Vonoprazan fumarate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kosar Doraghi, M.D.[2]
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Black Box Warning
|
Warning : Acute Tubulointerstitial Nephritis, Clostridioides difficile-Associated Diarrhea, Interactions with Diagnostic Investigations
See full prescribing information for complete Boxed Warning.
Presence of Gastric Malignancy:
Symptomatic response to Voquezna doesn't exclude gastric malignancy. Consider follow-up and diagnostic testing for patients with suboptimal response or early symptomatic relapse, especially in older patients.
Discontinue Voquezna if acute tubulointerstitial nephritis is suspected.
Risk of CDAD exists with Voquezna, especially in hospitalized patients. Consider CDAD in patients with persistent diarrhea. Use Voquezna for the shortest duration necessary.
Long-term use of Voquezna may increase the risk of osteoporosis-related fractures.
Monitor magnesium levels before and during Voquezna treatment, especially in patients on prolonged treatment or taking medications affected by hypomagnesemia.
Temporarily discontinue Voquezna before assessing serum chromogranin A (CgA) levels for neuroendocrine tumor diagnostics.
Long-term use of Voquezna is associated with an increased risk of fundic gland polyps.
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Overview
Vonoprazan fumarate is a potassium-competitive acid blocker that is FDA approved for the treatment of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
- to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults.
- in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori infection in adults.
- in combination with amoxicillin for the treatment of H. pylori infection in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include gastritis, diarrhea, abdominal distension, abdominal pain, and nausea in Healing of Erosive Esophagitis.
- Maintenance of Healed Erosive Esophagitis (≥3%): gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.
- Treatment of H. pylori Infection (≥2%): diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis
- Acute Tubulointerstitial Nephritis
- Clostridioides difficile-Associated Diarrhea
- Bone Fracture
- Severe Cutaneous Adverse Reactions
- Vitamin B12 Deficiency
- Hypomagnesemia.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
For healing erosive esophagitis and relief of heartburn, the recommended adult oral dosage of Voquezna is 20 mg once daily for 8 weeks.
- For maintaining healed erosive esophagitis and managing heartburn, the recommended dosage is 10 mg once daily for up to 6 months.
- H. pylori infection treatment can involve either triple therapy (Voquezna 20 mg, amoxicillin 1,000 mg, clarithromycin 500 mg, all twice daily for 14 days) or dual therapy (Voquezna 20 mg twice daily, amoxicillin 1,000 mg three times daily for 14 days).
- Dosage adjustments are necessary in patients with renal impairment or hepatic impairment based on their estimated glomerular filtration rate (GFR) or Child-Pugh classification, respectively.
- For renal impairment: Adjustments for both healing erosive esophagitis and H. pylori infection treatment are based on GFR, while maintenance dosage remains the same as in patients with normal renal function.
- For hepatic impairment: Adjustments for healing erosive esophagitis and H. pylori infection treatment are based on Child-Pugh classification, with different dosages recommended for each class. Maintenance dosage remains the same as in patients with normal hepatic function.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Vonoprazan fumarate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA. Reactions have included anaphylactic shock.
- VOQUEZNA is contraindicated with rilpivirine-containing products (Atazanavir, Nelfinavir)
Warnings
|
Warning : Acute Tubulointerstitial Nephritis, Clostridioides difficile-Associated Diarrhea, Interactions with Diagnostic Investigations
See full prescribing information for complete Boxed Warning.
Presence of Gastric Malignancy:
Symptomatic response to Voquezna doesn't exclude gastric malignancy. Consider follow-up and diagnostic testing for patients with suboptimal response or early symptomatic relapse, especially in older patients.
Discontinue Voquezna if acute tubulointerstitial nephritis is suspected.
Risk of CDAD exists with Voquezna, especially in hospitalized patients. Consider CDAD in patients with persistent diarrhea. Use Voquezna for the shortest duration necessary.
Long-term use of Voquezna may increase the risk of osteoporosis-related fractures.
Monitor magnesium levels before and during Voquezna treatment, especially in patients on prolonged treatment or taking medications affected by hypomagnesemia.
Temporarily discontinue Voquezna before assessing serum chromogranin A (CgA) levels for neuroendocrine tumor diagnostics.
Long-term use of Voquezna is associated with an increased risk of fundic gland polyps.
|
- Presence of Gastric Malignancy:
Symptomatic response to Voquezna doesn't exclude gastric malignancy. Consider follow-up and diagnostic testing for patients with suboptimal response or early symptomatic relapse, especially in older patients.
- Acute Tubulointerstitial Nephritis:
Discontinue Voquezna if acute tubulointerstitial nephritis is suspected.
- Clostridioides difficile-Associated Diarrhea (CDAD)
- Bone Fracture:
Long-term use of Voquezna may increase the risk of osteoporosis-related fractures. Use the shortest duration appropriate for the condition.
- Severe Cutaneous Adverse Reactions:
Discontinue Voquezna at the first signs of severe cutaneous adverse reactions.
- Vitamin B12 Deficiency
- Hypomagnesemia and Mineral Metabolism:
Monitor magnesium levels before and during Voquezna treatment, especially in patients on prolonged treatment or taking medications affected by hypomagnesemia.
- Interactions with Diagnostic Investigations:
Temporarily discontinue Voquezna before assessing serum chromogranin A (CgA) levels for neuroendocrine tumor diagnostics.
- Fundic Gland Polyps:
Long-term use of Voquezna is associated with an increased risk of fundic gland polyps.
- Use the shortest duration appropriate for the condition.
Adverse Reactions
Clinical Trials Experience
Healing of Erosive Esophagitis and Maintenance:
- Safety evaluated in a double-blind trial for healing (2 to 8 weeks) and maintenance (up to 24 weeks) in the US and Europe.
- Adverse reactions reported in at least 2% of patients:
- Healing Phase: Gastritis, diarrhea, abdominal distension, abdominal pain, nausea.
- Maintenance Phase: Gastritis, abdominal pain, dyspepsia, hypertension, urinary tract infection.
- COVID-19 incidence reported.
Other Clinical Trials:
- Similar adverse reactions noted in US trial compared to additional global studies.
- Less common adverse reactions include anemia, tachycardia, vertigo, duodenal polyp, dry mouth, bone fracture, etc.
Treatment of H. pylori Infection: Safety evaluated in triple and dual therapy trials in the US, Europe, and Japan.
- Discontinuation due to adverse reactions:
- Triple therapy: 2.3%
- Dual therapy: 0.9%
- Most common adverse reactions:
- Diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, nasopharyngitis.
- Less Common Adverse Reactions:
Include QT prolongation, orbital edema, hematochezia, fatigue, drug hypersensitivity, decreased appetite, renal hypertrophy, vaginal discharge, etc. Note: Clinical trials' adverse reaction rates are not directly comparable between drugs or reflective of real-world practice.
Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of vonoprazan outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic system disorders: thrombocytopenia
- Immune system disorders: anaphylactic shock
Drug Interactions
Antiretrovirals: Clinical Effect: Vonoprazan reduces intragastric acidity, potentially affecting the absorption of antiretroviral drugs and altering their safety and/or effectiveness. Prevention or Management:
- Rilpivirine-containing products: Concomitant use with Voquezna is contraindicated.
- Atazanavir: Avoid concomitant use with Voquezna.
- Nelfinavir and other antiretrovirals: Refer to the prescribing information of other antiretroviral drugs dependent on gastric pH for absorption before using them concomitantly with Voquezna.
- Other Drugs (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole):
Clinical Effect: Vonoprazan reduces intragastric acidity, potentially decreasing the absorption of drugs and affecting their effectiveness. Prevention or Management: Refer to the prescribing information for other drugs dependent on gastric pH for absorption. Combination Therapy with Clarithromycin and/or Amoxicillin: Clinical Effect: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and is contraindicated. Amoxicillin also has drug interactions. Prevention or Management: See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS in the prescribing information for clarithromycin. Refer to DRUG INTERACTIONS in the prescribing information for amoxicillin. Certain CYP3A Substrates where minimal concentration changes may lead to serious *toxicities: Clinical Effect: Vonoprazan is a weak CYP3A inhibitor. It may increase exposure of CYP3A4 substrates, leading to an increased risk of adverse reactions related to these substrates. Prevention or Management: Monitor concentrations and adverse reactions related to substrate drugs when used with Voquezna. Dosage reduction of substrate drugs may be necessary. Refer to the prescribing information for relevant substrate drugs. CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol): Clinical Effect: Vonoprazan is a CYP2C19 inhibitor. It may reduce plasma concentrations of the active metabolite of clopidogrel and increase exposure of CYP2C19 substrate drugs (e.g., citalopram, cilostazol). Prevention or Management:
- Clopidogrel: Monitor the efficacy and consider alternative anti-platelet therapy.
- Citalopram and Cilostazol: Monitor patients for adverse reactions. Refer to the prescribing information for dosage adjustments.
Chromogranin (CgA) Test for Neuroendocrine Tumors:
- Clinical Effect: Vonoprazan decreases intragastric acidity, leading to increased CgA levels, which may result in false positive results in neuroendocrine tumor diagnostic investigations.
- Prevention or Management: Assess CgA levels at least 14 days after discontinuing VOQUEZNA treatment. Repeat the test if initial CgA levels are elevated.
Interaction with Secretin Stimulation Test:
- Clinical Effect: Vonoprazan may cause hyper-response in gastrin secretion during secretin stimulation tests, falsely indicating gastrinoma.
- Prevention or Management: Temporarily cease VOQUEZNA at least 14 days before conducting the test to allow gastrin levels to return to baseline.
- Vonoprazan is a CYP3A substrate. Strong or moderate CYP3A inducers decrease vonoprazan exposure. Avoid concomitant use with VOQUEZNA.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Vonoprazan fumarate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vonoprazan fumarate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Vonoprazan fumarate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Vonoprazan fumarate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Vonoprazan fumarate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Vonoprazan fumarate in geriatric settings.
Gender
There is no FDA guidance on the use of Vonoprazan fumarate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Vonoprazan fumarate with respect to specific racial populations.
Renal Impairment
- Dosage reduction is advised for patients with severe renal impairment (eGFR < 30 mL/min).
Maintenance of Healed Erosive Esophagitis:
- No dosage adjustment of VOQUEZNA is recommended for patients with any degree of renal impairment.
Treatment of H. pylori Infection:
- Use of VOQUEZNA is not recommended for treating H. pylori infection in patients with severe renal impairment (eGFR < 30 mL/min).
Hepatic Impairment
Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C).
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Vonoprazan fumarate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Vonoprazan fumarate in patients who are immunocompromised.
Administration and Monitoring
Administration
- For healing erosive esophagitis and relief of heartburn, the recommended adult oral dosage of Voquezna is 20 mg once daily for 8 weeks.
- For maintaining healed erosive esophagitis and managing heartburn, the recommended dosage is 10 mg once daily for up to 6 months.
- H. pylori infection treatment can involve either triple therapy (Voquezna 20 mg, amoxicillin 1,000 mg, clarithromycin 500 mg, all twice daily for 14 days) or dual therapy (Voquezna 20 mg twice daily, amoxicillin 1,000 mg three times daily for 14 days).
- Dosage adjustments are necessary in patients with renal impairment or hepatic impairment based on their estimated glomerular filtration rate (GFR) or Child-Pugh classification, respectively.
- For renal impairment: Adjustments for both healing erosive esophagitis and H. pylori infection treatment are based on GFR, while maintenance dosage remains the same as in patients with normal renal function.
- For hepatic impairment: Adjustments for healing erosive esophagitis and H. pylori infection treatment are based on Child-Pugh classification, with different dosages recommended for each class. Maintenance dosage remains the same as in patients with normal hepatic function.
Monitoring
There is limited information regarding Vonoprazan fumarate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Vonoprazan fumarate and IV administrations.
Overdosage
There is limited information regarding Vonoprazan fumarate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Vonoprazan fumarate Pharmacology in the drug label.
Mechanism of Action
- Suppression of Gastric Acid Secretion: Vonoprazan inhibits both basal and stimulated gastric acid secretion at the secretory surface of gastric parietal cells.
- Inhibition of H, K ATPase Enzyme System: It achieves this by competitively inhibiting the H, K ATPase enzyme system, which is responsible for proton pumping.
- Potassium Competitive Inhibition: Vonoprazan competes with potassium.
- As a Gastric Proton-Pump Inhibitor: Vonoprazan is classified as a gastric proton-pump inhibitor, as it blocks the final step of acid production by targeting the acid (proton) pump within parietal cells.
- Activation Independent: Unlike some proton-pump inhibitors, vonoprazan does not require activation by acid.
- Selective Concentration: It may selectively accumulate in parietal cells, both during resting and stimulated states.
- Reversible Binding: Vonoprazan binds reversibly to active pumps in a noncovalent
Structure
Vonoprazan (as the fumarate), is a potassium-competitive acid blocker. Chemically, it is 1H-pyrrole-3-methanamine, 5-(2-fluorophenyl)-N-methyl-1-(3-pyridinylsulfonyl)-, (2E)-2-butenedioate.Vonoprazan fumarate has the following structure:
Vonoprazan fumarate is white to nearly white crystals or crystalline powder which melts at 194.8°C. Vonoprazan fumarate is soluble in dimethyl sulfoxide; sparingly soluble in N,N–dimethylacetamide, slightly soluble in N,N-dimethylformamide, methanol and water; very slightly soluble in ethanol (99.5%); and practically insoluble in 2-propanol, acetone, 1-octanol, and acetonitrile. VOQUEZNA (vonoprazan) tablets are available in two dosage strengths for oral administration: 10 mg of vonoprazan (equivalent to 13.36 mg of vonoprazan fumarate) and 20 mg of vonoprazan (equivalent to 26.72 mg of vonoprazan fumarate). Each film-coated tablet contains the following inactive ingredients: ascorbic acid, croscarmellose sodium, ferric oxide red (only in 20 mg tablets), ferric oxide yellow (only in 10 mg tablets), fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.
Pharmacodynamics
- After a single 10 mg or 20 mg dose of vonoprazan, the antisecretory effect, as measured by intragastric pH, begins within 2 to 3 hours.
- Increased intragastric pH levels compared to placebo are dose-dependent and sustained for over 24 hours post-dosing.
- With repeated daily dosing, vonoprazan's inhibitory effect on acid secretion increases, reaching steady state by Day 4.
- Antisecretory effect decreases upon drug discontinuation, but elevated intragastric pH persists for 24 to 48 hours post the last dose on Day 7.
Cardiac Electrophysiology:
- A single dose of 120 mg of vonoprazan, six times the maximum recommended dose, does not clinically significantly prolong the QT interval.
Serum Gastrin Effects:
- Vonoprazan treatment increases fasting gastrin levels from baseline during the healing phase, which stabilizes by Week 8.
- During the 6-month maintenance phase, gastrin levels remain elevated with vonoprazan, returning to normal within 4 weeks post-discontinuation.
- Elevated gastrin levels may lead to enterochromaffin-like cell hyperplasia and increased serum CgA levels, possibly causing false positive results in neuroendocrine tumor diagnostic investigations.
Enterochromaffin-Like Cell (ECL) Effects:
- Parietal cell and G-cell hyperplasia increases with vonoprazan treatment, consistent with its pharmacological action as a potassium-competitive acid blocker.
- No neoplastic changes were observed in human gastric biopsy specimens treated with vonoprazan for up to 260 weeks.
Pharmacokinetics
- Following once or twice daily dosing of vonoprazan 10 mg or 20 mg, the steady state pharmacokinetic parameters are summarized in Table 11.
- Time to reach maximum plasma concentration (Tmax) ranges from 1.5 to 3.0 hours.
- Maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) increase with dose.
- Steady state concentrations are typically achieved by Day 3 to 4.
Absorption:
- Vonoprazan exhibits time-independent pharmacokinetics.
- Multiple doses ranging from 10 to 40 mg once daily for 7 days result in dose-proportional increases in Cmax and AUC.
- Little plasma accumulation occurs after once daily multiple doses.
Effect of Food:
- In healthy subjects receiving vonoprazan 20 mg with a high-fat meal, there is a slight increase in Cmax and AUC, along with a delay in Tmax. These changes are not clinically significant.
Distribution:
- Vonoprazan plasma protein binding ranges from 85 to 88% and remains independent of concentration within the range of 0.1 to 10 mcg/mL.
Metabolism:
- Vonoprazan undergoes metabolism to inactive metabolites via multiple pathways involving various cytochrome P450 (CYP) isoforms and sulfo- and glucuronosyl-transferases.
- CYP2C19 polymorphisms do not significantly impact vonoprazan pharmacokinetics.
Excretion:
- After oral administration, approximately 67% of the radiolabeled dose (with 8% as unchanged vonoprazan) is recovered in urine, while approximately 31% (with 1.4% as unchanged vonoprazan) is recovered in feces.
Nonclinical Toxicology
There is limited information regarding Vonoprazan fumarate Nonclinical Toxicology in the drug label.
Clinical Studies
Healing of Erosive Esophagitis and Relief of Heartburn Study Overview:
- Design: Randomized, active-controlled, double-blind, eight-week study.
- Population: 1024 adult patients with erosive esophagitis.
- Treatment Groups: VOQUEZNA 20 mg once daily or lansoprazole 30 mg once daily for 2 to 8 weeks.
- Exclusion Criteria: H. pylori infection positivity, Barrett's esophagus, or definite dysplastic changes in the esophagus at baseline.
- Baseline Characteristics: Mean age 51 years; 53% female; 66% had mild erosive esophagitis (Grades A or B), 34% had moderate to severe erosive esophagitis (Grades C or D).
Healing of Erosive Esophagitis:
- Primary Endpoint: Endoscopically confirmed complete healing of all grades of erosive esophagitis at Week 2 or Week 8.
- VOQUEZNA: 93% achieved healing vs. 85% with lansoprazole (8% treatment difference).
- Secondary Endpoint: Complete healing of erosive esophagitis at Week 2 in patients with LA Grade C or D disease.
- VOQUEZNA: 70% achieved healing vs. 53% with lansoprazole (18% treatment difference).
Relief of Heartburn:
- Secondary Endpoint: Percentage of 24-hour heartburn-free days through Week 8.
- VOQUEZNA: Mean of 67% vs. 64% with lansoprazole (3% treatment difference).
Maintenance of Healed Erosive Esophagitis and Relief of Heartburn:
- Maintenance Phase: Patients with confirmed healed erosive esophagitis were re-randomized to VOQUEZNA 10 mg once daily, higher dosage of VOQUEZNA, or lansoprazole 15 mg once daily.
- Primary Endpoint: Maintenance of healed erosive esophagitis through Week 24.
- VOQUEZNA: 79% vs. 72% with lansoprazole (7% treatment difference).
- Secondary Endpoint: Percentage of 24-hour heartburn-free days through Week 24. *VOQUEZNA: Mean of 81% vs. 79% with lansoprazole (2% treatment difference).
Other Studies:
- Two additional studies demonstrated non-inferiority of VOQUEZNA compared to lansoprazole for healing of erosive esophagitis and maintenance of healed erosive esophagitis.
Treatment of Helicobacter pylori Infection Study Overview:
- Randomized, controlled, double-blind (triple therapy)/open-label (dual therapy) study.
- Treatment H. pylori-positive adult patients with dyspepsia, peptic ulcer, or stable NSAID treatment.
- Patients randomized to triple therapy (VOQUEZNA, amoxicillin, clarithromycin) or dual therapy (VOQUEZNA, amoxicillin) vs. lansoprazole, amoxicillin, clarithromycin.
H. pylori Eradication Rates:
- Triple Therapy vs. Lansoprazole Triple Therapy:
- VOQUEZNA triple therapy was non-inferior and superior to lansoprazole triple therapy.
- Dual Therapy vs. Lansoprazole Triple Therapy:
- VOQUEZNA dual therapy was non-inferior and superior to lansoprazole triple therapy in patients with clarithromycin-resistant strains of H. pylori and in the overall population.
Conclusion:
- VOQUEZNA demonstrated effectiveness in healing erosive esophagitis, relieving heartburn, and treating H. pylori infection, with favorable outcomes compared to lansoprazole in various patient populations.
How Supplied
10 mg of vonoprazan: pale yellow, oval, film-coated tablets debossed V10 on one side and plain on the other side. Bottles of 30 (NDC 81520-100-30). 20 mg of vonoprazan: pale red, oval, film-coated tablets debossed V20 on one side and plain on the other side. Bottles of 30 (NDC 81520-200-30).
Storage
Store between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
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Patient Counseling Information
Patients should be advised to carefully read the FDA-approved patient labeling (Patient Information) provided with VOQUEZNA. Additionally, they should be informed about the following:
- Acute Tubulointerstitial Nephritis:
Patients should contact their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis. Clostridioides difficile-Associated Diarrhea: Patients should promptly notify their healthcare provider if they experience diarrhea that does not improve. Bone Fracture: Patients should report any fractures, particularly of the hip, wrist, or spine, to their healthcare provider. Severe Cutaneous Adverse Reactions: Patients should discontinue VOQUEZNA and seek medical attention if they notice the first signs of a severe cutaneous adverse reaction or any other signs of hypersensitivity. Vitamin B12 (Cobalamin) Deficiency: Patients receiving VOQUEZNA long-term should report any clinical symptoms suggestive of Vitamin B12 deficiency to their healthcare provider. Hypomagnesemia and Mineral Metabolism: Patients should inform their healthcare provider about any clinical symptoms that may indicate hypomagnesemia, hypocalcemia, and/or hypokalemia. Drug Interactions: Patients should inform their healthcare provider if they are starting treatment with rilpivirine-containing products. Pregnancy: Patients should contact Phathom Pharmaceuticals, Inc. if they are exposed to VOQUEZNA during pregnancy. Lactation: Patients should refrain from breastfeeding while receiving treatment with VOQUEZNA. Important Administration Instructions: VOQUEZNA can be taken with or without food. Patients should swallow VOQUEZNA tablets whole and should not chew or crush them. For missed doses: For the healing or maintenance of healed erosive esophagitis: If a dose is missed, it should be taken as soon as possible within 12 hours after the missed dose. If more than 12 hours have passed, the missed dose should be skipped, and the next dose should be taken at the regular scheduled time. For the treatment of H. pylori infection: If a dose is missed, it should be taken as soon as possible within 4 hours after the missed dose. If more than 4 hours have passed, the missed dose should be skipped, and the next dose should be taken at the regular scheduled time. The normal dosing schedule should be continued until the treatment is completed. Patients should follow these instructions closely and contact their healthcare provider for any concerns or questions related to VOQUEZNA treatment.
Precautions with Alcohol
Alcohol-Vonoprazan fumarate interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Vonoprazan fumarate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Vonoprazan fumarate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.