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  2. VENXXIVA™ (tiopronin) Delayed-Release Tablets 100 mg and 300 mg

VENXXIVA™ (tiopronin) Delayed-Release Tablets 100 mg and 300 mg

What is VENXXIVA?

VENXXIVA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.1

It can help you find relief, by reducing the frequency and severity of stone formation.2

VENXXIVA (tiopronin) Delayed-Release Tablets must be taken without food.

At Cycle, we know that life-changing treatments need life-improving support to match. That’s why we created Cycle Vita, delivering individualized product support* every step of the way with VENXXIVA.

FIND OUT MORE about venxxiva
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Support available to you with VENXXIVA

Start your VENXXIVA enrollment here

Download and print the enrollment form, share it with your doctor and discuss why you think VENXXIVA may be suited to your needs.

Enroll here

The first steps

Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.

We will route your VENXXIVA therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.

We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to help your healthcare provider with your Prior Authorization and document requirements.

Additional assistance, when required, throughout your journey

If you have commercial insurance, you may be eligible for the Co-Pay Assistance Program. Commercially insured eligible patients may pay as little as $0.

Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as the Bridge Program).

Important notice

A free supply of VENXXIVA will allow you to begin therapy immediately while we secure appropriate Benefit Verification and assist with Prior Authorization. It may also be requested if you’re an existing patient experiencing a temporary lapse in insurance coverage. Bridge duration is driven by insurance coverage and the active collaboration of your clinic.

Important notice

We will provide you with product support to help manage every aspect of the VENXXIVA therapeutic routine, such as clinical education and onboarding onto tiopronin.

Translation services are available on request.

We will provide you with on-going personal guidance and education through the duration of your therapy. Monthly calls with a dietitian from our team to reinforce your clinic’s nutrition plan, specific to cystinuria.

What is Cystinuria?

Cystinuria is a rare condition in which stones made from an amino acid called cysteine form in the kidney, ureter, and bladder. Cystine is formed when two molecules of the amino acid cysteine are bound together. Cystinuria is an autosomal recessive condition, inherited only if both parents pass a faulty gene onto a child. Cystine stones tend to reoccur and are typically larger than other kidney stones.3

Symptoms of cystinuria include blood in the urine, flank pain, or pain in the side or back. Pain is most often felt on one side and is rarely felt on both sides. Pain is often severe and may become more severe over a period of days.4 Other symptoms may include pain while urinating, nausea, and vomiting.5

The first step in diagnosing cystinuria is clinical suspicion. Cystinuria can be diagnosed by stone analysis, microscopic examination of urine, or urine cystine quantification. Although it is not always required, genetic testing may be useful in certain situations such as atypical clinical presentation.6

Resources

Resource IconFull Prescribing Information
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Resource IconPHI Form
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Resource IconEnrollment Form
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Resource IconPatient Initiation Brochure
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Resource IconLiving Well with Cystinuria Brochure
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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.

VENXXIVA™ is a trademark of Torrent Pharma Inc. in the United States.

References

  1. VENXXIVA (tiopronin) Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc.
  2. Pak et al. (2018). The Journal of Urology. Management of cystine nephrolithiasis with alpha-mercaptopropionylglycine. 136(5):1003-8. DOI: 10.1016/s0022-5347(17)45188-3. [Accessed: May 21 2024].
  3. National Kidney Foundation. (2016). Cystine Stones. [online] Available at: https://www.kidney.org/atoz/content/what-are-cystine-stones [Accessed: November 1 2024].
  4. Mount Sinai Health System. (2020). Cystinuria. [online] Available at: https://www.mountsinai.org/health-library/diseases-conditions/cystinuria [Accessed: November 1 2024].
  5. National Kidney Foundation. 2016. Cystine Stones. [online] Available at: https://www.kidney.org/atoz/content/what-are-cystine-stones [Accessed: November 1 2024].
  6. Sadiq, S. and Onur Çil (2022). Cystinuria: An Overview of Diagnosis and Medical Management. PubMed Central, [online] 57(4), pp.377–384. Available at: https://doi.org/10.5152/turkarchpediatr.2022.22105 [Accessed: November 1 2024].

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Indications

VENXXIVA is a prescription medication provided in a delayed-release tablet. It is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and pediatric patients 9 years of age and older and who do not respond to these measures alone.

Important Safety Information

Do not take VENXXIVA if you are allergic to tiopronin or any other ingredients. Tell your healthcare provider about any health problems, and if you are pregnant or planning to become pregnant and/or breastfeeding, before starting treatment.

Serious Adverse Reactions:

VENXXIVA Can cause proteinuria (high amounts of protein in urine), including serious kidney problems, and hypersensitivity reactions (including fever, rash, joint pain and enlarged or swollen lymph nodes).

  • Your healthcare provider will monitor you throughout your treatment for signs of proteinuria.
Common Adverse Reactions:

The most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, joint pain, proteinuria and vomiting.

These are not all of the possible side effects of VENXXIVA. Call your healthcare provider for medical advice about side effects.

Drug Interactions:

Alcohol can interfere with the effect of tiopronin. Avoid alcohol consumption 2 hours before and 3 hours after taking VENXXIVA.

Use in Specific Populations:

Pregnancy: No major drug-associated risks have been identified with tiopronin. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or plan to become pregnant.
Lactation: Breastfeeding is not recommended during treatment with VENXXIVA. Tell your healthcare provider if you plan on breastfeeding.

Pediatric Use: VENXXIVA is indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone.

VENXXIVA is not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets.

Geriatric patients: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, your healthcare provider may monitor your renal function during your treatment.

For more detailed information, please refer to the full Prescribing Information at www.venxxiva.com/PI/

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at
1-857-437-3969, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.