Ethiqa XR is packaged in a 5 mL glass vial containing 3.0 mL injectable drug suspension. The carton and vial have a yellowish color. Is this normal? Yes, the vial, label, and/or carton may appear yellowish. This is a result of the sterilization process. I see separation of the suspension in the vial. Is this normal? Yes, Ethiqa XR is a suspension and not a solution. It is an oil suspension, and the ingredients in the suspension do separate over time. The product must be shaken before use. This will bring the components back into suspension. There is no need to vortex the product; however, vortexing will not negatively affect the product. It is normal to see some small particulates in the suspension. Is the product clear and white? No, the product has a yellowish tinge, which is a result of the sterilization process. Because it is a particulate suspension, it appears cloudy, not clear. What is the NDC number for Ethiqa XR? The NDC number is 86084-100-30

Ethiqa XR currently has a 36-month expiration date from the date of manufacture.  The expiration date is indicated on both the vial label and carton.

For questions regarding expiration, please contact Fidelis Animal Health, Inc at 833-ETHIQAXR (833-384-4729)

Does the shelf-life apply if the product is removed from the original vial and stored in plastic or glass syringes?
No, the expiration date is based on data generated on products stored in the original vial container.

Are there any known issues with keeping the aliquots under the original expiration date?
There is no clinical or storage data to support aliquoting of the product.

Once broached, Ethiqa XR should be discarded after 90 days.

An in-use broaching study was performed using aged product and maximum number of punctures to evaluate a worst-case scenario. All of the test results out to 90-days passed the release specification limits.

Please note: Previous batches were packaged with a date that reflected less than 90-days; however, the 90-day broach/puncture period is applicable to all Ethiqa XR inventory in your organization.

Is the new broach data suitable for vials that are refrigerated?

Yes, the product can be refrigerated, and refrigerated vials of Ethiqa XR should be discarded after 90 days of being broached. However, it’s important to note that Ethiqa XR should be stored at room temperature between 15°C to 25°C +/- 2°C (59°F to 77°F). If Ethiqa XR has been refrigerated, it should be brought to room temperature before use.

Ethiqa XR does not require refrigeration and should be stored at room temperature, specifically between 15° to 25°C +/- 2°C (59°F to 77°F). If Ethiqa XR has been refrigerated, it should be allowed to reach room temperature before use. Do not heat Ethiqa XR. Heating the product or not storing the product in its original container or within the specified storage conditions could cause the product to change its physical properties.

• Be sure to weigh each animal to calculate an accurate dose. For example, the dose for a 20-gram mouse would be a single subcutaneous injection of 0.05 mL (3.25 mg/kg body weight)
• If needed, a single dose can be repeated in all species.

Ethiqa XR is currently available through MWI Animal Health (phone 800.824.3703, mwiah.com) and Covetrus (phone 855-724-3461, northamerica.covetrus.com), Midwest Veterinary Supply (phone 800-MIDWEST, midwestvetsupply.com), Patterson Veterinary (phone 800.225.7911, pattersonvet.com) or Hanna’s Pharmaceutical Supply (phone 203.571.8761, hannapharm.com). Ethiqa XR can be ordered by a licensed veterinarian or lab technician. If ordered by a lab technician, the use of the drug must be overseen by a licensed vet. Please visit EthiqaXR.com/ordering/ for more information.

If you have any questions or need assistance ordering product, please contact us at info@fidelisah.com

Ethiqa XR is not a compounded product and is not available directly from pharmacies. It is distributed through animal health distributors, similar to other controlled pharmaceutical products your institution may source. To determine whether a prescription is required for your specific application, we recommend contacting your distributor for further information and guidance.

 

The list price of Ethiqa XR is $415/vial. When factoring for labor and materials costs, Ethiqa XR is comparable or more cost-effective compared to other available products. Please visit EthiqaXR.com/ordering/ for more information.

Approximate cost for 72 hours of pain control (includes materials and labor¹)

 
1. Technician time ~3 mins./injection @ $52/hour; $0.25/injection for materials

2. $415/vial (1.3mg/ml); 3.25, 0.65, 0.20 mg/kg dose for mice, rats, and marmosets, respectively, https://ethiqaxr.com/full-prescribing-information/.

3. ~$150-$190/vial cost (0.5, 1.0 mg/ml); 1.25, 1.10, and 0.15 mg/kg dose for mice, rats, and marmosets, respectively.

https://www.wedgewood.com/uploads/Buprenorphine%20ER-LAB_Data%20Sheet%201022.pdf; Fabian NJ, Mannion AJ, Jamiel M, Anderson DJ, Rower JE, Reilly CA, Menegas W, Muthupalani S, Ta C, Fox JG, Kramer R, Haupt JL. Evaluation and comparison of pharmacokinetic profiles and safety of two extended-release buprenorphine formulations in common marmosets (Callithrix jacchus). Sci Rep. 2023 Jul 22;13(1):11864. doi: 10.1038/s41598-023-38973-2. PMID: 37481609; PMCID: PMC10363172.

4. ~$18.40/vial cost; diluted (=compounded); 1.0, 0.5, and 0.02 mg/kg for mice, rats, and marmosets, respectively; dosing frequency q8 hrs. for mice and rats, q12 hrs. for marmosets. Gaddes et al., 2000; Martin, et al., 2001; Flecknell, 1996.

Ethiqa XR is a controlled drug substance (CIII) and is generally not returnable; however, the return policy is determined by the distributor.  For additional information, please contact your distributor.

Ethiqa XR is indicated for control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. See the Package Insert, including Boxed Warning, for additional details.

Ethiqa XR should only be administered by subcutaneous intrascapular injection. It is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. See the Package Insert for full injection instructions.

Please see the table below for dosing Ethiqa XR based upon time to reach estimated therapeutic blood levels.

It should be noted that adverse events, including death, have been reported when NSAIDs and Ethiqa XR have been administered concomitantly in mice. To minimize the risk, it is recommended to administer the NSAID preoperatively and Ethiqa XR postoperatively, ensuring approximately 30 minutes between the two during the perioperative period in mice.

In the pharmacokinetic studies, therapeutic drug concentrations of Ethiqa XR were maintained for up to 72 hours post-injection in all captive rodents, ferrets, laboratory rabbits, and non-human primates.

Ethiqa XR is indicated for control of post procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. Ethiqa XR can be used as part of a multimodal approach to pain management.

It should be noted that adverse events, including death, have been reported when NSAIDs and Ethiqa XR have been administered concomitantly in mice. To minimize the risk, it is recommended to administer the NSAID preoperatively and Ethiqa XR postoperatively, ensuring approximately 30 minutes between the two during the perioperative period in mice.

You can access available publications on our website at: www.ethiqaxr.com/publications

In 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. 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.

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.

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).

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.

 

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.

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 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.

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 Buprenorphine HCl for compounding office stock drugs for use in nonfood-producing animals, including mice, rats, and ferrets.

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 symbol. 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.

Ethiqa XR is FDA-Indexed and allows for marketing within the United States.  The product has not been cleared for marketing in any other countries.

The FDA aims to ensure that certain controlled substances, such as buprenorphine, are not administered to animals that could become part of the “food chain”, and therefore, specifically restricts Ethiqa XR to use in captive rodents and laboratory rabbits that are held in captivity.