March 1, 2010
CONTACT: Dr. Jared Gould (Elanco) — 317-277-3177 

Elanco Announces Micotil^® (tilmicosin injection) Offers Important New Label Updates

Greenfield, Indiana — Elanco announced Micotil is now approved for a flexible dose range from 10 mg/kg (1.5 mL/cwt) to 20 mg/kg (3.0 mL/cwt) for both metaphylaxis and individual pull-and-treat BRD treatment. The updated label also includes a new withdrawal time of 42 days, regardless of dose, and a maximum injection volume of 10 mL per injection site. New treatment claims for Pasteurella multocida and Histophilus somni were added in addition to Mannheimia haemolytica. Micotil is still indicated for the control of Bovine Respiratory Disease (BRD) associated with M. haemolytica . Ovine Respiratory Disease (ORD) indications have not changed.

“The recent label change gives producers and animal-health professionals the opportunity to adjust the dose of Micotil upward, if needed, due to increased BRD risk in certain groups of cattle,” says Jared Gould, DVM, marketing consultant for Elanco. “Micotil gives producers the flexibility to optimize the value of their BRD treatment and better manage variation associated with risk of cattle developing BRD.”

Micotil is indicated for the treatment of BRD and ORD associated with Mannheimia (Pasteurella) haemolytica. The new Micotil label, which includes the addition of Pasteurella multocida and Histophilus somni for BRD treatment, confirms the observations made in clinical trials that Micotil is effective in treatment of BRD caused by these common BRD pathogens.

Two recent trials conducted in Texas and Colorado¹ compared a non-treated control group to on-arrival treatment with Micotil at 10 mg/kg and 20 mg/kg of body weight. The trials demonstrated that Micotil metaphylaxis continues to reduce BRD morbidity.

In the Texas study, calves receiving 20 mg/kg Micotil metaphylaxis demonstrated the following compared to non-treated controls and cattle receiving 10 mg/kg Micotil metaphylaxis:

• Significantly reduced BRD morbidity (16.8 percent vs. 34.0 percent and 24.3 percent, respectively)
• Profit/hd did not differ statistically, however was numerically greatest in calves receiving 20 mg/kg Micotil metaphylaxis compared to the non-treated control and cattle receiving 10 mg/kg Micotil metaphylaxis (difference of $126, 20 mg/kg vs. negative control, and $87, 10 mg/kg vs. negative control, respectively)

In the Colorado study, findings included:

• Significantly reduced BRD morbidity in both Micotil metaphylaxis groups (20 mg/kg and 10 mg/kg) relative to non-treated controls (44.0 percent and 49.9 percent vs. 68.5 percent, respectively)
• Profit/hd did not differ statistically, however was numerically greatest in calves receiving 20 mg/kg Micotil metaphylaxis compared to the non-treated control and cattle receiving 10 mg/kg Micotil metaphylaxis (difference of $45.18, 20 mg/kg vs. negative control, and $34.58, 10 mg/kg vs. negative control, respectively)

Added Dr. Gould, “Micotil is the proven, fast-acting, long-lasting BRD treatment that offers a flexible, cost-effective dose range for both metaphylaxis and individual pull-and-treat therapy.”

Important Safety Information
Micotil is to be used by, or on the order of, a licensed veterinarian. For cattle or sheep, inject subcutaneously. Intravenous use in cattle or sheep will be fatal. Do not use in female dairy cattle 20 months of age or older. Use in lactating dairy cattle or sheep may cause milk residues. The following adverse reactions have been reported: in cattle: injection site swelling and inflammation, lameness, collapse, anaphylaxis/anaphylactoid reactions, decreased food and water consumption, and death; in sheep: dyspnea and death. Always use proper drug handling procedures to avoid accidental self-injection. Do not use in automatically powered syringes. Consult your veterinarian on the safe handling and use of all injectable products prior to administration. Micotil has a pre-slaughter withdrawal time of 42 days. See label for complete use information, including boxed human warnings and non-target species safety information.

About Elanco
Elanco is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 75 countries. Elanco employs 2,300 people worldwide, with offices in more than 40 countries, and is a division of Eli Lilly and Company, a leading global pharmaceutical corporation. Additional information about Elanco is available at www.elanco.com.

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