Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL CIII is indicated for the control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. Please read the Important Safety Information and Boxed Warning information before reading the Frequently Asked Questions and Answers.
Please also refer to the full Package Insert. Frequently Asked Questions: Please call 833-ETHIQAXR (833-384-4729) with additional questions.
These FAQs provide general information and should not be used to substitute or replace a veterinarian’s individual or independent professional expertise or judgement.
In mice, rats, ferrets, laboratory rabbits, and non human primates: 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. Pica involving wood chip type bedding can be lethal. 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.
Animals may exhibit an obtunded response to stimuli up to 4 hours after receiving Ethiqa XR. Weight loss has been observed in mice treated post-procedurally with Ethiqa XR.
Ethiqa XR forms a depot near the injection site. Granulomatous inflammation nodules have been observed in naked-skinned mice, and rats administered Ethiqa XR.
| Species | Ethiqa EX Dose (mg/kg body weight) | Precautions/Adverse Events |
| Mice | 3.25 mg/kg | Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly. Granulomatous inflammatory nodules have been observed in naked-skinny mice and rats administered Ethiqa XR In one study, two male mice died following the third surgery and redosing; weight loss |
| Naked mole rats (NMR) | 3.25 mg/kg | No published data available administering Ethiqa XR to naked mole rats. |
| Gerbils | 1 mg/kg | Granulomatous inflammation at injection site. |
| Hamsters | 0.8 mg/kg | No published data available administering Ethiqa XR to hamsters. |
| Rats | 0.65 mg/kg | Nausea within 24 hours of dosing, self-licking, self-gnawing and efforts to eat wood-chip bedding, one out of 36 rats exposed to wood bedding died, 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. |
| Chinchillas | 0.48 mg/kg | No published data available administering Ethiqa XR to chinchillas. |
| Guinea pigs | 0.48 mg/kg | Decrease in body weight and fecal output. Increase in passive behavior, such as eyes closed or squinting, subtle body movement, and incomplete movement. |
| Prairie Dogs | 0.48 mg/kg | No published data available administering Ethiqa XR to prairie dogs. |
| Ferrets | 0.6 mg/kg | No adverse reactions observed. |
| Non-human primates | 0.2 mg/kg | Injection site reactions including inflammation and necrosis have been observed in common marmosets. Mild sedation, decreased body weight, increased cage movements, acute necrosis and inflammation at the injection site. |
| Laboratory rabbits | 0.15 mg/kg | Reduced fecal output post-operatively. Returned to normal at 72 hours. |
For Humans: Not for use in humans. Keep out of reach of children and pets.
Wear protective clothing when administering Ethiqa XR. Ethiqa XR should only be handled and administered by a veterinarian, veterinary technician, or laboratory staff trained in the handling of potent opioids. Accidental exposure to the mucous membrane, eye, or skin could result in absorption of buprenorphine and the potential for adverse reactions.
Mucous Membrane or Eye Contact During Application:
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.
Abuse:
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. Ethiqa XR an opioid substance 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.
For more information, consult the Prescribing Information including the Boxed Warning.
To report suspected adverse drug experiences, contact Fidelis Animal Health at 833-ETHIQAXR (833-384-4729) or EthiqaXR.com. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or visit How to Report Animal Drug and Device Side Effects and Product Problems | FDA
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.
Please report product defects to Fidelis Animal Health at 833-ETHIQAXR (833-384-4729).
There is published data demonstrating buprenorphine reacting with certain plastics. The time of interaction varies. Ethiqa XR should be stored in the original vial container.
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Boxed Warning
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
Important Safety Information
For Captive Rodents, Ferrets, Laboratory Rabbits, and Non-Human Primates:
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.
Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.
Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.
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.
For Humans:
Not for use in humans. Keep out of reach of children and pets.
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids, which may lead to overdose and death.
Ethiqa XR should be handled appropriately to minimize the risk of misuse, abuse, addiction, and criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.
Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory staff trained in the handling of potent opioids. Wear protective clothing when administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions.
For more information, consult the Prescribing Information including the Boxed Warning.
SA.EthiqaXR.060.05.2024