Important Safety Information | VOQUEZNA® (vonoprazan)

INDICATION AND IMPORTANT SAFETY INFORMATION

What is VOQUEZNA?

VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
- for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.
- for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.
- for 4 weeks for relief of heartburn related to gastroesophageal reflux disease (GERD).
It is not known if VOQUEZNA is safe and effective in children.

Do not take VOQUEZNA if you:

are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching, and swelling of your face, lips, tongue or throat.
are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you:

have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).
have kidney or liver problems.
are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

VOQUEZNA may affect how other medicines work, and other medicines may affect how VOQUEZNA works. Especially tell your healthcare provider if you take medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY).

What are the possible side effects of VOQUEZNA?

VOQUEZNA may cause serious side effects including:

A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.
Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools, stomach pain, and fever that does not go away.
Bone fractures (hip, wrist, or spine): Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.
Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
- Skin rash which may have blistering, peeling, or bleeding on any part of your skin.
- You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be the first sign of a severe skin reaction.

Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you have been on VOQUEZNA for a long time.
Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of the hands, feet, or voice.
Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

The most common side effects of VOQUEZNA for treatment of Erosive Esophagitis and/or relief of heartburn related to gastroesophageal reflux disease include:

stomach inflammation
diarrhea
stomach bloating
stomach pain
nausea
indigestion
constipation
high blood pressure
urinary tract infection

These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

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

Please see Patient Information and full Prescribing Information for VOQUEZNA.

INDICATION

VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
- for 8 weeks to heal acid-related damage to the ... Read more

VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
- for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.
- for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.
- for 4 weeks for relief of heartburn related to gastroesophageal reflux disease (GERD).
It is not known if VOQUEZNA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take VOQUEZNA if you:

are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching, and swelling of your face, lips, tongue or throat.
are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you:

have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).
have kidney or liver problems.
are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both.

INDICATION AND

IMPORTANT SAFETY INFORMATION

INDICATION

VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
- for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.
- for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.
It is not known if VOQUEZNA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take VOQUEZNA if you:

are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching and swelling of your face, lips, tongue or throat.
are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you:

have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).
have kidney or liver problems.
are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both.

What are the possible side effects of VOQUEZNA?

VOQUEZNA may cause serious side effects including:

A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.
Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools, stomach pain, and fever that does not go away.
Bone fractures (hip, wrist, or spine): Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.
Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
- Skin rash which may have blistering, peeling, or bleeding on any part of your skin.
- You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be the first sign of a severe skin reaction.

Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you have been on VOQUEZNA for a long time.
Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of hands, feet, or voice.
Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

The most common side effects of VOQUEZNA for treatment of Erosive Esophagitis include:

stomach inflammation
diarrhea
stomach bloating
stomach pain
nausea
indigestion
high blood pressure
urinary tract infection

These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

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

What is VOQUEZNA?

VOQUEZNA® (vonoprazan) is a prescription medicine used in adults:
- for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.
- for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.
It is not known if VOQUEZNA is safe and effective in children.

Please see Patient Information and full Prescribing Information for VOQUEZNA.

INDICATION AND IMPORTANT SAFETY INFORMATION

What are VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK?

VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) are co-packaged prescription medicines for the treatment of a Helicobacter pylori (H. pylori) bacterial infection in adults.
It is not known if VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are safe and effective in children.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs, these products should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Do not take VOQUEZNA TRIPLE PAK if you

are known to have an allergy or be sensitive to the components of VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin), macrolide antibiotics (such as azithromycin and erythromycin), or penicillin.
are taking:
- medicines that contain rilpivirine (Edurant, Complera, Odefsey)
- pimozide
- colchicine, if you have kidney or liver problems
- lomitapide, lovastatin, and simvastatin
- ergot alkaloids (ergotamine or dihydroergotamine)
have a history of yellowing of the skin (jaundice) or liver problems when taking clarithromycin.

Do not take VOQUEZNA DUAL PAK if you

are known to have an allergy or be sensitive to the components of VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) or penicillin.
are taking medicines that contain rilpivirine (Edurant, Complera, Odefsey).

Before you take VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK, tell your healthcare provider about all of your medical conditions, including if you

are breastfeeding. If breastfeeding, pump and discard breast milk during treatment and for 2 days after treatment.
have severe kidney disease.
have moderate to severe liver disease.
have myasthenia gravis.

Additionally, do not take VOQUEZNA TRIPLE PAK if:

you are pregnant or plan to become pregnant. Clarithromycin, a medicine in VOQUEZNA TRIPLE PAK may harm your unborn baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. There can be serious side effects when some are used in combination with this product. 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, and other drugs.

What are the possible side effects of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK?
VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK can cause serious side effects including:

Allergic reactions (hypersensitivity): Call your doctor right away if you have rash, hives, or other skin changes, face swelling or difficulty breathing.
Severe skin reactions: VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can cause severe skin reactions, such as skin rash or allergic reaction on or in any part of your body. Symptoms can also include, but are not limited to, fever, chills, body aches or shortness of breath. If you experience any of these symptoms, stop taking VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK immediately and call your doctor right away.
Severe diarrhea: Call your doctor right away if you have watery stools, stomach pain, and fever that does not go away while taking VOQUEZNA DUAL PAK or VOQUEZNA TRIPLE PAK or after therapy is completed.
Rash in patients with mononucleosis: Amoxicillin (a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) may cause a rash in patients who have mononucleosis. Stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK if you are diagnosed with mononucleosis and call your doctor right away.
Altered test results for some tumors: VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK lower stomach acid which can cause increased levels of a certain protein (CgA) in your blood. When this level is increased it may alter test results for detecting some tumors. Notify your doctor of the use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK prior to blood tests.

Additionally, VOQUEZNA TRIPLE PAK can cause:

Irregular heartbeats: Clarithromycin may cause irregular heartbeats. Call your doctor right away if you feel faint, light-headed, or feel your heart beating irregularly.
Liver problems: Call your doctor right away if you have any of the following symptoms: weight loss, yellowing of the skin and eyes (jaundice), dark urine, rash, or pain on the right side of your abdomen.

The most common side effects may include:

diarrhea
temporary changes in sense of taste
vaginal yeast infection
stomach pain
headache
high blood pressure and
cold-like symptoms

These are not all of the possible side effects of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. Call your doctor for medical advice about side effects.

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

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

Important Safety Information and Indication