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NOW APPROVED

Introducing H. pylori regimens containing a new class of acid suppression: The first PCAB (potassium-competitive acid blocker).1

VOQUEZNA™ Triple Pak™ and VOQUEZNA™ Dual Pak™ are co-packaged products containing a novel acid suppressant plus antibiotics, and both are indicated for the treatment of Helicobacter pylori infection in adults.1

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA Triple Pak, VOQUEZNA Dual Pak, and other antibacterial drugs, both products should be used only to treat or prevent infections that are proven or strongly suspected of being caused by bacteria.1

Get ready to use the first PCAB approved in an H. pylori regimen.

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Frequently Asked Questions

What is the indication for both VOQUEZNA Triple Pak (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA Dual Pak
(vonoprazan, amoxicillin)?
VOQUEZNA Triple Pak and VOQUEZNA Dual Pak are indicated for the treatment of H. pylori infection in adults.1
What are PCABs?
Potassium-competitive acid blockers (PCABs) are a new class of acid suppressants that inhibit H+, K+ ATPase via a competitive interaction with K+ site of the enzyme. Although PCABs have been marketed overseas, vonoprazan will be the first PCAB approved for use in the United States.1

Vonoprazan does not require activation by acid. Vonoprazan may selectively concentrate in the parietal cells in both the resting and stimulated states. Vonoprazan binds to the active acid pumps in a noncovalent and reversible manner.1
When will VOQUEZNA Triple Pak and VOQUEZNA Dual Pak be available?
Sign up to receive updates on the timing of availability for VOQUEZNA Triple Pak and VOQUEZNA Dual Pak.
How are VOQUEZNA Triple Pak and VOQUEZNA Dual Pak packaged?

VOQUEZNA Triple Pak is a co-packaged product in daily blister packs containing vonoprazan tablets—a potassium-competitive acid blocker (PCAB)—along with amoxicillin capsules, and clarithromycin tablets.1

VOQUEZNA Dual Pak is a co-packaged product in daily blister packs containing vonoprazan tablets—a potassium-competitive acid blocker (PCAB)—along with amoxicillin capsules.1

What is the recommended dose for VOQUEZNA Triple Pak and VOQUEZNA Dual Pak?

Recommended dosing of VOQUEZNA Triple Pak is 14 days of:

  • Vonoprazan 20 mg + amoxicillin 1000 mg (2 capsules, 500 mg each) + clarithromycin 500 mg, each given twice daily in the morning and evening (12 hours apart)
  • Taken with or without food
If patients miss a dose:

Administer VOQUEZNA Triple Pak as soon as possible, within 4 hours after the missed dose. If more than 4 hours have passed, skip the missed dose and administer the next dose on the regularly scheduled time. Patients should continue the normal dosing schedule until the medication is completed.

Recommended dosing of VOQUEZNA Dual Pak is 14 days of:

  • Vonoprazan 20 mg given twice daily, in the morning and evening, plus
  • Amoxicillin 1000 mg (2 capsules, 500 mg each), given 3 times a day: in the morning, at mid-day, and in the evening
  • Taken with or without food
If patients miss a dose:

Administer VOQUEZNA Dual Pak as soon as possible, within 4 hours after the missed dose. If more than 4 hours have passed, skip the missed dose and administer the next dose on the regularly scheduled time. Patients should continue the normal dosing schedule until the medication is completed.

What are the study design and efficacy results of clinical trials for H. pylori ?
Please refer to the Prescribing Information for the clinical study design and for efficacy results.
What are the most common side effects of VOQUEZNA Triple Pak and VOQUEZNA Dual Pak?

For VOQUEZNA Triple Pak, the most common adverse reactions (≥2%) were dysgeusia, diarrhea, vulvovaginal candidiasis, headache, abdominal pain, and hypertension.1

For VOQUEZNA Dual Pak, the most common adverse reactions (≥2%) were diarrhea, abdominal pain, vulvovaginal candidiasis, and nasopharyngitis.1

Do VOQUEZNA Triple Pak and VOQUEZNA Dual Pak need to be taken with food?
Both VOQUEZNA Triple Pak and VOQUEZNA Dual Pak can be taken with or without food.1

INDICATIONS AND USAGE

VOQUEZNA™ TRIPLE PAK™ is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin-class antibacterial, and clarithromycin, a macrolide antimicrobial. VOQUEZNA™ DUAL PAK™ is a co-packaged product containing vonoprazan and amoxicillin. Both products are indicated for the treatment of Helicobacter pylori infection in adults.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, and other antibacterial drugs, both products should be used only to treat or prevent infections that are proven or strongly suspected of being caused by bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with known hypersensitivity to vonoprazan or amoxicillin, any other components of the formulation, any other beta-lactams, or in patients receiving rilpivirine-containing products.

Due to the clarithromycin component, VOQUEZNA TRIPLE PAK is also contraindicated in patients with any known hypersensitivity to clarithromycin or any macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in patients with renal or hepatic impairment, or those with a history of cholestatic jaundice/hepatic dysfunction.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If hypersensitivity reactions occur, discontinue use and institute immediate therapy (e.g., anaphylaxis management).

Severe Cutaneous Adverse Reactions (SCAR): Discontinue use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. SCAR, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the components of both products. In addition, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with amoxicillin and clarithromycin.

Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK. CDAD has been reported with use of acid suppressing therapies and nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If CDAD is confirmed, discontinue therapy and treat appropriately.

Rash in Patients with Mononucleosis: A high percentage of patients with mononucleosis who receive amoxicillin (a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) develop an erythematous skin rash. Avoid use of both products in patients with mononucleosis.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Assess CgA levels at least 14 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK treatment and consider repeating the test if initial CgA levels are high.

VOQUEZNA TRIPLE PAK Warnings or Precautions Due to the Clarithromycin Component:

QT Prolongation: Avoid VOQUEZNA TRIPLE PAK in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.

Hepatotoxicity: Discontinue use of VOQUEZNA TRIPLE PAK if signs and symptoms of hepatitis occur.

Serious adverse reactions due to concomitant use with other drugs: Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, hypoglycemic agents including insulin, quetiapine, warfarin, benzodiazepines, and other drugs.

Embryo-Fetal Toxicity: VOQUEZNA TRIPLE PAK is not recommended for use in pregnancy as clarithromycin may cause fetal harm.

Myasthenia Gravis: Exacerbation of myasthenia gravis can occur with VOQUEZNA TRIPLE PAK since it has been reported in patients receiving clarithromycin tablets.

ADVERSE REACTIONS

VOQUEZNA TRIPLE PAK: The most common adverse reactions (≥2%) include dysgeusia (4.6%), diarrhea (4.0%), vulvovaginal candidiasis (3.2%), headache (2.6%), abdominal pain (2.3%), and hypertension (2.0%).

VOQUEZNA DUAL PAK: The most common adverse reactions (≥2%) include diarrhea (5.2%), abdominal pain (2.6%), vulvovaginal candidiasis (2.0%), and nasopharyngitis (2.0%).

DRUG INTERACTIONS

Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK have the potential for clinically important drug interactions. See full Prescribing Information for important drug interactions.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding not recommended during treatment, but a lactating woman can pump and discard breast milk during treatment and for 2 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK administration.

Geriatrics: VOQUEZNA TRIPLE PAK increased risk of torsades de pointes due to clarithromycin.

Renal and Hepatic Impairment: Avoid use in patients with severe renal impairment and avoid use in patients with moderate to severe hepatic impairment.

You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428)1-888-775-PHAT (7428) or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VOQUEZNA Triple Pak and VOQUEZNA Dual Pak are contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams, or in patients receiving rilpivirine-containing products.

VOQUEZNA Triple Pak is also contraindicated in patients with any known hypersensitivity to any macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, or a history of cholestatic jaundice/hepatic dysfunction, colchicine in renal or hepatic impairment.

Serious and occasionally fatal hypersensitivity reactions have been reported with components of VOQUEZNA Triple Pak and VOQUEZNA Dual Pak.

WARNINGS AND PRECAUTIONS

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to
fatal colitis.
VOQUEZNA Triple Pak and VOQUEZNA Dual Pak should not be used in patients with moderate to severe hepatic impairment or severe renal impairment.

Rash in Patients with Mononucleosis: A high percentage of patients with mononucleosis who receive amoxicillin (a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) develop an erythematous skin rash. Avoid use of both products in patients with mononucleosis.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Assess CgA levels at least 14 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK treatment and consider repeating the test if initial CgA levels are high.

Avoid use of VOQUEZNA Triple Pak in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades
de pointes
), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.

Discontinue use of VOQUEZNA Triple Pak if signs and symptoms of hepatitis occur.

VOQUEZNA Triple Pak is not recommended for use in pregnancy as a component, clarithromycin, may cause fetal harm.

Exacerbation of myasthenia gravis can occur since it has been reported in patients receiving clarithromycin tablets.

The most common adverse reactions (≥2%) include dysgeusia, diarrhea, headache, abdominal pain, vulvovaginal candidiasis, hypertension and nasopharyngitis.

INDICATIONS AND USAGE

VOQUEZNA™ TRIPLE PAK™ is a co-packaged product containing vonoprazan, a potassium-competitive acid blocker (PCAB), amoxicillin, a penicillin-class antibacterial, and clarithromycin, a macrolide antimicrobial. VOQUEZNA™ DUAL PAK™ is a co-packaged product containing vonoprazan and amoxicillin. Both products are indicated for the treatment of Helicobacter pylori infection in adults.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs, both products should be used only to treat or prevent infections that are proven or strongly suspected of being caused by bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are contraindicated in patients with known hypersensitivity to vonoprazan or amoxicillin, any other components of the formulation, any other beta-lactams, or in patients receiving rilpivirine-containing products.

Due to the clarithromycin component, VOQUEZNA TRIPLE PAK is also contraindicated in patients with any known hypersensitivity to clarithromycin or any macrolide antibiotic, in patients receiving pimozide, lomitapide, lovastatin, simvastatin, ergotamine, dihydroergotamine, colchicine in patients with renal or hepatic impairment, or those with a history of cholestatic jaundice/hepatic dysfunction.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. If hypersensitivity reactions occur, discontinue use and institute immediate therapy (e.g., anaphylaxis management).

Severe Cutaneous Adverse Reactions (SCAR): Discontinue use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK at first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. SCAR, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the components of both products. In addition, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with amoxicillin and clarithromycin.

Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs with VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK. CDAD has been reported with use of acid suppressing therapies and nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If CDAD is confirmed, discontinue therapy and treat appropriately.

Rash in Patients with Mononucleosis: A high percentage of patients with mononucleosis who receive amoxicillin (a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) develop an erythematous skin rash. Avoid use of both products in patients with mononucleosis.

Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Assess CgA levels at least 14 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK treatment and consider repeating the test if initial CgA levels are high.

VOQUEZNA TRIPLE PAK Warnings or Precautions Due to the Clarithromycin Component:

QT Prolongation: Avoid VOQUEZNA TRIPLE PAK in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia (torsades de pointes), hypokalemia/hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics.

Hepatotoxicity: Discontinue use of VOQUEZNA TRIPLE PAK if signs and symptoms of hepatitis occur.

Serious adverse reactions due to concomitant use with other drugs: Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, hypoglycemic agents including insulin, quetiapine, warfarin, benzodiazepines, and other drugs.

Embryo-Fetal Toxicity: VOQUEZNA TRIPLE PAK is not recommended for use in pregnancy as clarithromycin may cause fetal harm.

Myasthenia Gravis: Exacerbation of myasthenia gravis can occur with VOQUEZNA TRIPLE PAK since it has been reported in patients receiving clarithromycin tablets.

ADVERSE REACTIONS

VOQUEZNA TRIPLE PAK: The most common adverse reactions (≥2%) include dysgeusia (4.6%), diarrhea (4.0%), vulvovaginal candidiasis (3.2%), headache (2.6%), abdominal pain (2.3%), and hypertension (2.0%).

VOQUEZNA DUAL PAK: The most common adverse reactions (≥2%) include diarrhea (5.2%), abdominal pain (2.6%), vulvovaginal candidiasis (2.0%), and nasopharyngitis (2.0%).

DRUG INTERACTIONS

Components of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK have the potential for clinically important drug interactions. See full Prescribing Information for important drug interactions.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding not recommended during treatment, but a lactating woman can pump and discard breast milk during treatment and for 2 days after VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK administration.

Geriatrics: VOQUEZNA TRIPLE PAK increased risk of torsades de pointes due to clarithromycin.

Renal and Hepatic Impairment: Avoid use in patients with severe renal impairment and avoid use in patients with moderate to severe hepatic impairment.

You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428)1-888-775-PHAT (7428) or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.