Frequently Asked 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. Please call 833-384-4729 with additional questions.

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

Ethiqa XR is packaged in a 3 mL vial.

What is the shelf life?

Ethiqa XR currently has a 12-month expiration date. The expiration date is located on the vial label and carton.

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

Multi-use vials should be discarded 28-days after broaching. Fidelis does not have data to support beyond 28-days after the vial has been broached. Please discard after 28-days.

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) (www.mwiah.com) and Covetrus (phone 855-724-3461) (www.northamerica.covetrus.com). 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) or Covetrus (phone 855-724-3461) www.northamerica.covetrus.com for current pricing.

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) or Covetrus (phone 855-724-3461) www.northamerica.covetrus.com returns policy.

For what species is Ethiqa XR approved?

Ethiqa XR is indicated for use 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 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 72 hours post-injection in both mice and rats.

What studies are available on the efficacy of Ethiqa XR?

Ethiqa XR has been used in clinical trials that evaluated safety, efficacy, tolerability 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. This data was reviewed by the FDA and used to support the granting of the FDA-Index Drug for use for post-procedural pain in mice and rats.

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

What if I receive a product with a manufacturer defect (i.e. – broken vial, missing label, etc.)?

Please report product defects to Fidelis Pharmaceuticals at 833-384-4729.

How are adverse events reported?

Concerns or adverse events can be reported by calling Fidelis Pharmaceuticals at (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.

Can Ethiqa XR be used with other pharmaceuticals?

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

Boxed Warning

WARNING: ABUSE POTENTIAL and 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, Not for use in humans

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. 

For more information, consult the prescribing information including the boxed warning.