Sepiapterin (Oral)
Sepiapterin is used with diet to lower blood levels of phenylalanine in adults and children at least one month old with a certain type of phenylketonuria (PKU).
Sepiapterin may also be used for purposes not listed in this medication guide.
uses
What is Sepiapterin (Oral) used for?
- Hyperphenylalaninemia
warnings
What is the most important information I should know about Sepiapterin (Oral)?
Tell your doctor if you have or have ever had:
- active bleeding or bleeding problems.
It is not known if sepiapterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Sepiapterin (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- low blood levels of phenylalanine;
- bruising, purple or red skin spots;
- any bleeding that will not stop; or
- heavy menstrual bleeding.
Common side effects may include:
- diarrhea;
- headache;
- stomach pain;
- yellow or orange stools; or
- pain in your throat.
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.
Pregnancy & Breastfeeding
Can I take Sepiapterin (Oral) if I’m pregnant or breastfeeding?
It is not known if sepiapterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Sepiapterin (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Sepiapterin (Oral)?
Use Sepiapterin (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Sepiapterin can cause phenylalanine levels to get too low in people who use this medicine.
Sepiapterin is usually taken once per day with food. Be sure to eat more food after your dose.
Doses are based on age and weight. Your dose may change if you gain or lose weight.
Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand these instructions.
- For doses less than 1,000 mg: mix the powder with water or apple juice before taking.
- For doses of 1,000 mg or more: mix the powder with water, apple juice, strawberry jam, or applesauce before taking.
- You may save the mixture for later use at room temperature or refrigerated. Stir for 30 seconds before use (if prepared with water or apple juice) or 60 seconds (if prepared with strawberry jam or applesauce).
- Throw away the mixture if not used within 6 hours at room temperature or within 24 hours if refrigerated.
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.
Your doctor will need to check your progress on a regular basis. Your blood will need to be tested before and during your treatment with sepiapterin.
You may have increased bleeding while taking sepiapterin. Tell your doctor if you notice any unusual bleeding, bruising, or if your bleeding continues or is very heavy.
Store unopened packets at room temperature away from moisture and heat.
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 at one time.