About SolosecTM (secnidazole)
Solosec (secnidazole) is the first and only bacterial vaginosis treatment designed to deliver a full course of therapy in just one oral dose.1,2 Many women struggle with completing commonly prescribed treatments.3 But Solosec is an oral single-dose option that may potentially improve adherence.4 The single packet of oral granules can be taken with yogurt, pudding, or applesauce at any time of the day, making it easy to take.1,4 Plus, with Solosec, there are no alcohol restrictions, and it doesn’t interfere with oral contraceptives.1 This effective and generally well-tolerated treatment is a next-generation option for the 4 million women treated for BV each year.1,5,6
About Lupin Pharmaceuticals, Inc.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, and is the 4th largest pharmaceutical company in the U.S. prescriptions filled. Together, all Lupin-owned entities combine to make up the 7th largest pharmaceutical company in the world in total sales. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications trusted by healthcare professionals and patients across many treatment areas. Lupin Pharmaceuticals Inc.’s branded pharmaceuticals division, headquartered in Baltimore, MD, is the provider of numerous products designed to help prevent and manage women’s health conditions with serious health consequences, including Methergine® (methylergonovine maleate), the only FDA-approved oral uterotonic for the prevention and management of uterine hemorrhage, and the soon-to-be-released Solosec 2g oral granules, the only single-dose oral therapy for bacterial vaginosis approved by the FDA.
SOLOSECTM (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.
Important Safety Information
- SOLOSEC is contraindicated in patients with a history of hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives.
- Vulvo-vaginal candidiasis may develop with SOLOSEC and require treatment with an antifungal agent.
- Potential risk of carcinogenicity in patients taking single-dose of SOLOSEC to treat bacterial vaginosis is unclear. Chronic use should be avoided.
- SOLOSEC may pass into breast milk. Patients should discontinue breastfeeding for 96 hours after administration of SOLOSEC.
- SOLOSEC is a single-dose therapy for oral use. The entire contents of SOLOSEC packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. SOLOSEC is not intended to be dissolved in any liquid.
- In clinical studies, the most common adverse events occurring in (≥2%) of patients receiving SOLOSEC 2g oral granules were vulvovaginal candidiasis (9.6%), headache (3.6%),nausea (3.6%), dysgeusia (3.4%), vomiting (2.5%), diarrhea (2.5%), abdominal pain (2.0%), andvulvovaginal pruritus (2.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Please see accompanying full Prescribing Information.
References: 1. SOLOSEC [prescribing information]. Newark, NJ: Symbiomix Therapeutics, LLC (a Lupin Company); 2017. 2. Broumas AG, Basara LA. Potential patient preference for 3-day treatment of bacterial vaginosis: responses to new suppository form of clindamycin. Adv Ther. 2000;17(3):159-166. 3. Bartley JB, Ferris DG, Allmond LM, Dickman ED, Dias JK, Lambert J. Personal digital assistants used to document compliance of bacterial vaginosis treatment. Sex Transm Dis. 2004;31:488-491. 4. Schwebke JR, Morgan FG, Koltun W, Nyirjesy P. A phase-3, double-blind, placebo-controlled study of the effectiveness and safety of single oral doses of secnidazole 2 g for the treatment of women with bacterial vaginosis. Am J Obstet Gynecol. 2017;217:678.e1-678.e9. 5. Bohbot JM, Vicaut E, Fagnen D, Brauman M. Treatment of bacterial vaginosis: a multicenter, double-blind, double-dummy, randomized phase III study comparing secnidazole and metronidazole. Infect Dis Obstet Gynecol. 2010;2010. pii: 705692. 6. Chavoustie SE, Eder SE, Koltun WD, et al. Experts explore the state of bacterial vaginosis and the unmet needs facing women and providers. Int J Gynaecol Obstet. doi:10.1002.12114.