JAVYGTORTM (sapropterin dihydrochloride) Tablets for Oral Use and Powder For Oral Solution
What is JAVYGTOR?
JAVYGTOR (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.1
Treatment with JAVYGTOR should be directed by physicians knowledgeable in the management of PKU.1 All patients with PKU who are being treated with JAVYGTOR should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction.1
At Cycle, we know that a patient’s wellbeing not only depends on life-changing treatments, but also a support system which may help improve quality of life. That’s why we created Cycle Vita, delivering individualized product support every step of the way with JAVYGTOR.
Support available to you with JAVYGTOR
Start your JAVYGTOR enrollment here
Download and print the enrollment form,
share it with your doctor and discuss why
you think JAVYGTOR may be suited to
your needs.
The first steps
Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.
If prior authorization is needed, our experienced team will work with your insurer to understand the requirements and provide support to your doctor to ensure documentation and requirements are met.
We will route your JAVYGTOR therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.
Additional assistance, when required, throughout your journey
In some cases, an appeal for insurance coverage may be needed. Where this is the case, our experienced team will work with your insurance provider and doctor to understand the requirements and help address any JAVYGTOR reimbursement gaps.
If you have commercial insurance, you may be eligible for the Cycle Vita Co-Pay Assistance Program. Commercially insured eligible patients may pay as little as $0. Please contact us to find out more about this and other programs that may be available to you (such as the Bridge Program and the New Patient Free Trial etc.).
A free supply of JAVYGTOR is available to allow you to begin therapy immediately while Cycle Vita secures appropriate Benefit Verification and assists with Prior Authorization. It may also be requested if you experience a temporary disruption in therapy due to insurance coverage.
If you agree, our proactive team will remind your healthcare provider when your JAVYGTOR prescription needs to be renewed, in a timely manner to ensure your therapy is not interrupted.
We provide product support to help you manage every aspect of your JAVYGTOR therapeutic routine, such as clinical education and one-on-one administration training.
Translation services are available upon request.
We provide you with on-going personal guidance and education through the duration of your therapy, to support you in reaching your healthcare provider’s nutritional goals and adherence plan.
What is phenylalanine hydroxylase (PAH) deficiency, traditionally called 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.2
The incidence of PKU is highest amongst Caucasians, occurring in approximately 1 in 10,000 births.3
Untreated individuals with PKU appear healthy at birth, but if they do not restrict the phenylalanine in their diet, they can develop severe intellectual and developmental disabilities. Other signs and symptoms of PKU may include behavioral problems, slow growth, small head size, eczema or skin rashes, seizures, jerking movements of the arms or legs and musty odor of breath, skin or urine. In addition, individuals may have fair skin and blue eyes, due to the body’s failure to transform phenylalanine into melanin, the pigment responsible for a person’s coloring.4
All 50 US states require newborns to be screened for PKU, which is how nearly all cases of PKU are diagnosed. A test is performed using a few drops of blood from a newborn’s heel to determine the level of phenylalanine in the blood.5
Remember, you are not alone. The Cycle Vita team is here to support you at every step of your treatment process.
Resources
Footnote
*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 888-360-8482.
JAVYGTOR™ is a trademark of Cycle Pharmaceuticals Limited in the United States.
References
- JAVYGTOR (sapropterin dihydrochloride). Prescribing Information. Dr Reddy’s Laboratories Ltd.
- National Institutes of Health. Phenylketonuria (PKU). Available at: https://www.nichd.nih.gov/health/topics/pku. [Accessed: October 10 2024].
- Williams, R. A. et al. 2008. Phenylketonuria: An Inborn Error of Phenylalanine Metabolism. The Clinical Biochemist Reviews. 29(1) 31-41.
- National Institutes of Health. What are common symptoms of phenylketonuria (PKU)? Available at: https://www.nichd.nih.gov/health/topics/pku/conditioninfo/symptoms. [Accessed: October 10 2024].
- National Institutes of Health. How do health care providers diagnose phenylketonuria (PKU)? Available at: https://www.nichd.nih.gov/health/topics/pku/conditioninfo/diagnosed [Accessed: October 10 2024].