sapropterin

What is the most important information I should know about sapropterin?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is sapropterin?

Sapropterin is used to lower blood levels of phenylalanine in adults and children at least one month old with a certain type of phenylketonuria (PKU).

Sapropterin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sapropterin?

Tell your doctor if you have ever had:

• stomach ulcer or bleeding; or
• loss of appetite, or if you are malnourished.

It is not known if sapropterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sapropterin on the baby.

How should I take sapropterin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may swallow the tablet whole or dissolve it in 4 to 8 ounces of water or apple juice.

• It will take a few minutes for the tablet to dissolve, and you may see small pieces in the liquid. These pieces are safe for you to swallow.
• Stir the mixture and then drink all of it within 15 minutes after the tablet dissolves.
• To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
• You may also crush the tablet and mix it with a small amount of soft food such as pudding or applesauce.

The powder for oral solution must be dissolved in 4 to 8 ounces of water or apple juice.

• If you are giving this medicine to a baby who weighs less than 22 pounds, you may dissolve the powder in as little as 1 teaspoon of water or apple juice. Then give the liquid to the baby using an oral dosing syringe. If you do not have a dosing syringe, ask your pharmacist for one.
• Stir the mixture and then drink all of it within 30 minutes after the powder dissolves.
• You may also mix the powder with a small amount of soft food such as pudding or applesauce.
• Make sure the powder is completely dissolved before drinking or eating the mixture.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

While using sapropterin, you may need frequent blood tests.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses in a day.

What happens if I overdose?

What should I avoid while taking sapropterin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sapropterin?

• behavior changes, seizures, or problems with speech;
• fever, loss of appetite, difficulty swallowing, throat pain, severe stomach discomfort or pain, nausea, vomiting;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• hyperactive behavior, such as fidgeting or moving around often, or talking too much.

Common side effects may include:

• headache;
• diarrhea;
• vomiting; or
• runny or stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sapropterin?

Tell your doctor about all your other medicines, especially:

• levodopa;
• methotrexate, valproic acid, phenobarbital, trimethoprim; or
• medicine to treat impotence or pulmonary arterial hypertension--sildenafil (Viagra, Revatio), avanafil (Stendra), tadalafil (Adcirca, Cialis) vardenafil (Levitra, Staxyn).

This list is not complete. Other drugs may affect sapropterin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about sapropterin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01. Revision date: 6/23/2023.