Vonoprazan

WHY is this medicine prescribed?

Vonoprazan is used to heal and maintain healing of erosive esophagitis (inflammation that causes damage to the tube that runs from the throat to the stomach) and help lessen symptoms of heartburn associated with erosive esophagitis in adults. Vonoprazan is also used in combination with clarithromycin and/or amoxicillin to eliminate Helicobacter pylori, a type of bacteria that causes ulcers (sores in the lining of the stomach or intestine). Vonoprazan is in a class of medications called potassium-competitive acid blockers (PCAB). It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Vonoprazan comes as a capsule to take by mouth. It can be taken with or without food. For erosive esophagitis, it is taken once a day for 8 weeks (for healing of erosive esophagitis) and up to 6 months (for maintenance of erosive esophagitis healing). For treatment of H. pylori, vonoprazan is taken twice daily for 14 days. Take vonoprazan at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vonoprazan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

What SPECIAL PRECAUTIONS should I follow?

Before taking vonoprazan,

• tell your doctor and pharmacist if you are allergic to vonoprazan, any other medications, or any of the ingredients in vonoprazan capsule. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• some medications should not be taken with vonoprazan. Other medications may cause dosing changes or extra monitoring when taken with vonoprazan. Make sure you have discussed any medications you are currently taking or plan to take before starting vonoprazan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking vonoprazan, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with vonoprazan: iron salt tablets and St John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking vonoprazan. Do not start any of these medications while taking vonoprazan without discussing with your healthcare provider.

• tell your doctor if you have or have ever had kidney or liver disease, osteopenia (bone condition that causes loss in bone mass) or osteoporosis (condition with loss in bone mass that makes bones weak or brittle and easy to fracture), or low calcium, magnesium or potassium in your blood.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking vonoprazan, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if taking it once daily for erosive esophagitis and it has been 12 hours since the schedule dose, skip the missed dose and continue your regular dosing schedule. If taking vonoprazan twice daily for H. pylori and it has been 4 hours since the missed dose, skip the missed dose and continue your regular schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Vonoprazan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach bloating
• stomach pain
• nausea
• indigestion

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately {or get emergency medical treatment}:

• low urine output or blood in the urine
• watery stools, stomach pain, or fever
• skin rash or blistering, peeling or bleeding skin; fever, chills, body aches, shortness of breath or enlarged lymph nodes
• irregular heart beat, shortness of breath, lightheadedness, tingling or numbness in arms or legs, muscle weakness, pale skin, feeling tired or mood changes
• bone pain or bone fracture
• seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of hands, feet or voice

You should know that vonoprazan has caused stomach polyps (pre-cancerous lesions in certain regions of the stomach) with long-term use. Talk to your doctor about the risk if you have been taking vonoprazan for longer than a year.

Vonoprazan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.