Recuvyra
Loading...Recuvyra Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Not for use in humans. Keep out of reach of children. Avoid unprotected contact with application site for 72 hours.
SECONDARY EXPOSURE TO FENTANYL: Strict adherence to the requirements of the RiskMAP and the INSTRUCTIONS FOR USE provided in this product insert is imperative in order to reduce the potential of secondary exposure to fentanyl from RECUVYRA treated skin.
Do not dispense RECUVYRA for administration at home by the pet owner. RECUVYRA should only be handled and administered to dogs by hospital staff specially trained in its use. To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during administration of RECUVYRA.
To prevent direct contact of RECUVYRA with human skin or mucous membranes when handling and/or applying the solution, wear impermeable latex or nitrile gloves, protective glasses and a laboratory coat. To avoid inadvertent contamination of other humans or animals, remove and appropriately dispose of protective garments after RECUVYRA minimum drying time of 5 minutes.
Mucous membrane or eye contact during administration: Direct contact of RECUVYRA with the eyes, oral cavity or mucous membranes of dogs or humans could result in systemic, clinically relevant fentanyl concentrations. If accidental eye, oral or other mucous membrane contact is made during administration, flush the area with water and seek immediate medical attention.
If human skin is accidentally exposed to RECUVYRA, wash the exposed area with soap and water and seek medical attention immediately. Accidental exposure could cause adverse reactions.
Drying time:
Following application to the dog, allow a minimum drying time of 5 minutes. As a precaution, hospital staff responsible for handling the dog prior to, during, and after surgery, should wear gloves. All others (including owners) should avoid contact with the application site for 72 hours following application. Within this period, any part of the body that directly contacts the application site should be washed with soap and water and not placed in the mouth.
User Safety following discharge of the dog to the owner:
Adults should avoid contact with the application site for 72 hours (3 days) following the application of RECUVYRA to the dog. Within this period, any part of the body that directly contacts the application site should be washed with soap and not placed in the mouth.
The dog should be isolated from children for 72 hours (3 days) from the time of RECUVYRA application to the dog.
If a child comes in direct contact with the dog within 72 hours (3 days) from the time of RECUVYRA application to the dog, the exposed part of the child's body should not contact the child's mouth or eyes, and the area should be washed with soap and water.
If a child's tongue comes in contact with the dog, or another part of the child's body comes in contact with the dog and is then placed in the mouth, it is possible for fentanyl to enter the bloodstream; this is a medical emergency and the child should be seen immediately by a physician.
RECUVYRA contains fentanyl, a μ-opioid agonist and a Class II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, oxycodone, and
oxymorphone. Fentanyl can be abused and may be subject to misuse, and criminal diversion. RECUVYRA should be handled appropriately to minimize the risk of diversion, including restriction of access, the use of accounting procedures, and proper disposal methods, as appropriate to the clinical setting and as required by law.
Fentanyl is a μ (mu) opioid receptor agonist (50 mg/mL). The antidote for human exposure to RECUVYRA is an opioid reversal agent such as naltrexone or naloxone. In the case of an emergency, provide the physician with the package insert and Client Information Sheet.
Individual dogs sensitive to the effects of fentanyl may develop pronounced sedation, decreased food and water intake and gastrointestinal (GI) stasis, which may increase the risk of bacterial overgrowth. Dehydration and elevations in hematocrit, albumin and fibrinogen may occur. Feces, if present, could be soft and contain blood. If severe GI stasis occurs, the dog should be reversed with naloxone (see PRECAUTIONS) and administered supportive intravenous fluids.
RECUVYRA has not been evaluated in dogs with respiratory disorders, cardiovascular disease, renal disease, or hepatic disease.
Opioid effects, including adverse reactions, may last for 7 days beyond administration in some dogs. To prevent potential overdose and severe adverse reactions, do not administer other opioids within 7 days of RECUVYRA administration.
During general anesthesia following administration of RECUVYRA, dogs should be continuously monitored and facilities should be available for the maintenance of a patent airway, artificial ventilation, IV fluids, and oxygen supplementation. Hypothermia may be severe and prolonged (greater than 24 hours) necessitating the use of an external heat source during surgery, throughout recovery, and after recovery from anesthesia.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
There is currently no usage information available for this product. We apologize for any inconvenience.
History
There is currently no drug history available for this drug.
Other Information
RECUVYRA is a volatile liquid transdermal solution intended for topical application that provides continuous, systemic delivery of a potent analgesic opioid. RECUVYRA is a clear, colorless to light yellow solution that contains 5% w/v (50 mg/mL) fentanyl as the active pharmaceutical ingredient in alcohol and octyl salicylate. Fentanyl is a μ (mu) opioid receptor agonist. Once applied to the skin, RECUVYRA is a rapid drying formulation resulting in fast dermal absorption and sequestration of fentanyl in the stratum corneum.
Sources
Recuvyra Manufacturers
-
Elanco Animal Health Co
![Recuvyra (Fentanyl) Solution [Elanco Animal Health Co]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Recuvyra | Elanco Animal Health Co
NOT FOR INJECTION
The dosage of RECUVYRA is 1.2 mg/lb (2.7 mg/kg) applied topically to the dorsal scapular area 2 to 4 hours prior to surgery. A single application provides analgesia for 4 days. Use the provided syringe and applicator tips. Apply RECUVYRA only once. Accumulation of fentanyl following repeated administration could result in severe adverse reactions, including death (see ANIMAL SAFETY).
Do not dispense RECUVYRA for administration at home by the pet owner.
RECUVYRA should only be handled and administered to dogs by hospital staff specially trained in its use. To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during administration of RECUVYRA. Wear impermeable latex or nitrile gloves, protective glasses and a laboratory coat to prevent direct contact with human skin, eyes or mucosa when handling and/or applying the solution. Do not administer RECUVYRA outside of the hospital setting. Use only the syringes provided and do not store RECUVYRA in the syringe. Use of syringes incompatible with RECUVYRA will result in inaccurate dosing or human exposure (see Instructions for Use for details regarding drug application and restraint during drying time).
RECUVYRA DOSE (1.2 mg/lb; 2.7 mg/kg) in mL based on body weight* RECUVYRA cannot be accurately dosed in dogs less than 6 pounds of body weight. The average dose in each weight band is approximately 2.7 mg/kg, except for the lowest weights, that average slightly higher.
POUNDS OF BODY WEIGHT DOSE
(mL) KILOGRAMS OF BODY WEIGHT 6 to 9.3* 0.2 2.7 to 4.2 9.4 to 13.4 0.3 4.3 to 6.1 13.5 to 17.6 0.4 6.2 to 8 17.7 to 21.8 0.5 8.1 to 9.9 21.9 to 25.9 0.6 10 to 11.7 26 to 30.1 0.7 11.8 to 13.6 30.2 to 34.3 0.8 13.7 to 15.5 34.4 to 38.4 0.9 15.6 to 17.4 38.5 to 42.6 1 17.5 to 19.3 42.7 to 46.8 1.1 19.4 to 21.2 46.9 to 50.9 1.2 21.3 to 23.1 51 to 55.1 1.3 23.2 to 25 55.2 to 59.3 1.4 25.1 to 26.9 59.4 to 63.4 1.5 27 to 28.8 63.5 to 67.6 1.6 28.9 to 30.6 67.7 to 71.8 1.7 30.7 to 32.5 71.9 to 75.9 1.8 32.6 to 34.4 76 to 80.1 1.9 34.5 to 36.3 80.2 to 84.3 2 36.4 to 38.2 84.4 to 88.4 2.1 38.3 to 40.1 88.5 to 92.6 2.2 40.2 to 42 92.7 to 96.8 2.3 42.1 to 43.9 96.9 to 100.9 2.4 44 to 45.8 101 to 105.1 2.5 45.9 to 47.7 105.2 to 109.3 2.6 47.8 to 49.6 109.4 to 113.4 2.7 49.7 to 51.4 113.5 to 117.6 2.8 51.5 to 53.3 117.7 to 121.8 2.9 53.4 to 55.2 121.9 to 125 3 55.3 to 57Apply up to ½ mL onto the skin without moving the applicator tip. If the calculated volume is greater than ½ mL, reposition the applicator tip at least 1 inch from the initial site and apply up to ½ mL. Repeat the reposition and application steps until the entire calculated volume has been applied to the dog. Restrain the dog for a full 2 minutes and avoid contact with the application site for 5 minutes to allow complete drying of the solution (SEE INSTRUCTIONS FOR USE).
Login To Your Free Account