ONE DEATH TOO MANY

What you can do to reduce the human cost of 5-FU or capecitabine toxicity

Each year, thousands of patients are treated with 5-FU or capecitabine for colorectal and other solid-tumor cancers.¹ Approximately 10% of these patients will experience a toxic reaction to their treatment—and nearly 1% will die from severe 5-FU or capecitabine toxicity.^1-4

These toxic reactions can occur during the first or second treatment cycle and can quickly become life-threatening. This is known as early-onset 5-FU or capecitabine toxicity.

When patients die not from their cancer but from the medicine intended to treat it, it’s time to take action. Learn how to recognize the signs of 5-FU or capecitabine toxicity—and help your patients do the same. The patient you educate could be the one you save.

Mom was in the 96-hour window, and we missed it because no one knew what to look for.”

- Terri Fulton

Lost her mother to early-onset 5-FU toxicity

The Faces of 5-FU Toxicity Video

Real stories about a real problem

For patients and loved ones affected by early-onset 5-FU toxicity, the cost of inaction could not be higher. Listen to the stories of patients and caregivers as they discuss how 5-FU toxicity has forever changed their lives.

Download the Video

Chapter 1

Dr. Jay Saux, an oncologist from Covington, Louisiana, describes his 20 years of experience with early-onset 5-FU toxicity and how he and his team have responded to emergent situations.

Chapter 2

Terri Fulton shares how within days of her first 5-FU treatment cycle, her mother went from being active to completely incapacitated.

Chapter 3

Jane Harwood tells her story of improbable survival in her battle with severe 5-FU toxicity and explains the role toxicity has played in her ongoing battle with cancer.

Chapter 4

Ken Surprenant lost his wife to early-onset 5-FU toxicity after her very first treatment cycle. But his passion for raising awareness of 5-FU toxicity led him to take action in the oncology community.

In 3 years I will not be here...I don’t know if [resuming] chemotherapy would have prevented that, but I have to think it might have.”

- Jane Harwood

Discontinued chemotherapy due to early-onset 5-FU toxicity

Recognizing the Signs

Stopping early-onset 5-FU or capecitabine toxicity starts with you

Discerning the difference between expected reactions and signs of early-onset 5-FU or capecitabine toxicity could save your patient's life. This chart identifies red flags to look for when administering 5-FU or capecitabine treatment and strategies to educate patients about next steps.^3-6

When my wife reported that her mouth was sore, the response she got was, ‘It’s too early for these side effects’...She never left the hospital.”

- Ken Surpresant

Lost his wife to early-onset 5-FU toxicity

Toxicity Timeline

Don’t miss your window of opportunity

Common adverse reactions to 5-FU or capecitabine typically develop over a period of weeks and after multiple treatment cycles, but early-onset 5-FU or capecitabine toxicity can develop within hours or days of the very first treatment cycle.^7-10 When patients experience severe symptoms early in their treatment cycle, treating with VISTOGARD^® as quickly as possible is absolutely crucial.

Normal side effects of 5-FU or capecitabine vs early-onset 5-FU or capecitabine toxicity over time^7-10

Get a clinical action plan for addressing 5-FU or capecitabine toxicity

Early-Onset 5-Fluorouracil Toxicity: Clinical Indicators of a Life-Threatening Emergency

Learn how to effectively recognize and treat severe, potentially life-threatening cases of early-onset 5-FU or capecitabine toxicity

Download the paper

Indication

VISTOGARD^® is indicated for the emergency treatment of adult and pediatric patients:

following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration

Limitations of use

VISTOGARD^® is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD^® included vomiting (10%), nausea (5%), and diarrhea (3%).
One person receiving uridine triacetate experienced grade 3 nausea and vomiting.
VISTOGARD^® was discontinued for adverse reactions in 2 (1.4%) patients.

Vistogard^® is the first and only antidote for early-onset, severe, or serious 5-FU or capecitabine toxicity

Indication

VISTOGARD^® is indicated for the emergency treatment of adult and pediatric patients:

following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration

Limitations of use

VISTOGARD^® is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

In clinical studies, adverse reactions occurring in >2% of patients receiving VISTOGARD^® included vomiting (10%), nausea (5%), and diarrhea (3%).
One person receiving uridine triacetate experienced grade 3 nausea and vomiting.
VISTOGARD^® was discontinued for adverse reactions in 2 (1.4%) patients.

survival in historical case reports of 5-FU overdose before VISTOGARD^® became available¹¹

survival in patients who received VISTOGARD^® for either 5-FU overdose or early-onset 5-FU toxicity¹¹

of patients treated with VISTOGARD^® resumed chemotherapy within 30 days¹¹

Wellstat Medical Information

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is for U.S. residents only. The information on this website should not take the place of talking with your doctor or health care professional.

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