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Brief Summary of Prescribing Information Antiemetic For subcutaneous injection in dogs and cats CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: 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: Administer CERENIA Injectable Solution subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 1 mL/10 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days. Use of refrigerated product may reduce the pain response associated with the injection. CERENIA Injectable Solution is recommended for use in dogs 8 weeks and older and cats 16 weeks and older. INFORMATION FOR USE: If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing vomiting associated with chemo- therapy 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 reach of children. In case of accidental injection or exposure, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. In case of accidental skin exposure, wash with soap and water. 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. PRECAUTIONS: The safe use of CERENIA has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. The safe use of CERENIA has not been evaluated in dogs or cats with gastrointestinal obstruction, or dogs or cats that have ingested toxins. Use with caution in patients with hepatic dysfunction because CERENIA is metabolized by CYP3A enzymes. Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA 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. The influence of concomitant drugs that may inhibit the metabolism of CERENIA has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. CERENIA causes dose related decreases in appetite and body weight. To maximize therapeutic potential of CERENIA, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA. ADVERSE REACTIONS: 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 Pfizer Animal Health at 1-800-366-5288. 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 0 0 3 4 (swelling, pain upon injection) Lethargy 1 2.4 2 2.6 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 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 are listed in decreasing order of reporting frequency in dogs: Pain/vocalization upon injection, depression/lethargy, anorexia, anaphylaxis/anaphylactoid reactions (including swelling of the head/face), ataxia, convulsions, and hypersalivation. 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 The FDA Center for Veterinary Medicine has received reports of adverse events associated with the use of CERENIA in cats since its approval for dogs in 2007. 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 are listed in decreasing order of reporting fre- quency in cats: depression/lethargy, anorexia, injection site pain, and hyper- salivation. STORAGE CONDITIONS: 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 Injectable Solution is supplied in 20 mL amber glass vials. Each mL contains 10 mg of maropitant as maropitant citrate. NADA #141-263, Approved by FDA Distributed by: Div. of Pfizer Inc, NY, NY 10017 Revised: February 2012 Made in France 8811852