Frequently Asked Questions

Frequently Asked Questions and Answers For Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL CIII.

Ethiqa XR (buprenorphine extended-release injectable suspension) 1.3 mg/mL is approved for the control of post-procedural pain in rats and mice. 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.

How is Ethiqa XR™ (buprenorphine extended-release injectable suspension) 1.3 mg/mL CIII) packaged?

Ethiqa XR is packaged in a 5 mL glass vial containing 3.0 mL of injectable drug suspension.

The carton and vial has a yellowish color. Is this normal?
Yes, the vial, label and/or carton may be a yellowish color. 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 prior to 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.

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

What is the shelf life?

Ethiqa XR currently has a 24-month expiration date. The expiration date is located on the vial label and carton. There is currently product in the market with shorter expiration dates due to being packaged prior to having the supportive 24-month stability data. Please call 833-ETHIQAXR (833-384-4729), if you have any questions regarding the expiry date of the product.

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 upon data generated on product stored in the original vial container.

Can the product be diluted?
No, the product should not be diluted. There is no clinical or storage data supporting dilution of the product. Additionally, as the product is an oil based suspension, it will not mix with water based diluents.

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

Is there any problem with Ethiqa XR being stored in plastic syringes and how long can the product be stored in plastic syringes?
Yes, there is data with buprenorphine in general showing a reactivity with certain plastics, when stored in plastic syringes. The time of interaction varies. Ethiqa XR should be stored in the original vial container.

Is Ethiqa XR compatible with the plastics used for multidose vial adapters?
Ethiqa XR should not be in contact with plastic surfaces for an extended period of time. There is data showing a reactivity when buprenorphine products are stored in plastic syringes. The time of interaction varies. Ethiqa XR should be stored in the original vial container.

Can Ethiqa XR be used more than 28 days after broaching?

Yes, it can. Ethiqa XR should be discarded 56-days after broaching.

Is the new broach data good for vials that are refrigerated?
Yes, the product can be refrigerated and should be discarded after 56-days after being broached. However, Ethiqa XR should be stored at room temperature (15° to 25°C or 59° to 77°F). If Ethiqa XR is refrigerated, bring to room temperature before use. The expiration date is 24-months.

Does Ethiqa XR require refrigeration?

No, Ethiqa XR should be stored at room temperature (15° to 25°C or 59° to 77°F). If Ethiqa XR is refrigerated, bring to room temperature before use.

What is the dosage for mice and rats?

  • 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.

What needle size should be used?

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.

How do I buy Ethiqa XR? Who do I get It from?

Ethiqa XR is currently available through MWI Animal Health (phone 800.824.3703, mwiah.com) and Covetrus (phone 855-724-3461, northamerica.covetrus.com), as well as several smaller regional distributors. We are continuing to work with other distributors to expand availability. A purchasing account must be opened by a licensed veterinarian with a valid DEA license number before placing orders.

Does Ethiqa XR require a prescription?

No, a prescription is not required. Ethiqa XR is NOT compounded or available from any pharmacy. It is available through animal health distributors, and accessible in the same manner your institution sources other controlled pharmaceutical products.

What is the cost of Ethiqa XR?

The list price of Ethiqa XR is determined by the distributor. Please contact MWI Animal Health (phone 800.824.3703) (www.mwiah.com), Covetrus (phone 855-724-3461) (www.northamerica.covetrus.com) or Midwest Veterinary Supply (phone 800-MIDWEST) (www.midwestvetsupply.com/products).

What is the return policy?

The return policy is determined by the distributor. Please contact MWI Animal Health (phone 800.824.3703) (www.mwiah.com), Covetrus (phone 855-724-3461) (www.northamerica.covetrus.com) or Midwest Veterinary Supply (phone 800-MIDWEST) (www.midwestvetsupply.com/products).

For what species is Ethiqa XR approved?

Ethiqa XR is indicated for control of post-procedural pain in mice and rats. See the Package Insert, including Boxed Warning, for additional details.

How should Ethiqa XR be administered?

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.

When should Ethiqa XR be administered?

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

How long is analgesia shown to last?

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

Can Ethiqa XR be used with other pharmaceuticals?

No drug-drug interaction studies have been performed with Ethiqa XR.

What studies are available on the efficacy of Ethiqa XR?

Ethiqa XR has been used in clinical trials that evaluated safety, efficacy, tolerability, pharmacokinetics,and other measures in both mice and rats. Virtually all of this data has been published in peer-reviewed journals, and is available for review on our website, www.ethiqaxr.com/publications. This data was reviewed by the FDA as well as a Qualified Expert Panel of Veterinarians and a toxicologist, and used to support the granting of the FDA-Index Drug for use for post-procedural pain in mice and rats.

Could dehydration impact the therapeutic dose of Ethiqa XR?
There is no data regarding dehydration and use of Ethiqa XR. Ethiqa XR is administered SQ and is transported from the SQ depot that is formed and then transports into the blood and then to the receptors.

What are the most common adverse events?

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 mobility, 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 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 ingestion of wood chip-type bedding after administration of Ethiqa XR. Please note: Pica involving wood chip-type bedding can be lethal in rats.

Risks related to human exposure: Because of the potential for 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 of 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 physician. See Boxed Warning  

How are adverse events reported?

Concerns or adverse events can be reported by calling Fidelis Animal Health at 833-ETHIQAXR (833-384-4729).

Are there any 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 on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR.

How should I report a product with a manufacturer defect (i.e. – broken vial, missing label, etc.)?

Please report product defects to Fidelis Animal Health at 833-ETHIQAXR (833-384-4729).

Boxed Warning

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

Ethiqa XR contains buprenorphine, a high-concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological 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 drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision.

Do not dispense Ethiqa XR.

Life-Threatening Respiratory Depression

The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.

Important Safety Information: For Rats and Mice: 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. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. For Humans: Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans.