SAPROPTERIN - ORAL

SAPROPTERIN - ORAL

PHONETIC PRONUNCIATION: (SAP-roe-TER-in)

COMMON BRAND NAME(S): Kuvan

GENERIC NAME(S): sapropterin dihydrochloride

Uses

USES: This medication is used along with diet changes for long-term treatment of a certain inherited disorder (phenylketonuria-PKU). It helps remove a certain chemical (phenylalanine) from the body. Too much phenylalanine in the body can cause brain damage.


How to use SAPROPTERIN - ORAL

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking sapropterin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with a meal as directed by your doctor, usually once daily. The dosage is based on your medical condition, age, weight, lab tests, and response to treatment. Swallow the tablets whole or you may dissolve them in 120 to 240 milliliters (4 to 8 ounces) of water or apple juice. To help the tablets dissolve faster, you may stir or crush them. Drink this mixture within 15 minutes of mixing. If you see small pieces of the tablet remaining in the cup, add some more water or apple juice to the cup and drink it so you get all of the dose. You may also crush the tablets and mix them in a small amount of soft food (such as apple sauce or pudding). Eat all of the mixture right away. Do not prepare a supply in advance. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if you do not get better or if you get worse.

Side Effects

SIDE EFFECTS: Runny/stuffy nose or sore throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain that doesn't go away, nausea/vomiting that doesn't stop, black stools, blood in your vomit, signs of hyperactivity (such as not being able to sit still). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking sapropterin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for SAPROPTERIN - ORAL

Sapropterin oral is typically used to treat a certain hereditary disorder called phenylketonuria (PKU) in children and adults.

Sapropterin oral works by increasing the levels of a certain enzyme in the body that helps break down the amino acid phenylalanine. This helps to lower the levels of phenylalanine in individuals with PKU.

Common side effects of sapropterin oral may include headache, runny or stuffy nose, diarrhea, vomiting, stomach pain, and dizziness. However, it is important to note that not everyone experiences these side effects, and they may vary from person to person.

Sapropterin oral should be taken exactly as prescribed by your healthcare provider. It is usually taken once a day with a meal. It is important to follow the recommended dosage and instructions provided by your doctor.

It is important to consult your healthcare provider before using sapropterin oral during pregnancy or while breastfeeding, as it may pose potential risks to the unborn baby or nursing infant. Your doctor will weigh the potential benefits against the risks and make an informed decision.

The effectiveness of sapropterin oral may vary from person to person. Some individuals may experience an improvement in their symptoms within a few weeks, while others may take longer to respond to the treatment. It is essential to have regular follow-up appointments with your healthcare provider to monitor your progress.

It is important to inform your healthcare provider about any pre-existing medical conditions, allergies, or medications you are taking before starting sapropterin oral. Some individuals may be at a higher risk of developing certain side effects, and your doctor can provide you with appropriate guidance and precautions.

Yes, sapropterin oral can be used in children with phenylketonuria (PKU). However, the dosage and administration may vary depending on the age and weight of the child. It is important to follow the guidance of your child's healthcare provider.

If you miss a dose of sapropterin oral, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

Sapropterin is an oral medication that is used to treat a genetic condition called phenylketonuria (PKU). It is also known by the brand name Kuvan.

Sapropterin works by helping the body to process the amino acid phenylalanine, which is found in many foods. In people with PKU, their bodies cannot break down phenylalanine properly, leading to a buildup of this amino acid. Sapropterin helps to reduce the levels of phenylalanine in the blood.

PKU is a genetic disorder that affects the way the body processes phenylalanine. People with PKU are unable to break down phenylalanine properly, leading to a buildup of this amino acid in the blood. This can cause various health problems, including intellectual disability if left untreated.

Sapropterin is not a cure for PKU, but it can help manage the condition by reducing levels of phenylalanine in the blood. It is used in combination with a special diet low in phenylalanine.

Sapropterin is taken orally as a tablet or powder that is dissolved in water. The dosage and frequency of taking the medication will be determined by your healthcare provider based on your individual needs.

Common side effects of sapropterin may include headache, runny nose, sore throat, diarrhea, vomiting, and stomach pain. It is important to report any new or worsening symptoms to your doctor.

Yes, sapropterin can be used in children with PKU who are at least 1 month old. The dosage and administration will be determined by the child's pediatrician.

The use of sapropterin during pregnancy or while breastfeeding should be discussed with a healthcare provider. It is important to weigh the potential benefits against the possible risks.

The effectiveness of sapropterin may vary from person to person. Some people may see an improvement in their symptoms within a few days or weeks of starting the medication, while others may take longer.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.