Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia.
Reletrans is not suitable for the treatment of acute pain.
Reletrans is indicated in adults.
Reletrans should be administered every 7th day.
The lowest Reletrans strength (Reletrans 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient.
Reletrans should not be used at higher doses than recommended.
During initiation and titration with Reletrans, patients should use the usual recommended doses of short-acting supplemental analgesics (see section 4.5) as needed until analgesic efficacy with Reletrans is attained.
The dose of Reletrans may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established. Subsequent dose increases may then be titrated based on the need for supplemental pain relief and the patient’s analgesic response to the transdermal patch.
To increase the dose, a patch with a higher strength should replace the transdermal patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two transdermal patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine. Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.
Buprenorphine transdermal patches can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose (Reletrans 5 microgram/hour transdermal patch) and continue taking short-acting supplemental analgesics (see section 4.5) during titration, as required.
Reletrans should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Reletrans is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
After removal of the transdermal patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Reletrans is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the transdermal patch. At present, only limited information is available on the starting dose of other opioids administered after discontinuation of the transdermal patch (see section 4.5).
No dose adjustment of Reletrans is required in elderly patients.
No special dose adjustment of Reletrans is necessary in patients with renal impairment.
Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore, patients with hepatic insufficiency should be carefully monitored during treatment with Reletrans.
Patients with severe hepatic impairment may accumulate buprenorphine during Reletrans treatment. Alternate therapy should be considered, and Reletrans should be used with caution, if at all, in such patients.
Since CYP3A4 inhibitors may increase concentrations of buprenorphine (see section 4.5), patients already treated with CYP3A4 inhibitors should have their dose of buprenorphine transdermal patches carefully titrated since a reduced dose might be sufficient in these patients.
The safety and efficacy of buprenorphine transdermal patches in children and adolescents below 18 years of age has not been established. No data are available.
Transdermal use.
Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.
Reletrans should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars. Reletrans should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven.
If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the transdermal patch is applied. The transdermal patches should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges. If the edges of the transdermal patch begin to peel off, the edges may be taped down with suitable skin tape, to ensure a 7-day period of wear.
Bathing, showering, or swimming should not affect the transdermal patch. If a transdermal patch falls off, a new one should be applied and worn for 7 days.
A new transdermal patch should not be applied to the same skin site for the subsequent 3-4 weeks (see section 5.2).
While wearing the patch, patients should be advised to avoid exposing the application site to external heat sources (see section 4.4).
Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.
Any transdermal patches should be removed from the patient’s skin. A patent airway should be established and maintained, respiration assisted or controlled as indicated and adequate body temperature and fluid balance should be maintained. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.
A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone may be less effective in reversing the effects of buprenorphine than other mu-opioid agonists. Treatment with continuous intravenous naloxone should begin with the usual doses but high doses may be required.
2 years.
Do not store above 25°C.
Each transdermal patch is individually packed in a child resistant sachet made of PET/Alu/PE.
Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20 transdermal patches.
Not all pack sizes may be marketed.
Used transdermal patches should be folded with the adhesive surface in wards. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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