Vonoprazan (von-OH-pra-zan)

Treats erosive esophagitis, heartburn, and H. pylori infection.

Brand Name(s):

Voquezna

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not chew or crush it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • For erosive esophagitis and heartburn: If you miss a dose and it is within 12 hours of your usual time, take it as soon as possible. If you miss a dose and it is more than 12 hours after the missed dose, skip the missed dose and take your next dose at the regular time.
  • For H. pylori infection: If you miss a dose and it is within 4 hours of your usual time, take it as soon as possible. If you miss a dose and it is more than 4 hours after the missed dose, skip the missed dose and take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use vonoprazan if you are also using medicines that contain rilpivirine.
• Some medicines can affect how vonoprazan works. Tell your doctor if you are using any of the following:
  • Atazanavir, cilostazol, citalopram, clarithromycin, dasatinib, digoxin, efavirenz, erlotinib, itraconazole, ketoconazole, midazolam, mycophenolate mofetil, nelfinavir, nilotinib, rifampicin
  • Blood thinner (including clopidogrel)
  • Diuretic (water pill)
  • Iron supplements

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, electrolyte problems, or osteoporosis.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Kidney problems, including acute tubulointerstitial nephritis
  • Increased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis
  • Vitamin B12 deficiency
  • Fundic gland polyps (abnormal growth in the upper part of your stomach)
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, headache, pounding in the ears, nervousness
• Bone fractures or pain
• Chills, cough, sore throat, body aches
• Dry mouth, increased thirst, confusion, numbness and tingling around the mouth, fingertips, or feet
• Fever, swelling in your body, unusual weight gain, changes in how much or how often you urinate, blood in the urine
• Seizures, dizziness, fast or uneven heartbeat, muscle cramps or twitching
• Severe diarrhea that does not go away, stomach cramps or pain, nausea, vomiting, loss of appetite, weight loss

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088