Zorbium: Product Information

ZORBIUM- buprenorphine solution
Elanco US Inc.

For use in cats only

ZorbiumTM
(buprenorphine transdermal solution)
20 mg/mL

For topical application in cats
Opioid analgesic
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

HUMAN SAFETY WARNING

Abuse Potential
ZORBIUM contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ZORBIUM. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g. depression).

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ZORBIUM. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.

Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ZORBIUM should only be administered by veterinarians or veterinary technicians who are trained in the handling of potent opioids. Accidental exposure to even one tube of ZORBIUM, especially in children, can result in a fatal overdose of buprenorphine.

Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

See Human Safety Warnings for detailed information.

DESCRIPTION:

ZORBIUM is a volatile liquid transdermal solution intended for topical application that provides continuous, systemic delivery of the opioid analgesic, buprenorphine. Buprenorphine belongs to the opioid class of drugs and is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine. Once ZORBIUM is applied to the skin, rapid drying results in dermal absorption and sequestration of buprenorphine into the stratum corneum. Each mL of ZORBIUM contains 20 mg buprenorphine (administered as 21.56 mg of buprenorphine hydrochloride). The inactive ingredients are dehydrated alcohol, padimate O, butylated hydroxyanisole, and butylated hydroxytoluene.
Buprenorphine hydrochloride has an empirical formula of C29 H41 NO4 •HCl and a molecular weight of 504.10. The chemical structure of buprenorphine HCl is:

chemical structure of buprenorphine HCl
(click image for full-size original)

INDICATION:

ZORBIUM is indicated for the control of postoperative pain associated with surgical procedures in cats.

DOSAGE AND ADMINISTRATION:

This product should only be administered by veterinary personnel.

ZORBIUM is for administration only once for the surgical procedure. ZORBIUM should be applied 1 to 2 hours before surgery. A single application provides analgesia for 4 days. ZORBIUM should only be applied topically to the dorsal cervical area at the base of the skull. Do not apply if dorsal cervical skin is diseased or injured. The dosage of ZORBIUM is 1.2 – 3.1 mg/lb (2.7 – 6.7 mg/kg) administered topically as the entire tube contents according to the following dosing table:

Pounds of Body Weight

Kilograms of Body Weight

Dose of ZORBIUM

2.6 to 6.6

1.2 to 3

0.4 mL (8 mg) pink tube

>6.6 to 16.5

>3 to 7.5

1 mL (20 mg) green tube

Dose Application Wear impermeable latex or nitrile gloves, protective glasses, and a laboratory coat to prevent direct solution contact with human skin, eyes, or mucosa when handling and applying the solution. Do not dispense ZORBIUM for administration at home by the pet owner (see HUMAN SAFETY WARNINGS).

Figure 1 — Diagram of tube components.

tube components
(click image for full-size original)

Figure 2 – Proper grasp of the applicator tube: To prepare to open the tube for application, the tube must be held in an upright position to avoid spilling contents. Grasp the tube just beneath the ribbed portion of the tip.

grasp of applicator tube

Figure 3 – Opening the applicator tube: Keeping the tube upright, grasp the ribbed portion of the tip, and turn the applicator tip in either direction at least 180° to open the tube. The applicator tip is designed to stay on the tube and should not be removed. The tube is ready for application when a breaking of the seal is felt.

opening applicator tube
(click image for full-size original)

Figure 4 – Solution application: Fur should not be clipped. Do not apply to injured or diseased skin. Gently hold the cat both before and after application to prevent the cat from shaking or rubbing.

Part the fur and apply the tip of the tube directly onto the skin at the base of the head. Squeeze the tube 2 – 3 times to empty the contents without moving the tube or the tip. Lift the tube directly away from the skin, avoiding contact of the tip with the cat’s fur.

solution application
(click image for full-size original)

CONTRAINDICATIONS:

ZORBIUM is contraindicated in cats with known hypersensitivity to buprenorphine hydrochloride, any of the inactive ingredients of ZORBIUM, or known intolerance to opioids.

WARNINGS:

HUMAN SAFETY WARNINGS:
Not for use in humans. Keep this and all medications out of reach of children and pets.

Human User Safety While Handling ZORBIUM in the Hospital:
Protective Covering: Do not come into direct contact with ZORBIUM. Wear impermeable latex or nitrile gloves, protective glasses, and a laboratory coat when applying ZORBIUM.

Mucous Membrane or Eye Contact During Application:
Direct contact of ZORBIUM with the eyes, oral, or other mucous membranes could result in absorption of buprenorphine and the potential for adverse reactions. If accidental eye, oral, or other mucous membrane contact is made during application, flush the area with water and contact a physician immediately. If wearing contact lenses, flush the eye first and then remove the contact lens.

Skin Contact During Application:
Following application to the cat, allow a minimum drying time of 30 minutes before direct contact with the application site. If human skin is accidentally exposed to ZORBIUM, wash the exposed area immediately with soap and water and contact a physician. Accidental exposure could result in absorption of buprenorphine and the potential for adverse reactions.

Drug Abuse, Addiction, and Diversion of Opioids:
Controlled Substance:
ZORBIUM contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids.

Abuse:
ZORBIUM contains buprenorphine, an opioid substance, that can be abused and is subject to misuse, abuse, and addiction, which may lead to overdose and death. This risk is increased with concurrent use of alcohol and other central nervous system depressants, including other opioids and benzodiazepines.

ZORBIUM 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.

Prescription drug abuse is the intentional, non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse.

Storage and Disposal:
ZORBIUM is a Schedule III opioid. Store in a locked cabinet according to federal and state controlled substance requirements/guidelines. Any unused or expired tubes must be destroyed by a reverse distributor; for further information, contact your local DEA field office or call Elanco US Inc. at 1-888-545-5973.

Information for Physician:
ZORBIUM transdermal solution contains a mu opioid partial agonist (20 mg buprenorphine/mL). In the case of an emergency, provide the physician with this package insert. Naloxone may not be effective in reversing respiratory depression produced by buprenorphine. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride has also been used as a respiratory stimulant.

ANIMAL SAFETY WARNINGS:
For topical use in cats only. This product should only be administered by veterinary personnel.
Do not apply ZORBIUM if the application site at the dorsal cervical area has diseased or injured skin.
Do not apply ZORBIUM to anatomic areas other than the dorsal cervical area because absorption characteristics may be different.

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