Generic Name: sapropterin (SAP-roe-TER-in)
Brand Name: Kuvan
Sapropterin is used for:
Reducing blood phenylalanine levels in certain patients with phenylketonuria. It is used along with a diet that is low in phenylalanine.
Sapropterin is a form of BH4. It helps to activate phenylalanine hydroxylase (PAH), the enzyme that breaks down phenylalanine in the body.
Do NOT use sapropterin if:
- you have had a severe allergic reaction to any ingredient in sapropterin
Contact your doctor or health care provider right away if any of these apply to you.
Before using sapropterin:
Some medical conditions may interact with sapropterin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver or kidney problems, fever, poor nutrition, or anorexia
Some MEDICINES MAY INTERACT with sapropterin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Levodopa because seizures, irritability, or overstimulation may occur
- Methotrexate because it may decrease sapropterin's effectiveness
- Phosphodiesterase inhibitors (eg, sildenafil, vardenafil, tadalafil) because the risk of their side effects may be increased by sapropterin
This may not be a complete list of all interactions that may occur. Ask your health care provider if sapropterin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use sapropterin:
Use sapropterin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with sapropterin. Talk to your pharmacist if you have questions about this information.
- Take sapropterin by mouth with food.
- Do not chew or swallow the tablet whole. Dissolve the tablet in 4 to 8 oz (120 to 240 mL) of cold water or apple juice. Drink within 15 minutes.
- It may take a few minutes for the medicine to dissolve. You may crush or stir the tablet to make it dissolve faster.
- The tablet may not dissolve completely. There may be small pieces floating on top of the water or apple juice. This is normal and safe for you to swallow.
- You may still see small pieces of the tablet in the cup after you take your dose. If this occurs, rinse the container with an additional small amount of water or juice and drink the contents to ensure the entire dose is taken.
- Take sapropterin at about the same time each day.
- Continue to take sapropterin even if you feel well. Do not miss any doses.
- If you miss a dose of sapropterin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.
Ask your health care provider any questions you may have about how to use sapropterin.
Important safety information:
- Sapropterin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use sapropterin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Follow the diet program given to you by your health care provider. Do not make any changes to your dietary phenylalanine intake without discussing it with your doctor first.
- If you have a fever or you are sick, your blood phenylalanine level may go up. Contact your doctor as soon as possible if this occurs. Your dose may need to be adjusted.
- The tablets may change over time to a light yellow color. This is normal and not cause for concern.
- Lab tests, including blood phenylalanine levels, may be performed while you use sapropterin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Sapropterin should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using sapropterin while you are pregnant. It is not known if sapropterin is found in breast milk. Do not breast-feed while taking sapropterin.
Possible side effects of sapropterin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; nausea; runny or stuffy nose; sore throat; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; chest pain; fainting; fever, chills, or persistent sore throat; numbness of an arm or leg; seizures; severe or persistent stomach pain; shortness of breath; signs of urinary tract infection (eg, back pain; difficult, frequent, or painful urination); sudden severe headache or vomiting; swelling of the hands, ankles, or feet.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of sapropterin:
Store sapropterin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original bottle with the cap closed tightly. Store away from heat, moisture, and light. Do not store in the bathroom. Do not remove the small packet (desiccant) included with your tablets; it absorbs moisture. Keep sapropterin out of the reach of children and away from pets.
- If you have any questions about sapropterin, please talk with your doctor, pharmacist, or other health care provider.
- Sapropterin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take sapropterin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sapropterin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sapropterin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sapropterin.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.