Buprenorphine

Indications

Ethiqa XR is indicated for the control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates.

Dosage and Administration

Wear protective clothing when administering Ethiqa XR. Do not dispense Ethiqa XR for administration at home by the pet owner (see HUMAN SAFETY WARNINGS ). Dosing Administer Ethiqa XR subcutaneously according to the dose listed in the table for the appropriate species. Doses were derived either from published literature or using allometric principles. Consider the time to reach estimated therapeutic blood levels when administering Ethiqa XR for post-procedural pain. If needed, a single repeat dose may be administered subcutaneously 72 hours after the initial dose. Definitive therapeutic blood levels of Ethiqa XR have not been established for all species. The times to reach blood levels thought to be therapeutic is presented below and is representative of what has been found in published literature. For more information, consult the published literature referenced at the end of this package insert. DOSING TABLE FOR SUBCUTANEOUS INJECTION OF ETHIQA XR Species Ethiqa XR Dose (mg/kg body weight) Time to reach estimated therapeutic blood levels Precautions/ Adverse Events Mice 3.25 mg/kg 10 30 minutes 10 • Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly. 5 • Granulomatous inflammatory nodules have been observed in naked-skinned mice and rats administered Ethiqa XR. 4,5 • In one study, two male mice died following the third surgery and redosing; weight loss. 11 Naked mole rats (NMR) 3.25 mg/kg* • No published data available administering Ethiqa XR to naked mole rats. Gerbils 1 mg/kg 13 30 minutes 13 • Granulomatous inflammation at injection site. 13 Hamsters 0.8 mg/kg* • No published data available administering Ethiqa XR to hamsters. Rats 0.65 mg/kg 12 4 hours 16 • Nausea within 24 hrs of dosing, self-licking, self-gnawing and efforts to eat wood-chip bedding, one out of 36 rats exposed to wood bedding died 3,12 , 3 of 222 rats bled profusely from jugular vein, which was used for obtaining blood samples, and died. • Granulomatous inflammatory nodules have been observed in naked-skinned mice and rats administered Ethiqa XR. 4,5 Chinchillas 0.48 mg/kg* • No published data available administering Ethiqa XR to chinchillas. Guinea pigs 0.48 mg/kg 17* 8 hours 17 • Decrease in body weight 14,17 and fecal output. 14 Increase in passive behavior, such as eyes closed or squinting, subtle body movement, and incomplete movement. 17 Prairie dogs 0.48 mg/kg* • No published data available administering Ethiqa XR to prairie dogs. Ferrets 0.6 mg/kg 9 30 minutes 9 • No adverse reactions observed. 9 Non-human primates 0.2 mg/kg 6 15 minutes 6 • Injection site reactions including inflammation and necrosis have been observed in common marmosets. 6 • Mild sedation, decreased body weight, increased cage movements, acute necrosis and inflammation at the injection site. 6 Laboratory rabbits 0.15 mg/kg 19 • 60 minutes 19 • 30 minutes in female and 60 minutes in male rabbits 20 • Reduced fecal output post-operatively. Returned to normal at 72 hours. 19 *These doses are based on allometric principles. Allometric principles (i.e., animals among closely related species and of similar body size should have similar metabolic rates) can be used to determine the dose of Ethiqa XR for rodent species not listed in the table above and where no published data is available. For example, doses for hamsters and guinea pigs were calculated using published allometric scaling factors (see Nair 21 and FDA 22 for detailed discussion and how to apply allometric scaling). The dose of Ethiqa XR can also be estimated by using the known dose for a rodent species of similar size (the doses listed in the table above for NMR, chinchillas, and prairie dogs were calculated using this approach). Based upon the time to reach estimated therapeutic blood levels, Ethiqa XR can be administered 30 minutes prior to painful stimulus in mice 10 and gerbils 13 , 8-12 hours prior in guinea pigs 17 , 60 minutes prior in laboratory rabbits 19 , and 15 minutes prior in non-human primates. 6 Administration Shake the vial well before each use to ensure uniform suspension. If stored refrigerated, bring to room temperature before use. Use aseptic technique to subcutaneously administer Ethiqa XR by utilizing minimally stressful restraint techniques or sedation. An oily sheen may be observed in the fur after injection due to leakage of Ethiqa XR, which is an oil-based drug suspension, from the injection site. The oily sheen may last for 4 to 5 days post-injection. Leakage from the injection site can be minimized by slowly injecting Ethiqa XR into the subcutaneous space. Do not return any unused drug suspension from the syringe back into the vial. The animal can be returned to its cage immediately after receiving Ethiqa XR. (See CONTRAINDICATIONS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION for additional information on bedding.)

Contraindications

Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use in animals with pre-existing respiratory compromise. Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Signs of nausea, including pica, have been observed in rats for up to 3 days post-treatment with Ethiqa XR. Pica involving wood chip type bedding can be lethal (see ADVERSE REACTIONS ). HUMAN SAFETY WARNINGS Not for use in humans. Keep this and all medications out of reach of children and pets. Human User Safety While Handling Ethiqa XR in the Hospital: Ethiqa XR should only be handled and administered by a veterinarian, veterinary technician, or laboratory staff trained in the handling of potent opioids. To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during injection of Ethiqa XR. Wear protective clothing when administering Ethiqa XR. Mucous Membrane or Eye Contact During Application: Direct contact of Ethiqa XR with the eyes, oral, or other mucous membranes could result in absorption of buprenorphine and the potential for adverse reactions. If accidental eye, oral, or other mucous membrane contact is made during application, flush the area with water and contact a physician immediately. If wearing contact lenses, flush the eye first and then remove the contact lens. Skin Contact During Application: If human skin is accidentally exposed to ETHIQA XR, wash the exposed area immediately with soap and water and contact a physician. Accidental exposure could result in absorption of buprenorphine and the potential for adverse reactions. Drug Abuse, Addiction, and Diversion of Opioids: Controlled Substance: Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. Abuse: Ethiqa XR contains buprenorphine, an opioid substance, that can be abused and is subject to misuse, abuse, and addiction, which may lead to overdose and death. This risk is increased with concurrent use of alcohol and other central nervous system depressants, including other opioids and benzodiazepines. Ethiqa XR should be handled appropriately to minimize the risk of diversion, including restriction of access, the use of accounting procedures, and proper disposal methods, as appropriate to the clinical setting and as required by law. Prescription drug abuse is the intentional, non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse. Storage and Disposal: Ethiqa XR is a Schedule III opioid. Store in a locked cabinet according to federal and state controlled substance requirements/guidelines. Discard any broached vials after 90 days. Any unused or expired vials must be destroyed by a reverse distributor; for further information, contact your local DEA field office or call Fidelis Animal Health at 1-833-384-4729. Information for Physician: Ethiqa XR contains a mu opioid partial agonist (1.3 mg buprenorphine/mL). In the case of an emergency, provide the physician with this package insert. Naloxone may not be effective in reversing respiratory depression produced by buprenorphine. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride has also been used as a respiratory stimulant.

Precautions

The use of paper or soft bedding for up to 3 days following administration of Ethiqa XR should be considered (see CONTRAINDICATIONS and ADVERSE REACTIONS ). Buprenorphine is excreted in the feces (see CLINICAL PHARMACOLOGY ). Coprophagy may lead to ingestion of buprenorphine or its metabolites by animals treated with Ethiqa XR and untreated cage mates. Ethiqa XR forms a depot near the injection site. Animals may exhibit an obtunded response to stimuli up to 4 hours after receiving Ethiqa XR. When using Ethiqa XR, an opiate antagonist such as naloxone, should be available in case reversal is required. Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR. The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised animals. Species-specific precautions described in the published literature are included in the dosing table under the DOSAGE AND ADMINISTRATION section.

Adverse Reactions

See the dosing table under the DOSAGE AND ADMINISTRATION section for species-specific adverse reactions.

Description

Ethiqa XR is an injectable suspension of extended-release buprenorphine. Ethiqa XR is an extended-release formulation using the Fidelipid LAI™ technology, a proprietary lipid combination of glycerides and cholesterol. Buprenorphine hydrochloride, an opioid analgesic, is the active ingredient in Ethiqa XR. Lipid-bound buprenorphine hydrochloride is suspended in medium chain fatty acid triglyceride (MCT) oil. Lipids encapsulate the buprenorphine limiting diffusion which provides for larger doses and prolonged action. 1,2 Ethiqa XR has a slightly yellow to white opaque appearance. Each mL contains approximately 1.3 mg buprenorphine hydrochloride. The sterile product contains cholesterol, benzyl alcohol, glyceryl tristearate, and buprenorphine hydrochloride suspended in MCT oil. Buprenorphine belongs to the opioid class of drugs and is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine. Buprenorphine Formula C 29 H 41 NO 4 STRUCTURE

Storage

Store between 15° and 25° C +/- 2°C (59° and 77°F) or refrigerated. DO NOT FREEZE. If stored refrigerated, bring to room temperature before use. Once broached, the multi-dose vial should be discarded after 90 days. Product could change its physical properties if not stored within the specified storage conditions and original vial container.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Zorbium TM (buprenorphine transdermal solution), Elanco US Inc.. Set id c00709bf-12fd-40fc-9cff-7a7e7390fcb8.
• Simbadol ®, Zoetis Inc.. Set id 3395bb4d-e032-4c16-81cf-d8f364033bb8.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming buprenorphine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.