visit or call 1-877-422-2030 cancer.net ... · avastin is a tumor-starving (or anti-angiogenic)...

Additional resourcesIf you’d like to join a support group, ask your health care team if there’s one in your area. Here are some national organizations that provide services to people with cancer and their families:

American Gastroenterological AssociationMedical information website about digestive system diseases, including colorectal cancer Visit www.gastro.org/patient

Colon Cancer AllianceTelephone helpline, online support community, and survivor buddy program. A network of caregiver support groups is also available. Visit www.ccalliance.org or call 1-877-422-2030

Cancer.netOnline resource providing timely, oncologist-approved information from the American Society of Clinical Oncology to help patients and families make informed health care decisions. Visit www.cancer.net or call 1-888-651-3038

National Comprehensive Cancer NetworkNCCN creates clinical practice guidelines for use by patients, clinicians, and other health care decision makers with the goal of improving the quality of oncology practice. Visit www.nccn.com or call 1-215-690-0300

Information is provided for informational purposes and convenience only. Genentech is not responsible for the accuracy of the information contained on a third-party site and does not recommend or endorse the content provided on the site. The information provided by Genentech USA, Inc. or these organizations is meant for informational purposes only and is not meant to replace a physician’s medical advice.

Please see pages throughout this brochure and accompanying full Product Information, including Serious Side Effects, for additional important safety information.

Avastin is approved to treat metastatic colorectal cancer (mCRC) for:• First- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy • Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy

after cancer progresses following a first-line treatment that includes AvastinAvastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

*Anti-angiogenesis.

Discover the facts about tumor-starving* therapy

FOR METASTATIC COLORECTAL CANCER (mCRC) PATIENTS STARTING AVASTIN FOR

FIRST- OR SECOND-LINE TREATMENT

Possible serious side effects

Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are.

Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur.

Be sure to contact your health care team if there are any signs of these side effects.

GI PERFORATIONA hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever.

WOUNDS THAT DON’T HEALA cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed.

SERIOUS BLEEDINGThis includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor.

Most serious side effects (not common, but sometimes fatal):

The information in this brochure is not meant to be medical advice and should not replace the advice of your doctor.

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What you should know when starting Avastin

Avastin is a tumor-starving (anti-angiogenic) therapy. Avastin works differently than chemotherapy

Avastin is used with IV 5-FU–based chemotherapy for first- or second-line metastatic colorectal cancer (or mCRC) in patients who have not previously received Avastin

In clinical studies, people with mCRC were more likely to live longer when Avastin was added to their chemotherapy

In clinical studies, Avastin was shown to significantly increase the time people live without their tumors growing or spreading

There are serious side effects associated with Avastin therapy. You should discuss any side effects with your doctor

Avastin Access Solutions may be able to help you understand how to get the medicine you need. For more information, please call 1-888-249-4918.

Visit www.Avastin.com.

Tumor

Blood VesselsAvastin therapy prevents the growth of blood vessels

Chemotherapy attacks cancer cells

54

Starving your tumorThe purpose of Avastin is to block a protein called vascular endothelial growth factor, or VEGF. Normal cells produce VEGF, but cancer cells overproduce VEGF. Blocking VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors.

* Avastin is used with IV 5-FU–based chemotherapy for mCRC. Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

About AvastinAvastin is a tumor-starving (or anti-angiogenic) therapy. Avastin works differently than chemotherapy. For metastatic colorectal cancer (mCRC), Avastin is taken with chemotherapy and hits your cancer from another angle.

The difference between Avastin and chemotherapyChemotherapy attacks fast-growing cells, like cancer cells. The purpose of Avastin is to prevent the growth of new blood vessels. This includes normal blood vessels and blood vessels that feed tumors.

Tumor before treatmentNew blood vessels feed the tumor so it can grow and spread.

Tumor with Avastin and chemotherapy* Avastin helps prevent blood vessels from reaching the tumor; this could starve the tumor. However, in a study of mCRC patients who continued on Avastin for second-line treatment after a first-line treatment that included Avastin, tumors did not shrink.

Tumor

Blood VesselsAvastin therapy prevents the growth of blood vessels

Chemotherapy attacks cancer cells

54

Starving your tumorThe purpose of Avastin is to block a protein called vascular endothelial growth factor, or VEGF. Normal cells produce VEGF, but cancer cells overproduce VEGF. Blocking VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors.

* Avastin is used with IV 5-FU–based chemotherapy for mCRC. Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.

About AvastinAvastin is a tumor-starving (or anti-angiogenic) therapy. Avastin works differently than chemotherapy. For metastatic colorectal cancer (mCRC), Avastin is taken with chemotherapy and hits your cancer from another angle.

The difference between Avastin and chemotherapyChemotherapy attacks fast-growing cells, like cancer cells. The purpose of Avastin is to prevent the growth of new blood vessels. This includes normal blood vessels and blood vessels that feed tumors.

Tumor before treatmentNew blood vessels feed the tumor so it can grow and spread.

Tumor with Avastin and chemotherapy* Avastin helps prevent blood vessels from reaching the tumor; this could starve the tumor. However, in a study of mCRC patients who continued on Avastin for second-line treatment after a first-line treatment that included Avastin, tumors did not shrink.

7

Avastin has been shown to effectively treat mCRC.

—Lorraine, oncology nurse

Important Safety Information Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal.

The benefits and risks for patients who started on Avastin for initial treatmentIn studies, when patients took Avastin and IV 5-FU-based chemotherapy* for first- or second-line treatment instead of chemotherapy alone:

To learn about some of the possible serious side effects of Avastin in the treatment of mCRC, see the next page. Please see page 2 for the most serious side effects.

More people saw their tumors shrink

Individual results may vary.

More people lived longerThe length of time people lived without their tumors growing or spreading increased significantly

Avastin +

chemo

1st line: 20.3 months vs 15.6 months2nd line: 13.0 months vs 10.8 monthsTML†: 11.2 months vs 9.8 months

1st line: 45% vs 35%2nd line: 23% vs 9%TML†: No difference in tumor shrinkage

Avastin + chemoAvastin + chemo

* IV 5-FU-based chemotherapy for first- and second-line treatment; fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after cancer progresses following a first-line treatment that includes Avastin.

†TML: First- through second-line treatment.

7

Avastin has been shown to effectively treat mCRC.

—Lorraine, oncology nurse

Important Safety Information Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal.

The benefits and risks for patients who started on Avastin for initial treatmentIn studies, when patients took Avastin and IV 5-FU-based chemotherapy* for first- or second-line treatment instead of chemotherapy alone:

To learn about some of the possible serious side effects of Avastin in the treatment of mCRC, see the next page. Please see page 2 for the most serious side effects.

More people saw their tumors shrink

Individual results may vary.

More people lived longerThe length of time people lived without their tumors growing or spreading increased significantly

Avastin +

chemo

1st line: 45% vs 35%2nd line: 23% vs 9%TML†: No difference in tumor shrinkage

Avastin + chemoAvastin + chemo

* IV 5-FU-based chemotherapy for first- and second-line treatment; fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after cancer progresses following a first-line treatment that includes Avastin.

†TML: First- through second-line treatment.

98

Other possible serious side effects of Avastin

Across different cancers

% = Percentage of patients who had this side effect in clinical studies across different cancers

UP TO

18%

SEVERE HIGH BLOOD PRESSUREBlood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment.

SEVERE STROKE OR HEART PROBLEMSThese may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure, 1%). These can sometimes be fatal.

INFUSION REACTIONSThese were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions.

UP TO

2%UP TO

3%UP TO

0.5%UP TO 7%

KIDNEY PROBLEMSThese may be caused by too much protein in the urine and can sometimes be fatal.

ABNORMAL PASSAGE IN THE BODY NOT INVOLVING YOUR STOMACH OR INTESTINEThis type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal.

NERVOUS SYSTEM AND VISION PROBLEMSSigns include headache, seizure, high blood pressure, sluggishness, confusion, and blindness.

UP TO 11%

98

Other possible serious side effects of Avastin

Across different cancers

% = Percentage of patients who had this side effect in clinical studies across different cancers

UP TO

18%

SEVERE HIGH BLOOD PRESSUREBlood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment.

SEVERE STROKE OR HEART PROBLEMSThese may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure, 1%). These can sometimes be fatal.

INFUSION REACTIONSThese were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions.

UP TO

2%UP TO

3%UP TO

0.5%UP TO 7%

KIDNEY PROBLEMSThese may be caused by too much protein in the urine and can sometimes be fatal.

ABNORMAL PASSAGE IN THE BODY NOT INVOLVING YOUR STOMACH OR INTESTINEThis type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal.

NERVOUS SYSTEM AND VISION PROBLEMSSigns include headache, seizure, high blood pressure, sluggishness, confusion, and blindness.

UP TO 11%

1110

Possible side effects of Avastin in mCRC: First-line

Side effects of Avastin and IV 5-FU–based chemotherapy: First-line% = Percentage of patients who had this side effect in this clinical study

Possible side effects of Avastin in mCRC: Second-line

Side effects of Avastin and IV 5-FU–based chemotherapy: Second-line % = Percentage of patients who had this side effect in this clinical study

SEVERE TO FATAL SIDE EFFECTS CHEMO+AVASTIN(n=287)

CHEMO ALONE(n=285)

• TIREDNESS 19% 13%• DIARRHEA 18% 13%• NUMBNESS AND TINGLING IN FINGERS AND TOES 17% 9%• NAUSEA 12% 5%• VOMITING 11% 4%• DEHYDRATION 10% 5%• HIGH BLOOD PRESSURE 9% 2%• ABDOMINAL PAIN 8% 5%• SEVERE BLEEDING 5% 1%• NERVOUS SYSTEM DISTURBANCES 5% 3%• BLOCKAGE OF THE BOWEL 4% 1%• HEADACHE 3% 0%

SEVERE TO LIFE-THREATENING SIDE EFFECTS CHEMO+AVASTIN(n=392)

CHEMO ALONE(n=396)

• WEAKNESS 10% 7%• ABDOMINAL PAIN 8% 5%• PAIN 8% 5%• HIGH BLOOD PRESSURE 12% 2%• BLOOD CLOTS IN THE VEINS OF THE BODY 9% 5%• BLOOD CLOTS INSIDE THE ABDOMEN 3% 1%• A BRIEF LOSS OF CONSCIOUSNESS 3% 1%• DIARRHEA 34% 25%• CONSTIPATION 4% 2%• REDUCED WHITE BLOOD CELL COUNT 37% 31%

• REDUCED WHITE BLOOD CELL COUNT THAT MAY INCREASE THE CHANCE OF INFECTION

21% 14%

1110

Possible side effects of Avastin in mCRC: First-line

Side effects of Avastin and IV 5-FU–based chemotherapy: First-line% = Percentage of patients who had this side effect in this clinical study

Possible side effects of Avastin in mCRC: Second-line

Side effects of Avastin and IV 5-FU–based chemotherapy: Second-line % = Percentage of patients who had this side effect in this clinical study

SEVERE TO FATAL SIDE EFFECTS CHEMO+AVASTIN(n=287)

CHEMO ALONE(n=285)

• TIREDNESS 19% 13%• DIARRHEA 18% 13%• NUMBNESS AND TINGLING IN FINGERS AND TOES 17% 9%• NAUSEA 12% 5%• VOMITING 11% 4%• DEHYDRATION 10% 5%• HIGH BLOOD PRESSURE 9% 2%• ABDOMINAL PAIN 8% 5%• SEVERE BLEEDING 5% 1%• NERVOUS SYSTEM DISTURBANCES 5% 3%• BLOCKAGE OF THE BOWEL 4% 1%• HEADACHE 3% 0%

SEVERE TO LIFE-THREATENING SIDE EFFECTS CHEMO+AVASTIN(n=392)

CHEMO ALONE(n=396)

• WEAKNESS 10% 7%• ABDOMINAL PAIN 8% 5%• PAIN 8% 5%• HIGH BLOOD PRESSURE 12% 2%• BLOOD CLOTS IN THE VEINS OF THE BODY 9% 5%• BLOOD CLOTS INSIDE THE ABDOMEN 3% 1%• A BRIEF LOSS OF CONSCIOUSNESS 3% 1%• DIARRHEA 34% 25%• CONSTIPATION 4% 2%• REDUCED WHITE BLOOD CELL COUNT 37% 31%

• REDUCED WHITE BLOOD CELL COUNT THAT MAY INCREASE THE CHANCE OF INFECTION

21% 14%

1312

If you have any questions about your condition or treatment, talk to your doctor.

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

• HIGH BLOOD PRESSURE • TASTE CHANGE

• TOO MUCH PROTEIN IN THE URINE • DRY SKIN

• NOSEBLEEDS • INFLAMMATION OF THE SKIN

• RECTAL BLEEDING • INFLAMMATION OF THE NOSE

• BACK PAIN • WATERY EYES

• HEADACHE

Avastin is not for everyone

Talk to your doctor if you are:

UNDERGOING SURGERY Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed.

PREGNANT OR THINK YOU ARE PREGNANTData have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant.

PLANNING TO BECOME PREGNANTTaking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children.

BREASTFEEDINGBreastfeeding while on Avastin may harm your baby and is therefore not recommended during and for 6 months after taking Avastin.

1312

If you have any questions about your condition or treatment, talk to your doctor.

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

• HIGH BLOOD PRESSURE • TASTE CHANGE

• TOO MUCH PROTEIN IN THE URINE • DRY SKIN

• NOSEBLEEDS • INFLAMMATION OF THE SKIN

• RECTAL BLEEDING • INFLAMMATION OF THE NOSE

• BACK PAIN • WATERY EYES

• HEADACHE

Avastin is not for everyone

Talk to your doctor if you are:

UNDERGOING SURGERY Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed.

PREGNANT OR THINK YOU ARE PREGNANTData have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant.

PLANNING TO BECOME PREGNANTTaking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children.

BREASTFEEDINGBreastfeeding while on Avastin may harm your baby and is therefore not recommended during and for 6 months after taking Avastin.

Avastin is taken every 2 weeks

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90minutes 60

minutes 30 30minutes minutes

1st infusion 2nd infusion 3rd infusion Future infusions

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Taking AvastinWhen do I take Avastin?For patients starting on Avastin for first- or second-line treatment, Avastin is taken every 2 weeks to treat your metastatic colorectal cancer (mCRC). Because Avastin can be scheduled on the same day you get your chemotherapy, it may not require extra trips to an infusion center.

For mCRC patients continuing on Avastin for second-line treatment after a first-line treatment that included Avastin, Avastin is taken every 3 weeks.

If you have questions about how often you’ll receive Avastin infusions, speak with your health care team.

How do I take Avastin?You take Avastin as an infusion. That means you receive Avastin through a small needle in your vein or through a port, which is a device placed under the skin.

What can I expect from my infusion?Your doctor or nurse will monitor you for signs of infusion reactions, and may stop Avastin treatment if severe reactions occur. Reactions can include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating.

You always get the same dose of Avastin. If your Avastin

infusions are tolerated, they can take as little as 30 minutes.

If your Avastin infusions are tolerated:

Avastin is taken every 2 weeks

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1

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90minutes 60

minutes 30 30minutes minutes

1st infusion 2nd infusion 3rd infusion Future infusions

1514

Taking AvastinWhen do I take Avastin?For patients starting on Avastin for first- or second-line treatment, Avastin is taken every 2 weeks to treat your metastatic colorectal cancer (mCRC). Because Avastin can be scheduled on the same day you get your chemotherapy, it may not require extra trips to an infusion center.

For mCRC patients continuing on Avastin for second-line treatment after a first-line treatment that included Avastin, Avastin is taken every 3 weeks.

If you have questions about how often you’ll receive Avastin infusions, speak with your health care team.

How do I take Avastin?You take Avastin as an infusion. That means you receive Avastin through a small needle in your vein or through a port, which is a device placed under the skin.

What can I expect from my infusion?Your doctor or nurse will monitor you for signs of infusion reactions, and may stop Avastin treatment if severe reactions occur. Reactions can include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating.

You always get the same dose of Avastin. If your Avastin

infusions are tolerated, they can take as little as 30 minutes.

If your Avastin infusions are tolerated:

ChemotherapyChemotherapy

Avastin

1716

How long do I take Avastin?You start taking Avastin with IV 5-FU–based chemotherapy to treat your metastatic colorectal cancer (mCRC). And you keep taking Avastin as long as your disease is controlled and your side effects are manageable.

If your cancer progresses during this initial treatment, talk to your doctor about whether continuing Avastin with a different chemo may be an option.

Important Safety InformationAvastin may cause severe stroke or heart problems, which can sometimes be fatal. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal.

What to remember about AvastinThere are some side effects that may require you to stop Avastin. But as long as your side effects stay manageable and your cancer is under control, you may keep taking Avastin.

If you are having issues paying for Avastin, call Avastin Access Solutions® (1-888-249-4918) for resources that can connect you to the medicine you need.

You change your chemotherapy treatment because of side effects

You want a break from your treatment and your side effects are manageable

You are seeing good results. Continuing to take Avastin may help to control your cancer

Continue taking Avastin even if:

If your doctor changes your IV 5-FU–based chemotherapy,

you may still take Avastin as long as your disease is controlled and your side effects are manageable