Voquezna 10mg Tablets
It is used to treat a certain type of reflux.It is used to treat heartburn.It is used to treat syndromes caused by lots of stomach acid.It is used to treat a certain type of infection (H. pylori) that causes GI (gastrointestinal) ulcers.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Potassium-competitive acid blocker (P-CAB)
Pharmacologic Class
Potassium-competitive acid blocker
Pregnancy Category
Not available
FDA Approved
Nov 2023
DEA Schedule
Not Controlled
Overview
What is this medicine?
Voquezna (vonoprazan) is a medicine that reduces the amount of acid in your stomach. It works differently from older acid-reducing medicines by blocking a specific pump in your stomach that makes acid. This helps to heal damage to your esophagus caused by stomach acid and can also be used with antibiotics to treat stomach infections caused by H. pylori bacteria.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs 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 has been more than 12 hours since the missed dose (or 4 hours if you are taking this medication for H. pylori treatment), skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs 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 has been more than 12 hours since the missed dose (or 4 hours if you are taking this medication for H. pylori treatment), skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow your doctor's instructions regarding diet and lifestyle modifications for acid reflux (e.g., avoiding trigger foods, eating smaller meals, not lying down immediately after eating).
- Avoid smoking and excessive alcohol consumption, as these can worsen acid reflux.
- Take the medication exactly as prescribed; do not crush, chew, or split the tablets.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For H. pylori eradication: 10 mg twice daily for 14 days, in combination with amoxicillin and clarithromycin or amoxicillin and metronidazole. For maintenance of healing of erosive esophagitis: 10 mg once daily for up to 6 months.
Dose Range:
10 - 20 mg
Condition-Specific Dosing:
H. pylori eradication:
10 mg twice daily for 14 days (as part of a triple therapy regimen)
Healing of Erosive Esophagitis:
20 mg once daily for up to 8 weeks (Note: 10mg tablet is not the initial dose for healing, but for maintenance)
Maintenance of Healing of Erosive Esophagitis:
10 mg once daily for up to 6 months
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
Not studied; use with caution
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
No dose adjustment needed (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
Vonoprazan is a potassium-competitive acid blocker (P-CAB) that reversibly and competitively inhibits the H+/K+-ATPase (proton pump) in gastric parietal cells. This action blocks the final step of acid secretion, leading to potent and sustained inhibition of gastric acid production.
Pharmacokinetics
Absorption:
Bioavailability:
Not determined (rapidly absorbed)
Tmax:
1.5-2 hours
FoodEffect:
No clinically meaningful effect on absorption
Distribution:
Vd:
Approximately 100 L
ProteinBinding:
Approximately 85%
CnssPenetration:
Limited
Elimination:
HalfLife:
7-9 hours
Clearance:
Not available
ExcretionRoute:
Approximately 60% renal, 40% fecal
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours
PeakEffect:
Not available (sustained acid suppression)
DurationOfAction:
Prolonged (due to accumulation in parietal cells and high affinity)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low magnesium levels: mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, decreased appetite, severe upset stomach or vomiting, or an abnormal heartbeat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Bone pain.
Vaginal irritation or discharge.
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems that may not resolve and can be life-threatening. Seek medical help immediately if you notice any of the following symptoms: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Constipation, diarrhea, stomach pain, or upset stomach.
Bloating.
Changes in taste.
Headache.
Signs of a common cold.
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low magnesium levels: mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, decreased appetite, severe upset stomach or vomiting, or an abnormal heartbeat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Bone pain.
Vaginal irritation or discharge.
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems that may not resolve and can be life-threatening. Seek medical help immediately if you notice any of the following symptoms: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Constipation, diarrhea, stomach pain, or upset stomach.
Bloating.
Changes in taste.
Headache.
Signs of a common cold.
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also 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 or persistent diarrhea
- New or worsening abdominal pain
- Unexplained weight loss
- Difficulty or pain when swallowing
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Symptoms of low magnesium (e.g., dizziness, irregular heartbeat, muscle spasms, seizures)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Existing health conditions, such as kidney disease or liver disease, that may affect your ability to take this medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, including those used to treat HIV, seizures, cancer, and other conditions, should not be taken with this drug. There are many potential drug interactions, so it is crucial to disclose all medications you are taking.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is vital to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Existing health conditions, such as kidney disease or liver disease, that may affect your ability to take this medication.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, including those used to treat HIV, seizures, cancer, and other conditions, should not be taken with this drug. There are many potential drug interactions, so it is crucial to disclose all medications you are taking.
If you are breastfeeding, as you should not breastfeed while taking this medication.
This list is not exhaustive, and it is vital to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure safe use. Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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 laboratory tests should be conducted as directed by your doctor to monitor your condition.
Do not exceed the prescribed duration of treatment with this medication. Taking it for longer than recommended by your doctor may lead to adverse effects.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit. These symptoms may indicate a more severe health issue.
Long-term use of this medication, particularly in high doses or for more than a year, may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.
Prolonged use of this medication (typically more than three months) may lead to rare cases of low magnesium levels, often occurring after one year of treatment. This condition may cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.
This medication can prevent other drugs from being absorbed by the body. If you are taking other medications, consult your doctor or pharmacist to determine if you should take them at a different time than this medication.
The risk of developing stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than a year. If you have concerns, discuss them with your doctor.
Rarely, long-term treatment with this medication (typically more than three years) can cause low vitamin B-12 levels. If you experience symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs, contact your doctor immediately.
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Do not exceed the prescribed duration of treatment with this medication. Taking it for longer than recommended by your doctor may lead to adverse effects.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
If you experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit. These symptoms may indicate a more severe health issue.
Long-term use of this medication, particularly in high doses or for more than a year, may increase the risk of hip, spine, and wrist fractures in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.
Prolonged use of this medication (typically more than three months) may lead to rare cases of low magnesium levels, often occurring after one year of treatment. This condition may cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.
This medication can prevent other drugs from being absorbed by the body. If you are taking other medications, consult your doctor or pharmacist to determine if you should take them at a different time than this medication.
The risk of developing stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than a year. If you have concerns, discuss them with your doctor.
Rarely, long-term treatment with this medication (typically more than three years) can cause low vitamin B-12 levels. If you experience symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs, contact your doctor immediately.
If you are pregnant or plan to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 120 mg/day for 7 days were well tolerated.
What to Do:
In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management should be symptomatic and supportive.
Drug Interactions
Contraindicated Interactions
- Rilpivirine-containing products (due to pH-dependent absorption)
Major Interactions
- Atazanavir
- Nelfinavir
- Dasatinib
- Erlotinib
- Ketoconazole
- Itraconazole
- Methotrexate (potential increase in methotrexate levels)
- Clopidogrel (potential reduction in antiplatelet effect, though less studied than with PPIs)
Moderate Interactions
- Digoxin (increased absorption)
- Tacrolimus (increased tacrolimus levels)
- Mycophenolate mofetil (decreased exposure)
- Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole - may increase vonoprazan exposure)
- Strong CYP3A4 inducers (e.g., rifampin - may decrease vonoprazan exposure)
Monitoring
Baseline Monitoring
H. pylori status
Rationale: To confirm indication for eradication therapy.
Timing: Prior to initiation for H. pylori eradication
Liver function (AST, ALT, bilirubin)
Rationale: To assess baseline hepatic function, especially given hepatic metabolism and contraindication in severe hepatic impairment.
Timing: Prior to initiation
Renal function (SCr, eGFR)
Rationale: To assess baseline renal function, though no dose adjustment is needed for most impairment levels.
Timing: Prior to initiation
Routine Monitoring
Symptom resolution
Frequency: Throughout treatment
Target: Resolution or significant improvement of acid-related symptoms
Action Threshold: Persistent or worsening symptoms may require further investigation or alternative therapy
Magnesium levels
Frequency: Periodically, especially with prolonged use or concomitant diuretics
Target: Normal serum magnesium levels
Action Threshold: Hypomagnesemia may require supplementation or discontinuation
Vitamin B12 levels
Frequency: Periodically with prolonged use (e.g., >1 year)
Target: Normal serum Vitamin B12 levels
Action Threshold: Deficiency may require supplementation
Symptom Monitoring
- Persistent or worsening heartburn
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Unexplained weight loss
- Recurrent vomiting
- Gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit)
- New or unusual abdominal pain
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of vonoprazan in pregnant women. Animal studies did not show evidence of teratogenicity. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies showed no teratogenicity.
Second Trimester:
Limited human data; animal studies showed no teratogenicity.
Third Trimester:
Limited human data; animal studies showed no teratogenicity.
Lactation
It is unknown whether vonoprazan is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Voquezna and any potential adverse effects on the breastfed infant from Voquezna or from the underlying maternal condition.
Infant Risk:
Unknown; potential for adverse effects cannot be ruled out.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. No dose adjustment is needed based on age alone.
Clinical Information
Clinical Pearls
- Voquezna is the first potassium-competitive acid blocker (P-CAB) approved in the US, offering a new mechanism of action for acid suppression compared to traditional PPIs.
- It provides rapid, potent, and sustained acid suppression, often achieving full acid suppression faster than PPIs.
- Unlike PPIs, vonoprazan is stable in acid and does not require an enteric coating, and its efficacy is not significantly affected by food.
- It has less inter-patient variability in acid suppression compared to PPIs, as its metabolism is less dependent on CYP2C19 polymorphism.
- Voquezna 10mg is specifically indicated for H. pylori eradication (as part of combination therapy) and for maintenance of healing of erosive esophagitis. The 20mg dose is used for initial healing of erosive esophagitis.
Alternative Therapies
- Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
- H2-receptor antagonists (H2RAs): Famotidine, Cimetidine, Nizatidine
- Antacids
Cost & Coverage
Average Cost:
Price range varies, typically high for new brand-name drugs per 30 tablets
Insurance Coverage:
Tier 3 or higher (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.