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Buvidal is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Verbatim from this product's EMA label. Tap a section to expand.
Administration of Buvidal is restricted to healthcare professionals. Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid dependence therapies. Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring according to the patient's needs, should be taken when prescribing and dispensing buprenorphine.
Take-home use or self-administration of the product by patients is not allowed. 4). Consideration should be given to the types of opioid used (that is long- or short-acting opioid), time since last opioid use and the degree of opioid dependence.
• For patients using heroin or short-acting opioids, the initial dose of Buvidal must not be administered until at least 6 hours after the patient last used opioids. • For patients receiving methadone, the methadone dose should be reduced to a maximum of 30 mg/day before starting treatment with Buvidal which should not be administered until at least 24 hours after the patient last received a methadone dose.
Buvidal may trigger withdrawal symptoms in methadone-dependent patients. Posology Initiation of treatment in patients not already receiving buprenorphine Patients not previously exposed to buprenorphine should receive a sublingual buprenorphine 4 mg dose and be observed for an hour before the first administration of weekly Buvidal to confirm tolerability to buprenorphine.
The recommended starting dose of Buvidal is 16 mg, with one or two additional 8 mg doses at least 1 day apart, to a target dose of 24 mg or 32 mg during the first treatment week. The recommended dose for the second treatment week is the total dose administered during the week of initiation.
Treatment with monthly Buvidal can be started after treatment initiation with weekly Buvidal, in accordance with the dose conversion in Table 1 and once patients have been stabilised on weekly treatment (four weeks or more, where practical).
Switching from sublingual buprenorphine products to Buvidal Patients treated with sublingual buprenorphine may be switched directly to weekly or monthly Buvidal, starting on the day after the last daily buprenorphine sublingual treatment dose in accordance with the dosing recommendations in Table 1.
Closer monitoring of patients is recommended during the dosing period after the switch. Table 1. Conventional sublingual buprenorphine daily treatment doses and recommended corresponding doses of weekly and monthly Buvidal Dose of daily sublingual buprenorphine Dose of weekly Buvidal Dose of monthly Buvidal 2-6 mg 8 mg 8-10 mg 16 mg 64 mg 12-16 mg 24 mg 96 mg 18-24 mg 32 mg 128 mg 26-32 mg 160 mg Patients may be switched from sublingual buprenorphine 26-32 mg directly to monthly Buvidal 160 mg with close monitoring during the dosing period after the switch.
Summary of the safety profile The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain. Tabulated list of adverse reactions Table 2 presents adverse reactions reported for buprenorphine, including Buvidal.
The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) and frequency not known (cannot be estimated from available data). Table 2. Adverse reactions listed by body system System Organ Class Very common Common Uncommon Not known Infections and infestations Infection Influenza Pharyngitis Rhinitis Injection site cellulitis Blood and lymphatic system disorders Lymphadenopathy Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Insomnia Anxiety Agitation Depression Hostility Nervousness Thinking abnormal Paranoia Medical dependence Hallucinations Euphoric mood Nervous system disorders Headache Somnolence Dizziness Migraine Paraesthesia Syncope Tremor Hypertonia Speech disorders Eye disorders Lacrimal disorder Mydriasis Miosis 11 Table 2.
Adverse reactions listed by body system System Organ Class Very common Common Uncommon Not known Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Vascular disorders Vasodilation Hypotension Respiratory, thoracic and mediastinal disorders Cough Dyspnoea Yawning Asthma Bronchitis Gastrointestinal disorders Nausea Constipation Vomiting Abdominal pain Flatulence Dyspepsia Dry mouth Diarrhoea Gastrointestinal disorder Hepatobiliary disorders Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzymes increased Skin and subcutaneous tissue disorders Rash Pruritus Urticaria Rash macular Erythema Musculoskeletal and connective tissue disorders Arthralgia Back pain Myalgia Muscle spasms Neck pain Bone pain Renal and urinary disorders Urinary retention Reproductive system and breast disorders Dysmenorrhoea General disorders and administration site conditions Hyperhidrosis Drug withdrawal syndrome Pain Injection site pain Injection site pruritus Injection site erythema Injection site swelling Injection site reaction Injection site induration Injection site mass Oedema peripheral Asthenia Malaise Pyrexia Chills Neonatal withdrawal syndrome Chest pain Injection site inflammation Injection site bruising Injection site urticaria Injection site abscess Injection site ulceration Injection site necrosis 12 Table 2.
Administration Care must be taken to avoid inadvertent injection of Buvidal. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally. Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or thromboembolic events.
To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine. Healthcare professionals should administer Buvidal directly to the patient. Take-home use or self-administration of the product by patients is not allowed.
Any attempts to remove the depot should be monitored throughout treatment. 2). 2). 5) or when buprenorphine was not used according to prescribing information. 5) or other opioids. g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis).
Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it. 7). Tolerance and opioid use disorder (abuse and dependence) Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration can produce opioid dependence.
6 Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as buprenorphine. Abuse or intentional misuse of buprenorphine may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). g. too early requests for refills). This includes the review of concomitant opioids and psychoactive drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
1 Severe respiratory insufficiency Severe hepatic impairment Acute alcoholism or delirium tremens
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The dose of buprenorphine in mg can differ between sublingual products, which needs to be taken into consideration on a product-by-product basis. 2. Maintenance treatment and dose adjustments Buvidal can be administered weekly or monthly.
Doses may be increased or decreased and patients can be switched between weekly and monthly products according to individual patient’s needs and treating physician’s clinical judgement as per recommendations in Table 1. Following switching, patients may need closer monitoring.
Assessment of long-term treatment is based on 48-week data. 4 Supplemental dosing A maximum of one supplemental Buvidal 8 mg dose may be administered at an unscheduled visit between regular weekly and monthly doses, based on individual patient’s temporary needs.
The maximum dose per week for patients who are on weekly Buvidal treatment is 32 mg with an additional 8 mg dose. The maximum dose per month for patients who are on monthly Buvidal treatment is 160 mg. Missed doses To avoid missed doses, the weekly dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point.
If a dose is missed, the next dose should be administered as soon as practically possible. Treatment goals and discontinuation Before initiating treatment with Buvidal treatment goals should be agreed together with the patient. 4). If the patient is switched to treatment with sublingual buprenorphine, this should be done one week after the last weekly dose or one month after the last monthly dose of Buvidal according to the recommendations in Table 1.
Special populations Elderly The efficacy and safety of buprenorphine in elderly patients > 65 years have not been established. No recommendation on posology can be made. In general, recommended dosing for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
However, because elderly patients may have diminished renal/hepatic function, dose adjustment may be necessary (see below). 2). 3). Renal impairment Modification of the buprenorphine dose is not required for patients with renal impairment.
2). Paediatric population The safety and efficacy buprenorphine in children and adolescents […]
9%) of the 213 patients (5% of the administered injections) in the Buvidal treatment group. 7%). The injection site reactions were all mild or moderate in severity and most events were transient. Injection site-related adverse reactions of abscess, ulceration and necrosis have been reported during post-marketing use with Buvidal.
Drug dependence Repeated use of buprenorphine can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medical product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. Hepatitis and hepatic events Baseline liver function tests and documentation of viral hepatitis status are recommended prior to starting therapy.
5) and/or who have existing liver dysfunction are at greater risk of liver injury. Regular monitoring of the liver function is recommended. Cases of acute hepatic injury have been reported in opioid-dependent patients both in clinical studies and in post-marketing adverse reaction reports with medicinal products containing buprenorphine.
The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of cytolytic hepatitis, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
In many cases, the presence of pre-existing liver enzyme abnormalities, genetic disease, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicinal products and ongoing injecting drug use may have a causative or contributory role.
These underlying factors must be taken into consideration before prescribing buprenorphine and during treatment. When a hepatic event is suspected, further biological and aetiological evaluation is required. Depending on the findings, Buvidal may be discontinued.
Monitoring beyond the weekly and monthly treatment period may be needed. If treatment is continued, hepatic function should be monitored closely. Precipitation of opioid withdrawal […]