Belbuca (buprenorphine)

Important Dosage And Administration Instructions

Belbuca should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
• Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Belbuca and adjust the dosage accordingly.
• Belbuca buccal film is for oral buccal use only and is to be applied to the buccal mucosa every 12 hours.
• Instruct patients not to use Belbuca if the pouch seal is broken or the buccal film is cut, damaged, or changed in any way and to avoid applying Belbuca to areas of the mouth with any open sores or lesions.

Table 5 includes clinically significant drug interactions with Belbuca.

Table 5: Clinically Significant Drug Interactions

Drug Abuse And Dependence

Controlled Substance

• Belbuca contains buprenorphine hydrochloride, a Schedule III controlled substance.

Abuse

• Belbuca contains buprenorphine, a substance with a potential for abuse similar to other Schedule III opioids. Belbuca can be abused and is subject to misuse, abuse, addiction, and criminal diversion.
• All patients treated with opioids, including Belbuca, require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carry the risk of addiction, even under appropriate medical use.
• Prescription drug abuse is the intentional, non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
• Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
• “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating healthcare providers. “Doctor shopping” (visiting multiple
• prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
• Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all persons with substance use disorders. In addition, abuse of opioids can occur in the absence of true addiction.
• Belbuca, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
• Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific To Abuse Of Belbuca

• Belbuca is intended for buccal use only. Abuse of Belbuca poses a risk of overdose and death. This risk is increased with concurrent abuse of Belbuca with alcohol and other substances, including other opioids and benzodiazepines.
• Intentional compromise of the buccal film might result in the uncontrolled delivery of buprenorphine and pose a significant risk to the abuser that could result in overdose and death.
• Abuse may occur by applying the buccal film in the absence of legitimate purpose, or by swallowing, snorting, or injecting buprenorphine extracted from the buccal film. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Dependence

• Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.
• Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), or mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
• Do not abruptly discontinue Belbuca in a patient physically dependent on opioids. Rapid tapering of Belbuca in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
• When discontinuing Belbuca, gradually taper the dosage using a patient-specific plan that considers the following: the dose of Belbuca the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
• Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.

• Inform female patients of reproductive potential that prolonged use of Belbuca during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
• Belbuca can cause fetal harm. Women should inform their healthcare provider of a known or suspected pregnancy.
• Breastfeeding is not recommended during treatment with Belbuca.