![]() Table 1: Initial BELBUCA Dose Based on Prior Opioid Expressed as Oral Morphine Sulfate Equivalents Prior Daily Dose of Opioid Analgesic Before Taper to 30 mg Oral MSEīELBUCA 75 mcg once daily or every 12 hoursīELBUCA doses of 600 mcg, 750 mcg, and 900 mcg are only for use following titration from lower doses of BELBUCA. In a BELBUCA clinical trial with an open-label titration period, patients were converted from their prior opioid to BELBUCA using Table 1 as a guide for the initial BELBUCA dose. It is safer to underestimate a patient's 24-hour oral buprenorphine dosage and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour buprenorphine dosage and manage an adverse reaction due to overdose. Therefore, a conservative approach is advised when determining the total daily dosage of BELBUCA. There is inter-patient variability in the relative potency of opioid drugs and opioid formulations. ![]() Consider the use of an alternate analgesic. Patients may require additional short-acting analgesics during the taper period and during titration.īELBUCA may not provide adequate analgesia for patients requiring greater than 160 mg oral MSE per day. Following analgesic taper, base the starting dose on the patient's daily opioid dose prior to taper, as described in Table 1. To reduce the risk of opioid withdrawal, taper patients to no more than 30 mg oral morphine sulfate equivalents (MSE) daily before beginning BELBUCA. There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. Ĭonsider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.ĭiscontinue all other around-the-clock opioid drugs when BELBUCA therapy is initiated. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).Ĭonsider prescribing naloxone, based on the patient's risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdoseĭiscuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with BELBUCA. 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. īELBUCA buccal film is for oral buccal use only and is to be applied to the buccal mucosa every 12 hours.
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