Brixadi (Buprenorphine) 128mg Monthly Discontinuation
You must taper Brixadi (buprenorphine) 128mg monthly when discontinuing—abrupt discontinuation should never be done in physically-dependent patients, as it will precipitate withdrawal symptoms and carries significant risks. 1
Critical FDA Safety Warning
The FDA label explicitly states that "Buprenorphine should not be abruptly discontinued in a physically-dependent patient" and warns that abrupt discontinuation will trigger a withdrawal syndrome characterized by restlessness, lacrimation, rhinorrhea, perspiration, chills, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. 1
Physical dependence develops after several days to weeks of continued opioid use, and withdrawal may be precipitated through abrupt discontinuation or significant dose reduction. 1
Recommended Tapering Protocol for Buprenorphine
The standard approach is to begin with 10% monthly dose reductions, with slower tapers (5-10% per month) for patients on long-term treatment (≥1 year). 2
Specific Tapering Guidelines:
For patients on buprenorphine less than 1 year: reduce by 10% monthly 2
For patients on buprenorphine 1 year or longer: reduce by 5-10% monthly 2
Each new dose should be 90% of the previous dose, not a linear reduction from the starting dose—this prevents disproportionately large final reductions 2
The taper will likely require a minimum of 6-12 months, and the goal is durability of the taper, not speed 2
Critical Pre-Discontinuation Counseling
Before initiating any taper, patients must be strongly counseled that maintenance therapy is superior to tapering. The CDC guidelines emphasize that medication-assisted treatment with buprenorphine reduces overdose death by up to threefold, and maintenance therapy is significantly more effective than tapering for preventing relapse in opioid use disorder. 2
Managing Withdrawal Symptoms During Taper
Aggressively treat withdrawal symptoms with adjuvant medications including clonidine, tizanidine, lofexidine, gabapentin, trazodone, and loperamide 2
Patients must be counseled about protracted withdrawal syndrome, which can persist for months after opioid elimination and includes dysphoria, irritability, insomnia, anhedonia, and increased pain 2
Monitoring Requirements
Follow up at least monthly during the taper, with more frequent contact needed during difficult phases 2
Monitor for return of psychiatric symptoms, suicidal ideation, and assess for depression, anxiety, and insomnia proactively, as these predict taper failure 2
Pauses in the taper are acceptable and often necessary when withdrawal symptoms emerge 2
Critical Safety Obligations
Clinicians are obligated to either offer a comfortable, safe tapering regimen with close monitoring, obtain agreement from another physician to accept care, or continue maintenance therapy if taper fails. "Cold referrals" to clinicians who have not agreed to accept the patient constitute abandonment. 2
Key Pitfall to Avoid
Never abruptly discontinue buprenorphine—this is equivalent to suddenly stopping antihypertensives or antihyperglycemics and is never appropriate. 1 The FDA label makes clear that physical dependence is expected with chronic opioid use, and withdrawal symptoms will occur with abrupt cessation. 1