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Sapropterin
Specialty Drug

Kuvan

SAPROPTERIN works to lower phenylalanine levels in the blood. It is used with a special diet to treat phenylketonuria. This medicine is not a cure. Compare enzyme replacement therapies.
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What is Sapropterin?

Commonly Used Brand Name(s)Kuvan

Therapeutic ClassificationsEndocrine-Metabolic Agent

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OverviewTOP

Sapropterin is used to lower phenylalanine levels in the blood of patients with phenylketonuria (PKU). High levels of phenylalanine (an amino acid) in the blood can cause severe brain damage, including severe mental retardation, seizures, tremors, or decreased learning ability. This medicine is usually given along with a special diet.

This medicine is available only with your doctor's prescription.

Proper UseTOP

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food at the same time each day.

Carefully follow your doctor's instructions about any special diet. It is important that you maintain a diet with restricted amounts of phenylalanine.

Patients who weight more than 10 kilograms who are using the powder for oral solution: Pour the contents of the 100 mg- or 500 mg- packet in 4 to 8 ounces (1/2 to 1 cup) of water or apple juice. Mix thoroughly. Drink this mixture within 30 minutes. You may also add it in a small amount of food, such as applesauce or pudding before taking.

Patients who weight more than 10 kilograms who are using the tablets: You may swallow the tablets whole or mix them in 4 to 8 ounces (1/2 to 1 cup) of water or apple juice before taking. It may take a few minutes for the tablets to dissolve. To make the tablets dissolve faster, you may stir or crush them. Drink this mixture within 15 minutes. You may also crush the tablets and mix in a small amount of soft food, such as apple sauce or pudding before taking.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution or tablets):
    • Adults and children 7 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose if needed.
    • Children 1 month to 6 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 mg per kg of body weight per day. Your doctor may adjust your dose if needed.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor. .

Missed DoseTOP

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use & StorageTOP

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of sapropterin in children younger than 1 month of age. Safety and efficacy have not been established. .

GeriatricTOP

Appropriate studies on the relationship of age to the effects of sapropterin have not been performed in the geriatric population. Safety and efficacy have not been established.

PregnancyTOP

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Eating disorder (eg, anorexia) or
  • Malnutrition—Proper diet is important while taking this medicine.
  • Fever or any illness—May increase phenylalanine levels in your blood. Your doctor may need to change your dose of this medicine.
  • Kidney disease—Use with caution. This medicine has not been tested in patients with this condition.

PrecautionsTOP

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.

This medicine may cause gastritis (inflammation of the stomach). Check with your doctor right away if you or your child have a burning feeling in the chest or stomach, indigestion, stomach upset, or tenderness in the stomach area.

This medicine may cause hyperactivity (too much or constant activity). Tell your doctor if you or your child have any signs of the following: fidgeting or moving around too much or talking too much.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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