When fighting metastatic breast cancer*

little things count

A Patients Guide to ABRAXANE

*Please see Indication, Boxed Warning & Important Safety Information on page 2.

Indication, Boxed Warning & Important Safety Information

ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. One of the more important side effects associated with chemotherapy is neutropenia, which is a decrease in the number of infection-fighting white blood cells (neutrophils). Normal levels range from approximately 1,500 cells/mm3 to 1,800 cells/mm3 (but vary according to several factors, such as age and race). If levels fall below 500 cells/mm3, your risk of developing an infection increases and treatment may be interrupted. To avoid the risk of serious infection and fever, your doctor will monitor your absolute neutrophil count (ANC) during therapy. Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Discuss with your doctor how ABRAXANE may affect fertility. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk. The most important adverse events included lower white and red blood cell counts, infections, tingling and numbness, nausea, vomiting, diarrhea, muscle and joint aches, and mouth sores. Other adverse reactions included weakness, visual disturbances, fluid retention, hair loss, and liver and kidney dysfunction. Low platelet counts, allergic reactions (which in rare cases were severe), cardiovascular reactions, and injection site reactions were uncommon. Sensory neuropathy (numbness, tingling, or burning in the hands and feet) can occur with ABRAXANE and other paclitaxel medications. Severe sensory neuropathy can improve with proper management, as prescribed by your doctor. You should tell your nurse or doctor if you experience numbness, tingling, or burning in your hands or feet while taking ABRAXANE. Please talk to your doctor or nurse if you have questions regarding the potential side effects of ABRAXANE therapy. You may want to review the Product Information, including Warnings, Precautions, and Contraindications.

You should receive ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) under the care of a doctor who is trained to use cancer drugs. Because you may have side effects from your treatment, you should get this medicine in a clinic or hospital with doctors, nurses, and pharmacists who are trained to give cancer drugs. ABRAXANE therapy should not be given to patients with metastatic breast cancer who have low white blood cell counts, which may make you more likely to get an infection. Your doctor will schedule frequent blood tests for you in order to check for low blood counts. Note: ABRAXANE is paclitaxel made with the human blood protein albumin. This makes it behave differently in the body than regular paclitaxel. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL DRUGS.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

Introduction
Receiving a diagnosis of metastatic breast cancer can be overwhelming, to say the least. Youve already been through a lot, and emotionally it can be difficult to accept. But despite all of the feelings you may be experiencing right now, know that it is still important to stop and enjoy the little things
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Table of contents
Perhaps you have heard of ABRAXANE and want to learn more. Maybe youre currently receiving solvent-based paclitaxel (Taxol (paclitaxel) Injection) and want to know how ABRAXANE differs. Or maybe your doctor has already prescribed ABRAXANE to help you fight your disease. Whatever the case, this guide will help you better understand your condition, address questions you may have, and discuss how ABRAXANE can help you in your battle against metastatic breast cancer. Please note that this material is not intended to replace conversations with your health care team. If you have questions, comments, or concerns, please speak with your doctor or nurse. Indication, Boxed Warning & Important Safety Information.......................2 What is metastatic breast cancer?.............................................................................6 What is ABRAXANE? ........................................................................................................8 Why ABRAXANE? ...........................................................................................................10 ABRAXANE side effects.................................................................................................12 Resources .............................................................................................................................16 Insurance and payment support...............................................................................19 Questions to ask your doctor....................................................................................20 Coping tips ..........................................................................................................................22 Contact information ......................................................................................................24 Notes......................................................................................................................................26 Prescribing Information................................................................Inside back cover
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in life.

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

What is metastatic breast cancer?

Before you can understand and make informed decisions about possible treatment options for metastatic breast cancer, you need to know what is happening inside your body and why.
Normal Cells

How a tumor forms

Unlike normal body cells that divide, multiply, and die in an orderly way, cancer cells multiply uncontrollably and accumulate into a mass of extra tissue called a tumor. The reasons for this abnormal growth are not well understood.

How breast cancer cells spread to other parts of the body

When a tumor invades surrounding healthy body tissue, it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body. Because of their spread and growth in other organs, malignant breast tumors can interfere with normal body function and become life-threatening. If breast cancer metastasizes, it is still considered breast cancer in that new site. For example, if breast cancer spreads to a lung, the tumor in the lung is not lung cancer but breast cancer that has metastasized.

Stage IV breast cancer

Doctors use the term stage to refer to the extent of cancer within the body. Breast cancer staging takes into account the size and location of the primary breast tumor, any regional lymph node involvement near the breast and underarm, and any metastatic disease. In stage IV, also known as metastatic cancer, the disease has spread from the breast to other parts of the body, such as the bone, liver, lungs, or brain.

Metastatic breast cancer has spread to other parts of the body.

Primary tumor has developed in the breast.

Cancerous Cells

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

What is ABRAXANE ?

ABRAXANE is a treatment option that uses a unique technology to deliver the drug paclitaxel. Paclitaxel is a potent chemotherapy treatment that stops cancer cells from growing and dividing by interfering with certain cell structures and killing the cancer
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How is ABRAXANE different?

Traditionally, paclitaxel must first be dissolved in a chemical solvent in order for the drug to be administered. This type of paclitaxel is referred to as solvent-based (Taxol Injection). These solvents can cause side effects such as difficulty breathing, hives, swollen eyes and lips, a flushed face, and severe allergic reactions (hypersensitivity reactions). To reduce the risk of developing these solventrelated side effects, patients need to take additional medications such as steroids and antihistamines before they receive solvent-based paclitaxel (Taxol Injection). This is called premedication.

cells. Paclitaxel can slow tumor growth or temporarily stop tumor growth altogether.

ABRAXANE offers a different approach for treating metastatic breast cancer compared to solvent-based paclitaxel (Taxol Injection). It uses a process called nab technology to deliver paclitaxel. This technology uses albumin to create a formulation that eliminates the need for solvents. Albumin is a human protein, normally present in the bloodstream, that carries nutrients throughout the body. Because ABRAXANE does not contain solvents, there is no risk of solvent-related hypersensitivity reactions, so premedication with steroids and antihistamines is not necessary. The lack of solvents in ABRAXANE allows patients to receive a higher dose of tumorfighting paclitaxel. One study showed that patients who received ABRAXANE compared to solvent-based paclitaxel (Taxol Injection) had a 49% higher dose of chemotherapy.

ABRAXANE has also been shown to be more effective than solvent-based paclitaxel (Taxol Injection). In a clinical trial, the tumor response rate was nearly double for patients who received ABRAXANE compared to those who received solvent-based paclitaxel.

How is ABRAXANE administered?

ABRAXANE is administered into a vein as an intravenous infusion. Each infusion is given in an outpatient clinic and takes only 30 minutes (unlike solvent-based paclitaxel (Taxol Injection), which can take up to 3 hours), giving you more free time to spend doing the little things that matter. Your doctor or nurse will determine the correct dose and treatment schedule for you. The information found in this brochure is not intended to replace conversations with your health care team. If you have questions, comments, or concerns, please speak with your doctor or nurse.

ABRAXANE is the first and only albumin-bound taxane that utilizes nab technology
ABRAXANE Albumin-bound paclitaxel
Bloodstream Paclitaxel Paclitaxel

Taxol Injection Solvent-based paclitaxel

Bloodstream

ABRAXANE is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Albumin Tumor Site

Solvent* Tumor Site

nab technology eliminates the need for solvents and allows for a higher dose of tumor-fighting paclitaxel to be given.

* Solvents (chemical detergents) may cause severe, solvent-related hypersensitivity reactions requiring premedication.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

Why ABRAXANE ? Benefit highlights

Highlight 1: Nearly double the tumor response rate

In a clinical trial, the number of women who had tumors that reduced in size when given ABRAXANE was nearly double that of those who were given solvent-based paclitaxel (Taxol Injection). Because ABRAXANE is solvent-free, women participating in the study were not subject to solvent-related toxicities and therefore could be given a higher dose of tumorfighting paclitaxel.
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Highlight 2: No premedication
As mentioned, one of the most important differences between ABRAXANE and solvent-based paclitaxel (Taxol Injection) is the lack of solvents. Solvents can cause side effects such as difficulty breathing, hives, swollen eyes and lips, a flushed face, and severe allergic reactions (hypersensitivity reactions), which is why patients need to be premedicated with steroids and antihistamines. Because ABRAXANE is solvent-free, patients treated with ABRAXANE do not need premedication. What this means to you: Without the need for premedication, ABRAXANE offers you a more convenient treatment option compared to solventbased paclitaxel (Taxol Injection). Severe allergic reactions to ABRAXANE, although rare, can occur. Contact your doctor if you experience any signs of an allergic reaction.

Highlight 3: Shorter infusion time

ABRAXANE is administered in only 30 minutes, while solventbased paclitaxel (Taxol Injection) can take up to 3 hours. What this means to you: ABRAXANE takes only about a half-hour to administer. This gives you more free time away from the clinicup to 2 12 hours moreto spend doing the things you enjoy.
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What this means to you: Each dose of solvent-free ABRAXANE provides you with more tumor-fighting paclitaxel than would a dose of solvent-based paclitaxel (Taxol Injection).

Because ABRAXANE helps you fight the cancer, not the treatment, you can focus on the little things that matter mostand enjoy all life has to offer.

Please see Indication, Boxed Warning & Important Safety Information on page 2.

ABRAXANE side effects

The following side effects were reported in ABRAXANE clinical trials. Provided here is a description of these side effects and some helpful information.

Hair loss
Loss of eyebrows, eyelashes, pubic hair, and scalp hair may occur 14 to 21 days after you begin treatment. Your hair will grow back once the ABRAXANE treatment has ended. What can I do? Be gentle to your hair and scalp Use low heat when using a hair dryer Consider cutting your hair short Protect your scalp from the sun

Infections due to low white blood cell count (neutropenia)

White blood cells are among the bodys defenses against bacterial infections. ABRAXANE usually causes a brief drop in white blood cells, which may cause you to be more susceptible to infection and fever. Between your treatment cycles, you will have blood tests to check your white blood cell counts. What can I do? Call your doctor if you experience a fever over 100.4F Wash your hands often Try to avoid crowds and people with colds Immediately clean and protect cuts Check with your doctor before getting immunization shots Take a bath or shower daily using mild soap Use lotion to prevent your skin from cracking

Numbness, tingling, or burning of hands and feet (neuropathy)

These side effects, known as sensory neuropathy, occur often and usually get better or go away without medication within 3 weeks of interrupting treatment. (It is sometimes necessary to interrupt treatment with ABRAXANE until these symptoms improve, after which time treatment can be restarted at a lower dose.) What can I do? Immediately tell your doctor about these side effectsyour doctor may find it necessary to adjust the dose Massage your hands and feet to stimulate nerves Apply moisturizing cream/lotion to your hands and feet Avoid activities in extreme weather Avoid wearing tight footwear Avoid standing for long periods of time and walk only short distances Take extra precaution near fires, hot water, or other sources of heat Avoid using an ice pack on any part of your body

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Please see Indication, Boxed Warning & Important Safety Information on page 2.

ABRAXANE side effects, continued

Fatigue and weakness (asthenia)

Tiredness and weakness after treatment is known as asthenia. It often disappears without interruption or modification of treatment. What can I do? Get proper rest Take part in activities that relax you Eat a well-balanced diet Drink plenty of fluids Perform light exercise daily

Low red blood cell count (anemia)

Anemia occurs when there are not enough red blood cells in your blood. It may make you feel tired, appear pale, and experience shortness of breath. Contact your doctor if you experience any of these symptoms. What can I do? Talk to your doctor about medications that increase your red blood cell count Conserve energy by doing only the things that are most important to you Take short naps throughout the day instead of one long nap Perform light exercise Get up slowly from lying or sitting positions to reduce dizziness Eat small meals frequently throughout the day Drink plenty of fluids

Mouth or lip sores (mucositis)

Mouth or lip sores may occur a few days after starting treatment. This side effect usually disappears within 1 week. What can I do? Use lip balm or another lip moisturizer Use a soft toothbrush and brush your teeth after eating Use mouthwash that does not contain alcohol Frequently rinse your mouth with warm salt water Avoid foods that might irritate your mouth, such as spicy foods, orange juice, and pretzels

Upset stomach and diarrhea

Nausea, vomiting, and/or diarrhea may occur following treatment. If you experience nausea or stomach upset, tell your doctor, because medicines can be given to reduce or eliminate these symptoms. Diarrhea will usually disappear without treatment; however, tell your doctor right away if you experience severe abdominal or stomach area pain and/or severe diarrhea. What can I do? Drink plenty of fluids slowly and frequently Avoid drinking coffee, tea, and alcohol Avoid sweets as well as fried, greasy, or spicy foods Eat low-fiber foods such as eggs, potatoes, white bread, or creamed cereals Avoid dairy products such as milk, cheese, or ice cream

Irritation at the injection site

You may experience discomfort, redness, swelling, inflammation, or a deep sore or break in the skin at the site of the injection. What can I do? Inform your doctor if you experience any irritation at the injection site

Low blood pressure (hypotension)

If you experience dizziness, fainting, or shortness of breath, talk to your doctor. What can I do? Have your doctor check your blood pressure Drink plenty of water Exercise moderately to increase blood flow Avoid heavy lifting Elevate the head of your bed to improve blood circulation Eat small meals frequently Rest after meals to minimize dizziness Avoid hot showers and baths Rise slowly from sitting or lying positions

Low heart rate (bradycardia)

It is possible to experience a drop in your heart rate, but patients do not usually notice these changes and they usually do not require treatment. What can I do? Tell your doctor if you have a history of heart disease

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Joint and muscle pain

Soreness of the joints and muscles may occur shortly after treatment begins, but usually disappears within a few days. What can I do? Tell your doctor if you are experiencing any severe joint or muscle pain Perform light exercise

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

Resources
When going through treatment for metastatic breast cancer, it is important to have access to as many helpful resources as possible. The following provide information and support to help you stay focused on your treatment plan and overall health.
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Books and publications

Advanced Breast Cancer: A Guide to Living with Metastatic Disease
By Musa Mayer. 2nd edition. OReilly & Associates, Inc., 1998.

Betty Crockers Living with Cancer Cookbook: Easy Recipes and Tips Through Treatment and Beyond
Betty Crocker, 2001.

The Cancer Monologue Project

By Tanya Taylor and Pamela Thompson. MacAdam/Cage Publishing, 2002.

Here for Now: Living Well with Cancer Through Mindfulness

By Elana Rosenbaum. Satya House Publications, 2005.

Online support and community

www.ABRAXANE.com Your primary source of information about ABRAXANE. www.abraxisoncology.com Provides information about the proprietary nab technology of ABRAXANE. www.astrazeneca-us.com A corporate site containing additional information on breast cancer treatment options. www.breastcancer.org A clearinghouse of breast cancer education information on a spectrum of topics. Support resources include chat rooms, discussion boards, and online conferences.

Practical advice and emotional support for women and families dealing with the realities of metastatic breast cancer. Art.Rage.Us.: Art and Writing by Women with Breast Cancer
By Jill Eikenberry and Terry Tempest. Chronicle Books, 1998.

Advice from cancer patients, from tips for coping with emotions to making recipes more appealing. Recipes are tagged to show which are helpful for common side effects of cancer treatment. The Breast Cancer Book of Strength & Courage: Inspiring Stories to See You Through Your Journey
By Ernie Bodai, M.D., and Judie Fertig Panneton. 1st edition. Prima Lifestyles, 2002.

In a series of workshops, people affected by cancer were invited to write and perform their stories about living, resulting in these 30 engaging monologues. Holding Tight, Letting Go: Living with Metastatic Breast Cancer
By Musa Mayer. 1st edition. Patient Center Guides, 1997.

Mindfulness-based stress reduction techniques. Live Longer, Live Larger: A Holistic Approach for Cancer Patients and Their Families
By Susan W. Buchholz, Ph.D., and William M. Buchholz, M.D. 1st edition. Patient Center Guides, 2001.

In addition to the information provided here, be sure to talk to your doctor about other sources of support.

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This list of resources is provided merely as a convenience. Abraxis and AstraZeneca take no responsibility for the content of, or services provided by, the resources and make no representations as to the accuracy or completeness of any information provided and shall have no liability for any damages or injuries of any kind arising from the information contained within these resources.

Inspiring artwork and writing by breast cancer survivors, an outgrowth of an exhibit at the San Francisco Main Library Gallery.

Uplifting stories of women who faced mastectomies, radiation, and chemotherapy with courage, humor, and grace.

A personalized and highly informed guide to life with metastatic breast cancer.

Stories and exercises to help conquer fear, find the right treatment, and increase the quality and meaning of life.

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Please see page 24 for full Prescribing Information, including Warnings, Precautions, and Contraindications.

Resources, continued
www.bcmets.org The largest online community of people living with advanced breast cancer, their families, and their friends. Enter search criteria for information and patient mailing list submissions. www.breastcancerstories.com Breast cancer patients can upload diary entries and photos in this online community. Friends and family members can follow their loved ones stories. www.cancer.org The site of the American Cancer Society (ACS). www.komen.org The Susan G. Komen Breast Cancer Foundation provides useful information, research news, and information on how to get involved with the Komen Race for the Cure. www.cancerhopenetwork.org Offers free, confidential, one-on-one support for people with cancer and their families. www.clinicaltrials.gov Information about federally and privately supported clinical research. www.lbbc.org Provides news and message boards for women with breast cancer. www.nci.nih.gov Provides information from the National Cancer Institute (NCI) on cancer and its treatment. www.canceradvocacy.org The National Coalition for Cancer Survivorship (NCCS)the oldest cancer advocacy organization in the country. nano.cancer.gov NCI Alliance for Nanotechnology in Cancer provides up-to-date information on nanotech oncology. www.nihroadmap.nih.gov The NIH Roadmap offers a guide to finding information on medical research. www.y-me.org Offers general cancer and lifestyle information from the Y-ME National Breast Cancer Organization.

Insurance and payment support

This program is available through your doctor and can help you with insurance claims, reimbursement, and payment issues. Our specially trained professionals can also assist your doctor with researching coverage options and verifying benefits on your behalf. This program offers assistance to both uninsured and insured patients based upon financial need. In addition, eligible patients may qualify for the Abraxis Oncology Patient Access Program (APAP). Please talk to your doctor or nurse if you need assistance with insurance or payment issues related to ABRAXANE.

The ARC of Support is a comprehensive program that provides a broad range of services for physicians and their patients who are being treated with ABRAXANE. You or your doctor can call 800-564-0216, option 3, to find out if you are eligible.

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Please see Indication, Boxed Warning & Important Safety Information on page 2.

Questions to ask your doctor

Is ABRAXANE right for me? My doctor said: What are the side effects of ABRAXANE? My doctor said: Write any additional questions you may have for your doctor:

How can ABRAXANE treat my disease? My doctor said:

How will I receive ABRAXANE? How often? And for how long? My doctor said:

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How will I know if ABRAXANE is working? My doctor said:

Where will I receive my treatment? My doctor said:

How can I prepare for treatment and reduce the chances of side effects? My doctor said:

Will my diet be restricted in any way? My activities? Work? Exercise? Sexuality? My doctor said:

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Coping tips
Life is different with metastatic breast cancer. Despite the challenges each day may bring, there are things you can do to take control and help ensure youre getting the most benefit from your chemotherapy treatment.

Follow your treatment plan

Follow the treatment plan established by your doctor. Alert your doctor immediately if you need to miss an appointment Drink plenty of fluids, especially in the first few days after your treatment Do not take aspirin during chemotherapy, and tell your doctor about any medicines, herbal remedies, or home remedies you are taking during your treatment cycles. Some medications may interfere with the effects of chemotherapy Keep a journal of treatment dates and schedules. Write down detailed information about any symptoms or side effects you notice, including the severity, number of occurrences, and time of occurrence. Bring this journal with you to each doctor visit

Become an active partner in your care

Be persistent when communicating your concerns to your doctor Know that you have a say in all aspects of your care Stay informed about your disease and treatment options. If you have any questions, ask your doctor

Take care of your body

Become familiar with your body and be aware of what is normal for you Report any noticeable changes to your doctor Establish and maintain a healthy lifestyle that includes good nutrition. Try experimenting with new recipes to find those that agree with your changing taste budsespecially if treatment side effects are causing loss of appetite, nausea, or changes in taste and smell. Also talk to your doctor about medications that may help prevent or reduce these side effects Stay active. Aerobic exercise and resistance training have been shown to help alleviate some side effects associated with breast cancer and its treatment, such as fatigue, depression, and anxiety. Before beginning any exercise program, be sure to talk to your doctor Dont overdo it. Whenever possible, try to plan your daily activities around times when you feel your best. Get plenty of sleep at night, and rest during the day if you feel tired

Pay attention to your emotional needs

Be positive. A positive attitude and hopeful outlook will help you feel better Take time to do the things you enjoy. Nurture yourself with the little things life has to offer Reach out to family and friends when youre feeling sick, lonely, or scared theyll be eager to help however they can Consider joining a support group studies show that women with metastatic disease who participate in support group therapy experience less pain and emotional distress than women who do not

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Get organized
Keep emergency contact information handy. Make a list of the names and phone numbers of your doctors, pharmacists, family members, friends, and health insurance provider. Keeping all of your records in one place can help give you a sense of control and help you stay on top of your diagnosis

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Contact information
My doctors and other health care providers
Primary care physician Telephone number Oncologist Telephone number Oncology nurse
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Appointment schedule
Family or friends to contact in case of emergency
Name Telephone number Name Telephone number Name Telephone number Date Results Time Location Date Results Time Location
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Date Results

Time

Location

Date Results

Time

Location

Date Results

Time

Location

Date Results

Time

Location

Telephone number Nutritionist Telephone number Pharmacy Telephone number Emergency hospital Address Telephone number

My health insurance provider

Provider/plan Telephone number Group ID number Date Results Time Location

Date Results

Time

Location

Please see Indication, Boxed Warning & Important Safety Information on page 2.

Notes

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Visit ABRAXANE.com or talk with your doctor to learn if ABRAXANE is right for you.
Reference ABRAXANE [prescribing information]. Los Angeles, Calif: Abraxis Oncology, a Division of Abraxis BioScience, Inc; May 2007.

Please see Indication, Boxed Warning & Important Safety Information on page 2.

ABRAXANE is marketed under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca. Abraxis Oncology is a division of Abraxis BioScience, Inc. All Abraxis BioScience, Inc. corporate names, names of services, and names of products referred to herein are trade names, service marks and/or trademarks that are owned by or licensed to Abraxis BioScience, its divisions or its affiliates, unless otherwise noted. All other trademarks are the property of their respective owners. AO 461/249652 6/07

Visit ABRAXANE.com or talk with your doctor to learn if ABRAXANE is right for you.