Label: FOLLTROPIN- follicle stimulating hormone (porcine)

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 8, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    NADA 141-431, Approved by FDA

    CAUTION:

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • DESCRIPTION

    DESCRIPTION:

    FOLLTROPIN® (porcine pituitary-derived follicle stimulating hormone for injection) is a powder for solution containing 700 IU (equivalent to 400 mg NIH-FSH-P1) of follicle stimulating hormone (FSH) per vial. FOLLTROPIN® contains a low amount of luteinizing hormone (less than 1000 µg NIH-LH-S19 per vial). When reconstituted according to label directions the final solution contains 35 IU FSH per mL for intramuscular injection. There are no inactive ingredients in the FSH vial. A 20 mL vial of sterile diluent for FOLLTROPIN® is supplied containing 9 mg/mL sodium chloride, 18 mg/mL benzyl alcohol, sodium hydroxide in sufficient quantity to adjust pH, and water for injection q.s.

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  • VETERINARY INDICATIONS

    INDICATIONS FOR USE:

    For the induction of superovulation in beef and dairy heifers and cows.

    Not for use in male cattle or reproductively immature heifers because safety and effectiveness have not been tested.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION:

    For intramuscular injection only.

    Reconstitute FOLLTROPIN® with 20 mL of the diluent provided using strict aseptic technique. Do not use if clumps or particles are visible after gentle mixing.

    Regimen: Start injections on day 8 to 10 following observed or induced estrus. Administer 2.5 mL (87.5 IU1) of FOLLTROPIN® intramuscularly, twice daily at 12 hour intervals, for 4 consecutive days. In conjunction with the 6th dose of FOLLTROPIN®, administer an FDA-approved prostaglandin product (cloprostenol sodium or dinoprost tromethamine) for cattle, using the labeled dosage and administration instructions to cause luteolysis and induce estrus.

    Inseminate animals at 12 and 24 hours after the onset of estrus or 60 and 72 hours after prostaglandin treatment. Additional inseminations may be conducted at 12 hour intervals, if indicated.

    Collection of embryos is normally started on day 7 following insemination.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS:

    Do not use in pregnant cattle. Laboratory studies with FSH in rats and rabbits have shown evidence of embryotoxicity/fetotoxicity and the safety of the product has not been assessed in pregnant cows. Do not use FOLLTROPIN® in cows that are known to be hypersensitive to the active ingredient, porcine pituitary-derived follicle stimulating hormone.

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  • WARNINGS

    WARNINGS AND PRECAUTIONS:

    Withdrawal Period:

    Withdrawal Period
    Neither a withdrawal period nor a milk discard time is required when this product is used according to label directions.
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  • SPL UNCLASSIFIED SECTION

    User Safety Warnings:

    Not for use in humans. Keep out of reach of children. Care should be taken when handling the product to avoid accidental self-injection. Accidental self-injection may cause biological effects in women and, if pregnant, to the unborn child. In the event of accidental self-injection seek medical attention immediately by consulting a physician/health professional, particularly in women who are pregnant, or whose pregnancy status is unknown. To obtain a Safety Data Sheet or to report adverse reactions, contact 1-800-835-9496 and make this number available to the physician/health professional.

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  • SPL UNCLASSIFIED SECTION

    Animal Safety Warnings and Precautions:

    Management considerations: Successful use of FOLLTROPIN® depends on good reproductive health of the cow and quality herd management procedures. Cattle should be clinically healthy and cycling normally. A comprehensive and ongoing nutritional, reproductive, and herd health program should be in place when using FOLLTROPIN® for superovulation.

    The use of this product may result in trim loss of edible tissue at slaughter.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS:

    Following superovulation, a delayed return to heat is possible. Use of this product has been associated with a low incidence of hypersensitivity or anaphylactic reactions. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinarian.

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  • SPL UNCLASSIFIED SECTION

    TARGET ANIMAL SAFETY:

    Existing pharmacology and toxicology information and knowledge gained from the widespread clinical use of FOLLTROPIN® in cattle was sufficient to demonstrate that FOLLTROPIN® is not systemically toxic to the cow and the targets of toxicity in both cattle and other species are limited to the reproductive organs and functions. A field safety study demonstrated that the use of FOLLTROPIN® in accordance with label directions did not produce any reactions at the injection site. A retrospective study of dairy cattle superovulated up to six times at intervals of less than 93 days did not show any adverse effect of repeated superovulation on the yield of transferable embryos. Cows within the superovulation program produced embryos that were successfully transferred into recipient cows and were able to themselves conceive and deliver normal calves. The development of cystic ovaries following treatment with FOLLTROPIN® has been reported; however, these results have not been substantiated by well-controlled studies or through a comprehensive literature review.

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  • SPL UNCLASSIFIED SECTION

    EFFECTIVENESS:

    The effectiveness of FOLLTROPIN® for the induction of superovulation in beef and dairy heifers and cows was substantiated through a systematic review and meta-analysis which included 2685 superovulation records obtained from twenty clinical studies and one retrospective study. The analysis revealed a high level of variability in the number of transferable embryos obtained between treatment groups; such variability is representative of the expected variation for superovulation programs. The estimated mean number of transferable embryos was 4.5 per study animal and the 95% confidence limits of the mean were 3.5 (lower limit) and 5.6 (upper limit).

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  • STORAGE AND HANDLING

    STORAGE, HANDLING, AND DISPOSAL:

    Freeze-dried powder and diluent vials: Do not store above 25°C (77°F).

    Reconstituted solution: Store under refrigeration (2 to 8 °C; 36 to 46°F).

    Keep the vials in the outer carton in order to protect from light.

    Shelf life following reconstitution according to directions: 4 days

    Do not freeze after reconstitution.

    Discard any unused portion of the reconstituted FOLLTROPIN® solution.

    See FDA's website http://www.fda.gov/safesharpsdisposal for information on safe disposal of needles and other sharps.

    Unless otherwise directed, dispose of unused medicine and empty containers in solid waste following applicable Federal, State and local environmental laws and regulations.

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  • HOW SUPPLIED

    HOW SUPPLIED:

    FOLLTROPIN® contains one 20 mL vial containing 700 IU1 FSH as a lyophilized powder and one 20 mL diluent vial containing Bacteriostatic Sodium Chloride.


    1
    IU = International Units (established by WHO Expert Committee on Biological Standardization in 1986).
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  • SPL UNCLASSIFIED SECTION

    CONTACT INFORMATION:

    Contact Vétoquinol USA, Inc. at 1-800-267-5707 for customer service or to obtain product information, including a SDS. After hours or to report adverse reactions, call 1-800-835-9496.

    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.

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  • SPL UNCLASSIFIED SECTION

    Made in Canada
    Distributed by:
    Vétoquinol USA, Inc.
    4250 N. Sylvania Ave.
    Ft. Worth, TX (USA) 76137
    www.vetoquinolusa.com

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    FOLLTROPIN ®
    [Porcine Pituitary-Derived Follicle
    Stimulating Hormone for Injection]

    INJECTABLE SOLUTION

    For use in beef and dairy
    heifers and cows only.

    CAUTION: Federal law restricts this drug to use by or on the order
    of a licensed veterinarian.

    Net Contents:
    One 20 mL vial containing 700 IU FSH as a lyophilized powder
    One 20 mL diluent vial containing Bacteriostatic Sodium Chloride

    vetoquinoL

    NDC 17030 101 70
    NADA 141-431, Approved by FDA

    PRINCIPAL DISPLAY PANEL - Kit Carton
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  • INGREDIENTS AND APPEARANCE
    FOLLTROPIN 
    follicle stimulating hormone (porcine) kit
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17030-101
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17030-101-70 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 VIAL, MULTI-DOSE
    Part 2 1 VIAL, GLASS 20 mL
    Part 1 of 2
    FOLLTROPIN 
    follicle stimulating hormone (porcine) injection, powder, for solution
    Product Information
    Route of Administration INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Follicle Stimulating Hormone (Porcine) (UNII: 8FYM5179QJ) (Follitropin - UNII:076WHW89TW) Follicle Stimulating Hormone (Porcine) 700 [iU]
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141431 03/01/2016
    Part 2 of 2
    STERILE DILUENT 
    bacteriostatic sodium chloride injection, powder, for solution
    Product Information
    Route of Administration INTRAMUSCULAR
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 20 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141431 03/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA141431 03/01/2016
    Labeler - Vetoquinol USA, Inc. (106824209)
    Establishment
    Name Address ID/FEI Business Operations
    Vetoquinol N.-A. 202717443 API MANUFACTURE, ANALYSIS, LABEL, PACK
    Establishment
    Name Address ID/FEI Business Operations
    Jubilant HollisterStier General Partnership 246762764 MANUFACTURE, ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    Vetoquinol N.-A. INC 202919940 MANUFACTURE, ANALYSIS, LABEL, PACK
    Establishment
    Name Address ID/FEI Business Operations
    Nucro-Technics 241266845 ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    Neopharm Labs Inc. 243379372 ANALYSIS
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