Transtec▼
(buprenorphine matrix patches)
Patient profiles
Napp Pharmaceuticals Limited
Prescribing information is given at the end of the case studies
Contents
Page 2
Introduction
Page 3
Osteoarthritis
Page 5
Fractures secondary to osteoporosis
Page 8
Low back pain
Page 9
Other types of pain
Page 11
Example of written script
Page 12
Prescribing information
Introduction
Transtec matrix patches contain the opioid analgesic, buprenorphine in a
technologically advanced transdermal delivery system. Clinically effective levels are
reached after one day and the patches provide pain relief for the full 72-hour
application period.
The following are real case studies of patients who have been successfully treated
with Transtec matrix patches. Most of these patients had previously received other
analgesics, but had remained in pain. To the best of our knowledge, these patients
were treated according to the licensed indications for Transtec matrix patches, i.e.
moderate to severe cancer pain and severe pain not responsive to non-opioid
analgesics.
In a long-term clinical trial in which patients with chronic non-malignant pain were
treated with Transtec matrix patches (35 g/h) for an average of 6.6 months, 94.3%
of patients had satisfactory or better pain relief.1
The photographs are for illustrative purposes only and are not of the actual patients.
Osteoarthritis
Case 1
This 89-year old female patient had osteoarthritis with chronic joint pain and stiffness.
She had pain on movement and at rest, and her mobility was limited. She was
treated with nefopam (30 mg once-daily) and co-prescribed metoclopramide (10 mg)
to control nausea. However, her compliance was an issue at times. She was
switched to Transtec patches (35 g/h). Her pain was well controlled and her
stiffness and mobility improved. The nausea also resolved and an anti-emetic was
not required. The patient was described as ‘happy’ and compliance was no longer a
problem.
Case 2
This 77-year old female patient had chronic, severe osteoarthritis, characterised by
pain on movement. She was treated with tramadol (150 mg twice-daily) and
diclofenac (100 mg twice-daily) for the pain, and was also taking temazepam to help
her sleep. She was switched to Transtec patches (35 g/h), supplemented with
tramadol for breakthrough pain, and her pain was reduced by 30 – 40%. Her sleeping
also improved and she was able to stop taking the temazepam.
Fractures secondary to osteoporosis
Case 3
This 62-year old female patient developed an osteoporotic crush fracture, together
with fractures of the sacrum and two ribs. She also had a history of rheumatoid
arthritis and was receiving low-dose methylprednisolone. She was given tramadol to
treat the fracture pain, and received physiotherapy, but these had little effect. She
was therefore switched to Transtec patches (35 g/h) for five months. During this
time, she was mobile and had good pain control. Her articular pain also diminished to
the extent that the corticosteroids could be withdrawn at the end of the 5-month
treatment period.
Case 4
This 50-year old female patient presented with a vertebral fracture secondary to
osteoporosis. She was in severe pain and confined to bed. She was treated with
pamidronate and analgesics, and received physiotherapy, but these were not
effective. She was therefore switched to Transtec patches (35 g/h). Pain control
was good and the patient became mobile again. She was treated for six months, at
which point she was mobile and pain-free.
Case 5
This 75-year old female patient had osteoporosis, with chronic back pain, sleep
disturbance, anxiety, restlessness, and chronic constipation. She had been treated
with paracetamol/codeine (4 g/240 mg per day), but was switched to Transtec
patches (35 g/h). Her pain was well controlled and her other symptoms, including
constipation, also resolved. The patient was described as being much more settled
and content.
Low back pain
Case 6
This 47-year old male patient had chronic low back pain and was waiting for a
referral to a pain clinic. The cause of his back pain was unknown, although he had
been in a traffic accident. He was started on Co-proxamol tablets (paracetamol
325 mg/
dextropropoxyphene 32.5 mg), but was eventually switched to tramadol. However,
his pain was not controlled and he was therefore switched to Transtec patches
(35 g/h). After starting the patches, the patient was pain-free and able to wait for his
appointment at the pain clinic without discomfort.
Other types of pain
Case 7
This 54-year old female patient had psoriatic arthritis and fibromyalgia syndrome.
She has severe pain in her wrists and lower back, and was being treated with
tramadol (600 mg), ibuprofen (600 mg), paracetamol (1-2 g), and an NMDA receptor
antagonist, flupirtine (200 mg). She was switched to Transtec patches (35 g/h),
supplemented with sublingual buprenorphine tablets for breakthrough pain, and
reported good to satisfactory pain relief. This patient was taking part in a clinical trial
and at the end of the trial, she requested to continue treatment with Transtec
patches (35 g/h). She was treated for 34 months with no increase in dose.
Case 8
This 51-year old female patient had a history of surgery for carpal tunnel syndrome
and had also been treated for thoracic outlet syndrome. She presented with severe
cervicobrachialgia radiating to her little finger with numbness. Examination revealed
degenerative changes to her spine. The patient was treated with tramadol, several
NSAIDs, and physiotherapy, but with no relief. She was switched to Transtec
patches (35 g/h), which produced excellent analgesia within five days. Treatment
was continued for three months and when it was stopped, the patient was pain free.
Case 9
This 52-year old male diabetic patient presented with a bi-lateral frozen shoulder
(diabetes is known to exacerbate this condition). He was unable to move his
shoulders at all because of the intensity of the pain. The patient had received
manipulation under anaesthetic, followed by physiotherapy and treatment with Cocodamol (paracetamol 500 mg/codeine phosphate 30 mg; formulation not stated in
case report) and dihydrocodeine, but was still in pain. He was switched to tramadol,
which provided some relief, and then to Transtec patches (35 μg/h). His pain relief
improved significantly, but not completely, so he was titrated to the 52.5 μg/h patch.
The patient was described as being pain-free, and was able to travel abroad, go
swimming, and look for employment.
Transtec® 35 g/h, 52.5 g/h, 70 g/h
PRESCRIBING INFORMATION
Presentation
Transdermal patch with rounded corners.
‘Transtec 35 g/h’ contains 20 mg of buprenorphine.
‘Transtec 52.5 g/h’ contains 30 mg of buprenorphine.
‘Transtec 70 g/h’ contains 40 mg of buprenorphine.
Indications
Moderate to severe cancer pain and severe pain not responding to non-opioid analgesics. Transtec is not
suitable for the treatment of acute pain.
Administration
Elderly and adults over 18 years:
Transtec patches should be replaced every 3 days. The dosage is dependent on the severity of the pain and the
patient’s previous history of analgesic requirements. The usual starting dose for opioid naïve patients is 35 g/h.
To transfer patients receiving weak or strong opioids, please refer to the Transtec SmPC. Analgesia can be
increased by increasing patch strength or adding another patch. Do not use more than two patches at a time.
Children under 18 years:
Not recommended.
Contra-indications
Respiratory depression, known buprenorphine or excipient sensitivity, delirium tremens, myasthenia gravis,
concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use,
opioid-dependency and narcotic withdrawal treatment.
Precautions and warnings
Increased intracranial pressure, acute alcohol intoxication, convulsive disorders, head injury, shock, reduced
consciousness, impaired respiratory function or drugs causing this effect, liver function disorders, febrile patients
or other increased skin temperature, history of drug abuse. Patients should not drive or use machines while
wearing a patch and for at least 24 hours after the patch has been removed.
CNS effects may be intensified when Transtec patches are applied with other opioids, anaesthetics, hypnotics,
sedatives, antidepressants, neuroleptics, alcohol, and drugs that depress respiration. Effects may be intensified
with inhibitors of CYP 3A4 and weakened by inducers.
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Pregnancy and lactation
Contra-indicated in pregnancy. Avoid during lactation.
Side-effects
Common adverse events are erythema, pruritus, nausea, vomiting, dizziness, tiredness, headache, constipation,
diaphoresis, dyspnoea, oedema.
Some side-effects which are uncommon, but can be serious, are micturition disorders, urinary retention,
respiratory depression, miosis, rashes, blurred vision, sedation, drowsiness, serious allergic reactions,
hallucinations, and other psychomimetic effects.
Please refer to the SmPC for further details of other uncommon side-effects.
Legal category
CD (Sch3) POM
Package quantities and price
Transtec 35 g/h 5 patches
Transtec 52.5 g/h 5 patches
Transtec 70 g/h 5 patches
£28.97
£43.46
£57.94
Marketing authorisation numbers
PL 04539/0014-16
Marketing authorisation holder
Grunenthal GmbH, Zieglestrasse 6, 52078 Aachen, Germany
Further information is available from Napp Pharmaceuticals Limited,
Cambridge Science Park, Milton Road, Cambridge CB4 0GW.
Date of preparation
December 2005
® Transtec and the NAPP device are Registered Trade Marks.
© Napp Pharmaceuticals Limited 2005
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