Elanco News icon with shot of G'field HQ and an Elanco News overlay
19 February 2021

Increxxa™ (tulathromycin injection) Approved by FDA for U.S. Cattle and Swine Producers and Veterinarians

Share

Posted by: Sarah Morehouse


GREENFIELD, Ind. (February 19, 2021) – Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. FDA approval of Increxxa(tulathromycin injection) for the treatment of bovine respiratory disease (BRD) and swine respiratory disease (SRD). 

“We recognize what a challenge respiratory disease can be for the livestock industry and are excited to offer Increxxa to veterinarians and producers, giving them yet another solution to help combat this problematic disease in cattle and swine,” said Jose Simas, executive vice president, U.S. farm animal business at Elanco. “Like all Elanco products, veterinarians and producers can be confident that Increxxa is held to the company’s uncompromising standard of potency, uniformity and quality.”

“Elanco is committed to offering a broad portfolio of products to keep livestock healthy,” Simas noted. “With the availability of Increxxa, producers now have another strong option to support the responsible use of antibiotics in their herds.”

INCREXXA FOR CATTLE

In cattle, Increxxa quickly targets the site of infection in the lungs for fast-acting performance combined with a long half-life, giving cattle more time to bolster an effective defense against BRD.*1 The launch marks a new option for producers to complement the company’s already extensive portfolio of BRD solutions.

“BRD contributes to 40-50% of all cattle mortality,” said Dr. Brett Terharr, Elanco consulting veterinarian. “Studies consistently show tulathromycin, the active ingredient in Increxxa, helps decrease the negative effects of BRD, such as morbidity and mortality, when used metaphylactically.1 This can lead to more profits by avoiding return trips to the hospital pen and getting cattle back to the feedbunk.”2

Increxxa is indicated for the treatment of BRD and control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasturella multocida, Histophilus somni and Mycobacterium bovis in beef and non-lactating dairy cattle. It is also approved for treatment of infectious bovine keratoconjunctivitis (IBK) associated with Mycobacterium bovis and treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

In suckling calves, dairy calves, and veal calves, Increxxa is indicated for the treatment of BRD associated with Mannheimia haemolytica, Pasturella multocida, Histophilus somni and Mycobacterium bovis.

*Clinical relevance is unknown.

INCREXXA FOR SWINE

In swine, Increxxa expands Elanco’s SRD portfolio, offering producers more choices to find the right solution for their challenges. Balancing whole-herd health and individual pig solutions with an industry-proven molecule, Increxxa is a single-dose application indicated for the treatment and control of SRD in swine. Producers have long understood that SRD leads to negative impacts on performance as well as increased mortality, causing substantial production and economic losses.3 By quickly targeting and rapidly circulating at the site of infection, Increxxa controls SRD early while providing pigs more time to mount an effective SRD defense.4*

"The addition of Increxxa to Elanco’s portfolio continues to strengthen the tool chest against swine diseases in our modern production systems. Our product portfolio offers multiple active ingredients, multiple routes of administration and multiple label indications, leading to more innovative veterinarian-derived treatment and control options," said Dr. Eric Christianson, Elanco consulting veterinarian.

Controlling disease challenges requires a balanced approach to management practices, biosecurity and herd health choices. With the addition of Increxxa, Elanco’s expanded SRD portfolio — supported by the company’s industry-leading technical team and unwavering quality assurance — offers even more choices to find the right solution.

Increxxa injectable solution is indicated for the treatment of swine respiratory disease (SRD), associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

ABOUT BOVINE RESPIRATORY DISEASE

Factors putting cattle at risk include age, parasites, season and stressors including transportation, weather and vaccination/immune status.

Respiratory problems account for the highest percentage of deaths in cattle and calves due to nonpredators.5 Additionally, BRD accounts for 70-80% of all feedlot morbidity and 40-50% of all mortality.6 In dairy operations, respiratory disease was reported by 60.5% of dairy operations, affecting 2.8% of dairy cows.5 BRD has a variety of impacts on beef cow-calf productivity. In addition to mortality, calves that survive summer pneumonia typically have reduced weaning weights.7

More information on the entire Elanco cattle portfolio is available at elancolivestock.com.

ABOUT SWINE RESPIRATORY DISEASE

Respiratory disease remains at the forefront of concern for producers. The impact of respiratory disease has consistently caused serious damage to producers’ bottom lines across the world.8,9,10 Respiratory disease occurrence and severity is affected by factors such as weaning, transfer of pathogens from sow to piglet, handling, temperature and ventilation.10 Early SRD intervention is critical to ensure nursery pig health.

IMPORTANT SAFETY INFORMATION

Not for human use. Keep out of reach of children. Do not use in animals previously found to be hypersensitive to the drug. Increxxa has a pre-slaughter withdrawal time of 18 days in cattle. Do not use in female dairy cattle 20 months of age or older. Increxxa has a pre-slaughter withdrawal time of five days in swine.

For more information about Increxxa, producers should consult their veterinarian or Elanco representative. For technical product information or to report an adverse event, call 800-422-9874. For customer service, call 877-352-6261.

*Clinical relevance unknown.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ Sustainability/ESG Pledges –all to advance the health of animals, people, and the planet. Learn more at elanco.com.

References

1 Villarino N, Brown SA, Martin-Jimenez T. Understanding the pharmacokinetics of tulathromycin: a pulmonary perspective. Vet Pharmacol Ther. 2014;37(3):211-21.

2 Nickell JS, White BJ. Metaphylactic antimicrobial therapy for bovine respiratory disease in stocker and feedlot cattle. Vet Clin North Am Food Anim Pract. 2010;26(2):285-301.

3Qin, S., et al. 2018. “Viral communities associated with porcine respiratory disease complex in intensive commercial farms in Sichuan province, China.” Sci. Rep. 8, 13341. doi:10.1038/s41598-018-31554-8.

4Benchaoui, H., et al. 2004. “Pharmacokinetics and lung tissue concentrations of tulathromycin in swine.” J Vet Pharmacol Ther.; 27(4):203-10.

5 USDA website. Feedlot 2011 Part IV: Health and health management on U.S. feedlots with a capacity of 1,000 or more head. (2013).

6 Hilton, W. Mark. “BRD in 2014: Where Have We Been, Where Are We Now, and Where Do We Want to Go?” Animal Health Research Reviews 15, no. 2 (2014): 120–22. https://doi.org/10.1017/s1466252314000115.

7 Peel D. The Effect of Market Forces on Bovine Respiratory Disease. Veterinary Clinics of North America: Food Animal Practice. 2020;36(2):497-508.

8Straw B., et al. 2006. “Diseases of Swine. 9th ed.” Wiley: 149-79.​

9Neumann E., et al. 2010. “Swine Disease Manual. 4th ed.” AASV: 2-4. ​

10Brockmeier S., et al. 2002. “Porcine respiratory disease complex.” In: “Polymicrobial diseases.” ASM Press, Washington, DC: Ch. 13.


Increxxa, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

©2021 Elanco. PM-US-21-0464

Media Contact

Sarah Morehouse

+1.317.914.7568

SARAH.MOREHOUSE@network.elancoah.com

Investor Contact

Tiffany Kanaga

+1.302.897.0668

Tiffany.Kanaga@elancoah.com

Share


Connect with Elanco

Country selector

Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco.