Active Ingredient: Buprenorphine
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.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
4 - 32 mg
From 4 To 32 mg once every day
To avoid precipitating symptoms of withdrawal, treatment with buprenorphine should be started when objective and clear signs of mild to moderate withdrawal are evident. 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.
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 buprenorphine to confirm tolerability to buprenorphine.
The recommended starting dose of buprenorphine 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 buprenorphine can be started after treatment initiation with weekly buprenorphine, in accordance with the dose conversion in Table 2 and once patients have been stabilised on weekly treatment (four weeks or more, where practical).
Patients treated with sublingual buprenorphine may be switched directly to weekly or monthly buprenorphine, 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 buprenorphine:
| Dose of daily sublingual buprenorphine | Dose of weekly buprenorphine | Dose of monthly buprenorphine |
|---|---|---|
| 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 |
The dose of buprenorphine in mg can differ between sublingual products, which needs to be taken into consideration on a product-by-product basis.
Buprenorphine 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 2. Following switching, patients may need closer monitoring. Assessment of long-term treatment is based on 48-week data.
Table 2. Recommended dose conversion when switching from weekly to monthly dosing or from monthly to weekly dosing:
| Weekly dose of buprenorphine | Monthly dose of buprenorphine |
|---|---|
| 16 mg | 64 mg |
| 24 mg | 96 mg |
| 32 mg | 128 mg |
A maximum of one supplemental buprenorphine 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 buprenorphine treatment is 32 mg with an additional 8 mg dose. The maximum dose per month for patients who are on monthly buprenorphine treatment is 128 mg with an additional 8 mg dose.
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.
If buprenorphine treatment is discontinued, its prolonged-release characteristics and any withdrawal symptoms experienced by the patient must be considered. 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.
Buprenorphine is intended for subcutaneous administration only. It should be injected slowly and completely into the subcutaneous tissue of different areas (buttock, thigh, abdomen, or upper arm), provided there is enough subcutaneous tissue. Each area can have multiple injection sites. Injection sites should be rotated for both weekly and monthly injections. A minimum of 8 weeks should be left before reinjecting a previously used injection site with the weekly dose. There is no clinical data supporting reinjection of the monthly dose into the same site. This is unlikely to be a safety concern. The decision to reinject at the same site should also be guided by the attending physiciansยด clinical judgement.
Administered dose should be as a single injection and not divided. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally (into the skin).
Sublingual
0.4 - 24 mg
From 0.4 To 24 mg once every day
Treatment is intended for use in adults and adolescents aged 16 years or older who have agreed to be treated for addiction.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medication and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended.
Prior to treatment induction, consideration should be given to the type of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence. To avoid precipitating withdrawal, induction with Buprenorphine should be undertaken when objective and clear signs of withdrawal are evident.
The initial dose is from 0.8mg to 4mg, administered as a single daily dose. 0.4mg dose strength of Buprenorphine is not available. If low dose is required, the patient should use tablets (0.4mg) of another brand.
The dosage should be individualised for each patient. The maintenance dosage will vary between individuals and should be determined by progressively increasing the dose until the minimal effective dose is identified. The mean maintenance daily dose is 8mg. The majority of patients will not require doses exceeding 16mg/day, however, the efficacy and safety of buprenorphine tablets was tested in clinical trials in doses up to 24mg per day.
The dosage is titrated according to reassessment of the clinical status and global management of the patient. Unsatisfactory stabilisation on 16mg per day may be related to potential misuse or psychiatric comorbidities. In these cases alternative treatment options should be taken into account.
Daily dispensing of buprenorphine is recommended, particularly during the initiation of treatment. Then, after stabilisation, the patient may be given a supply of the product sufficient for several days of treatment. However, it is recommended that the amount of the product dispensed be limited to a maximum of 7 days or according to local requirements.
After a satisfactory period of stabilisation has been achieved, the dosage 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 0.4mg, 2mg and 8mg, respectively, allows for a downward titration of dosage. Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.
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 tablet should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes.
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