Type of medicine: enzyme cofactor
Generic and brand names: sapropterin dihydrochloride, oral; Kuvan
This medicine is taken by mouth to treat phenylketonuria (PKU). It is used along with a special diet.
Before taking this medicine, tell your healthcare provider if you have ever had:
Also tell your provider if you have a fever or infection of any kind.
Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.
Check the label on the medicine for directions about your specific dose. Take this medicine with food at the same time each day. Dissolve the tablets in 4 to 8 ounces of water or apple juice. It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster, you can stir or crush them. If you still see small pieces of the tablet after you drink the medicine, add more water or apple juice and drink it to make sure that you take all of your medicine.
If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
Symptoms of an acute overdose have not been reported.
While taking this medicine, it is important to follow your provider's instructions about diet. Do not make changes in your diet unless your healthcare provider approves.
You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.
If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away). If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).
The most common side effects of this medicine are headache, diarrhea, nausea, vomiting, stomach pain, sore throat, and upper respiratory infections such as colds.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:
It is very important to follow the diet prescribed by your healthcare provider.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
