, dermatitis (skin inflammation).
- Others: Fatigue and fever.
What should I do if I experience side effects?
The side effects that occur can be serious, so it is important for you to temporarily stop using Xeloda® if the side effects that occur are disturbing or before they become more serious. Don't forget to contact your team of doctors for further instructions. This prevents side effects from becoming very serious.
How to deal with side effects that occur?Hand Foot Syndrome (HFS)
Prevention that can be done is as follows:
Avoid potential injuries to the hands and feet:
NOTE
PT.Roche Indonesia expressed its objection to writing the title "Xeloda Doesn't Work For Breast Cancer" which is inappropriate and can lead to misunderstandings for readers, especially patients and medical practitioners who handle breast cancer treatment.
- Diarrhea Consult your doctor and take any prescribed medication for diarrhea. The drug that is generally given can be loperamide 4 mg taken at the first diarrhea followed by 2 mg every 6 hours and stopped after the last 12 hours of diarrhea. Drink enough water to prevent fluid deficiency. Stop Xeloda® temporarily if you have diarrhea 4 or more times a day, and if you have diarrhea at night, and consult your doctor.
- Vomiting, Consult your doctor and take any prescribed anti-emetic medication, eg 1-2 Granisetron (Kytril®) tablets daily. If accompanied by nausea, eat easily digestible foods such as biscuits and avoid foods that smell stimulating. Stop Xeloda® for a while if you vomit more than 1 time a day and consult your doctor.
- Canker sores, keep your teeth and mouth clean: for example gargling with a solution of soda and salt (1 teaspoon of soda and 1 teaspoon of salt in warm water), do it 3-4 times a day. Avoid mouth irritants such as citrus fruits, juices, cigarettes and spicy foods. Stop Xeloda® for a while if you experience symptoms of stomatitis such as mouth redness, pain and swelling, and consult your doctor.
Prevention that can be done is as follows:
Avoid potential injuries to the hands and feet:
- Avoid higher temperatures on your hands and feet, such as taking a hot bath.
- Avoid friction, pressure, on the palms and feet, such as wearing tight shoes. Avoid perfume products that stimulate or can irritate and dry the skin.
- Use mild soap. Use a moisturizing cream or lotion on the feet and hands 2 times a day (eg Uredrem, Tupepe, Soft-U-derm or topical 99% dimethyl-sulfoxide). Take vitamin B6 or vitamin E, ask your doctor for the right dosage for you, the dose generally given is above 100 mg/day for vitamin B6 and 300 mg/day for vitamin E.
Stop Xeloda® temporarily if you experience swelling or redness accompanied by pain and consult your doctor. Your doctor can temporarily stop Xeloda® until your symptoms improve, then the doctor will determine whether the dose needs to be changed. The use of moisturizing creams or lotions can be continued (for example Soft-U-Derm or Urea Cream such as Uredrem or Tupepe Cream), it is recommended that after you use the cream or lotion, use cotton gloves or socks, this will help absorb the cream or lotion and your skin is always covered. Your doctor may recommend creams that contain corticosteroids, which can reduce inflammation.
Vitamin B6 can also be recommended by your doctor, follow the recommended frequency of use and dosage. Some health centers recommend soaking your feet and hands in cold water or placing ice packs on the affected area. Cooling the hands and feet will reduce blood flow to the affected area and make symptoms less severe. Placing the hands and feet in an elevated position can also provide improvement. Always consult your doctor and nurse before you self-medicate.
What you SHOULD do if you have HFS:
- Call your doctor or nurse if you see any signs of HFS.
- Wear comfortable and loose clothing and shoes.
- Wear sandals while you are at home.
- Keep showering with cold water.
- Use mild soap when you shower or wash your hands and feet.
- Do not wipe your skin dry with a towel after showering.
- Wear sun protection cream when you are out in the sun.
- Use a skin protection cream.
- Avoid prolonged exposure of hands and feet to hot water.
What you SHOULD NOT do if you have HFS:
- Don't wait for your HFS symptoms to get worse before calling your doctor or nurse.
- Do not expose your body to heat, such as sitting in the sun.
- Don't let your skin get too dry, gently apply a moisturizing cream.
- Do not do activities that cause friction or pressure on your skin such as:
- Kneel or lean on your elbows for long periods of time.
- Do menial work such as gardening.
- Take a brisk walk, jog or do aerobics.
- Using hand tools such as screws and kitchen knives.
- Walked for a long time.
Do not wear rubber gloves because they will cause heat near the palms of your hands.
Note: Temporarily stopping therapy will help you get optimal therapy results, because then side effects can be treated immediately and further therapy can be given to get more optimal results. This has been proven from many studies which show that discontinuing therapy will not cause your disease to become more severe, as long as therapy is continued immediately if the side effect symptoms have resolved. Research shows that temporary cessation can help you deal with side effects better naturally, even if you don't experience the severe side effects you experienced before.
- If the side effects mentioned above are serious enough, contact your doctor or nurse for advice.
- Medicines that should be prepared at home include: diarrhea and anti-vomiting medicines.
How to consume Xeloda ® ?
The doctor will tell you to take Xeloda® twice for 14 days and followed by a seven-day rest period, during which Xeloda® does not need to be taken. This 21-day period (14 days of medication and seven days of rest) is known as one treatment cycle.
- Take the drug 30 minutes after eating in the morning and evening with an interval of 12 hours.
- Swallow Xeloda® tablets with a glass of water.
- Drink lots of water, at least two liters a day. If you find it difficult to swallow or use a catheter to insert food through your nose, then Xeloda® can be crushed because Xeloda® is soluble in water.
Can I take other medicines while I am taking Xeloda ® ?
You may continue to use other medications while you are taking Xeloda®. But you must inform this to your doctor, including all types of drugs that you buy at pharmacies, supermarkets or other places. Your doctor will tell you: Which drugs can be taken with Xeloda ® and which drugs when taken together with Xeloda ® require close monitoring , such as:
- Anticoagulants, anti-clotting drugs.
- Phenytoin, a drug used to treat epilepsy or seizures.
- Allopurinol, a drug used to treat gout.
Can I go on holiday while still taking Xeloda ® ?
Because Xeloda® is packaged in tablet form, it lets you be free and able to travel. But it's better if you inform this to your doctor. While you are traveling, make sure that you can contact your doctor or other medical team if anything goes wrong.
How often should I visit the hospital?
Because Xeloda® is packaged in tablet form, you do not need to visit the hospital or clinic as many times as needed for injection/infusion treatment. Your doctor will still control you while taking Xeloda®, and therefore your doctor will tell you how many times you have to come to the hospital.
Can I take Xeloda ® while pregnant?
Before starting treatment, you must inform your team of doctors if you are pregnant or wish to become pregnant. You should not take Xeloda® if you think you are pregnant.
Can I take Xeloda ® while I am breastfeeding my child?
You should not breastfeed while you are taking Xeloda®.
How to store Xeloda ® ?
Xeloda® must be stored in a cool and dry place, not at temperatures above 300 C. Xeloda® must be stored in the specified packaging (bottle/blister). Do not remove the tablet from the bottle or blister until you are ready to take it. As with other medicines, keep Xeloda® out of the reach of children. Do not share Xeloda® with other people even if they have the same disease as you. If you think you have accidentally taken more tablets than the recommended dose, contact your doctor immediately.
What should I do if I forget to take Xeloda ® ?
Do not take the missed dose and forget to take it or do not double the dose the next time you take it. Take your usual dose. For example, if during the day you realize you forgot to take your morning medication, wait until the afternoon and take your usual afternoon dose, no need to take two doses. If you're not sure what you're doing, ask your doctor. Tell your doctor at your next appointment that you are not taking Xeloda® as directed.
When should I stop using Xeloda ® ?
It is important that you stop using Xeloda® and contact your doctor immediately for advice if you experience:
- Diarrhea : You have diarrhea more than four times during the night.
- Nausea : If your appetite is reduced because of the nausea.
- Vomiting : More than once in 24 hours.
- Hand-Foot Syndrome : If you feel pain in the palms and feet or red with swelling that hinders your activities.
- Thrush : If it hurts and ulcers appear in the mouth.
- Fatigue : If it interferes with daily activities.
- Fever or Infection : If body temperature is 38.10C (100.50F).
- Dehydration : Less urination, dizziness, weakness or feeling restless.
Is Xeloda ® still effective even if the dose is temporarily stopped in case of side effects?
The effectiveness of your treatment will not decrease even if the dose of Xeloda® is stopped temporarily or if necessary it is reduced. Studies have shown that Xeloda® continues to provide the same effect even when the dose is reduced to overcome side effects. Remember that everyone is different and your doctor will determine the most appropriate dose for you.
Will I go bald while taking Xeloda ® ?
You will not go bald while taking Xeloda® although a small number of patients have reported hair loss. From a number of patients who experienced hair loss while consuming Xeloda®, it was reported that their hair could grow again.
How long will I be treated with Xeloda ® ?
The period of treatment with Xeloda® will vary, depending on your disease and your response to treatment. Your doctor will tell you how long you will take Xeloda®. Keep all appointments with your doctor to ensure your progress is monitored.
PT.Roche Indonesia expressed its objection to writing the title "Xeloda Doesn't Work For Breast Cancer" which is inappropriate and can lead to misunderstandings for readers, especially patients and medical practitioners who handle breast cancer treatment.
Xeloda® is the world's first innovative oral chemotherapy that has been licensed in more than 100 countries and is proven to be effective, safe, easy to consume and has been used to treat more than 1,800,000 patients worldwide. The unique way of working of Xeloda® is able to provide therapy that works stronger with less side effects than infusion chemotherapy. The tablet form reduces the discomfort and burden caused by infusion chemotherapy. Xeloda® does not cause hair loss side effects and only slightly neutropenic effects, thereby reducing the risk of infection. Xeloda® prolongs life expectancy when added to patients receiving docetaxel, and improves tumor control in patients with metastatic breast cancer.
Xeloda® in the treatment of breast cancer is used in combination with docetaxel in women with metastatic breast cancer whose disease continues to progress after being given infusion chemotherapy with anthracyclines. Xeloda® as monotherapy is indicated for patients with metastatic breast cancer who are already resistant to other chemotherapy such as paclitaxel and anthracycline.
The study featured in the article compared the safety and efficacy of combined postoperative (adjuvant) chemotherapy using doxorubicin and cyclophosphamide (AC) or cyclophosphamide and methotrexate plus 5*fluorouracil(CMF) compared with adjuvant Xeloda® monotherapy in women > 65 years of age with cancer. early stage breast. The study concluded that elderly patients with early-stage breast cancer could be treated with adjuvant combination chemotherapy (AC or CMF) or monotherapy (Xeloda®), and that standard combination chemotherapy was more effective than Xeloda® monotherapy as adjuvant therapy in this group of patients. Until now, There is no single adjuvant chemotherapy that is better than combination chemotherapy in patients with early-stage breast cancer, so the results of standard adjuvant combination chemotherapy are better than Xeloda® monotherapy. There are several studies evaluating Xeloda® in early breast cancer. Recent interim data from the randomized study of FinXX (Joensuu et al, SABCS 2008) demonstrated a significant increase in efficacy when Xeloda® was added to a regimen containing anthracyclines and taxane in moderate-high-risk early-stage breast cancer patients, reducing the risk of recurrence or death by 34% . It is of course important to consider all available data when trying to determine the optimal role of Xeloda® in early stage breast cancer. There are several studies evaluating Xeloda® in early breast cancer. Recent interim data from the randomized study of FinXX (Joensuu et al, SABCS 2008) demonstrated a significant increase in efficacy when Xeloda® was added to a regimen containing anthracyclines and taxane in moderate-high-risk early-stage breast cancer patients, reducing the risk of recurrence or death by 34% . It is of course important to consider all available data when trying to determine the optimal role of Xeloda® in early stage breast cancer. There are several studies evaluating Xeloda® in early breast cancer. Recent interim data from the randomized study of FinXX (Joensuu et al, SABCS 2008) demonstrated a significant increase in efficacy when Xeloda® was added to a regimen containing anthracyclines and taxane in moderate-high-risk early-stage breast cancer patients, reducing the risk of recurrence or death by 34% . It is of course important to consider all available data when trying to determine the optimal role of Xeloda® in early stage breast cancer. SABCS 2008) demonstrated a significant increase in efficacy when Xeloda® was added to a regimen containing anthracycline and taxane in early-stage breast cancer patients at moderate-high risk, reducing the risk of recurrence or death by 34%. It is of course important to consider all available data when trying to determine the optimal role of Xeloda® in early stage breast cancer. SABCS 2008) demonstrated a significant increase in efficacy when Xeloda® was added to a regimen containing anthracycline and taxane in early-stage breast cancer patients at moderate-high risk, reducing the risk of recurrence or death by 34%. It is of course important to consider all available data when trying to determine the optimal role of Xeloda® in early stage breast cancer.
Reference:
1 Maroon JA. Expert Rev Anticancer Ther 2001; 1(3): 327 - 333
2 Cunningham D, James RD. Euro J Cancer 2001; 37:826-834
3 Hoff PM, Ansari R, Batist G. et al. J Clin Oncol 2001; 19:2282 - 2292
4 Van Cutsem E, Twelves C, Cassidy J et al. J Clin Oncol 2001; 19:4097 - 4106
5 Twelves C. Eur J Cancer 2002:38:S15-S20
6 Liu G, Franssen E, Fitch MI et al. J Clin Oncol 1997:15:110 - 115
7 Borner M, Schoffski P, de Wit R et al. Proc Am Soc Clinic Oncol 2000; 19:191a (Abstract 741)
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