Companion Animal Product & Promotions Guide

Tablets and Injectable Solution Antiemetic CERENIA Tablets For oral use in dogs only CERENIA Injectable For subcutaneous or intravenous injection in dogs and cats CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: CERENIA (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs. CERENIA (maropitant citrate) Injectable Solution is indicated for the prevention and treatment of acute vomiting in dogs and for the treatment of vomiting in cats. DOSAGE AND ADMINISTRATION: For Prevention of Acute Vomiting (CERENIA Tablets) For Prevention of Acute Vomiting in dogs 2-7 months of age: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety). For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting. If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing acute vomiting associated with chemotherapy if administered prior to the chemotherapeutic agent. For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose: Dog body weight Number of Tablets Pounds Kilograms 16 mg 24 mg 60 mg 8 4 1/2 15 8 1 25 12 1 50 24 2 65 30 1 130 60 2 Interchangeable use with CERENIA Injectable Solution for Prevention of Acute Vomiting: In dogs that are actively vomiting, to ensure that the full initial dose is administered, CERENIA Injectable Solution is recommended at a dose of 1 mg/kg once daily. Thereafter, for the prevention of acute vomiting, CERENIA Tablets at a dose of 2 mg/kg once daily may be used interchangeably with CERENIA Injectable Solution for up to 5 days. For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older (CERENIA Tablets) For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days (see WARNINGS and Animal Safety). Administer CERENIA Tablets a minimum of two hours prior to travel with a small amount of food to mitigate vomiting associated with administration of the dose on an empty stomach; however, refrain from feeding a full meal prior to travel. Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older: Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive days: Dog body weight Number of Tablets Pounds Kilograms 16 mg 24 mg 60 mg 160 mg 2 1 1/2 3 1.5 1/2 4 2 1 6 3 1 8 4 2 13 6 2 16 7.5 1 22 10 1/2 33 15 2 44 20 1 66 30 1 1/2 88 40 2 132 60 3 CERENIA Injectable Solution should not be used interchangeably with CERENIA Tablets for the prevention of vomiting due to motion sickness (8mg/kg). For Prevention and Treatment of Acute Vomiting in Dogs (CERENIA Injectable): Dogs 2-4 Months of Age: Administer CERENIA Injectable Solution subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days. Dogs 4 months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days. In dogs that are actively vomiting, it is recommended to initiate treatment with CERENIA Injectable Solution. Thereafter, CERENIA Tablets may be used for the prevention of acute vomiting at 2 mg/kg once daily. (See CERENIA Tablets package insert for complete prescribing information). For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time, 45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents. For Treatment of Vomiting in Cats 4 Months of Age and Older (CERENIA Injectable): Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days. The underlying cause of acute vomiting should be identified and addressed in dogs and cats that receive CERENIA Injectable Solution. If vomiting persists despite treatment, the case should be re-evaluated. INFORMATION FOR USE: If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing vomiting associated with chemotherapy if administered prior to the chemotherapeutic agent. For dogs, CERENIA Injectable Solution may be used interchangeably with CERENIA Tablets for once daily dosing for the prevention of acute vomiting. WARNINGS: Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. Wash hands with soap and water after administering drug. CERENIA is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention. In puppies younger than 11 weeks of age, histological evidence of bone marrow hypocellularity was observed at higher frequency and greater severity in puppies treated with CERENIA compared to control puppies. In puppies 16 weeks and older, bone marrow hypocellularity was not observed (see ANIMAL SAFETY). PRECAUTIONS: The safe use of CERENIA Tablets has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins. Use with caution in patients with hepatic dysfunction because CERENIA Injectable Solution is metabolized by CYP3A, CYP2D15 (dogs) and CYP1A (cats) enzymes (see Pharmacokinetics). The influence of concomitant drugs that may inhibit the metabolism of CERENIA Injectable Solution has not been evaluated. CERENIA Injectable Solution is highly protein bound. Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA Injectable Solution with other protein bound drugs has not been studied in dogs or cats. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. Drug compatibility should be monitored in patients requiring adjunctive therapy. CERENIA Tablets causes dose related decreases in appetite and body weight (see ANIMAL SAFETY). To maximize therapeutic potential of CERENIA Tablets, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA Tablets. The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. ADVERSE REACTIONS: Prevention of Acute Vomiting (minimum of 2 mg/kg) (CERENIA Tablets) The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs treated with CERENIA Tablets at a minimum of 2 mg/kg orally and/or Injectable Solution at 1 mg/kg subcutaneously once daily for up to 5 consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=69) CERENIA (n=206) # dogs % occurrence # dogs % occurrence Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 Endotoxic Shock 1 1.4 2 1 Hematuria 0 0 2 1 Excoriation 0 0 2 1 Other clinical signs were reported but were <0.5% of dogs. Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg) (CERENIA Tablets) The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs treated with CERENIA Tablets at a minimum of 8 mg/kg orally one time. Dogs may have experienced more than one of the observed adverse reactions. Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=195) CERENIA (n=208) # dogs % occurrence # dogs % occurrence Hypersalivation 19 9.7 26 12.5 Vomiting 1 0 0 11 5.3 Muscle Tremors 1 0.5 2 1 Sedation/Depression 3 1.5 2 1 Retching 3 1.5 1 0.5 Flatulence 0 0 1 0.5 1 Not associated with motion sickness The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in dogs treated with CERENIA Tablets at a minimum of 8 mg/kg orally once daily for 2 consecutive days. Dogs may have experienced more than one of the observed adverse reactions. Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=106) CERENIA (n=107) # dogs % occurrence # dogs % occurrence Vomiting 4 4 10 9 Drowsiness/Lethargy/Apathy 1 1 8 8 Hypersalivation 2 2 5 5 Anxiety 0 0 2 2 Trembling/Tremors 0 0 2 2 Inappetence 0 0 2 2 Mucus in stool 0 0 1 1 The following Adverse Reactions were reported during the conduct of a US clinical field trial where CERENIA Tablets were administered once daily for 28 consecutive days to 32 dogs: lethargy, vomiting, inappetence, corneal edema, and enlarged lymph nodes. Post-Approval Experience (CERENIA Tablets - Revised May 2019) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for dogs are listed in decreasing order of frequency: anorexia, depression/lethargy, hypersalivation, vomiting, diarrhea, trembling, ataxia, allergic reactions, weight loss, convulsion, hyperactivity, and panting. Cases of ineffectiveness have been reported. Cases of death (including euthanasia) have been reported. To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com. (CERENIA Injectable): 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. For a complete listing of adverse reactions for CERENIA Injectable Solution reported to CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055369.htm For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call Zoetis Inc. at 1-888-963-8471. DOGS: In a US field study for the prevention and treatment of vomiting associated with administration of cisplatin for cancer chemotherapy, the following adverse reactions were reported in 77 dogs treated with CERENIA Injectable Solution at 1 mg/kg subcutaneously or 41 dogs treated with placebo: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=41) CERENIA (n=77) # dogs % occur # dogs % occur Diarrhea 1 2.4 6 7.8 Anorexia 0 0 4 5.2 Injection site reaction (swelling, pain upon injection) 0 0 3 4 Lethargy 1 2.4 2 2.6 Brief Summary of Prescribing Information The following adverse reactions were reported during the course of a US field study for the prevention and treatment of acute vomiting in dogs treated with 1 mg/kg CERENIA Injectable Solution subcutaneously and/or CERENIA Tablets at a minimum of 2 mg/kg orally once daily for up to 5 consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=69) CERENIA (n=206) # dogs % occur # dogs % occur Death during study 4 5.8 10 4.9 Euthanized during study 0 0 2 1 Diarrhea 6 8.7 8 3.9 Hematochezia/bloody stool 5 7.2 4 1.9 Anorexia 2 2.9 3 1.5 Otitis/Otorrhea 0 0 3 1.5 Endotoxic Shock 1 1.4 2 1 Hematuria 0 0 2 1 Excoriation 0 0 2 1 Other clinical signs were reported but were <0.5% of dogs. Adverse reactions seen in a European field study included ataxia, lethargy and injection site soreness in one dog treated with CERENIA Injectable Solution. Post-Approval Experience ( Rev. 2015 CERENIA Injectable Solution) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for dogs are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Pain/vocalization upon injection, depression/ lethargy, anorexia, anaphylaxis/anaphylactoid reactions (including swelling of the head/face), ataxia, convulsions, hypersalivation, tremors, fever, dyspnea, collapse/loss of consciousness, recumbency, injection site reactions (swelling, inflammation) and sedation. Cases of death (including euthanasia) have been reported. CATS: The following adverse reactions were reported during the course of a US field study for the treatment of vomiting in cats treated with 1 mg/kg CERENIA Injectable Solution subcutaneously once daily for up to five consecutive days: Frequency of Adverse Reactions by Treatment Adverse Reaction Placebo (n=62) CERENIA (n=133) # cats % occur # cats % occur Moderate Response to Injection 1,2 1 1.6 30 22.6 Significant Response to Injection 1,3 1 1.6 15 11.3 Fever/Pyrexia 2 3.2 2 1.5 Dehydration 0 0 3 2.3 Lethargy 0 0 2 1.5 Anorexia 0 0 1 0.8 Hematuria 0 0 1 0.8 Hypersalivation 0 0 1 0.8 Injection site swelling 1 1.6 0 0 1 The clinician observed and graded each cat's response to injection. 2 Cat objected to the injection by retreating and vocalizing 3 Cat objected to the injection by retreating, hissing, scratching, and vocalization Post-Approval Experience ( Rev. 2015 CERENIA Injectable Solution) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported for cats are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Depression/lethargy, anorexia, hypersalivation, pain/vocalization upon injection, dyspnea, ataxia, fever, recumbency, vomiting, panting, convulsion, and muscle tremor. Cases of death (including euthanasia) have been reported. CLINICAL EXPERIENCE (CERENIA Injectable): The pain or vocalization upon injection resolves within minutes without treatment. Administration of CERENIA Injectable Solution at refrigerated temperature may mitigate this response (see DOSAGE AND ADMINISTRATION). Allergic reactions typically resolve with treatment within 48 hours after discontinuing CERENIA administration. STORAGE CONDITIONS: CERENIA Tablets should be stored at controlled room temperature 20°–25°C (68°–77°F) with excursions between 15°–30°C (59°–86°F). CERENIA Injectable Solution should be stored at controlled room temperature 20-25°C (68-77°F) with excursions between 15-30°C (59-86°F). After first vial puncture, CERENIA Injectable Solution should be stored at refrigerated temperature 2-8°C (36-46°F). Use within 90 days of first vial puncture. Stopper may be punctured a maximum of 25 times. HOW SUPPLIED: CERENIA peach-colored tablets are scored with a break line, and contain 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet. Each tablet is marked with "MPT" and the tablet strength. Each tablet size is packaged in a bottle containing 60 tablets and packaged in blister packs containing 4 tablets per perforated sheet. CERENIA Injectable Solution is supplied in 20 mL amber glass vials. Each mL contains 10 mg of maropitant as maropitant citrate. Approved by FDA under NADA # 141-262 Approved by FDA under NADA # 141-263 Distributed by: Zoetis Inc. Kalamazoo MI 49007 Based on Cerenia Tablets PI 8834091, Revised May 2019; and Cerenia Injectable Solution PI 4019387, Revised March 2019 8834091/4019387A&P

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