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PREFIBIN is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 15 years and over who have agreed to be treated for addiction.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. The result of the treatment depends on the dose prescribed as well as on the combined medical, psychological, social and educational measures taken in monitoring the patient Precautions to be taken before dosing Prior to treatment induction, physicians should be aware of the partial agonist profile of buprenorphine to the opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence. g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
8 mg to 4 mg, administered as a single daily dose. - For patients -dependent on heroin or short-acting opioids: the first dose of buprenorphine should be started when objective signs of withdrawal appear, but not less than 6 hours after the patient last used opioids.
- For patients receiving methadone: before beginning buprenorphine therapy, the dose of methadone should be reduced to a maximum of 30 mg/day. Buprenorphine may precipitate symptoms of withdrawal in patients dependent on methadone. The first dose of buprenorphine should be started only when objective signs of withdrawal appear and generally not less than 24 hours after the patient last used methadone because of the long half-life of methadone.
Dose adjustment and maintenance The dose of buprenorphine should be increased progressively according to the clinical effect of the individual patient. The mean maintenance daily dose is 8 mg. The majority of patients will not require doses exceeding 16 mg/day, however, the efficacy and safety of buprenorphine sublingual tablets was tested in clinical trials in doses up to 24 mg per day.
The dose is titrated according to reassessment of the clinical and psychological status of the patient and should not exceed a maximum single daily dose of 24 mg buprenorphine. Less than daily dosing After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
g. insomnia, headache, nausea and hyperhidrosis) and pain. Tabulated list of adverse reactions Table 1 summarises: adverse reactions reported from pivotal clinical studies. The frequency of possible side effects listed below is based on the following convention: very common (≥ 1/10) ; common (≥ 1/100 to <1/10) ; uncommon (≥ 1/1,000 to <1/100) the most commonly reported adverse drug reactions during post-marketing surveillance.
Events occurring in at least 1% of reports by healthcare professionals and considered expected are included. Frequency of events not reported in pivotal studies cannot be estimated and is given as not known. 4). - In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone.
- The most common signs and symptoms of hypersensitivity include rashes, urticaria, and pruritus. 3). 4). - Neonatal drug withdrawal syndrome has been reported among newborns of women who have received buprenorphine during pregnancy. The syndrome may be milder than that seen with a full μ-opioid agonist and may be delayed in onset.
6). - Drug dependence: Repeated use of Prefibin can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.
Prefibin is recommended only for the treatment of opioid drug dependence. It is also recommended that treatment is prescribed by a physician who ensures comprehensive management of the opioid dependent patients. Misuse, abuse and diversion Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Some risks of misuse and abuse include overdose, spread of blood borne viral or localised infections, respiratory depression and hepatic injury. Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicine is not safeguarded against theft.
Sub-optimal treatment with buprenorphine may prompt medication misuse by the patient, leading to overdose or treatment dropout. A patient who is under-dosed with buprenorphine may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
To minimise the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient’s level of stability.
5) or when buprenorphine was not used according to prescribing information. 5) or other opioids. If buprenorphine is administered to some non opioid dependent individuals who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
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-dependent persons who accidentally or deliberately ingest it.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For example, a patient stabilised to receive a daily dose of 8 mg may be given 16 mg on alternate days, with no dose on the intervening days. In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days. However, the dose given on any one day should not exceed 24 mg.
Patients requiring a titrated daily dose of more than 8 mg/day may not find this regimen adequate. Dose reduction and termination of treatment After a satisfactory period of stabilisation has been achieved, the dose may be reduced gradually to a lower maintenance dose; when deemed appropriate, treatment may be discontinued in some patients.
The availability of the sublingual tablet in doses of 2 mg (divisible into 2x1 mg) and 8 mg (divisible into 2x4 mg), respectively, allows for a downward titration of dose. Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.
Special populations Elderly The safety and efficacy of buprenorphine in elderly patients over 65 years has not been established. Hepatic impairment Patients who are positive for viral hepatitis, on concomitant medicinal products and/or have existing liver dysfunction are at risk of greater liver injury.
4). 2). 3). Renal impairment Modification of the buprenorphine dose is not generally required for patients with renal impairment. 2). 3). Method of administration Administration is sublingual. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this medicinal product.
The sublingual tablet should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes. Treatment goals and discontinuation Before initiating treatment with Prefibin, a treatment strategy including treatment duration and treatment goals, should be agreed together with the patient.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4).
Protect children and non-dependent persons against exposure. 7). Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of buprenorphine and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicinal products the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 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.
Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Prefibin. Abuse or intentional misuse of Prefibin 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.
Dependence Buprenorphine is a partial agonist at the μ-opiate receptor and chronic administration produces dependence of the opioid type. Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist.
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