Today's Veterinary Practice

SEP-OCT 2018

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Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Description: ProZinc® insulin is a sterile aqueous protamine zinc suspension of recombinant human insulin. Each mL contains: recombinant human insulin 40 International Units (IU) protamine sulfate 0.466 mg zinc oxide 0.088 mg glycerin 16.00 mg dib asic sodium phosp hate, hep tahyd rate 3.78 mg phenol (added as p reservative) 2.50 mg hydrochloric acid 1.63 mg water for injection (maximum) 1005 mg pH is adjusted with hydrochloric acid and/or sodium hydroxide. Indi ca tion: P roZinc (p ro tamine zinc recombinan t human insulin) is i ndi cated fo r the reduction o f hyperglycemia and hyperglycemia-associated clini cal signs in cats with diabetes mellitus. Dosage and Administration: USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT IN INCORRECT DOSING. FOR SUBCUTANEOUS INJECTION IN CATS ONLY. DO NOT SHAKE OR AGITATE THE VIAL. ProZinc insulin should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. On ce mi xed, P roZinc suspension has a whi te, cloud y appearan ce. Clumps o r visible whi te particles can fo rm in insulin suspensions: do no t use the product if clumps or visible white particles persist after gently rolling the vial. Using a U-40 insulin syringe, the injection should be administered subcutaneously on the back of the neck or on the side of the cat. Always p rovide the Cat Owner In fo rmation Sheet with each p rescription. The initial recommended ProZinc dose is 0.1 – 0.3 IU insulin/pound of body weight (0.2 – 0.7 IU/kg) every 12 hours. The dose should be given concurrently with or right after a meal. The veterinarian should re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained. In the effectiveness field study, glycemic co ntrol was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 150 mg/dL and clinical signs of hyperglycemia such as polyuria, polydipsia, and weight loss were improved. Further adjustments in the dosage may be necessary with changes in the cat's diet, body weight, or concomitant medication, or if the cat develops concurrent infection, inflammation, neoplasia, or an additional endocrine or other medical disorder. Contraindications: ProZinc insulin is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in the ProZinc product. ProZinc insulin is contraindicated during episodes of hypoglycemia. Warnings: User Safety: For use in cats only. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with running water for at least 15 minutes. Accidental injection may cause hypoglycemia. In case of accidental injection, seek medi cal attention immediately. Exposu re to p roduct may i ndu ce a lo cal o r systemic allergic reaction in sensiti zed i ndi viduals. Animal Safety: Owners should be advised to observe for signs of hypoglycemia (see Cat Owner Information Sheet). Use of this product, even at established doses, has been associated with hypoglycemia. An animal with signs of hypoglycemia should be treated immediately. Glucose should be given o rally o r in travenously as dictated by clini cal signs. Insulin should be tempo rarily withheld and, i f i ndi cated, the do sage adjusted. Any change in insulin should be made cautiously and only under a veterinarian's supervision. Changes in insulin strength, manufacturer, type, species (human, animal) or method of manufacture (rDNA versus animal-source insulin) may result in the need for a change in dosage. App rop riate diagnostic tests should be perfo rmed to rule ou t other endocrinopathi es in diabetic cats that are difficult to regulate. P recau tions: Animals p resenti ng with severe ketoacidosis, ano rexia, lethargy, and/o r vomiti ng should be stabili zed with sho rt-acti ng insulin and app rop riat e suppo rtive therapy until th ei r co ndition is stabili zed. As with all insulin p roducts, careful patien t moni to ri ng fo r hypoglycemia and hyperglycemia is essential to attain and main tain adequate glycemic con trol and to p reven t associated compli cations. Overdo sage can result in profound hypoglycemia and death. Progestogens, certain endocrinopathies and glucoco rticoids can have an an tagonistic effect on insulin acti vity. P rogestogen and glucoco rticoid use should be avoided. Rep roducti ve Sa fety: The safety and effectiven ess o f P roZinc insulin in b reedi ng, pregnant, and lactating cats has not been evaluated. Use in Kittens: The safety and effectiveness of ProZinc insulin in kittens has not been evaluated. Adverse Reactions: Effectiveness Field Study In a 45-d ay effectiven ess field stud y, 1 76 cats received P roZinc insulin. Hypoglycemia (defined as a blo od glucose value o f <50 mg/dL) occurred in 71 o f the cats at various times throughout the study. Clinical signs of hypoglycemia were generally mild in nature (described as lethargic, slu ggish, weak, trembling, uncoordinated, groggy, glassy-eyed or dazed). In 17 cases, the veterinarian provided oral glucose supplementation or food as treatmen t. Most cases were no t associated with clini cal signs and received no treatmen t. One cat had a serious hypoglycemic even t associated with stupo r, lateral recumbency, hypothermia and seizu res. All cases o f hypoglycemia resolved with app rop riate therapy and, i f needed, a dose reduction. Three cats had injection site reactions, which were described as either small, punctate, red lesions; lesions on neck; or palpable subcutaneous thickening. All injection site reactions resolved without cessation of therapy. Four cats developed diabetic neuropathy during the study as evidenced by plantigrade stan ce. Th ree cats en tered the stud y with plantigrade stan ce, one o f whi ch resolved by Day 45. Four cats were diagnosed with diabetic ketoacidosis during the study. Two were euthanized due to poor response to treatment. Five other cats were euthanized during the study, one of which had hypoglycemia. Four cats had received ProZinc insulin for less than a week and were euthanized due to worsening concurrent medical conditions. The follo wi ng additional clini cal observations o r diagnoses were repo rted in cats du ri ng the effectiveness field study: vomiting, lethargy, diarrhea, cystitis/hematuria, upper respiratory infection, dry coat, hair loss, ocular discharge, abnormal vocalization, black stool, and rapid breathing. Extended Use Field S tudy Cats that completed the effectiven ess stud y were en rolled in to an extended use field stud y. In this stud y, 145 cats received P roZinc insulin fo r up to an additional 1 36 d ays. Adverse reactions were similar to those reported during the 45-day effectiveness study and are listed in order of decreasing frequency: vomiting, hypoglycemia, anorexia/ poor appetite, diarrhea, lethargy, cystitis/hematuria, and weakness. Twenty cats had signs consistent with hypoglycemia described as: sluggish, lethargic, unsteady, wobbly, seizures, trembling, or dazed. Most of these were treated by the owner or veterinarian with oral glucose supplementation or food; others received intravenous glucose. One cat had a serious hypoglycemic event associated with seizures and blindness. The cat fully recovered after supportive therapy and finished the study. All cases of hypoglycemia resolved with appropriate therapy and if needed, a dose reduction. Fourteen cats died or were euthanized during the extended use study. In two cases, continued use of insulin despite anorexia and signs of hypoglycemia contributed to the deaths. In one case, the owner decided not to continue therapy after a presumed episode of hypoglycemia. The rest were due to concurrent medical conditions or worsening of the diabetes mellitus. To report suspected adverse reactions, or to obtain a copy of the Material Safety Data Sheet (MSDS), call 1-866-638-22 26. Information for Cat Owners: Please refer to the Cat Owner Information Sheet for more information about ProZinc insulin. ProZinc insulin, like other insulin products, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be in fo rmed o f the associated clini cal signs. Po tential adverse reactions include: hypoglycemia, insulin an tagonism/resistan ce, rapid insulin metabolism, insulin-i ndu ced hyperglycemia (Somo gyi Effect), and lo cal o r sys temic reactions. The most common adverse reaction observed is hypoglycemia. Signs may include: weakn ess, dep ression, behavio ral changes, muscle twitchi ng, and anxiety. In severe cases o f hypoglycemia, seizu res and coma can occu r. Hypoglycemia can be fatal i f an affected cat d oes no t receive prompt treatment. Appropriate veterinary monitoring of blood glucose, adjustment of insulin dose and regimen as needed, and stabilization of diet and activity help minimize the risk o f hypoglycemic episod es. The attendi ng veterinarian should evaluate other adverse reactions on a case-by-case b asis to determine i f an adjustmen t in therapy is app rop riate, or i f alternative therapy should be considered. Effectiveness: A total of 187 client-owned cats were enrolled in a 45-day field study, with 176 receiving ProZinc insulin. One hundred and fifty-one cats were included in the effectiveness analysis. The patients included various purebred and mixed breed cats rangi ng in age from 3 to 19 years and in weigh t from 4.6 to 20.8 pou nds. Of the cats included in the effectiven ess analysis, 101 were castrated males, 49 we re sp ayed females, and 1 was an in tact female. Cats were started on ProZinc insulin at a dose of 0.1-0.3 IU/lb (0.2-0.7 IU/kg) twice daily. Cats were evaluated at 7, 14, 30, and 45 days after initiation of therapy, and the dose was adjusted based on clinical signs and results of 9-hour blood glucose curves on Days 7, 14, and 30. Effectiveness was based on successful control of diabetes, which was defined as improvement in at least one blood glucose variable (glucose curve mean, nadir, or fructosamine) and at least one clinical sign (polyuria, polydipsia, or body weight). Based on this definition, 115 of 151 cases (7 6.2%) were considered successful. Blood glucose curve means decreased from 415.3 mg/dL on Day 0 to 203.2 mg/dL by Day 45, and the mean blood glucose nadir decreased from 407.9 mg/dL on Day 0 to 14 2.4 mg/dL on Day 45. Mean fructosamine values decreased from 505.9 µmol/L on Day 0 to 380.7 µmol/L on Day 45. Cats that completed the effectiveness study were enrolled in an extended use field study. The mean fructosamine value was 34 2.0 µmol/L after a total of 181 days of ProZinc therapy. How Supplied: P roZinc insulin is supplied as a sterile injectable suspension in 10-mL multidose vials. Each mL o f P roZinc p roduct con tains 40 IU recombinan t human insulin. Storage Conditions: Store in an upright position under refrigeration at 36-46°F (2-8°C). Do no t freeze. P ro tect from ligh t. Manu factu red for: Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO 64506 U.S.A. Manufactured by: Alcami Carolin as Corpo ration, C harleston, SC 29405 P roZin c® is a registered trademark o f Boeh ri nger I ngelh eim Vetmedi ca, Inc. © 2016 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved. 449901-02 Revised 06/2016 Code 449911 NADA 141-297, Approved by FDA ProZinc® (protamine zinc recombinant human insulin)

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