Boxed Warnings
Risk of serious harm or death with intravenous administration. Serious harm or death could result if administered intravenously. Buvidal forms a gel depot upon contact with body fluids and may cause occlusion, local tissue damage and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously.
Hazardous and harmful use. Although Buvidal is indicated for the treatment of opioid dependence it still poses risks of hazardous and harmful use which can lead to overdose and death. Monitor the patient's ongoing risk of hazardous and harmful use regularly during opioid substitution therapy with Buvidal Monthly (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life‐threatening or fatal respiratory depression may occur with the use of Buvidal. Be aware of situations which increase the risk of respiratory depression, and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients and their caregivers should be made aware of the symptoms of respiratory depression. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Buvidal.
1 Name of Medicine
Buvidal Weekly 8 mg/0.16 mL buprenorphine modified release solution for injection.
Buvidal Weekly 16 mg/0.32 mL buprenorphine modified release solution for injection.
Buvidal Weekly 24 mg/0.48 mL buprenorphine modified release solution for injection.
Buvidal Weekly 32 mg/0.64 mL buprenorphine modified release solution for injection.
Buvidal Monthly 64 mg/0.18 mL buprenorphine modified release solution for injection.
Buvidal Monthly 96 mg/0.27 mL buprenorphine modified release solution for injection.
Buvidal Monthly 128 mg/0.36 mL buprenorphine modified release solution for injection.
Buvidal Monthly 160 mg/0.45 mL buprenorphine modified release solution for injection.
2 Qualitative and Quantitative Composition
Buvidal Weekly modified release solutions for injection prefilled syringes contain either 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL or 32 mg/0.64 mL buprenorphine as the active ingredient.
These strengths also contain small amounts of ethanol absolute.
Buvidal Monthly modified release solutions for injection prefilled syringes contain either 64 mg/0.18 mL, 96 mg/0.27 mL, 128 mg/0.36 mL or 160 mg/0.45 mL buprenorphine as the active ingredient.
For full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Modified release solution for injection.
Yellowish to yellow clear liquid in a pre-filled syringe.
4 Clinical Particulars
4.9 Overdose
Symptoms. Respiratory depression, as a result of central nervous system depression, is the primary symptom requiring intervention in the case of buprenorphine overdose because it may lead to respiratory arrest and death. Preliminary symptoms of overdose may also include excessive sweating, somnolence, amblyopia, miosis, hypotension, nausea, vomiting and/or speech disorders.
Treatment. General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient. Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted. A patent airway and assisted or controlled ventilation must be assured. The patient should be transferred to an environment within which full resuscitation facilities are available. If the patient vomits, precautions must be taken to prevent aspiration. Use of an opioid antagonist (i.e. naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
The long duration of action of buprenorphine and the modified release from Buvidal, should be taken into consideration when determining length of treatment needed to reverse the effects of an overdose. Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia) for advice.
5 Pharmacological Properties
5.3 Preclinical Safety Data
General. Chronic toxicity studies in rat and dog of the vehicle used for Buvidal revealed no specific special hazard for humans.
Genotoxicity. Buprenorphine has been shown to give negative results in mutagenicity and clastogenicity assays. Similarly, the other components of Buvidal have either been shown to lack in vitro mutagenic and clastogenic activity (i.e. ethanol, glyceryl dioleate, and N-methylpyrrolidone) or are generally recognised as safe (i.e. phosphatidyl choline).
Carcinogenicity. Buprenorphine and the other components of Buvidal are considered to have low carcinogenic potential.
6 Pharmaceutical Particulars
6.7 Physicochemical Properties
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUPREO.gif CAS number. 52485-79-7.
7 Medicine Schedule (Poisons Standard)
Schedule 8.
Summary Table of Changes
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BVMTWKST.gif
