SAPROPTERIN POWDER PACKET - ORAL

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SAPROPTERIN POWDER PACKET - 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 POWDER PACKET - 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. Open the packet and pour its contents into 120 to 240 milliliters (4 to 8 ounces) of water or apple juice. Stir well until the powder dissolves completely (2 to 3 minutes). Drink all of the mixture within 30 minutes of mixing. You may also mix the powder 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. If the dose is less than a full packet, ask your doctor or pharmacist how much water or apple juice you should use to mix with the dose. Mix the entire contents of the packet in water or apple juice as directed by your doctor. Mix well and measure the dose using a special measuring device. Do not use a household spoon because you may not get the correct dose. Take the dose within 30 minutes of mixing. Discard any unused medication. 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 POWDER PACKET - ORAL

Sapropterin powder packet is a medication used to treat certain genetic disorders that affect the body's ability to break down phenylalanine, an amino acid found in many foods.

Sapropterin helps to increase the production of an enzyme called phenylalanine hydroxylase, which is responsible for breaking down phenylalanine in the body. By increasing the activity of this enzyme, sapropterin helps to lower phenylalanine levels and prevent the buildup of harmful substances.

Sapropterin powder packet is primarily used to treat phenylketonuria (PKU) in patients who have a specific gene mutation that affects the production or function of phenylalanine hydroxylase. PKU is a rare genetic disorder where the body cannot process phenylalanine properly, leading to a buildup of this amino acid in the blood.

Sapropterin powder packet should be taken exactly as prescribed by a healthcare professional. The powder should be mixed with a small amount of water or another suitable liquid and taken orally. The dosage and frequency of administration will depend on the individual's condition.

Common side effects of sapropterin powder packet may include headache, runny or stuffy nose, cough, diarrhea, and vomiting. Serious side effects are rare but can include allergic reactions, severe rash, and changes in blood pressure. It is important to report any unusual or severe side effects to a doctor immediately.

Sapropterin powder packet is approved for use in children aged 1 month and older who have been diagnosed with PKU. However, the dosage and administration instructions may differ for children, so it is important to follow the advice of a healthcare professional.

There is limited information available on the use of sapropterin powder packet during pregnancy or breastfeeding. It is advised to consult with a doctor before taking this medication if pregnant, planning to become pregnant, or breastfeeding.

Sapropterin may interact with certain medications, including anticonvulsants and antipsychotics. It is important to inform the doctor about all other medications being taken to avoid any potential interactions.

Sapropterin is typically taken for long-term management of PKU. The duration of treatment will depend on the individual's condition and should be discussed with a doctor.

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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.