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.
No, the product should not be diluted. No clinical or storage data is available to support the product being diluted. It is important to note that the product is an oil-based suspension, and will not readily mix with water-based diluents.
The amount of hub loss depends on the syringes used. The design of a conventional syringe includes a dead space between the needle and barrel of the syringe called the hub. This space collects liquid that, once drawn up, cannot be plunged out. As a result, the substance remaining in the hub is inevitably wasted and difficult to account for. Ethiqa XR is a Schedule III controlled drug substance. When accounting for the use of Ethiqa XR, hub loss should also be recorded.
Ethiqa XR should not be in contact with plastic surfaces for an extended period of time. Data shows reactivity when buprenorphine products are stored in plastic syringes. The time of interaction varies. A study was conducted to evaluate if the product assay was affected by contact with plastic; the results indicated there was no effect. However, storing the product in its original container is still recommended.
The use of Ethiqa XR complies with FDA guidance #256, “Compounding Animal Drugs from Bulk Drug Substances.” Recent actions taken by the FDA do not impact the use of Ethiqa XR.
- Ethiqa XR is FDA-indexed and complies with FDA GFI #256, and is available through national distributors.
- In April 2023, the FDA reviewed and declined to list compounded Buprenorphine HCl for compounding office stock drugs for use in nonfood-producing animals, including mice, rats, and ferrets. Since FDA’s update in April 2023, Ethiqa XR is now also indicated for use in captive rodents, laboratory rabbits, and non-human primates for control of post-procedural pain. Ethiqa XR (an index drug) must be used unless there is a medical rationale for a particular patent and a compound drug is required.
Impact of the FDA decision:
- Compounders can NOT supply you with office stock for compounded drugs made from Buprenorphine HCl, as stated on the FDA’s list of Bulk Drug Substances Reviewed and Not Listed.
- Compounding pharmacies can NOT supply you with compounded drugs made from Buprenorphine HCl without a patient-specific prescription and a documented medical rationale that prevents you from using an FDA-approved or indexed product.
Buprenorphine HCl compounded from bulk drug substances or diluted using an FDA-approved drug does NOT qualify as an FDA-approved or indexed drug product.
Ethiqa XR is pronounced “eh-THEE-kuh eks ahr” with the emphasis on the second syllable. Ethiqa XR is based on the root word “ethical” and symbolizes the importance of honoring the need to relieve pain in all animals in the care of veterinarians and owners. Ethiqa XR is an example of our commitment to unique solutions that answer unmet needs in animal health and supports our commitment to improving animal welfare.
We’re Here to Support You
Your insights matter—because animal care starts with true collaboration. Ethiqa XR is a trusted, science-backed product for the control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. We are here to support you every step of the way. Connect with our team, ask questions, and stay informed. Together, we’re advancing animal welfare and raising the standard of care.
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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.
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