BELBUCA SIDE EFFECTS
- Generic Name: buprenorphine buccal film
- Brand Name: Belbuca
SIDE EFFECTS
The following serious adverse reactions described elsewhere in the labeling include:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Neonatal Opioid Withdrawal Syndrome
- Interactions with Benzodiazepines and Other CNS Depressants
- Adrenal Insufficiency
- QTc Prolongation
- Severe Hypotension
- Hepatotoxicity.
- Anaphylactic/Allergic Reactions.
- Gastrointestinal Adverse Reactions.
- Seizures.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 2,127 patients were treated with BELBUCA in controlled and open-label chronic pain trials. There were 504 patients treated for approximately six months and 253 patients treated for approximately one year. The clinical trial population consisted of patients with chronic moderate-to-severe pain.
The most common serious adverse drug reactions (all ≤ 0.2%) occurring during clinical trials with BELBUCA were: cellulitis, pneumonia, ileus, atrial fibrillation, coronary artery disease, cerebrovascular accident, syncope, transient ischemic attack, chest pain, non-cardiac chest pain, ankle fracture, cholecystitis, osteoarthritis, and dehydration.
The most common adverse events (≥ 2%) leading to discontinuation were nausea, vomiting, and liver function test abnormality.
The most common adverse events (≥ 5%) reported by opioid-naive, opioid-experienced, and overall patients exposed to BELBUCA in clinical trials and compared against placebo are shown in Table 2, Table 3 and Table 4:
Table 1: Adverse Events Reported in ≥ 5% of Patients during the Open-Label Titration Phase and Double-Blind Treatment Phase of Controlled Studies: Opioid-Naive Patients
| MedDRA Preferred Term | Open-Label Titration Phase | Double-Blind Treatment Phase | |
| BELBUCA (N=749) |
BELBUCA (N=229) |
Placebo (N=232) |
|
| Nausea | 50% | 10% | 7% |
| Constipation | 13% | 4% | 3% |
| Vomiting | 8% | 4% | <1% |
| Headache | 8% | 2% | 3% |
| Dizziness | 6% | 2% | <1% |
| Somnolence | 7% | 1% | <1% |
| Fatigue | 5% | 0% | 1% |
Table 2: Adverse Events Reported in ≥ 5% of Patients during the Open-Label Titration Phase and Double-Blind Treatment Phase of Controlled Studies: Opioid-Experienced Patients
| MedDRA Preferred Term | Open-Label Titration Phase | Double-Blind Treatment Phase | |
| BELBUCA (N=810) |
BELBUCA (N=254) |
Placebo (N=256) |
|
| Nausea | 17% | 7% | 7% |
| Constipation | 8% | 3% | 1% |
| Vomiting | 7% | 5% | 2% |
| Headache | 7% | 2% | 3% |
| Dizziness | 5% | 2% | <1% |
| Somnolence | 5% | 1% | <1% |
| Drug Withdrawal Syndrome | 0% | 4% | 10% |
Table 3: Adverse Events Reported in ≥ 5% of Patients during the Open-Label Titration Phase and Double-Blind Treatment Phase of Controlled Studies
| MedDRA Preferred Term | Open-Label Titration Phase | Double-Blind Treatment Phase | |
| BELBUCA (N=1889) |
BELBUCA (N=600) |
Placebo (N=606) |
|
| Nausea | 33% | 9% | 8% |
| Constipation | 11% | 4% | 2% |
| Vomiting | 7% | 5% | 2% |
| Headache | 8% | 4% | 3% |
| Dizziness | 6% | 2% | <1% |
| Somnolence | 6% | <1% | <1% |
| Drug Withdrawal Syndrome | 1% | 2% | 5% |
The most common (≥ 5%), common (≥ 1% to < 5%), and least common (< 1%) adverse reactions reported by patients taking BELBUCA in the controlled and open-label clinical studies are presented below:
Most common adverse reactions (≥ 5%): nausea, constipation, headache, vomiting, fatigue, dizziness, and somnolence.
Common (≥ 1% to < 5%) adverse reactions (organized by MedDRA [Medical Dictionary for Regulatory Activities] System Organ Class):
Blood and lymphatic system disorders: anemia
Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth
General disorders and administration site conditions: peripheral edema, pyrexia, drug withdrawal syndrome
Infections and infestations: upper respiratory tract infection, urinary tract infection, nasopharyngitis, sinusitis, bronchitis, gastroenteritis
Injury, poisoning, and procedural complications: contusion, fall
Metabolism and nutrition disorders: decreased appetite
Musculoskeletal and connective tissue disorders: muscle spasms, back pain
Psychiatric disorders: anxiety, insomnia, depression
Respiratory, thoracic and mediastinal disorders: oropharyngeal pain, sinus congestion
Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash
Vascular disorders: hot flush, hypertension
Least common (<1%) adverse reactions:
Abdominal discomfort, acute sinusitis, dyspepsia, toothache, asthenia, chills, cellulitis, tooth abscess, excoriation, laceration, aspartate aminotransferase increased, blood pressure increased, blood testosterone decreased, electrocardiogram QT prolonged, liver function test abnormal, musculoskeletal pain, neck pain, hypoesthesia, lethargy, migraine, tremor, cough, dyspnea, nasal congestion, rhinorrhea.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of buprenorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin Syndrome
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis
Anaphylaxis has been reported with ingredients contained in BELBUCA.
Androgen Deficiency
Cases of androgen deficiency have occurred with chronic use of opioids.
SRC: NLM .