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The VOQUEZNA (vonoprazan) Pregnancy Registry
Are you pregnant and diagnosed with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD), Erosive Esophagitis (Erosive GERD), or Helicobacter pylori (H. pylori) infection?
Have you taken VOQUEZNA® (vonoprazan) tablets for the treatment of Non-Erosive GERD, Erosive GERD or H. pylori infection, or VOQUEZNA® DUAL PAK® (vonoprazan tablets; amoxicillin capsules) or VOQUEZNA® TRIPLE PAK® (vonoprazan tablets; amoxicillin capsules; clarithromycin tablets) for the treatment of H. pylori infection, or taken other medications for the treatment of Non-Erosive GERD, Erosive GERD or H. pylori infection during your pregnancy?
Gastroesophageal conditions may have a significant impact on quality of life. Help future pregnant women, doctors, and researchers understand the safety of medications that treat these conditions.
Are you a healthcare provider who treats pregnant women with Non-Erosive GERD, Erosive GERD, or H. pylori infection?
Help us learn more about the safety profile of using VOQUEZNA, VOQUEZNA DUAL PAK or VOQUEZNA TRIPLE PAK, or other medications for the treatment of Non-Erosive GERD, Erosive GERD or H. pylori infection during pregnancy.
About the VOQUEZNA Pregnancy Registry
A pregnancy registry is a study that collects health information from women who take prescription medications while they are pregnant. Information is also collected on the newborn baby. This information is compared with women who have not or have taken other medications during pregnancy.
The goal of the VOQUEZNA Pregnancy Registry is to help healthcare providers, patients, and researchers better understand the safety of VOQUEZNA, VOQUEZNA DUAL PAK, and VOQUEZNA TRIPLE PAK, as well as other medications for the treatment of Non-Erosive GERD, Erosive GERD, or H. pylori infection during pregnancy. Pregnant women in the United States with Non-Erosive GERD, Erosive GERD, or H. pylori infection may be eligible to participate. The study gathers health information on pregnant women and their babies up to one year old, sourcing data from both the enrolled women and the healthcare providers involved in their care.
VOQUEZNA is not recommended during pregnancy or during breastfeeding or in women of childbearing potential not using effective contraception. It is important that you discuss the potential risks and benefits of taking VOQUEZNA or any other medication during pregnancy or during breastfeeding with your doctor.
Would you like to participate?
Additional Information
IMPORTANT SAFETY INFORMATION
VOQUEZNA
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.
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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.
- 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
The most common side effects of VOQUEZNA when used with antibiotics for treatment of H. pylori infection include:
- diarrhea
- temporary changes in sense of taste
- vaginal yeast infection
- stomach pain
- headache
- high blood pressure
- cold-like symptoms
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.
IMPORTANT SAFETY INFORMATION
VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK
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, JULUCA, ODEFSEY)
- pimozide
- colchicine, if you have kidney or liver problems
- lomitapide, lovastatin, and simvastatin
- ergot alkaloids (ergotamine or dihydroergotamine)
- lurasidone
- 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, JULUCA, 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 pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.
- are breastfeeding. If breastfeeding, pump and discard breast milk during treatment and for 2 days after treatment.
- have kidney or liver problems.
- 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.
- A type of kidney problem (acute tubulointerstitial nephritis): Some people who take vonoprazan, a component of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK, 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.
- 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.
- Gastrointestinal hypersensitivity (drug-induced enterocolitis syndrome): A type of allergic reaction that causes inflammation in the small and large intestine has been reported with use of amoxicillin, a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, mostly in patients ≤18 years of age. Symptoms include vomiting occurring 1 to 4 hours after taking the drug and may also be associated with skin paleness, tiredness, low blood pressure, shock, and diarrhea within 24 hours after taking amoxicillin. If you experience any of these symptoms, stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and notify your doctor.
- Severe diarrhea: Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away while taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL 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
- cold-like symptoms
These are not all of the possible side effects of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. Call your healthcare provider for medical advice about side effects.
General information about the safe and effective use of VOQUEZNA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK for a condition for which it was not prescribed. Do not give VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK to other people, even if they have the same symptoms you have. It may harm them.
For more information, ask your healthcare provider or pharmacist.
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.
If you have been prescribed VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK, please see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.