TRANSTEC Transdermal patch Ref.[27646] Active ingredients: Buprenorphine

Posology

Patients over 18 years of age

The TRANSTEC dosage should be adapted to the condition of the individual patient (pain intensity, suffering, individual reaction). The lowest possible dosage providing adequate pain relief should be given. Three transdermal patch strengths are available to provide such adaptive treatment: TRANSTEC 35 micrograms/h, TRANSTEC 52.5 micrograms/h and TRANSTEC 70 micrograms/h.

Initial dose selection: patients who have previously not received any analgesics should start with the lowest transdermal patch strength (TRANSTEC 35 micrograms/h). Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with TRANSTEC 35 micrograms/h. According to the WHO recommendations, the administration of a non-opioid analgesic can be continued, depending on the patient’s overall medical condition.

When switching from a step-III analgesic (strong opioid) to TRANSTEC and choosing the initial transdermal patch strength, the nature of the previous medication, administration and the mean daily dose should be taken into account in order to avoid the recurrence of pain. In general it is advisable to titrate the dose individually, starting with the lowest transdermal patch strength (TRANSTEC 35 micrograms/h). Clinical experience has shown that patients who were previously treated with higher daily dosages of a strong opioid (in the dimension of approximately 120 mg oral morphine) may start the therapy with the next higher transdermal patch strength (see also section 5.1).

To allow for individual dose adaptation in an adequate time period sufficient supplementary immediate release analgesics should be made available during dose titration.

The necessary strength of TRANSTEC must be adapted to the requirements of the individual patient and checked at regular intervals.

After application of the first TRANSTEC transdermal patch the buprenorphine serum concentrations rise slowly both in patients who have been treated previously with analgesics and in those who have not. Therefore initially, there is unlikely to be a rapid onset of effect. Consequently, a first evaluation of the analgesic effect should only be made after 24 hours.

The previous analgesic medication (with the exception of transdermal opioids) should be given in the same dose during the first 12 hours after switching to TRANSTEC and appropriate rescue medication on demand in the following 12 hours.

Dose titration and maintenance therapy

TRANSTEC should be replaced after 96 hours (4 days) at the latest. For convenience of use, the transdermal patch can be changed twice a week at regular intervals, e.g. always on Monday morning and Thursday evening. The dose should be titrated individually until analgesic efficacy is attained. If analgesia is insufficient at the end of the initial application period, the dose may be increased, either by applying more than one transdermal patch of the same strength or by switching to the next transdermal patch strength. At the same time no more than two transdermal patches regardless of the strength should be applied.

Before application of the next TRANSTEC strength the amount of total opioids administered in addition to the previous transdermal patch should be taken into consideration, i.e. the total amount of opioids required, and the dosage adjusted accordingly. Patients requiring a supplementary analgesic (e.g. for breakthrough pain) during maintenance therapy may take for example one to two 0.2 mg buprenorphine sublingual tablets every 24 hours in addition to the transdermal patch. If the regular addition of 0.4 – 0.6 mg sublingual buprenorphine is necessary, the next strength should be used.

Paediatric population

As TRANSTEC has not been studied in patients under 18 years of age, the use of the medicinal product in patients below this age is not recommended.

Elderly patients

No dosage adjustment of TRANSTEC is required for elderly patients.

Patients with renal insufficiency

Since the pharmacokinetics of buprenorphine is not altered during the course of renal failure, its use in patients with renal insufficiency, including dialysis patients, is possible.

Patients with hepatic insufficiency

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 liver insufficiency should be carefully monitored during treatment with TRANSTEC.

Method of application

TRANSTEC should be applied to non-irritated, clean skin on a non-hairy flat surface, but not to any parts of the skin with large scars. Preferable sites on the upper body are: upper back or below the collar-bone on the chest. Any remaining hairs should be cut off with a pair of scissors (not shaved). If the site of application requires cleansing, this should be done with water. Soap or any other cleansing agents should not be used. Skin preparations that might affect adhesion of the transdermal patch to the area selected for application of TRANSTEC should be avoided.

The skin must be completely dry before application. TRANSTEC is to be applied immediately after removal from the sachet. Following removal of the release liner, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds. The transdermal patch will not be affected when bathing, showering or swimming. However, it should not be exposed to excessive heat (e.g. sauna, infrared-radiation).

TRANSTEC should be worn continuously for up to 4 days. After removal of the previous transdermal patch a new TRANSTEC transdermal patch should be applied to a different skin site. At least one week should elapse before a new transdermal patch is applied to the same area of skin.

Duration of administration

TRANSTEC should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with TRANSTEC 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.

Discontinuation of TRANSTEC

After removal of TRANSTEC 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 TRANSTEC is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of TRANSTEC. For the time being only limited information is available on the starting dose of other opioids administered after discontinuation of TRANSTEC.

Buprenorphine has a wide safety margin. Due to the rate-controlled delivery of small amounts of buprenorphine into the blood circulation high or toxic buprenorphine concentrations in the blood are unlikely. The maximum serum concentration of buprenorphine after the application of the TRANSTEC 70 micrograms/h transdermal patch is about six times less than after the intravenous administration of the therapeutic dose of 0.3 mg buprenorphine.

Symptoms

In principal, on overdose with buprenorphine, symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These are: respiratory depression, sedation, somnolence, nausea, vomiting, cardiovascular collapse, and marked miosis.

Treatment

General emergency measures apply. Keep the airway open (aspiration!), maintain respiration and circulation depending on the symptoms. Naloxone has a limited impact on the respiratory depressant effect of buprenorphine. High doses are needed given either as repeated boluses or infusion (for example starting with a bolus administration of 1-2 mg intravenously. Having attained an adequate antagonistic effect, administration by infusion is recommended to maintain constant naloxone plasma levels). Therefore, adequate ventilation should be established.

3 years.

This medicinal product does not require any special storage conditions.

Type of container:

Sealed child-resistant sachet, composed of identical top and bottom layers of heat-sealable laminate, comprising (from outside to inside) paper, polyethylene terephthalate, polyethylene, aluminium and poly (acrylic acid-co-ethylene) (= surlyn).

Pack sizes:

Packs containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20 or 24 individually sealed transdermal patches.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.