TREATMENT WITH BUVIDAL®

TREATMENT WITH BUVIDAL®

Buvidal is indicated 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.

Administration of Buvidal is restricted to healthcare professionals.

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.

Buvidal can be administered as either a weekly or a monthly injection.

Buvidal is available in the following doses:

For weekly injection:

Pre-filled syringes containing Buvidal 8 mg, 16 mg, 24 mg and 32 mg prolonged-release solution for injection.

For monthly injection:

Pre-filled syringes containing Buvidal 64 mg, 96 mg and 128 mg prolonged-release solution for injection.

Posology

Administration of Buvidal is restricted to healthcare professionals.

Appropriate precautions, such as conducting 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.

Precautions to be taken before initiation of treatment

To avoid precipitating symptoms of withdrawal, treatment with Buvidal 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 (i.e. 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.

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 1 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 first treatment week.

Treatment with monthly Buvidal can be started after treatment initiation with weekly Buvidal, in accordance with the dose conversion in Table 2 and once patients have been stabilised on weekly treatment (4 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.

The dose of buprenorphine in mg can differ between sublingual products, which needs to be taken into consideration on a product-by-product basis.

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

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 dosing according to the individual patient’s needs and the treating physician’s clinical judgement as per the recommendations in Table 2.

Following switching, patients may need closer monitoring.

Table 2. Recommended dose conversion when switching from weekly to monthly dosing

Weekly dose of Buvidal Monthly dose of Buvidal
16 mg 64 mg
24 mg 96 mg
32 mg 128 mg

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 an 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 128 mg with an additional 8 mg dose.

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.

Termination of treatment

If Buvidal 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 1 week after the last weekly dose or 1 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, the 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.

Hepatic impairment

Buprenorphine should be used with caution in patients with moderate hepatic impairment.

In patients with severe hepatic impairment, the use of buprenorphine is contraindicated.

Renal impairment

Modification of the buprenorphine dose is not required for patients with renal impairment.

Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min).

Paediatric population

The safety and efficacy buprenorphine in children and adolescents below 16 years of age have not been established. No data are available.

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© 2020 Camurus AB. All rights reserved | INT-BUV-1900007 | Date of preparation: February 2019

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