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 24-month expiration date from the date of manufacture.  The expiration date is indicated on both the vial label and carton.

Please note: Batches manufactured prior to 2022 may have printed expiration dates reflecting less than 24 months, but expiry dates have since been extended.

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.

Yes, it can. 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 +/- 2°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 +/- 2°F ). If Ethiqa XR has been refrigerated, it should be allowed to reach room temperature before use.

• The dose for a mouse is a single subcutaneous injection of 0.05mL per 20-gram mouse (3.25 mg/kg body weight).
• The dose for a rat is a single subcutaneous injection of 0.1 mL per 200-gram rat (0.65 mg/kg body weight).
• Be sure to weigh each animal to calculate an accurate dose. A single dose can be repeated if needed after 72 hrs.

A 0.5 or 1.0 mL syringe fitted with a 20 or 23-gauge needle for injections can be used with aseptic technique to withdraw the dose.

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). A licensed veterinarian must open a purchasing account with a valid DEA license number before placing orders. Please visit EthiqaXR.com/ordering/ for more information.

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. It is designed to provide comparable or more cost-effective options compared to competitive products available in the market.

Please visit EthiqaXR.com/ordering/ for more information.

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 mice and rats. 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.

Ethiqa XR is indicated for the control of post-procedural pain in mice and rats. In the pharmacokinetic studies, Ethiqa XR was administered post-procedurally.

In the pharmacokinetic studies, therapeutic drug concentrations of Ethiqa XR were maintained for up to 72 hours post-injection in both mice and rats.

Adverse effects have been reported when NSAIDs and Ethiqa XR have been administered concomitantly in mice. Caution should be used if using NSAIDs and Ethiqa XR concomitantly in mice.

Pharmacokinetic studies in mice and rats have been conducted to assess the safety, tolerability, and pharmacokinetics (PK) of Ethiqa XR. These PK studies involved comprehensive evaluations in both mice and rats, and the results have been published in peer-reviewed journals. You can access these publications on our website at www.ethiqaxr.com/publications. It’s worth noting that the data underwent rigorous scrutiny by the FDA and a Qualified Expert Panel of veterinarians. These findings were instrumental in obtaining an FDA-Indexing for using Ethiqa XR to control post-procedural pain in mice and rats.

In Mice and Rats: The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised mice and rats. As with other opioids, buprenorphine may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal motility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. The use of paper or soft bedding for up to 3 days following the administration of Ethiqa XR should be considered.

Normal mice 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.

Rats may exhibit signs of nausea, including pica, up to 3 days post-treatment. Rats should be maintained on paper or soft bedding to avoid ingesting wood chip-type bedding after administration of Ethiqa XR. Please note: Pica involving wood chip-type bedding can be lethal in rats.

Ethiqa XR forms a depot near the injection site. Granulomatous inflammatory nodules have been observed in naked-skinned rats and mice.

Risks related to human exposure: Because of potential adverse reactions associated with exposure or accidental injection, Ethiqa XR should only be administered by trained personnel. Protective clothing is recommended when handling the suspension.

Direct contact with Ethiqa XR to the eyes, mouth, skin, or other mucous membranes could result in the absorption of buprenorphine and the potential for adverse reactions, including respiratory depression, which can be fatal in some cases. If contact is made to the eye, oral, or other mucous membranes, flush the area with water and contact a physician. If contact with the skin, wash the exposed area with soap and water and contact a physician. See 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 on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR.

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 and rats.

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.