Vistogard 10gm Oral Granules
It is used to treat fluorouracil or capecitabine overdose.It is used to treat very bad or life-threatening side effects caused by fluorouracil or capecitabine.
Drug Class
Antidote
Pharmacologic Class
Pyrimidine analog; Uridine prodrug
Pregnancy Category
Category C
FDA Approved
Dec 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vistogard is a medicine used to treat adults and children who have received too much of certain cancer medicines (fluorouracil or capecitabine). It works by helping your body to reduce the harmful effects of these cancer medicines.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and ask questions if you're unsure about any aspect of your treatment.
Your doctor will provide personalized guidance on how to take this medication, including the correct dosage, frequency, and storage instructions. If you have any doubts or concerns, be sure to discuss them with your doctor.
Preparing and Taking Your Dose
To take this medication, mix the granules with 3 to 4 ounces (90 to 120 mL) of applesauce, pudding, or yogurt. Do not chew the granules. After mixing, drink at least 4 ounces (120 mL) of water to help the medication move through your digestive system. Discard any unused portion of the packet after each use.
Take your dose within 30 minutes of mixing the granules. If you don't use the mixed medication within 30 minutes, discard it and prepare a new dose. If you vomit within 2 hours of taking your dose, take an additional dose as directed by your doctor.
You can take this medication with or without food. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and ask questions if you're unsure about any aspect of your treatment.
Your doctor will provide personalized guidance on how to take this medication, including the correct dosage, frequency, and storage instructions. If you have any doubts or concerns, be sure to discuss them with your doctor.
Preparing and Taking Your Dose
To take this medication, mix the granules with 3 to 4 ounces (90 to 120 mL) of applesauce, pudding, or yogurt. Do not chew the granules. After mixing, drink at least 4 ounces (120 mL) of water to help the medication move through your digestive system. Discard any unused portion of the packet after each use.
Take your dose within 30 minutes of mixing the granules. If you don't use the mixed medication within 30 minutes, discard it and prepare a new dose. If you vomit within 2 hours of taking your dose, take an additional dose as directed by your doctor.
You can take this medication with or without food. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take Vistogard exactly as prescribed by your doctor, even if you start to feel better.
- Do not miss any doses. It is critical to take all 20 doses over 5 days.
- Mix the granules with soft food (e.g., applesauce, pudding, yogurt) or water and consume immediately. Do not chew the granules.
- Report any new or worsening symptoms to your healthcare provider immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10 g orally every 6 hours for 20 doses (5 days)
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
Fluorouracil or Capecitabine Overdose:
Initiate as soon as possible, within 96 hours following the end of fluorouracil or capecitabine administration, regardless of the presence of symptoms.
Pediatric Dosing
Neonatal:
Not established
Infant:
Same as adult dosing for patients 6 months and older. Not established for patients less than 6 months of age.
Child:
Same as adult dosing (10 g orally every 6 hours for 20 doses)
Adolescent:
Same as adult dosing (10 g orally every 6 hours for 20 doses)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Dialysis:
Not available (Uridine is renally excreted, but specific dialysis recommendations are not provided in labeling)
Hepatic Impairment:
Mild:
No dose adjustment recommended
Moderate:
No dose adjustment recommended
Severe:
No dose adjustment recommended
Pharmacology
Mechanism of Action
Uridine triacetate is an orally administered prodrug of uridine. Uridine competes with fluorouracil's active metabolite, fluorouridine triphosphate (FUTP), for incorporation into RNA, thereby mitigating cellular toxicity and damage caused by fluorouracil. It also competes with fluorodeoxyuridine monophosphate (FdUMP) for binding to thymidylate synthase, reducing DNA synthesis inhibition.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified as a percentage for uridine triacetate, but rapidly absorbed and converted to uridine.
Tmax:
Approximately 1.5 to 2 hours (for uridine)
FoodEffect:
A high-fat meal decreases Cmax and AUC of uridine. Administer without regard to food, but consistency in administration with or without food is preferred.
Distribution:
Vd:
Not available
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited (Uridine can cross the blood-brain barrier to some extent)
Elimination:
HalfLife:
Approximately 2 to 3 hours (for uridine)
Clearance:
Not available
ExcretionRoute:
Primarily renal (for uridine and its metabolites)
Unchanged:
Not available (Uridine is further metabolized)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for an antidote; therapeutic uridine levels are achieved rapidly.
PeakEffect:
Not precisely defined for an antidote; peak uridine levels occur ~1.5-2 hours post-dose.
DurationOfAction:
Not precisely defined for an antidote; sustained uridine levels are maintained with q6h dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Some people may have no side effects or only mild ones. If you encounter any of the following side effects, or if you have any other concerns, contact your doctor for advice:
- Stomach upset or vomiting
- Diarrhea
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Some people may have no side effects or only mild ones. If you encounter any of the following side effects, or if you have any other concerns, contact your doctor for advice:
- Stomach upset or vomiting
- Diarrhea
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Severe diarrhea
- Severe mouth sores (mucositis)
- Unusual bleeding or bruising
- Signs of infection (fever, chills, sore throat)
- Severe fatigue or weakness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and other laboratory tests should be conducted as directed by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific symptoms of Vistogard overdose are known. The drug is intended to counteract toxicity.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Confirmation of fluoropyrimidine overdose or severe toxicity
Rationale: To ensure appropriate indication for treatment.
Timing: Prior to initiation of Vistogard
Routine Monitoring
Clinical signs and symptoms of fluoropyrimidine toxicity (e.g., mucositis, diarrhea, neutropenia, thrombocytopenia)
Frequency: Daily or as clinically indicated
Target: Resolution or improvement of symptoms
Action Threshold: Worsening symptoms may indicate inadequate treatment or other complications.
Complete Blood Count (CBC) with differential
Frequency: As clinically indicated, especially if myelosuppression is present or suspected
Target: Normal ranges for cell counts
Action Threshold: Significant drops in cell counts may require supportive care.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Mucositis
- Stomatitis
- Hand-foot syndrome
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies of Vistogard in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out. Animal studies have shown adverse effects.
Second Trimester:
Risk cannot be ruled out.
Third Trimester:
Risk cannot be ruled out.
Lactation
It is not known whether uridine triacetate or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for serious adverse reactions.
Pediatric Use
Approved for patients 6 months of age and older. Safety and effectiveness have not been established in pediatric patients less than 6 months of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. No dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Vistogard must be administered as soon as possible, ideally within 96 hours after the end of fluorouracil or capecitabine administration, to be effective.
- It is crucial to complete the full 20-dose, 5-day course of treatment, even if symptoms improve.
- Vistogard is an antidote for fluoropyrimidine overdose/toxicity, not a treatment for adverse effects of standard-dose chemotherapy.
- The granules should be mixed with soft food or water and swallowed immediately; they should not be chewed.
Alternative Therapies
- There is no direct alternative antidote for fluorouracil or capecitabine overdose. Supportive care is the primary alternative if Vistogard is not available or cannot be administered.
Cost & Coverage
Average Cost:
Extremely high (Orphan drug) per 10g sachet
Insurance Coverage:
Specialty Tier (requires prior authorization and medical necessity)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.