Addenda to the Depot buprenorphine clinical guidelines are proposed to and agreed upon by the Depot Buprenorphine Working Group, made up of experienced clinicians, a consumer representative , and NSW Health.

The following is to be read on page 15 under ii. contraindications:

  • Buvidal® Weekly or Buvidal® Monthly should not be administered to anyone hypersensitive to BPN (see below) or any of the excipients [phosphatidyl choline [soybean], glyceryl dioleate and ethanol anhydrous (in Buvidal® Weekly), and N-methyl-2- pyrrolidone (in Buvidal® Monthly)].
  • Sublocade® should not be administered to patients who have been shown to be hypersensitive (see below) to BPN or any component of the ATRIGEL® delivery system [i.e. N-methyl-2- pyrrolidone (NMP) and Poly (DL-lactide-co-glycolide) (PLGA/polyglactin)].
  • The features of hypersensitivity to BPN include rashes, hives, and pruritis. Most serious reported cases have involved bronchospasm, angioneurotic oedema, and anaphylactic shock. It should be noted that hypersensitivity to buprenorphine, and anaphylaxis to depot buprenorphine is very rare. However, all sites that administer depot buprenorphine should have anaphylaxis response procedures in place when giving depot injections.

Hospital inpatients

The following addendum is to be read at the bottom of page 40, in the section on hospital and correctional settings:
  • The NSW regulatory framework relating to s8 drugs of addiction allows for hospital inpatients to be prescribed depot buprenorphine without an authority from PRU if the patient was being treated with depot buprenorphine immediately before admission to hospital, and was prescribed before admission in accordance with an authority.
  • This means that if the patient is already being treated with depot buprenorphine prior to admission, then that treatment can continue without an authority while the patient is in hospital. This is regardless of the length of stay and is for the purpose of continuation of treatment.
  • The regulation also allows for hospital inpatients to be inducted and prescribed buprenorphine without an authority if the inpatient stay does not exceed 14 consecutive days.
  • The Depot buprenorphine Clinical Guidelines recommend that clinicians who are not addiction medicine or addiction psychiatry specialists should consult with local addiction specialists for advice before inducting hospital inpatients onto depot buprenorphine. This may include use of telehealth or DASAS where no local addiction specialists are available. Clinicians should also consider arrangements for the patient’s continued access to depot buprenorphine post-discharge.

Change to length of storage and shelf life for Sublocade®

Please read this as modification to information on pages 7 (Table 1) and 45 (section b.ii).
On 22 September 2020 the Therapeutic Goods Administration approved a new Product Information (PI) sheet for Sublocade®. The new PI states:
  • Store at 2 - 8°C. Refrigerate. Do not freeze.
  • Once outside the refrigerator this product may be stored in its original packaging at room temperature (below 25°C) for up to 28 days prior to administration.
  • Discard Sublocade® if left at room temperature for longer than 28 consecutive days.
Additionally the refrigerated shelf life of Sublocade® is now 18 months.
Please Note: This PI change does not apply to existing stock.  You will need to check the PI and expiry date of each individual item of Sublocade before storing and administration. If the PI in the Sublocade® packaging states the medicine can be out of refrigeration for seven (7) days only and has a refrigerated shelf life of two (2) years follow those directions to ensure the product is safe to use.  New stock is likely to become available in early-mid 2021 and it will have the new PI included with it indicating the new out-of-fridge and expiry limits.
Current as at: Friday 23 October 2020