voqueznapro.com Open in urlscan Pro
2600:9000:26fa:e00:11:4c7e:6700:93a1  Public Scan

Form analysis
0 forms found in the DOM

Text Content

This Site Is Intended for U.S. Healthcare Professionals Only
 * Indications
   
   
   
 * IMPORTANT SAFETY INFO.
 * PRESCRIBING INFO.

4 INDICATIONS VOQUEZNA® (vonoprazan) is indicated for the healing of all grades
of Erosive Esophagitis in adults READ MORE

BACK

VOQUEZNA logo surrounded by fire with the words “The power of Voquezna for acid
suppression. After 30 years of PPIs, a first-in-class PCAB is here.”
CHOOSE A CONDITION
Erosive Gerd
H. PYLORI INFECTION

Erosive GERD=Erosive Esophagitis;
GERD=Gastroesophageal Reflux Disease;
PCAB=potassium-competitive acid blocker.

IMPORTANT SAFETY INFORMATION

Contraindications

VOQUEZNA is contraindicated in patients with a known hypersensitivity to
vonoprazan or any component of VOQUEZNA, or in patients receiving
rilpivirine-containing products.

For information about contraindications of antibacterial agents (clarithromycin
and amoxicillin) indicated in combination with VOQUEZNA, refer to the
Contraindications section of the corresponding prescribing information.

WARNINGS AND PRECAUTIONS

Presence of Gastric Malignancy: In adults, symptomatic response to therapy with
VOQUEZNA does not preclude the presence of gastric malignancy. Consider
additional follow-up and diagnostic testing in patients who have a suboptimal
response or an early symptomatic relapse after completing treatment with
VOQUEZNA. In older patients, also consider endoscopy.

Acute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN) has
been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate
patients with suspected acute TIN.

Clostridioides difficile-Associated Diarrhea: Published observational studies
suggest that proton pump inhibitors (PPIs) may be associated with an increased
risk of Clostridioides difficile-associated diarrhea (CDAD), especially in
hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider
CDAD in patients with diarrhea that does not improve. Use the shortest duration
of VOQUEZNA appropriate to the condition being treated.

CDAD has been reported with use of nearly all antibacterial agents. For more
information specific to antibacterial agents (clarithromycin and amoxicillin)
indicated for use in combination with VOQUEZNA, refer to Warnings and
Precautions section of the corresponding prescribing information.

Bone Fracture: Several published observational studies suggest that PPI therapy
may be associated with an increased risk for osteoporosis-related fractures of
the hip, wrist, or spine, especially in patients receiving high dose (multiple
daily doses) and long-term therapy (a year or longer). Bone fracture, including
osteoporosis-related fracture, has also been reported with vonoprazan. Use the
shortest duration of VOQUEZNA appropriate to the condition being treated.
Patients at risk for osteoporosis-related fractures should be managed according
to the established treatment guidelines.

Severe Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions,
including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
have been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or
symptoms of SCAR or other signs of hypersensitivity and consider further
evaluation.

Vitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs can
lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin
B12 deficiency has been reported postmarketing with vonoprazan. If clinical
symptoms consistent with vitamin B12 deficiency are observed in patients treated
with VOQUEZNA, consider further workup.

Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported
postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or
hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.

Consider monitoring magnesium levels prior to initiation of VOQUEZNA and
periodically in patients expected to be on prolonged treatment, in patients
taking drugs that may have increased toxicity in the presence of hypomagnesemia
or drugs that may cause hypomagnesemia. Treatment of hypomagnesemia may require
magnesium replacement and discontinuation of VOQUEZNA.

Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA
and periodically while on treatment in patients with a preexisting risk of
hypocalcemia. Supplement with magnesium and/or calcium, as necessary. If
hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA.

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. Temporarily discontinue
VOQUEZNA treatment at least 14 days before assessing CgA levels and consider
repeating the test if initial CgA levels are high.

Fundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland
polyps that increases with long-term use, especially beyond one year. Fundic
gland polyps have been reported with vonoprazan in clinical trials and during
postmarketing use with PPIs. Most patients who developed fundic gland polyps
were asymptomatic and fundic gland polyps were identified incidentally on
endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition
being treated.

ADVERSE REACTIONS:

Healing of Erosive GERD: The most common adverse reactions (≥2% of patients in
the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal distention
(2%), abdominal pain (2%), and nausea (2%).

Maintenance of Healed Erosive GERD: The most common adverse reactions (≥3% of
patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%),
dyspepsia (4%), hypertension (3%), and urinary tract infection (3%).

Treatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common
adverse reactions (≥2% in any treatment arm) include diarrhea (5%), abdominal
pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%), dysgeusia (1%),
headache (1%), and hypertension (1%).

Treatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin): The
most common adverse reactions (≥2% in any treatment arm) include dysgeusia (5%),
diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%), abdominal pain
(2%), hypertension (2%), and nasopharyngitis (<1%).

For more information on adverse reactions and laboratory changes with
amoxicillin or clarithromycin, refer to Adverse Reactions section of the
corresponding prescribing information.

DRUG INTERACTIONS

VOQUEZNA has the potential for clinically important drug interactions, including
interactions with drugs dependent on gastric pH for absorption, drugs that are
substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant
use of VOQUEZNA with atazanavir or nelfinavir. See full Prescribing Information
for more details about important drug interactions. Consult the labeling of
concomitantly used drugs to obtain further information about interactions with
vonoprazan.

For information about drug interactions, contraindications, and warnings and
precautions of antibacterial agents (amoxicillin or clarithromycin) indicated in
combination with VOQUEZNA, refer to their corresponding prescribing information.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment. Because of the
potential risk of adverse liver effects shown in animal studies with vonoprazan,
advise patients not to breastfeed during treatment with VOQUEZNA.

Renal Impairment: For the healing of Erosive GERD, dosage reduction is
recommended in patients with severe renal impairment (eGFR < 30 mL/min). Use of
VOQUEZNA is not recommended for the treatment of H. pylori infection in patients
with severe renal impairment.

Hepatic Impairment: For the healing of Erosive GERD, dosage reduction is
recommended in patients with moderate to severe hepatic impairment (Child-Pugh
Class B and C). Use of VOQUEZNA is not recommended for the treatment of H.
pylori infection 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.


INDICATIONS AND USAGE

VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:

 * for the healing of all grades of Erosive Esophagitis (Erosive
   Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn
   associated with Erosive GERD in adults.
 * for the maintenance of healing of all grades of Erosive GERD and relief of
   heartburn associated with Erosive GERD in adults.
 * in combination with amoxicillin and clarithromycin for the treatment of
   Helicobacter pylori (H. pylori) infection in adults.
 * in combination with amoxicillin for the treatment of H. pylori infection in
   adults.

Reference: 1. VOQUEZNA Prescribing Information. Phathom Pharmaceuticals; 2023.

IMPORTANT SAFETY INFORMATION

Contraindications

VOQUEZNA is contraindicated in patients with a known hypersensitivity to
vonoprazan or any component of VOQUEZNA, or in patients
receiving rilpivirine-containing products.

For information about contraindications of antibacterial agents (clarithromycin
and amoxicillin) indicated in combination with VOQUEZNA, refer to the
Contraindications section of the corresponding prescribing information. READ
MORE

For information about contraindications of antibacterial agents (clarithromycin
and amoxicillin) indicated in combination with VOQUEZNA, refer to the
Contraindications section of the corresponding prescribing information.READ MORE

WARNINGS AND PRECAUTIONS

Presence of Gastric Malignancy: In adults, symptomatic response to therapy with
VOQUEZNA does not preclude the presence of gastric malignancy. Consider
additional follow-up and diagnostic testing in patients who have a suboptimal
response or an early symptomatic relapse after completing treatment with
VOQUEZNA. In older patients, also consider endoscopy.

Acute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN) has
been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate
patients with suspected acute TIN.

Clostridioides difficile-Associated Diarrhea: Published observational studies
suggest that proton pump inhibitors (PPIs) may be associated with an increased
risk of Clostridioides difficile-associated diarrhea (CDAD), especially in
hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider
CDAD in patients with diarrhea that does not improve. Use the shortest duration
of VOQUEZNA appropriate to the condition being treated.

CDAD has been reported with use of nearly all antibacterial agents. For more
information specific to antibacterial agents (clarithromycin and amoxicillin)
indicated for use in combination with VOQUEZNA, refer to Warnings and
Precautions section of the corresponding prescribing information.

Bone Fracture: Several published observational studies suggest that PPI therapy
may be associated with an increased risk for osteoporosis-related fractures of
the hip, wrist, or spine, especially in patients receiving high dose (multiple
daily doses) and long-term therapy (a year or longer). Bone fracture, including
osteoporosis-related fracture, has also been reported with vonoprazan. Use the
shortest duration of VOQUEZNA appropriate to the condition being treated.
Patients at risk for osteoporosis-related fractures should be managed according
to the established treatment guidelines.

Severe Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions,
including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
have been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or
symptoms of SCAR or other signs of hypersensitivity and consider further
evaluation.

Vitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs can
lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin
B12 deficiency has been reported postmarketing with vonoprazan. If clinical
symptoms consistent with vitamin B12 deficiency are observed in patients treated
with VOQUEZNA, consider further workup.

Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported
postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or
hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients.

Consider monitoring magnesium levels prior to initiation of VOQUEZNA and
periodically in patients expected to be on prolonged treatment, in patients
taking drugs that may have increased toxicity in the presence of hypomagnesemia
or drugs that may cause hypomagnesemia. Treatment of hypomagnesemia may require
magnesium replacement and discontinuation of VOQUEZNA.

Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA
and periodically while on treatment in patients with a preexisting risk of
hypocalcemia. Supplement with magnesium and/or calcium, as necessary. If
hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA.

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. Temporarily discontinue
VOQUEZNA treatment at least 14 days before assessing CgA levels and consider
repeating the test if initial CgA levels are high.

Fundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland
polyps that increases with long-term use, especially beyond one year. Fundic
gland polyps have been reported with vonoprazan in clinical trials and during
postmarketing use with PPIs. Most patients who developed fundic gland polyps
were asymptomatic and fundic gland polyps were identified incidentally on
endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition
being treated.

ADVERSE REACTIONS:

Healing of Erosive GERD: The most common adverse reactions (≥2% of patients in
the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal distention
(2%), abdominal pain (2%), and nausea (2%).

Maintenance of Healed Erosive GERD: The most common adverse reactions (≥3% of
patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%),
dyspepsia (4%), hypertension (3%), urinary tract infection (3%), diarrhea (1%),
and headache (1%).

Treatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin): The
most common adverse reactions (≥2% in any treatment arm) include dysgeusia (5%),
diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%), abdominal pain
(2%), hypertension (2%), and nasopharyngitis (<1%).

For more information on adverse reactions and laboratory changes with
amoxicillin or clarithromycin, refer to Adverse Reactions section of the
corresponding prescribing information.

DRUG INTERACTIONS

VOQUEZNA has the potential for clinically important drug interactions, including
interactions with drugs dependent on gastric pH for absorption, drugs that are
substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant
use of VOQUEZNA with atazanavir or nelfinavir. See full Prescribing Information
for more details about important drug interactions. Consult the labeling of
concomitantly used drugs to obtain further information about interactions with
vonoprazan.

For information about drug interactions, contraindications, and warnings and
precautions of antibacterial agents (amoxicillin or clarithromycin) indicated in
combination with VOQUEZNA, refer to their corresponding prescribing information.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment. Because of the
potential risk of adverse liver effects shown in animal studies with vonoprazan,
advise patients not to breastfeed during treatment with VOQUEZNA.

Renal Impairment: For the healing of Erosive GERD, dosage reduction is
recommended in patients with severe renal impairment (eGFR < 30 mL/min). Use of
VOQUEZNA is not recommended for the treatment of H. pylori infection in patients
with severe renal impairment.

Hepatic Impairment: For the healing of Erosive GERD, dosage reduction is
recommended in patients with moderate to severe hepatic impairment (Child-Pugh
Class B and C). Use of VOQUEZNA is not recommended for the treatment of H.
pylori infection in patients with severe renal 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.



 * Medical Information
 * Privacy Policy
 * Terms & Conditions
 * Contact Us
 * Sitemap

VOQUEZNA, Phathom Pharmaceuticals, and their respective logos, are registered
trademarks of Phathom Pharmaceuticals.

© 2024 Phathom Pharmaceuticals. All rights reserved.
1/24 US-VPZ-23-0250.

This website is intended for US healthcare professionals.




ARE YOU A HEALTHCARE PROFESSIONAL?


THE INFORMATION PROVIDED ON
THIS SITE IS INTENDED
FOR US
HEALTHCARE PROFESSIONALS ONLY.

YESNO