What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Kuvan (Sapropterin Dihydrochloride)


Kuvan (Sapropterin Dihydrochloride)

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  • Product Details


    Kuvan is a medication used with a phenylalanine (Phe)-restricted diet to decrease Phe levels in the blood in adults and pediatrics who are at least one month old with hyperphenylalaninemia caused by tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU).

    Kuvan tablets come in 100 mg. Kuvan powder for oral solution comes in 100 mg or 500 mg.


    Kuvan should be taken as directed by your doctor. If you have any questions or concerns, talk to your doctor or pharmacist.

    Each patient’s Kuvan dose is based on age and weight. Your doctor will tell you how much Kuvan is right for you.

    Kuvan should be taken with a meal. The tablets should be swallowed whole or after mixed in a small amount of soft foods (i.e., applesauce or pudding) or dissolved in recommended liquid (water or apple juice). The oral solution should be swallowed after mixing the powder in a small amount of soft foods or dissolving in recommended liquid.


    Sapropterin dihydrochloride is the active ingredient contained in Kuvan.

    Kuvan tablets also contain inactive ingredients, including ascorbic acid (USP), crospovidone (NF), dibasic calcium phosphate (USP), D-mannitol (USP), riboflavin (USP), and sodium stearyl fumarate (NF).

    Kuvan powder also contains inactive ingredients, including ascorbic acid (USP), D-mannitol (USP), potassium citrate (USP), and sucralose (NF).


    There are no contraindications according to the Kuvan Prescribing Information.


    • Before you begin treatment with Kuvan, be sure to tell your doctor about the following:
      • All the medications you take, including prescription and over-the-counter medications
      • Your allergies
      • Your past medical history and current health problems
      • Your pregnancy or breastfeeding status
    • Kuvan should not be given to patients with a history of a severe allergic reaction, including anaphylaxis, to Kuvan.
    • Kuvan can cause inflammation of the upper gastrointestinal mucosa. Esophagitis and gastritis may occur. Patients should be monitored for any of these effects.
    • Pediatric patients who are younger than seven years old and are taking 20 mg/kg per day of Kuvan are at an increased risk for low Phe blood levels compared with older patients.
    • Kuvan response cannot be determined by lab testing—only by therapeutic trial.
    • Taking Kuvan with levodopa can lead to seizures, over-stimulation, or irritability. Patients should be monitored for neurologic status changes.
    • Kuvan can cause hyperactivity. Patients should be monitored for this effect.

    Side Effects

    Common Kuvan side effects include headache, runny nose, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion; however, these are not the only side effects that can occur. Call your doctor right away if you have side effects that bother you or won’t go away.

    Looking for a lower Kuvan (sapropterin dihydrochloride) cost? With a valid prescription from your doctor, you can buy Kuvan online here at a competitive price.


    Kuvan. Novato, CA: BioMarin Pharmaceutical Inc.; 2021.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 12533

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