Buprenorphine buccal film
BELBUCA
Pronunciation: byoo-pre-NOR-feen (bel-BYOO-ka)
“Buccal Bell”
What it isPartial mu-opioid agonist and kappa antagonist in a buccal film (BELBUCA, 2015); around-the-clock chronic pain.
Why this onePain doses of 75-900 mcg BID are far below the OUD milligram range; t1/2 ~28 h.
What limits itRespiratory depression, dependence, and misuse persist; benzodiazepines and other depressants magnify the danger.
FDA-approved for
- chronic pain (around-the-clock) (2015)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Severe and persistent pain requiring an opioid analgesic (not prn) | Adults | Opioid-naïve: 75 mcg QD or q12h for ≥4 days, then 150 mcg q12h | Individually titrate in 150 mcg q12h increments | 900 mcg q12h |
Titration Increase no more frequently than every 4 days
Renal Undefined
Hepatic Severe (Child-Pugh C): reduce starting and titration/incremental dose by half
600, 750, and 900 mcg strengths only after titration from lower doses; do not exceed 900 mcg q12h (QTc)
Instructions
- Buccal film once daily or every 12 h; place yellow side against inside of cheek, hold 5 s, leave until dissolved
- Do not chew or swallow the film
- Convert from other opioids: taper to ≤30 mg oral morphine equivalents/day first, then base initial dose on prior opioid (Table 1)
- Do not abruptly discontinue in physically dependent patients — taper gradually
- Oral mucositis: reduce starting and incremental dose by half
Available strengths
- SL film 0.075, 0.15, 0.3, 0.45, 0.6, 0.75, 0.9 mg
- SL tab 2, 4, 8, 12 mg
- patch 5, 7.5, 10, 15, 20 mcg/hr
- inj 0.3 mg/mL
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
Cautions
- Opioid-induced hyperalgesia and allodynia
- Respiratory depression in chronic pulmonary disease or elderly/cachectic/debilitated patients
- Adrenal insufficiency
- Severe hypotension
- Increased intracranial pressure / head injury / impaired consciousness
- Hepatotoxicity
- GI complications (sphincter of Oddi spasm)
- Seizures in patients with seizure disorders
- Dental adverse events (caries, tooth loss)
- QTc prolongation
- Anaphylactic/allergic reactions
- Withdrawal on abrupt discontinuation
Adverse reactions
- Nausea
- Constipation
- Headache
- Vomiting
- Dizziness
- Somnolence
- Fatigue
Pregnancy Extended use during pregnancy can cause neonatal opioid withdrawal syndrome (may be life-threatening).
Lactation Buprenorphine present in human milk at low levels; breastfeeding not recommended (risk of sedation/respiratory depression).
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 0.075 mg | SL film | 30 qd | — | $226.25 | not offered |
| 0.15 mg | SL film | 30 qd | — | $226.73 | not offered |
| 0.3 mg | SL film | 30 qd | — | $355.69 | not offered |
| 0.45 mg | SL film | 30 qd | — | $483.43 | not offered |
| 0.6 mg | SL film | 30 qd | — | $515.71 | not offered |
| 0.75 mg | SL film | 30 qd | — | $542.97 | not offered |
| 0.9 mg | SL film | 30 qd | — | $557.72 | not offered |
Other forms: Buprenorphine (SUBUTEX) · Buprenorphine ER injection (SUBLOCADE) · Buprenorphine SC (weekly/monthly) (BRIXADI) · Buprenorphine patch (BUTRANS)
Available combined with: Buprenorphine/ naloxone (SUBOXONE)
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Risk from concomitant use with benzodiazepines
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityRespiratory depression and dependence remain possible, especially with benzodiazepines, alcohol or other sedatives.
Open Buprenorphine buccal film in the interactive console ↗
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