Information for US healthcare providers

FAQs

Phenylketonuria (PKU)

Phenylketonuria (PKU) is an inherited disorder caused by a deficiency of the phenylalanine hydroxylase (PAH) enzyme needed to process phenylalanine, which is found in all foods containing protein. High levels of phenylalanine can cause brain damage.¹

Find out more about PKU

Restriction of dietary phenylalanine intake remains the first line therapy for patients with PKU, requiring a decrease in the intake of natural protein and replacing it with a protein (amino acid mixture) source devoid of Phe.²

In addition to dietary therapy, some pharmaceutical treatment options are available, including JAVYGTOR (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution.

Find out more about JAVYGTOR

JAVYGTOR (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution

JAVYGTOR is a generic version of Kuvan®. This means that both products contain the same active ingredient – sapropterin dihydrochloride – and both products act the same way in the body.³

Your patients are eligible for JAVYGTOR without a trial if they have responded to sapropterin therapy previously. For patients new to sapropterin therapy, the American College of Medical Genetics and Genomics recommends a trial to assess their responsiveness to the medication.²

For further information, please contact Cycle Vita – +1 (888) 360-8482 – and ask to speak with our Medical Affairs department.

Find out more about JAVYGTOR

KUVAN® is a registered trademark of BioMarin Pharmaceutical Inc. Developed in collaboration with Asubio Pharma Co., Ltd.

Sapropterin dihydrochloride is the active ingredient in JAVYGTOR and is a proven treatment for PKU.³ JAVYGTOR is an orally active BH4 co-factor, which stimulates residual activity in the phenylalanine hydroxylase (PAH) enzyme, in patients who respond to treatment.

Find out more about JAVYGTOR

JAVYGTOR is a treatment for patients with PKU who want to remain on sapropterin dihydrochloride treatment while benefitting from Cycle Vita, which provides individualized support* as unique as your patients.

Find out more about JAVYGTORFind out more about Cycle Vita

To prescribe JAVYGTOR to your patients please complete a JAVYGTOR enrollment form.

Enrollment form

If you have any questions, please contact the Cycle Vita team at +1 (888) 360-8482.

Find out more about JAVYGTOR

JAVYGTOR is indicated in conjunction with a Phenylalanine (Phe)-restricted diet, so patients must continue dietary restriction of Phe.³

Your patients are eligible for JAVYGTOR without a trial if they have responded to sapropterin therapy previously. For patients new to sapropterin therapy, the ACMG recommends a trial to assess their responsiveness to the medication.²

Enrollment form

Cycle Vita

The Cycle Vita team will be just a phone call away for you and your patients. You can expect to hear from two types of people at Cycle Vita:

  • Access Specialists – help access JAVYGTOR through enrollment, financial and pharmacy support*
  • Clinical Specialists – provide clinical education, nutrition support and medication administration support*

A friendly, familiar team is waiting here at Cycle Vita, for you and your patients at every step.

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+1 (888) 360-8482

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hello@cyclevita.life

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www.cyclevita.life

Eligible patients* prescribed JAVYGTOR can expect to receive:

  • Access Support: financial, logistics and educational support including Co-pay Programs
  • Clinical Support: continuous access to a Registered Dietitian including the Patient Nutrition Program
Find out more about Cycle Vita

Commercially insured eligible patients prescribed JAVYGTOR may pay as little as $0 in co-pay*. To find out more about eligibility criteria please contact Cycle Vita on +1 (888) 360-8482.

Eligible patients* enrolled on JAVYGTOR have access to:

  • New Patient Free Trial*: Cycle Vita will provide up to a 30-day supply of JAVYGTOR for patients new to sapropterin dihydrochloride therapy in an effort to prove clinical effectiveness of the medication, as measured by HCP administered labs and appropriate lab results
  • Bridge Program*: A free supply of JAVYGTOR is available to allow patients to begin therapy immediately while Cycle Vita secures appropriate Benefit Verification and assists with Prior Authorization. The Bridge Program may also be requested for existing patients who are temporarily experiencing disruption in therapy due to insurance coverage
Find out more about Cycle Vita

At Cycle Vita, we see the support we provide to you and your patients as a collaboration and we are willing to tailor our support to the requirements of your clinic and your patients.

To discuss this further please contact the Cycle Vita team on +1 (888) 360-8482.

References

1. National Institutes of Health. Phenylketonuria (PKU). Available at: https://www.nichd.nih.gov/health/topics/pku. (Accessed February 12th, 2024).

2. Vockley J., et al; for the American College of Medical Genetics and Genomics Therapeutic Committee. Phenylalanine hydroxylase deficie nc y: diagnosis and management guideline. Genet Med. 2014;16(2):188 200. doi:10.1038/gim.2013.157

3. JAVYGTOR (sapropterin dihydrochloride). Prescribing Information. Dr Reddy’s Laboratories Ltd. 

*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.