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Vistogard® is being distributed by SERB Pharmaceuticals as of July 1, 2023. For more details please click here.

Don’t wait to
sound the
alarm

Early signs of severe side effects of 5‑FU or capecitabine are a medical emergency

Vistogard® (uridine triacetate) is the first and only FDA-approved emergency treatment for early-onset, severe toxicities associated with 5‑FU (fluorouracil) or capecitabine or following an overdose of 5‑FU or capecitabine.

Contact your care team or seek emergency care immediately if you experience severe side effects early.

SIGNS AND SYMPTOMS

The first 96 hours are critical

Severe or life-threatening side effects can develop quickly after treatment with 5‑FU or capecitabine chemotherapies. Contact your care team or seek emergency care immediately if you experience severe side effects early, especially within the first 96 hours.

Know the difference between common side effects and severe, early-onset side effects

Common side effects of chemotherapy

Call your oncology care team about any side effects you may be experiencing.

  • Mouth sores
  • Nausea
  • Vomiting
  • Diarrhea
  • Hand-foot syndrome (capecitabine only): Redness and mild tenderness on palms of hands and soles of the feet

Severe, early-onset (during, or within, 96 hours of the end of treatment) side effects of chemotherapy

Don’t wait. Call your oncology care team immediately.

  • Confusion, dizziness, or changes in awareness
  • Severe mouth sores (painful, difficulty eating or drinking)
  • Severe nausea (may prevent eating or drinking)
  • Severe vomiting (5+ times per day)
  • Severe diarrhea (7+ stools per day)
  • Heart-related symptoms (such as chest discomfort or irregular heartbeat)
  • Extreme fatigue or weakness (unable to do normal daily activities)
  • Hand-foot syndrome (capecitabine only): Severe pain, blisters, bleeding, and peeling that make performing daily activities difficult

VISTOGARD should only be used for the emergency treatment of side effects of fluorouracil or capecitabine, because it may decrease the effectiveness of these medicines.

It is not known if VISTOGARD is safe and effective if started more than 4 days (96 hours) after the end of a dose of 5‑FU or capecitabine.

5‑FU = fluorouracil.

Don’t wait to communicate

  • Call your oncology care team immediately—as soon as you suspect you are experiencing early signs of severe side effects, even if you are unsure about your symptoms and how you feel
  • Tell your care team that you recently received 5‑FU or capecitabine chemotherapy
WHY VISTOGARD

About VISTOGARD

VISTOGARD is an emergency treatment for early-onset, severe toxicities associated with 5‑FU (fluorouracil) or capecitabine, or following an overdose of 5‑FU or capecitabine, when given within 4 days (96 hours) after receiving treatment.

VISTOGARD may help treat the effects of early-onset, severe side effects of 5‑FU or capecitabine when used promptly, as directed by your healthcare team.

Treatment timing is important—the first 96 hours are critical

96%
(130/135)

survival in patients who received VISTOGARD for 5‑FU or capecitabine overdose or severe side effects

Results are from 2 open-label studies that did not compare VISTOGARD to another treatment. Of 135 patients, 117 received VISTOGARD after an overdose of 5‑FU or capecitabine, and 18 received it after developing early-onset, severe or life-threatening side effects.

VISTOGARD should only be used for the emergency treatment of side effects of fluorouracil or capecitabine, because it may decrease the effectiveness of these medicines.

It is not known if VISTOGARD is safe and effective if started more than 4 days (96 hours) after the end of a dose of 5‑FU or capecitabine.

What are possible side effects of VISTOGARD?

Common side effects of VISTOGARD include: vomiting, nausea, and diarrhea.

These are not all the possible side effects of VISTOGARD.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

5‑FU = fluorouracil.

DPYD TESTING

Understanding DPYD testing

Some people have genetic differences that affect how their body processes certain chemotherapy medicines, such as 5‑FU or capecitabine. This is related to an enzyme called dihydropyrimidine dehydrogenase (DPD).

  • DPD mutations, causing DPD deficiency, have been reported in ~3%–7% of some populations
  • Reduced DPD activity can increase the risk of severe side effects from these treatments
  • DPYD testing is a genetic test that may help identify reduced DPD enzyme activity (the DPYD gene encodes the enzyme DPD)
  • Not all patients with side effects have a DPYD variant, and not all variants are detected through testing

View FDA communication on this topic here.

It is important to know that serious side effects from 5‑FU or capecitabine can still occur even if testing was done before receiving treatment.

5‑FU = fluorouracil; DPYD; DPD = dihydropyrimidine dehydrogenase.

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