Buprenorphine buccal film

BELBUCA

Open Buprenorphine buccal film in the interactive console ↗

Pronunciation: byoo-pre-NOR-feen (bel-BYOO-ka)

Buprenorphine buccal film ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Buprenorphine buccal film ballicule

Buprenorphine buccal film BELBUCA mascot mnemonic cartoon — Visual mnemonic: Buprenorphine buccal film mascot
**“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.

Buprenorphine buccal film molecular structure (skeletal formula) — Molecular structure: Buprenorphine buccal film

Buprenorphine buccal film prescription history

Animated chart of estimated U.S. prescriptions per year, Opioid analgesics (1900–2026). Buprenorphine buccal film enters in 2016 (estimated).

FDA-approved for

chronic pain (around-the-clock) (2015)

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger3 / 4

Weight-gain liability1 / 4

Sedation liability2 / 4

QT / Torsades1 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityRespiratory depression and dependence remain possible, especially with benzodiazepines, alcohol or other sedatives.

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Addiction, abuse, and misuse; life-threatening respiratory depression; accidental exposure (fatal in children); risks with benzodiazepines/other CNS depressants; neonatal opioid withdrawal syndrome; REMS.

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

Buprenorphine buccal film (BELBUCA)

What pharmacies pay · NADAC 9/30/26

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