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NEW Alfaxan® Brief Summary of Prescribing Information ® Multidose Alfaxan Multidose Registered for induction and maintenance of anesthesia For Animal Use Only NADA#141-342 patient. during the transition to inhalant maintenance anesthesia, Alfaxan® Multidose ( 10 mg/mL) Inhalant maintenance of general anesthesia in especially with higher doses and rapid administration. General dosing instructions for and cats Intravenous injectable anesthetic for use in cats and dogs. and dogs: Additional low doses of Alfaxan® Multidose, similar to Endotracheal intubation, oxygen supplementation, and BRIEF SUMMARY OF PRESCRIBING INFORMATION a maintenance dose, may be required to facilitate the transition intermittent positive pressure ventilation (IPPV) should be can create stress. This summary does not include all the information needed to inhalant maintenance anesthesia. administered to treat and associated hypoxemia. Maintenance of Maintenance of Blood Pressure: The myocardial depressive effects of to use Alfaxan® Multidose safely and effectively. See full WARNINGS: Dose package insert for complete information. Alfaxan® Multidose combined with the vasodilatory Anesthesia Anesthesia Animal Safety: When anesthetized using Alfaxan® effects of inhalant can be additive, resulting in CAUTION: Multidose, patients should be continuously monitored, . Preanesthetics may increase the anesthesia Manage it with Federal law restricts this drug to use by or on the order of a and facilities for the maintenance of a patent airway, effect of Alfaxan® Multidose and result in more pronounced Induction 2 mg/kg 5-10 mins 5 mg/kg 15-30 mins licensed . artificial ventilation, and oxygen supplementation must be changes in systolic, diastolic, and mean arterial blood ® INDICATIONS: immediately available. pressures. Transient hypertension may occur, possibly due Maintenance 1.5-2.2 mg/kg 6-8 mins 1.4-1.5 mg/kg 3-5 mins Alfaxan® Multidose is indicated for the induction and Rapid bolus administration or anesthetic overdose may to elevated sympathetic activity. Alfaxan Multidose cause cardiorespiratory depression, including hypotension, Body Temperature: A decrease in body temperature occurs maintenance of anesthesia, and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in apnea, , or death. may occur secondary during Alfaxan® Multidose anesthesia unless an external cats and dogs. to apnea and hypoxia. In cases of anesthetic overdose, heat source is provided. Supplemental heat should be (alfaxalone 10 mg/mL injectable anesthetic) stop Alfaxan® Multidose administration and administer provided to maintain acceptable core body temperature DOSAGE AND ADMINISTRATION (highlights): Please refer treatment as indicated by the patient’s clinical signs. until full recovery. Now FDA registered to the complete package insert for full prescribing and Breeding Animals: Alfaxan® Multidose has not been Cardiovascular depression should be treated with plasma administration information before use of this product. evaluated in pregnant, lactating, and breeding cats. for 28 days of use expanders, pressor agents, anti-arrhythmic agents or other Registered dosing ranges for dogs and cats, with and without Administer by intravenous only. For induction, Alfaxalone crosses the , and as with other general techniques as appropriate for the treatment of the clinical after broaching administer Alfaxan® Multidose over approximately 60 anesthetic agents, the administration of alfaxalone may be signs. seconds or until clinical signs show the onset of anesthesia, associated with neonatal depression. titrating administration against the response of the Kittens and Puppies: Alfaxan® Multidose has not been Average Alfaxan Multidose Induction Dose Human Safety: Not for human use. Keep out of the reach patient. Rapid administration of Alfaxan® Multidose may be evaluated in cats less than 4 weeks of age or in dogs less than of children. associated with an increased incidence of cardiorespiratory 10 weeks of age. Premedicant (and range) in mg/kg Alfaxan® Multidose should be managed to prevent the risk depression or apnea. Apnea can occur following induction Compromised or Debilitated Cats and Dogs: The of diversion, through such measures as restriction of access or after the administration of maintenance boluses of administration of Alfaxan® Multidose to debilitated and the use of drug accountability procedures appropriate Dog Cat Alfaxan® Multidose. The use of preanesthetics may reduce patients or patients with renal disease, hepatic disease, or to the clinical setting. the Alfaxan® Multidose induction dose. The choice and the cardiorespiratory disease has not been evaluated. Doses may amount of phenothiazine, alpha2- adrenoreceptor agonist, Exercise caution to avoid accidental self-injection. Overdose need adjustment for geriatric or debilitated patients. Caution No premedicant 2.2 (1.5 – 4.5) 4.0 ( 2.2 – 9.7) or will influence the response of is likely to cause cardiorespiratory depression (such as should be used in cats or dogs with cardiac, respiratory, renal the patient to an induction dose of Alfaxan® Multidose. hypotension, bradycardia and/or apnea). Remove the or hepatic impairment, or in hypovolemic or debilitated cats Benzodiazepine + opioid + acepromazine 1.7 (0.9 – 3.5) 2.3 (1.2 – 5.0) individual from the source of exposure and seek medical and dogs, and geriatric animals. attention. Respiratory depression should be treated by When using Alfaxan® Multidose, patients should Analgesia during anesthesia: Appropriate analgesia artificial ventilation and oxygen. Opioid + acepromazine 1.6 (0.6 – 3.5) 3.2 (1.1 – 10.8) be continuously monitored, and facilities for the should be provided for painful procedures. maintenance of a patent airway, artificial ventilation, and Avoid contact of this product with skin, eyes, and clothes. In ADVERSE REACTIONS: oxygen supplementation must be immediately available. case of contact, eyes and skin should be liberally flushed with The primary side effects of alfaxalone are respiratory depression Alpha 2-agonist 1.1 (0.2 – 2.0) 3.6 (1.1 – 5.0) water for 15 minutes. Consult a physician if irritation persists. (apnea, bradypnea, hypoxia) and cardiovascular derangements In the case of accidental human ingestion, seek medical (hypertension, hypotension, tachycardia, bradycardia). (See full prescribing information, including some other combinations of premedicants) Alfaxan® Multidose contains preservatives. Use within 28 advice immediately and show the package insert or the Other adverse reactions observed in clinical studies include days of first puncture. Any unused Alfaxan® Multidose label to the physician. hypothermia, emesis, unacceptable anesthesia quality, lack of remaining after 28 days should be discarded. The Material Safety Data Sheet (MSDS) contains more detailed effectiveness, vocalization, paddling, and muscle tremors.

Alfaxan® Multidose should not be mixed with other occupational safety information. To report adverse reactions or obtain a copy of the SDS for this therapeutic agents prior to administration. product call 1-844-253-2926. To report adverse reactions in users or to obtain a copy of the For additional information about adverse drug experience INDUCTION OF GENERAL ANESTHESIA: MSDS for this product call 1-844-253-2926. reporting for animal drugs, contact FDA at 1-888-FDA-VETS or CATS: Induction dose guidelines range between 2.2 - 9.7 mg/ DRUG ABUSE AND DEPENDENCE: http://www.fda.gov/AnimalVeterinary/SafetyHealth. kg for cats that did not receive a preanesthetic, and between

1.0 - 10.8 mg/kg for cats that received a preanesthetic. The Controlled Substance: Alfaxan® Multidose contains alfaxalone, OVERDOSE: Rapid administration, accidental overdose, alfaxalone induction dose in the field study was reduced by a anesthetic and a class IV controlled substance. or relative overdose due to inadequate dose sparing of

10 - 43%, depending on the combination of preanesthetics Abuse: Alfaxalone is a central nervous system that Alfaxan® Multidose in the presence of preanesthetics may Fair Balance Statement (dose sparing effect). acts on GABA associated channels, similar cause cardiopulmonary depression. Respiratory arrest (apnea) may be observed. In cases of respiratory depression, DOGS: Induction dose guidelines range between 1.5 - 4.5 to the mechanism of action of Schedule IV such as Alfaxan® Multidose (alfaxalone 10 mg/mL) stop drug administration, establish a patent airway, and mg/kg for dogs that did not receive a preanesthetic, ( and ), Indications: Alfaxan® Multidose is indicated for the induction and maintenance of anesthesia and for the induction of anesthesia followed by initiate assisted or controlled ventilation with pure oxygen. and between 0.2 - 3.5 mg/kg for dogs that received a ( and ) and . In a drug Cardiovascular depression should be treated with plasma maintenance with an inhalant anesthetic in cats and dogs. preanesthetic. The Alfaxalone induction dose in the discrimination behavioral test in rats, the effects of alfaxalone expanders, pressor agents, antiarrhythmic agents or other field study was reduced by 23 - 50% depending on the were recognized as similar to those of midazolam. These Important Alfaxan® Multidose Risk Information: Warnings, precautions and Contraindications: When using Alfaxan® Multidose patients should techniques as appropriate for the observed abnormality. combination of preanesthetics (dose sparing effect). biochemical and behavioral data suggest that alfaxalone has be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be an abuse potential similar to other Schedule IV sedatives. HOW SUPPLIED: Dose sparing of Alfaxan® Multidose will depend on the Physical dependence: There are no data that assess Alfaxan® Multidose is supplied in 10 mL and 20 mL immediately available. Careful monitoring of the patient is necessary due to the possibility of rapid arousal. Alfaxan® Multidose is contraindicated in potency, dose, and time od administration of the various the ability of alfaxalone to induce physical dependence. multiple-dose vials containing 10 mg alfaxalone per mL. cats and dogs with a known sensitivity to alfaxalone or its components, or when general anesthesia and/or sedation are contraindicated. preanesthetics that are used prior to induction. To avoid However, alfaxalone has a mechanism of action similar Manufactured in by: Jurox Pty Ltd. Adverse Drug Reactions: the most common side effects of alfaxalone include respiratory and cardiovascular derangements, such as apnea, anesthetic overdose, titrate the administration of Alfaxan® to the benzodiazepines and can block the behavioral Marketed by: Multidose against the response of the patient. The average responses associated with precipitated benzodiazepine hypotension and hypertension. Appropriate analgesia should be provided for all painful procedures. Jurox Inc. Alfaxan® Multidose induction dose rates for healthy cats and withdrawal. Therefore, it is likely that alfaxalone can Kansas City, MO 64111 Storage and How Supplied: Alfaxan® Multidose should be stored at room temperature (i.e. 68-77°F). Alfaxan® Multidose contains preservatives dogs given alfaxalone alone, or when alfaxalone is preceded also produce physical dependence and withdrawal Phone: 1-844-253-2926 by a preanesthetic, are indicated in species specific tables signs similar to that produced by the benzodiazepines. and is supplied in 10 mL and 20 mL multiple-dose vials. The product can be used for 28 days after broaching the vial and should be stored at room Distributed by: found in the full package insert. These tables are based on field Psychological dependence: The ability of alfaxalone temperature during that period. Any unused Alfaxan® Multidose remaining after 28 days should be discarded. study results and are for guidance only. The dose and rate for Vedco, Inc. to produce psychological dependence is unknown St Joseph, MO 64507 Controlled Substance: Alfaxan® Multidose contains alfaxalone, a neurosteroid anesthetic and a class IV controlled substance. alfaxalone should be based upon patient response. because there are no data on the rewarding properties MAINTENANCE OF GENERAL ANESTHESIA: of the drug from animal self-administration studies or Alfaxan is a registered trademark of Jurox Pty Limited. FOI Summary: NADA #141-342 CATS and DOGS: Following induction of anesthesia with from human abuse potential studies. US Patent # 7897586 US Patents: #7897586 and #9492552 US Patent # 9492552 Alfaxan® Multidose and intubation, anesthesia may PRECAUTIONS: See full package for complete information. be maintained using intermittent Alfaxan® Multidose Rapid arousal: Careful monitoring of the patient is intravenous boluses or an inhalant anesthetic agent. necessary due to possibility of rapid arousal. Please review the full package insert for guidance on Preanesthesia: Benzodiazepines may be used safely recommended intermittent doses of Alfaxan® Multidose prior to Alfaxan® Multidose in the presence of other 1) Jurox and Ricera, ”An in vitro study evaluating the binding of alfaxalone…” (Ricerca Study No. AA94464). Records in house 2010; 2) Jurox and Ricera, ”An in vitro study evaluating the binding and the expected duration of effect. Clinical response preanesthetics. However, when a benzodiazepine was of alfaxalone…” (Ricerca Study No. AA94047). Records in house 2010; 3) Ibid; 4) Muir, W., et al, “The cardiorespiratory…of alfaxalone in dogs,” Vet Anaesth. and Analg., 2008. 35[6]: 451-462; 5) 4520 Main Street may vary, and is determined by the dose, rate of Muir, W., et al, “The cardiorespiratory…of alfaxalone in cats,” Vet Anaesth. and Analg., 2009. 36[1]: 42-54; 6) Pasloske, K., et al, “A multicenter clinical trial evaluating…Alfaxan administered for used as the sole preanesthetic, excitation occurred dogs…” in Brit. Small Animal Vet. Assn. Cong. 2005; 7) Pasloske, K., et al, “A multicenter clinical trial evaluating…Alfaxan administered for cats…” in Brit. Small Animal Vet. Assn. Cong. 2007; Kansas City, MO 64111 administration, and frequency of maintenance injections. in some dogs and cats during Alfaxan® Multidose 8) See full prescribing information for guidance on the effects of different premedicant regimes on expected induction and maintenance doses of alfaxalone; 9) Ferre, P. J., et al, ”Plasma anesthesia and recovery. of alfaxaone…,” CD RTU Vet Anaesth. and Analg., 2006, 33[4], 229-36; 10) Pasloske, K., et al, “Plasma pharmacokinetics of alfaxalone…Greyhound dogs…” Jrnl. of Vet. Alfaxan® Multidose maintenance dose sparing is greater in cats rd 844-253-2926 Apnea: Apnea may occur following administration of an Pharma. and Thera., 2009. 32: 510-513; 11) Metcalfe, S., et al, “A multi-centre clinical trial evaluating…of Alfaxan administered to bitches…,” 33 World Small Animal Congress, 2008. WSAVA/ and dogs that receive a preanesthetic. Maintenance dose and FECAVA; 12) O’Hagan, B, et al,” Clinical evaluation of alfaxalone…in dogs less than 12 weeks of age;” Australian Vet. Jrnl., 2012. 90[10], 395-401; 13) O’Hagan, B, et al,” Clinical evaluation of www.jurox.com/us frequency should be based on the response of the individual induction dose, a maintenance dose or a dose administered alfaxalone…in cats less than 12 weeks of age;” Australian Vet. Jrnl., 2012. 90[9], 346-350; 14) “Alfaxan…for use in cats and dogs,” US-FDA prescribing information, Rev. February, 2014; 15) Psatha, E., et al, “Clinical efficacy…,” Vet. Anaesth. Analg., 2011.38: 24-36; 16) Schnell, M., et al, “Margin of safety of the anesthetic Alfaxan®, CD RTU…dogs” in ACVIM, 2004; 17) Pasloske, K. and Whittem, T., JX9604.07-H004, "A target animal safety study in cats…,” 2004. On file at Jurox; 18) Whittem, T.,et al “The pharmacokinetics and pharmacodynamics of alfaxalone in cats...at © 2018 Jurox Pty Ltd clinical and supraclinical doses." J Vet Pharmacol Therap 2008;31(6):571-579. 19) Pasloske K et al. "The bioequivalence...alfaxalone in plus preservatives...cats", J Vet Pharmacol Therap Alfaxan is a registered trademark of Jurox Pty Ltd 2018;41(3):437-446. 20) Goodwin WA and Pasloske K. "A dose ranging study evaluating the pharmacodynamics of RD0327 as an anaesthetic and in after IM administration. Abstract (O14-1, pg.161), World Congress of Veterinary Anaesthesiology 02SEP15, Kyoto, . Comorbidities and other risk factors add uncertainty to outcomes Alfaxan Multidose - Breathe easier with alfaxalone's Rapid recoveries -

proceed with confidence wide safety profile the final step to a positive outcome z

What is Alfaxan Multidose?

Alfaxan Multidose has the same effectiveness, versatility Helps maintain acceptable cardiovascular Rapid drug elimination and and wide safety profile as original Alfaxan, but with a and respiratory parameters quick recoveries re-unite the non-irritating preservative that allows the product to be used for up to 28 days after the vial is broached and animal and client sooner, stored at room temperature. Wide safety margin in case of accidental so you and your staff can overdose: The preservative system in Alfaxan Multidose is assist other patients. v comprised of ethanol (150 mg/mL), chlorocresol (1.0 mg/mL), and benzethonium chloride (0.2 mg/mL). Dogs and cats recover from doses Alfaxalone is handled by the Alfaxan Multidose contains alfaxalone, a neuroactive equal to 10× and 5× recommended molecule that does not bind to sex hormone, rates, respectively, with only short-term patient much like New Alfaxan Multidose or mineralcorticoid receptors.1,2 Now FDA registered for 28 days ventilation4,5 • GABA is one of the major inhibitory of use after broaching neurotransmitters derived from the amino Metabolized in the acid glutamate Repeated over-dosing (dogs and • GABA and alfaxalone work in tandem producing cats received three doses 5× the Inactive metabolites excreted anesthesia by enhancing GABAA receptor-mediated neurotransmission3 recommended dose, every 48 hours) in the and . caused no observable adverse effects16,17 Effectiveness Versatility Average time to extubation after Alfaxalone does not accumulate18. discontinuation of maintenance Quick, anxiety-free unconsciousness4,5,6,7 with • FDA-registered for use in dogs AND cats muscle relaxation4,5 allows rapid intubation and • Use for induction AND maintenance of anesthesia Administer repeat boluses to maintain anesthesia ≈ 15 minutes transition to maintenance anesthesia • Use confidently among healthy populations, anesthesia • Works reliably with all premedicants8 special populations (brachycephalic patients, Average time to standing after • Rapid onset of anesthesia4,5,9 (usually within Sighthounds10, C-sections11 and juvenile dogs and 60 seconds) cats12,13,14), compromised patients (ASA I-V15) No pain upon injection IV and non extubation ≈ 20 minutes • The use of premedicants may reduce the irritating to tissue19,20 Alfaxan Multidose induction dose