TRAprod.bioonc.gene.s3.amazonaws.com/media/20100312/...Nausea can make you feel weak, dizzy or confused. Nausea, if not controlled, can lead to vomiting, which is more serious. Suck

1-877-XTRA-4-US (1-877-987-2487)9:30 to 10:00 (ET)Monday-Friday

www.myxelodasupport.com

19

XELODA® Patient Phone SupportTRA

XELODA® Patient Online Support

WITH

Drugs and trademark names mentioned are products of their respective owners.

Plandex 121379 18-002-121-315-0409 Copyright © 2009 Roche Laboratories Inc. All rights reserved.

Susan Moore, Nurse Practitioner, Consultant, consulted in the preparation of this brochure.

Support for XELODA treatment is available through the following services and resources:

American Cancer Society1-800-ACS-2345 (1-800-227-2345) www.cancer.org

National Cancer Institute Cancer Information Service (CIS)1-800-4-CANCER (1-800-422-6237) http://cis.nci.nih.gov

Support for cancer patients and caregivers is available through the following resources:

www.xeloda.com

www.oralchemoadvisor.com

www.XELODAreimbursement.com1-800-443-66769:00 to 7:00 (ET)Monday-Friday

XELODA Patient Starter Kit

References: 1. American Cancer Society. www.cancer.org. Accessed January 20, 2009. 2. Chemocare.com. Hand-foot syndrome. http://chemocare.com/managing/handfoot_syndrome.asp. Accessed January 20, 2009. 3. CancerConsultants.com. Hand-foot syndrome (palmar-plantar erythrodysesthesia). http://patient.cancerconsultants.com/ManagementOfCancer.aspx?DocumentID=23169#a3. Accessed January 20, 2009. 4. Mrozek-Orlowski ME, Frye DK, Sanborn HM. Capecitabine: nursing implications of a new oral chemotherapeutic agent. Oncol Nurs Forum. 1999;26(4):753-762. 5. Vachani C. Patient guide to hand-foot syndrome. OncoLink. www.oncolink.com/custom_tags/print_article.cfm?Page=2&id=384&Section=Treatment_Options. Accessed January 20, 2009. 6. Saif MW, Elfiky AA. Identifying and treating fluoropyrimidine-associated hand-and-foot syndrome in white and non-white patients. J Support Oncol. 2007;5:337-343. 7. Vachani C. Mucositis tip sheet (mouth sores). OncoLink. www.oncolink.com/coping/article.cfm?c=5&s=66&ss=166&id=966. Accessed January 20, 2009. 8. OncoLink. Managing symptoms: peripheral neuropathy (nerve damage). www.oncolink.com/coping/article.cfm?c=5&s=70&ss=52&id=577. Accessed January 20, 2009. 9. National Institute of Neurological Disorders and Stroke. Peripheral Neuropathy Fact Sheet. www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm#115863208. Accessed January 20, 2009. 10. National Cancer Institute. Managing chemotherapy side effects: nerve changes. www.cancer.gov/cancertopics/chemo-side-effects/nerve. Accessed January 20, 2009.

For Patient Information, see pages 12–17.Please see complete Prescribing Information enclosed in pocket.

Talk with your doctor or nurse about these sources of information

NOTES

For Patient Information, see pages 12–17. Please see complete Prescribing Information enclosed in pocket.

Learning about side effects to keep your treatment on track

Managing XELODA treatment

ROC55209_Cover 1 3/9/09 10:28:26 AM

Patient support is available through the XTRA support service.2

What to expect from XELODA treatment

XELODA comes in two tablet strengths:

500 mg (peach)

150 mg (light peach)

When you start XELODA treatment, the doctor or nurse will tell you about side effects that you may get. The tips here give information on managing these side effects.

Not all patients have the same side effects from XELODA. Ask your doctor or nurse what side effects you may experience from your treatment.

Fill in your prescribed dose below:

Dosage (taken twice daily)

x _____ 500-mg tablets

x _____ 150-mg tablets

Why are there side effects with chemotherapy?Chemotherapy, like XELODA, attacks fast-growing cells, like cancer cells. Some healthy cells also grow fast, and they may be damaged during treatment. This damage can cause side effects.

ROC55209_Cover 2 3/4/09 3:37:04 PM

For Patient Information, see pages 12–17. Please see complete Prescribing Information enclosed in pocket. 3

Keeping your treatment program on track If you have side effects, tell your doctor or nurse as soon as you

notice them.

Treating side effects early may prevent them from getting worse.1

A dose adjustment may not mean you should stop treatment. Your doctor will tell you the best way to manage any side effects you may have.

Your doctor may stop or change your dose to manage side effects. Do not change your dose on your own.

Do not take over-the-counter vitamins or supplements without asking your doctor.

Do not take any medicines unless your doctor or nurse tells you to do so. Always check with your doctor first for information about XELODA and its effects.

Fill out the card below. Then remove it so you can keep it handy in your calendar or wallet.

Introduction

ROC55209_Text 3 3/9/09 10:18:32 AM

Take your doses as prescribed:

Morning dose:

x 500-mg tablets and

x 150-mg tablets

Contacting your doctorBe sure to contact your doctor or nurse about side effects or questions.

Evening dose:

x 500-mg tablets and

x 150-mg tablets

18-082-121-315-0409

ROC55209_Card 1 3/4/09 3:28:22 PM

Nurse: _________________________________________

Nurse phone: ____________________________________

Doctor: ________________________________________

Doctor phone: ____________________________________

Hours: _________________________________________

After-hours instructions: _____________________________

______________________________________________

Pharmacy: ______________________________________

Pharmacy phone: _________________________________

Chemotherapy drug names, doses, and regimens: __________

______________________________________________

______________________________________________

______________________________________________

______________________________________________

ROC55209_Card 2 3/4/09 3:28:22 PM

Patient support is available through the XTRA support service.

DO

DON’T

4

Possible side effects with chemotherapy

Diarrhea1

Diarrhea includes loose, watery stools or increased stools daily. You may be given fluids if you get dehydrated (lose too many fluids).

Tell your doctor the amount and frequency of bowel movements.

Take medicine for diarrhea as prescribed by your doctor.

Drink clear liquids: water, weak tea, apple juice, clear broth, a Popsicle® or plain liquid JELL-O®.

Eat small meals easy to digest: rice, bananas, applesauce, mashed potatoes and dry toast.

Eat foods high in potassium like bananas, potatoes, and sports drinks like Gatorade® or Powerade®.

Drink beverages high in acid: tomato juice, citrus juices and fizzy soft drinks.

Eat spicy, greasy foods; bran; or raw fruits and vegetables.

Eat pastries, candies, rich desserts, jellies, preserves and nuts.

Drink alcohol or beverages with caffeine.

Use tobacco.

Drink milk or eat milk products.

XELODA can cause diarrhea, sometimes severe. If you have severe diarrhea, your doctor will watch you closely. Please see page 11 for specific information regarding side effects with XELODA treatment.

ROC55209_Text 4 3/9/09 10:19:07 AM

DO

DON’T

5For Patient Information, see pages 12–17. Please see complete Prescribing Information enclosed in pocket.

Possible side effects with chemotherapyDiarrhea,

Nausea/Vomiting

Nausea/Vomiting1

Nausea can make you feel weak, dizzy or confused. Nausea, if not controlled, can lead to vomiting, which is more serious.

Eat frequent, small meals and have a bedtime snack.

Suck on hard candy that has a pleasant smell (lemon or mint).

Eat food cold or at room temperature. This will lessen its smell and may bother you less.

Distract yourself with music, a favorite TV program or the company of others.

Take medicine to lessen nausea as directed by your doctor.

Eat large meals.

Eat red meat or meat broth if it makes you feel sick.

Eat foods that are very hot, fatty, fried, very sweet or spicy.

ROC55209_Text 5 3/5/09 7:24:23 AM


Examples of grade 1 (mild) hand-foot syndrome.

Grade 1 Symptoms (Mild)Mild redness, swelling or tingling/burning. Does not affect daily activities.

Grade 2 Symptoms (Moderate)Hands and feet are painful. Daily activities are difficult to do. Skin surface is not changed.

Grade 3 Symptoms (Severe)Severe pain. Using hands and walking are difficult. Skin may have blisters or be cracked.

Hand-foot syndrome2-6 Hand-foot syndrome is also called palmar-plantar erythrodysesthesia (PAHL•mahr PLAN•tahr eh•RITH•ro•DIS•es•THEE•zheh), or PPE. If you have hand-foot syndrome, your hands and/or feet may have:

Tingling, burning or numbness

Redness

Flaking or peeling skin

Swelling

Small blisters

ROC55209_Text 6 3/5/09 7:24:25 AM

DO

DON’T


One of the possible side effects with XELODA is hand-foot syndrome. If these symptoms happen, don’t wait for them to improve on their own. Hand-foot syndrome is likely to get worse if you ignore it. Please see page 11 for specific information regarding side effects with XELODA treatment.

Hand-foot syndrome

Call your doctor or nurse right away if you see symptoms.

Wear loose, comfortable shoes and slippers.

Pat (don’t rub) wet skin with a towel to dry it.

Wear sunscreen on all exposed skin when outside.

Gently apply cream to hands and feet 5-6 times per day.

Wait to see if symptoms become worse before calling your doctor or nurse.

Expose your skin to heat by sitting near a sunny window or in the sun.

Put pressure on your skin for an extended time. For example, don’t:

• Powerwalk,jogordoaerobics • Useitemsthatrequirepressureorsqueezing

(like garden or household tools) • Walkforlongstretches

ROC55209_Text 7 3/5/09 7:24:26 AM


DO

DON’T

8

Mouth sores1,7

Sores in your mouth (stomatitis) can be caused by damaged cells in your mouth. Ask your doctor about the best ways to prevent mouth sores during chemotherapy.

See your dentist before you start chemotherapy. You’ll want to take care of any cavities, abscesses, gum disease or dentures that need to be refitted.

Brush your teeth and gums after each meal. Use an extra-soft toothbrush and a gentle touch.

Eat foods cold or at room temperature.

Drink plenty of liquids and suck on ice chips, a Popsicle® or sugarless hard candy.

Use lip balm if your lips become dry.

Use retail mouthwash. It may contain irritants like salt or alcohol. Ask your doctor or nurse about mild mouthwash.

Eat hot, irritating, high-acid foods (tomatoes, oranges, grapefruit, lemons); spicy or salty foods; and rough, coarse or dry foods (raw vegetables, granola, toast).

ROC55209_Text 8 3/5/09 7:24:27 AM

DO

DON’T


Severe hair loss happens in less than 1% of XELODA patients. Please see page 11 for specific information regarding side effects with XELODA treatment.

Mouth sores, Hair loss

Hair loss1

Hair loss (alopecia) can happen when fast-growing hair cells are damaged by chemotherapy. Hair usually grows back after chemotherapy is finished.

Use mild shampoos and soft hair brushes.

Cut your hair short to make it look thicker and fuller. It will help you manage hair loss easier too.

Use sunscreen and a hat, scarf or wig to protect your scalp from the sun.

Choose a wig or toupee before hair loss begins. That way, you can match your color and texture.

Brush or pull your hair with force.

Use electric or brush rollers or a curling iron. This will help reduce hair loss and damage.

Dye your hair or get a permanent within 6 months of chemotherapy.

ROC55209_Text 9 3/5/09 7:24:29 AM


DO

DON’T

10

Nerve damage doesn’t happen often with XELODA. It may be more common with other chemotherapy.

Nerve damage1,8-10

Nerve damage is irritation or damage to the ends of nerves. It is also called peripheral neuropathy (peh•RIF•ehr•el noo•RAWP•eh•thee).

Damaged nerves cannot properly sense heat, cold, pressure, pain or body position. When you have nerve damage, you may have:

Loss of balance

Problems walking

Clumsiness

Difficulty picking up objects or buttoning clothing

Be very careful when handling sharp, hot or dangerous objects.

Use handrails on stairs.

Use a bath mat in the tub or shower.

Take pain medicine prescribed by your doctor.

Delay calling your doctor if you have symptoms.

Ignore difficulty in breathing or swallowing.

Move too fast because you may be more likely to trip.

Be afraid to ask for help with tasks that are difficult for numb fingers (like buttoning shirts).

ROC55209_Text 10 3/5/09 7:24:30 AM


Nerve damage

Stop taking XELODA immediately and contact your doctor right away if you have the side effects listed below, or other side effects that concern you. Your doctor can then adjust XELODA to a dose that is right for you or stop your XELODA treatment for a while. This should help to reduce the side effects and stop them from getting worse.

Diarrhea:• if you have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night

Vomiting:• if you vomit more than once in a 24-hour time period

Nausea:• if you lose your appetite, and the amount of food you eat each day is much less than usual

Stomatitis:• if you have pain, redness, swelling or sores in your mouth

Hand-and-Foot Syndrome: • if you have pain, swelling, or redness of your hands or feet that prevents normal activity

Fever or Infection:• if you have a temperature of 100.5°F or greater, or other signs of infection

ROC55209_Text 11 3/5/09 7:24:31 AM


Patient Information

XELODA® (capecitabine) TABLETS Rx onlyRead this leaflet before you start taking XELODA® [zeh-LOE-duh] and each time you refill your prescription in case the information has changed. This leaflet contains important information about XELODA. However, this information does not take the place of talking with your doctor. This information cannot cover all possible risks and benefits of XELODA. Your doctor should always be your first choice for discussing your medical condition and this medicine.

What is XELODA?XELODA is a medicine you take by mouth (orally). XELODA is changed in the body to 5-fluorouracil (5-FU). In some patients with colon, rectum or breast cancer, 5-FU stops cancer cells from growing and decreases the size of the tumor.

XELODA is used to treat:

cancer of the colon after surgery•

cancer of the colon or rectum (colorectal cancer) that has spread to other parts •of the body (metastatic colorectal cancer). You should know that in studies, other medicines showed improved survival when they were taken together with 5-FU and leucovorin. In studies, XELODA was no worse than 5-FU and leucovorin taken together but did not improve survival compared to these two medicines

breast cancer that has spread to other parts of the body •(metastatic breast cancer) together with another medicine called docetaxel (Taxotere®)

breast cancer that has spread to other parts of the body and has not improved •after treatment with other medicines such as paclitaxel (Taxol®) and anthracycline-containing medicine such as Adriamycin™ and doxorubicin

ROC55209_Text 12 3/5/09 7:24:32 AM

13

What is the most important information about XELODA?XELODA may increase the effect of other medicines used to thin your blood such as warfarin (Coumadin®). It is very important that your doctor knows if you are taking a blood thinner such as warfarin because XELODA may increase the effect of this medicine and could lead to serious side effects. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots and change the dose of the blood thinner, if needed.

Who should not take XELODA?1. DO NOT TAkE XELODA IF YOu

• are nursing a baby. Tell your doctor if you are nursing. XELODA may pass to the baby in your milk and harm the baby• areallergicto5-fluorouracil• areallergictocapecitabineortoanyoftheingredientsinXELODA• havebeentoldthatyoulacktheenzymeDPD(dihydropyrimidine dehydrogenase)

2. TELL YOuR DOcTOR IF YOu• take a blood thinner such as warfarin (Coumadin). This is very important

because XELODA may increase the effect of the blood thinner. If you are taking blood thinners and XELODA, your doctor needs to check more often how fast your blood clots and change the dose of the blood thinner, if needed

• takephenytoin(Dilantin®). Your doctor needs to test the levels of phenytoin in your blood more often or change your dose of phenytoin• arepregnantorthinkyoumaybepregnant.XELODAmayharmyour unborn child• havekidneyproblems.Yourdoctormayprescribeadifferentmedicineor lower the XELODA dose• haveliverproblems.Youmayneedtobecheckedforliverproblemswhile you take XELODA• haveheartproblemsbecauseyoucouldhavemoresideeffectsrelatedto your heart• takethevitaminfolicacid.ItmayaffecthowXELODAworks.

Patient InformationPatient Inform

ation

Please see complete Prescribing Information enclosed in pocket.

(continued)

ROC55209_Text 13 3/5/09 7:24:33 AM


Patient Information (continued)

How should I take XELODA?Take XELODA exactly as your doctor tells you to. Your doctor will prescribe a dose and treatment plan that is right for you. Your doctor may want you to take both 150 mg and 500 mg tablets together for each dose. If so, you must be able to identify the tablets. Taking the wrong tablets could cause an overdose (too much medicine) or underdose (too little medicine).

The 150 mg tablets are light peach in color with 150 on one side. The 500 mg tablets are peach in color with 500 on one side. Your doctor may change the amount of medicine you take during your treatment. Your doctor may prescribe XELODA Tablets with Taxotere or docetaxel injection.

XELODA is taken in 2 daily doses, a morning dose and an evening dose•

Take XELODA tablets • within 30 minutes after the end of a meal (breakfast and dinner)

Swallow XELODA tablets with water•If you miss a dose of XELODA, do • not take the missed dose at all and do not double the next dose. Instead, continue your regular dosing schedule and check with your doctor

XELODA is usually taken for 14 days followed by a 7-day rest period (no drug), •for a 21-day cycle. Your doctor will tell you how many cycles of treatment you will need

If you take too much XELODA, contact your doctor or local poison control center •or emergency room right away

What should I avoid while taking XELODA?Women should not become pregnant while taking XELODA. XELODA may harm •your unborn child. Use effective birth control while taking XELODA. Tell your doctor if you become pregnant

Do not breast-feed. XELODA may pass through your milk and harm your baby•

Men should use birth control while taking XELODA•

ROC55209_Text 14 3/5/09 7:24:34 AM

15Please see complete Prescribing Information enclosed in pocket.


What are the most common side effects of XELODA?The most common side effects of XELODA are:

diarrhea, nausea, vomiting, sores in the mouth and throat (stomatitis), stomach •area pain (abdominal pain), upset stomach, constipation, loss of appetite, and too much water loss from the body (dehydration). These side effects are more common in patients age 80 and older

hand-and-foot syndrome (palms of the hands or soles of the feet tingle, become •numb, painful, swollen or red), rash, dry, itchy or discolored skin, nail problems, and hair loss

tiredness, weakness, dizziness, headache, fever, pain (including chest, back, joint, •and muscle pain), trouble sleeping, and taste problems

These side effects may differ when taking XELODA with Taxotere. Please consult your doctor for possible side effects that may be caused by taking XELODA with Taxotere.

If you are concerned about these or any other side effects while taking XELODA, talk to your doctor.

Stop taking XELODA immediately and contact your doctor right away if you have the side effects listed below, or other side effects that concern you. Your doctor can then adjust XELODA to a dose that is right for you or stop your XELODA treatment for a while. This should help to reduce the side effects and stop them from getting worse.

Diarrhea:• if you have an additional 4 bowel movements each day beyond what is normal or any diarrhea at night

Vomiting:• if you vomit more than once in a 24-hour time period

Nausea:• if you lose your appetite, and the amount of food you eat each day is much less than usual

Stomatitis:• if you have pain, redness, swelling or sores in your mouth

Hand-and-Foot Syndrome: • if you have pain, swelling or redness of your hands or feet that prevents normal activity

Fever or Infection:• if you have a temperature of 100.5°F or greater, or other signs of infection (continued)

ROC55209_Text 15 3/5/09 7:24:34 AM



Your doctor may tell you to lower the dose or to stop XELODA treatment for a while. If caught early, most of these side effects usually improve after you stop taking XELODA. If they do not improve within 2 to 3 days, call your doctor again. After your side effects have improved, your doctor will tell you whether to start taking XELODA again and what dose to take. Adjusting the dose of XELODA to be right for each patient is an important part of treatment.

How should I store and use XELODA?Never share XELODA with anyone•

Store XELODA at normal room temperature (about 65° to 85°F)•

Keep XELODA and all other medicines out of the reach of children•

If you take too much XELODA by mistake, contact your doctor or local poison •control center or emergency room right away

General advice about prescription medicines:Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use XELODA for a condition for which it was not prescribed. Do not give XELODA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about XELODA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about XELODA that is written for health professionals.

Revised: April 2006

ROC55209_Text 16 3/5/09 7:24:35 AM

17Please see complete Prescribing Information enclosed in pocket.

• If caught early, most of these side effects usually improve after you stop taking XELODA.

• If they do not improve within 2 to 3 days, call your doctor again.

• After side effects have improved, your doctor will tell you whether to start taking XELODA again or what dose to use.

Moderate diarrhea.(increase of 4-6 stools a day)

STOP taking XELODA immediately and contact your doctor if any of these symptoms occur.

Diarrhea at night.Moderate pain and redness of the mouth, swelling of the mouthor mouth sores.

Moderate pain, swelling and redness of hands and/or feet.

If you have a temperature of 100.5°F or greater, or other signs of infection.

Nausea and vomiting.

Important Side Effect Information

(capecitabine) TabletsXELODA®

Adriamycin is a product of Bedford Laboratories.

Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.

Dilantin is a product of Parke-Davis.

Taxol is a product of Bristol-Myers Squibb Company.

Taxotere is a product of Aventis Pharma S.A.

Patient privacyExcept for reported side effects, anything you tell us about you will be kept private. When you report a side effect, your doctor will be informed. Also, Roche and the FDA will be told as required by law. Roche may contact you to ask more questions about the side effects.

ROC55209_Text 17 3/9/09 10:23:31 AM


NOTES

ROC55209_Text 18 3/5/09 7:24:38 AM

Documents

TRAprod.bioonc.gene.s3.amazonaws.com/media/20100312/...Nausea can make you feel weak, dizzy or confused. Nausea, if not controlled, can lead to vomiting, which is more serious. Suck