Cycle Pharmaceuticals Limited (Cycle) announced today the launch of VENXXIVA (tiopronin) Delayed-Release Tablets, for the treatment of cystinuria, approved by the US Food and Drug Administration (FDA).1 VENXXIVA is launched in partnership between Cycle and Torrent Pharma Inc. (Torrent), and exclusive distribution partner, Vanscoy Rare Pharmacy (Vanscoy Rare).
Affecting approximately 1 in 7,000 people worldwide,2 cystinuria is a rare condition in which the amino acid cysteine forms stones in the urinary system.3 VENXXIVA is a treatment option for patients with cystinuria who want to bene?t from the patient support services provided by Cycle Vita. Through Cycle Vita, eligible* patients will have access to ?nancial, product and clinical education programs tailored to their needs.
VENXXIVA follows on from the successful launch of Cycle and Torrent's generic tiopronin delayed-release tablets in March 2024. Cycle Vita and Vanscoy Rare will actively work with patients and clinics to support the transition of patients prescribed with generic tiopronin delayed-release tablets to VENXXIVA, and continue their access to Cycle Vita's patient support services.
"One in ?ve patients taking tiopronin have reported missing doses on a daily basis. If improvements in tiopronin adherence can be achieved, along with diet modi?cations for low salt and high ?uid intake, there is a possibility for a greater health-related quality of life.4 At Cycle, we understand that rare disease patients need additional support to manage their condition. That's why we're providing individualized support for patients with cystinuria, including dietary and nutritional support," says Jamie Ray, Director Patient Support Program, Cycle.
VENXXIVA (tiopronin) Delayed-Release Tablets must be taken without food and are available in 100 mg and 300 mg doses. The VENXXIVA 300 mg Delayed-Release Tablet may provide a convenient reduction in pill burden for patients.
VENXXIVA is indicated, in combination with high ?uid intake, alkali, and diet modi?cation, for the prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.1
To ?nd out more about Cycle Vita, please visit www.cyclevita.life or call 888-360-8482. To ?nd out more about VENXXIVA, please visit www.venxxiva.com and ?nd the Full Prescribing Information available at www.venxxiva.com/PI/.
Important Safety Information. Full Prescribing Information is available at www.venxxiva.com/PI/
INDICATIONS
VENXXIVA is a reducing and complexing thiol indicated, in combination with high ?uid intake, alkali, and diet modi?cation, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone.
WARNINGS AND PRECAUTIONS
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria.
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.
ADVERSE REACTIONS
Most common adverse reactions (=10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.
DRUG INTERACTIONS
Alcohol: Tiopronin is released faster from VENXXIVA in the presence of alcohol and the risk for adverse events associated with VENXXIVA when taken with alcohol is unknown. Advise patients to avoid alcohol consumption 2 hours before and 3 hours after taking VENXXIVA.
USE IN SPECIFIC POPULATIONS:
Pregnancy: Available published case report data with tiopronin have not identi?ed a drug- associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes.
Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with VENXXIVA.
Pediatric Use: VENXXIVA is indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high ?uid intake, alkali, and diet modi?cation, 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 Use: 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, care should be taken in dose selection, and it may be useful to monitor renal function.
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.
This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice.
US-TIO-2400034 (February 2025)
References
- VENXXIVA (tiopronin) Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc.
- Leslie, S.W., Sajjad, H. and Nazzal, L. (2023). Cystinuria. [online] Nih.gov. Available at: www.ncbi.nlm.nih.gov/books/NBK470527/. [Accessed December 3rd 2024].
- National Kidney Foundation. (2016). Cystine Stones. [online] Available at: www.kidney.org/atoz/content/what-are-cystine-stones. [Accessed December 3rd 2024].
- Modersitzki, F. et al. (2020). Assessment of health-related quality of life in patients with cystinuria on tiopronin therapy. Urolithiasis. 48(4): 313-320. Available at: https://doi.org/10.1007/s00240-019-01174-6. [Accessed December 3rd 2024].
*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 bene?ts 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 Pharmaceuticals Limited (ANDA holder) in the United States. Cycle Vita is a trademark of Cycle Pharmaceuticals Limited in the United States.
©2025 Cycle Pharmaceuticals Limited. All rights reserved.
About Cycle Pharmaceuticals
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X, LinkedIn and Facebook.
About Torrent Pharma Inc.
Torrent Pharma is one of the leading Pharma companies in India. Torrent is the pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). Torrent also has signi?cant presence in diabetology, pain management, gynecology, oncology and anti-infective segments.
Torrent Pharma is present in more than 40 countries. It is ranked ?rst amongst Indian Companies for having largest market share in Brazil and Germany.
About Vanscoy Rare Pharmacy
Vanscoy Rare Pharmacy is a dually accredited independent specialty pharmacy headquartered in Pittsburgh, Pennsylvania. It is a leading provider of specialized pharmacy services dedicated to improving the lives of patients with rare and complex medical conditions. With a focus on personalized care, patient education, and innovative solutions, Vanscoy Rare Pharmacy is committed to delivering exceptional service and support to its patients and partners.
For more information about Vanscoy Rare Pharmacy and its services, please visit www.vanscoyrare.com or email partnerships@vanscoyrare.com.
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Contacts:
FOR FURTHER INFORMATION PLEASE CONTACT
Marketing@cyclepharma.com
Cycle Pharmaceuticals
Tel: +44 1223 354 118
