Ad
related to: fda nifurtimoxReceive A Single Point Of Support Contact Through Stemline ARC Patient Advocates. Get Connected To Helpful Resources & ARC Patient Advocates. Sign Up For Patient Support.
- ORSERDU™ Side Effects
Get Information on the Most Common
Side Effects of ORSERDU™.
- Taking ORSERDU™
Find Info To Make Your Treatment
As Effective As Possible.
- Starting ORSERDU™
Learn About FDA Approved ORSERDU™.
Visit The Official Patient Site.
- About ORSERDU™
Learn About ORSERDU™ and if It's
The Right Fit for You.
- ORSERDU™ Savings Info
Find Savings & Support Info By
Visiting The Official Product Site.
- ORSERDU™ Treatment Option
Find Out if ORSERDU™ Is the Right
Treatment Option for You.
- ORSERDU™ Side Effects
Search results
- Nifurtimox is an antiprotozoal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi, in children who are less than 18 years of age and weigh at least 5.5 lbs. (2.5 kg).
clinicalinfo.hiv.gov › en › drugs
LAMPIT (nifurtimox) tablets, for oral use Initial U.S. Approval: 2020 . INDICATIONS AND USAGE ----- LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18...
** Lampit® (nifurtimox) is FDA approved for treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi in pediatric patients from birth to younger than 18 years (weighing at least 2.5 kg).
- Overview
- Discussion
- References
Altmetric:
Citations:
Views:
Views equals page views plus PDF downloads
Figure
Tables
CDC was the sole provider of nifurtimox in the United States for the 20 years before the drug became commercially available; this report represents the most complete description of the patients treated and adverse events reported during that time. CDC provided information on adverse events to FDA annually and before the drug’s approval. Providers should be aware of the frequency and profile of adverse events when counseling patients and prescribing nifurtimox.
Most patients for whom CDC released nifurtimox under the IND were adults aged 18–50 years. Twenty-seven (8.1%) patients were aged <18 years, the group for which FDA has approved the use of nifurtimox (Lampit). However, FDA-approved drugs can be used for nonapproved indications (i.e., off-label use), in accordance with the practice of medicine. The frequency of adverse events in adults and the most common adverse events and systems affected in children, adolescents, and adults were consistent with those reported in previous studies (3–7). The clinical study cited in the FDA approval of nifurtimox (Lampit) did not include adults but found that adverse events were more frequent in adolescents (aged 12 to <18 years) compared with younger age groups (8). Children and adolescents treated under the CDC IND were older (median age = 17 years) and reported more adverse events than in that study (90% versus 64.5%) (8). Among all age groups, the percentage of severe adverse events was higher than that described in other reports (10.4% versus 3.2%–5.1%) (5,6), including among children (13.3% versus 0.9%–1.6%) (3,8). These differences might be because of the way in which adverse events were reported, treatment dose differences, and older ages of children treated with nifurtimox under CDC’s protocol. The high frequency and types of adverse events reported in adults and older children under the CDC IND is important information for providers prescribing nifurtimox and could be included in discussions with patients during treatment decisions and counseling. However, most adverse events reported were mild, as reported in other studies, and in some studies, symptomatic treatment, dose reductions and temporary suspensions of treatment were employed to enable completion of a full 60-day treatment course (4,6).
Considerable variation was observed in the number of nifurtimox releases by state. Provider awareness and the availability of Chagas disease–focused health care services likely contributed to these differences. Although California has the highest estimated number of persons with Chagas disease and the most patients treated with nifurtimox, the majority of nifurtimox requests were from a single medical center in that state (9). Similarly, although the estimated number of patients with Chagas disease in New York is lower than that in Texas or Florida, more nifurtimox requests originated in New York, and many were for patients treated at a single New York City medical center with a large immigrant patient population where patients were actively tested for Chagas disease.
The findings in this report are subject to at least two limitations. First, 23% of patient reports lacked data on adverse events, and 10% of the adverse events recorded lacked information on severity. This might have led to overestimations of adverse events and severity if providers were more likely to report adverse events and adverse events of high severity. Second, adverse events and their severity were defined by patients and their physicians. CDC did not conduct investigations into any adverse events. Severity was not standardized; therefore, adverse events might be reported differently, leading to misclassification.
FDA approval and commercial availability of a nifurtimox product (Lampit) and benznidazole are anticipated to improve access to therapy for the approximately 300,000 estimated persons with T. cruzi infection living in the United States (10). Although CDC no longer distributes nifurtimox or benznidazole, CDC provides reference diagnostic testing for T. cruzi infection (https://www.cdc.gov/dpdx) and teleconsultative services regarding Chagas disease. Health care providers and U.S. health departments with questions about Chagas disease can contact CDC Parasitic Diseases Branch Inquiries by telephone (404-718-4745) or email (parasites@cdc.gov) or review CDC’s website https://www.cdc.gov/parasites/chagas.
Corresponding author: Andrew Abbott, aabbott@cdc.gov, 404-718-1216.
1.Bern C, Montgomery SP, Herwaldt BL, et al. Evaluation and treatment of Chagas disease in the United States: a systematic review. JAMA 2007;298:2171–81. https://doi.org/10.1001/jama.298.18.2171external icon PMID:18000201external icon
2.Herwaldt BL, Dougherty CP, Allen CK, et al. Characteristics of patients for whom benznidazole was released through the CDC-sponsored Investigational New Drug Program for Treatment of Chagas Disease—United States, 2011–2018. MMWR Morb Mortal Wkly Rep 2018;67:803–5. https://doi.org/10.15585/mmwr.mm6729a3external icon PMID:30048425external icon
3.Berenstein AJ, Falk N, Moscatelli G, et al. Adverse events associated with nifurtimox treatment for Chagas disease in children and adults. Antimicrob Agents Chemother 2021;65:e01135-20. https://doi.org/10.1128/AAC.01135-20external icon PMID:33168612external icon
4.Jackson Y, Alirol E, Getaz L, Wolff H, Combescure C, Chappuis F. Tolerance and safety of nifurtimox in patients with chronic Chagas disease. Clin Infect Dis 2010;51:e69–75. https://doi.org/10.1086/656917external icon PMID:20932171external icon
5.Olivera MJ, Cucunubá ZM, Álvarez CA, Nicholls RS. Safety profile of nifurtimox and treatment interruption for chronic Chagas disease in Colombian adults. Am J Trop Med Hyg 2015;93:1224–30. https://doi.org/10.4269/ajtmh.15-0256external icon PMID:26392162external icon
6.Forsyth CJ, Hernandez S, Olmedo W, et al. Safety profile of nifurtimox for treatment of Chagas disease in the United States. Clin Infect Dis 2016;63:1056–62. https://doi.org/10.1093/cid/ciw477external icon PMID:27432838external icon
Nifurtimox forms a nitro-anion radical metabolite that reacts with nucleic acids of the parasite causing significant breakdown of DNA. Its mechanism is similar to that proposed for the antibacterial action of metronidazole. Nifurtimox undergoes reduction and creates oxygen radicals such as superoxide. These radicals are toxic to T. cruzi.
- C₁₀H₁₃N₃O₅S
- By mouth
- Lampit
Nifurtimox is an antiprotozoal prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi, in children who are less than 18 years of age and weigh at least 5.5 lbs. (2.5 kg).
Oct 20, 2016 · Nifurtimox, developed by Bayer, is a nitrofuran antiprotozoal drug used in the treatment of Chagas disease. On August 6 2020, accelerated FDA approval was granted for its use in pediatric patients in response to promising results from phase III clinical trials.
Ad
related to: fda nifurtimoxReceive A Single Point Of Support Contact Through Stemline ARC Patient Advocates. Get Connected To Helpful Resources & ARC Patient Advocates. Sign Up For Patient Support.
