Belbuca

• BELBUCA exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of BELBUCA are essential. Instruct patients on proper administration of BELBUCA to reduce the risk.
• Accidental exposure to BELBUCA, especially in children, can result in fatal overdose of buprenorphine.
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate.
• If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.
• Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

• BELBUCA should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks.
• Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of BELBUCA for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks
• Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
• Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with BELBUCA. Consider this risk when selecting an initial dose and when making dose adjustments. .
• Discuss availability of naloxone with the patient and caregiver and assess each patient's need for access to naloxone, both when initiating and renewing treatment with BELBUCA. Consider prescribing naloxone based on the patient's risk factors for overdose.
• For opioid-naïve patients
  : Initiate therapy with 75 mcg BELBUCA once daily or every 12 hours, as tolerated, for at least 4 days before increasing dose to 150 mcg every 12 hours.
• Conversion from other opioids to BELBUCA
  : Taper current daily opioid dose to 30 mg oral morphine sulfate equivalents (MSE) or less prior to initiating therapy with BELBUCA.
  • For patients taking less than 30 mg oral MSE, initiate therapy with 75 mcg once daily or every 12 hours.
  • For patients taking between 30 mg and 89 mg oral MSE, initiate therapy with 150 mcg BELBUCA every 12 hours following analgesic taper.
  • For patients taking between 90 mg and 160 mg oral MSE, initiate therapy with 300 mcg BELBUCA every 12 hours following analgesic taper.
  • For patients taking greater than 160 mg oral MSE, consider alternate analgesic.
• BELBUCA doses of 600 mcg, 750 mcg, and 900 mcg are only for use following titration from lower doses of BELBUCA.
• Patients with Severe Hepatic Impairment
  : Reduce the starting and incremental dose by half that of patients with normal liver function.
• Patients with Oral Mucositis
  : Reduce the starting and incremental dose by half that of patients without mucositis.
• Do not abruptly discontinue BELBUCA in a physically-dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.

Dosage strengths of BELBUCA are based on the active moiety, buprenorphine.

The 75 mcg dosage form is a buccal film that contains 75 mcg buprenorphine. The film is white on one side, with E0 printed in black, and yellow on the other side.

The 150 mcg dosage form is a buccal film that contains 150 mcg buprenorphine. The film is white on one side, with E1 printed in black, and yellow on the other side.

The 300 mcg dosage form is a buccal film that contains 300 mcg buprenorphine. The film is white on one side, with E3 printed in black, and yellow on the other side.

The 450 mcg dosage form is a buccal film that contains 450 mcg buprenorphine. The film is white on one side, with E4 printed in black, and yellow on the other side.

The 600 mcg dosage form is a buccal film that contains 600 mcg buprenorphine. The film is white on one side, with E6 printed in black, and yellow on the other side.

The 750 mcg dosage form is a buccal film that contains 750 mcg buprenorphine. The film is white on one side, with E7 printed in black, and yellow on the other side.

The 900 mcg dosage form is a buccal film that contains 900 mcg buprenorphine. The film is white on one side, with E9 printed in black, and yellow on the other side.

• Pregnancy
  : May cause fetal harm.
• Lactation
  : Not recommended.
• Moderate or Severe Hepatic Impairment
  : Periodically assess for signs and symptoms of toxicity or overdose.