Lutalyse - 5mg/ml 30ml Vial

Lutalyse Injection (dinoprost tromethamine injection) is the most "veterinarian recommended" and "producer used" prostaglandin in the market.¹ Artificial insemination synchronization programs with Lutalyse can improve breeding success. Producers and veterinarians today have more options for using Lutalyse in reproduction programs than ever before. FACTREL Injection (gonadorelin injection) is now approved for use with Lutalyse to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows.

Lutalyse is the only prostaglandin approved to be used with EAZI-BREED CIDR Cattle Inserts in dairy heifers and dairy cows.

Key Benefits

• Use with FACTREL for estrous synchronization is consistent with protocols recommended by the Dairy Cattle Reproduction Council
• A synchronized breeding program with Lutalyse can:
• Improve pregnancy rates
• Reduce time necessary for heat detection
• Make more efficient use of labor
• Reduce cull rates
• An entirely natural prostaglandin
• No meat or milk withdrawal
• A product you can trust for performance and safety: Lutalyse is the most thoroughly researched prostaglandin in the world2
• Useful therapeutically for controlled breeding
• Ideal dose size reduces problems if injection-site leakage occurs

How It Works

This product uses dinoprost tromethamine to:

• Control estrous timing in estrous cycling mares or in clinically anestrous mares with a corpeus luteum
• Induce parturition in swine
• Induce abortion in non-lactating or feedlot cattle
• Treat chronic endometriosis (pyometra) and silent (unobserved) estrus in cattle
• Synchronize estrus in cattle

Indications

Cattle: Lutalyse Injection is indicated as a luteolytic agent. Lutalyse Injection is effective only in those cattle having a corpus luteum, i.e., those which ovulated at least five days prior to treatment.

Future reproductive performance of animals that are not cycling will be unaffected by injection of Lutalyse Injection.

• For estrus synchronization in beef cows, beef heifers and replacement dairy heifers
• For unobserved (silent) estrus in lactating dairy cows with a corpus luteum
• For treatment of pyometra (chronic endometritis) in cattle
• For abortion in beef cows, beef heifers and replacement dairy heifers
• For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows
• For use with EAZI-BREEDTM CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows
• For use with EAZI-BREEDTM CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers

View Lutalyse Drug Facts Sheet.

As with any multi-dose vial, practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the vial stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.

No vial stopper should be entered more than 20 times. For this reason, the 100 mL bottle should only be used for cattle. The 30 mL bottle may be used for cattle, swine, or mares.

Cattle:

1. For Estrus Synchronization in Beef Cows, Beef Heifers and Replacement Dairy Heifers. LUTALYSE Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.
2. For Unobserved (Silent) Estrus in Lactating Dairy Cows with a Corpus Luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus.
3. For Treatment of Pyometra (chronic endometritis) in Cattle. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly.
4. For Abortion in Beef Cows, Beef Heifers and Replacement Dairy Heifers. LUTALYSE Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Inject a dose of 25 mg dinoprost (5 mL) intramuscularly.Cattle that abort will abort within 35 days of injection.
5. For use with Factrel (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer 2 to 4 mL Factrel Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:
• Administer the first dose of Factrel Injection (2-4 mL) at Day 0
• Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine) Injection by intramuscular injection 6-8 days after the first dose of Factrel Injection.
• Administer a second dose of Factrel Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection.
• Perform FTAI 0 to 24 hours after the second dose of Factrel Injection, or inseminate cows on detected estrus using standard herd practices.

Below are three examples of treatment regimens for FTAI that fit within the dosage regimen framework described immediately above:

	Example 1	Example 2	Example 3
Day 0 (Monday)	1st Factrel	1st Factrel	1st Factrel
Day 7 (the following Monday)	Lutalyse	Lutalyse	Lutalyse
Day 9 (Wednesday)	2nd Factrel + FTAI at 48 hours after Lutalyse	2nd Factrel + FTAI at 48 hours after Lutalyse	2nd Factrel + FTAI at 48 hours after Lutalyse
Day 10 (Thursday)		FTAI 24 hours after 2nd Factrel	FTAI 24 hours after 2nd Factrel

6. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for Synchronization of Estrus in Lactating Dairy Cows:
• Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).
• Administer 5 mL LUTALYSE Injection at the time of removal of the EAZI-BREED CIDR Cattle Insert.
• Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices.
7. For use with EAZI-BREED CIDR (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers:
• Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).
• Inject 5 mL LUTALYSE Injection (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZI-BREED CIDR Cattle Insert removal, on Day 6 of the 7 day administration period.
• Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.

Warnings & Precautions

User Safety:

Not for human use. Keep out of the reach of children. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Dinoprost tromethamine is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Accidental spillage on the skin should be washed off immediately with soap and water. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Residue Warnings:

No milk discard or preslaughter drug withdrawal period is required for labeled uses in cattle. No preslaughter drug withdrawal period is required for labeled uses in swine. Use of this product in excess of the approved dose may result in drug residues. Do not use in horses intended for human consumption.

Animal Safety Warnings:

Severe localized clostridial infections associated with injection of LUTALYSE Injection have been reported. In rare instances, such infections have resulted in death.

Aggressive antibiotic therapy should be employed at the first sign of infection at the injection site whether localized or diffuse. Do not administer intravenously (IV) as this route may potentiate adverse reactions. Non-steroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently. Do not administer to pregnant cattle, unless abortion is desired. Cattle administered a progestin would be expected to have a reduced response to LUTALYSE Injection. Do not administer to sows and/or gilts prior to 3 days of normal predicted farrowing as an increased number of stillbirths and postnatal mortality may result. In mares, LUTALYSE Injection is ineffective when administered prior to day-5 after ovulation.

Effectiveness:

Cattle:

For Treatment of Pyometra (chronic endometritis) in Cattle: In studies conducted with LUTALYSE Injection, pyometra was defined as presence of a corpus luteum in the ovary and uterine horns containing fluid but not a conceptus based on palpation per rectum. Return to normal was defined as evacuation of fluid and return of the uterine horn size to 40mm or less based on palpation per rectum at 14 and 28 days. Most cattle that recovered in response to LUTALYSE Injection recovered within 14 days after injection. After 14 days, recovery rate of treated cattle was no different than that of non-treated cattle.

For Abortion in Beef Cows, Beef Heifers and Replacement Dairy Heifers: Commercial cattle were palpated per rectum for pregnancy in six feedlots. The percent of pregnant cattle in each feedlot less than 100 days of gestation ranged between 26 and 84; 80% or more of the pregnant cattle were less than 150 days of gestation. The abortion rates following injection of LUTALYSE Injection increased with increasing doses up to about 25 mg. As examples, the abortion rates, over 7 feedlots on the dose titration study, were 22%, 50%, 71%, 90% and 78% for cattle up to 100 days of gestation when injected IM with LUTALYSE Injection doses of 0,1 (5 mg), 2 (10 mg), 4 (20 mg) and 8 (40 mg) mL, respectively. The statistical predicted relative abortion rate based on the dose titration data, was about 93% for the 5 mL (25 mg) LUTALYSE Injection dose for cattle injected up to 100 days of gestation.

For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: For a full description of the studies conducted for the use of FACTREL Injection and LUTALYSE Injection, please refer to the labeling for FACTREL Injection.