Prescribing information For Healthcare Professionals Only

ACTIVE INGREDIENT: Fentanyl

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S): Adults: management of severe chronic pain that requires continuous long-term opioid administration. Children: Long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.

DOSAGE & ADMINISTRATION: Individualised (based on current opioid use, general condition and medical status of patient), assessed at regular intervals after application, use the lowest effective dose. Recommended for patients who have demonstrated opioid tolerance. Application instructions: see SmPC. Adults: Opioid naïve: generally transdermal route not recommended, consider alternative routes of administration. If Durogesic is the only appropriate treatment, use lowest starting dose of 12 mcg/hr; closely monitor patient. (see SmPC) Opioid tolerant: Convert from previous opioid use. Conversion based on 24 hour analgesic requirement and whether patient has been stabilised (see SmPC). Titration and maintenance: change 72 hourly; titrate to balance analgesic efficacy and tolerability. Children: Only for opioid-tolerant patients (ages 2-16 years) on at least 30 mg oral morphine equivalents per day. Convert dose from previous 24 hour opioid requirement (see SmPC). After initiation or up-titration of dose, monitor for adverse events for at least 48 hours. First dose will not be optimal within the first 24 hours - during the first 12 hours after switching give the previous regular dose of analgesics. Children under 2 years: not studied. (see SmPC) Titration and maintenance: change 72 hourly; adjust dose in 12 mcg/hr steps. Before initiating treatment with DUROGESIC, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. Elderly / Renal impairment / Hepatic impairment: observe carefully, individualised dose based on patient’s status. In opioid-naïve patients, only consider treatment if benefits outweigh risks; and only consider 12 mcg/hr dosage for initial treatment. Discontinuation of Durogesic: replace with other opioids gradually starting at low dose. Rapid discontinuation of opioid analgesics in patients dependant on opioids resulted in serious withdrawal symptoms and uncontrolled pain. Tapering should be based on the individual dose, treatment duration and response of the patient regarding pain and withdrawal symptoms. Patients on long-term treatment may need a more gradual tapering. For patients who had been treated for a short period, a faster reduction schedule may be considered.

CONTRAINDICATIONS:Acute or postoperative pain. Severe respiratory depression. Hypersensitivity to fentanyl or any of excipients.

SPECIAL WARNINGS & PRECAUTIONS: If serious adverse events occur, monitor for at least 24 hours after removal. Keep out of sight and reach of children. Keep in a safe and secure place, not accessible by others. Risk of significant respiratory depression and/or fatality when used as initial opioid therapy in opioid-naïve patients especially with non-cancer pain. Observe all patients for respiratory depression, including after patch removal. Opioids can cause sleep-related disorders including central sleep apnoea and sleep related hypoxia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA consider decreasing the total opioid dosage. Avoid concomitant use with Central Nervous System (CNS) depressants including sedative medicines such as benzodiazepines or related drugs, alcohol and CNS depressant narcotic drugs; may result in sedation, respiratory depression, coma and death. If alternative treatment options are not possible, use lowest effective dose and minimum duration for both drugs and monitor closely. Chronic pulmonary disease: opioids may decrease respiratory drive and increase airway resistance. Tolerance to the analgesic effects, hyperalgesia, physical and psychological dependence and psychological dependence may develop upon repeated administration of opioids, whereas incomplete tolerance is developed for some side effects like opioid-induced constipation.

During treatment there should be frequent contact between the physician and the patient to evaluate the need for continued treatment (see section 4.2 of SMPC). When it is decided that there is no benefit for continuation, gradual down-titration should be applied to address withdrawal symptoms. Do not abruptly discontinue DUROGESIC in a patient physically dependent on opioids. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. Repeated use of fentanyl may lead to Opioid use disorder (OUD), monitor for signs. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD.  Abuse or intentional misuse may result in overdose and/or death. Caution in patients with increased intracranial pressure, impaired consciousness, coma, brain tumours, bradyarrhythmias, myasthenia gravis, chronic constipation. Paralytic ileus: discontinue Durogesic. Hepatic / renal impairment: observe for signs of fentanyl toxicity, reduce dose. Hypotension and/or hypovolaemia: correct before treatment. Monitor patients with fever: potential temperature-dependent increase in fentanyl release resulting in overdose and death. Avoid exposure to direct external heat sources. Accidental patch transfer to skin of non-patch wearer may result in overdose: remove patch immediately. Not to be administered to opioid-naïve paediatric patients; potential for serious or life-threatening hypoventilation exists regardless of dose. If Opioid induced hyperalgesia is suspected, the dose of opioid should be reduced or tapered off, if possible. Guard against accidental ingestion by children, choose application site with caution and monitor adhesion of patch closely. CYP3A4 inhibitors: not recommended unless benefits outweigh risk; if used, closely monitor and consider reduced Durogesic dose. Generally, wait 2 days after stopping treatment with CYP3A4 inhibitor before applying first Durogesic patch. Suspected serotonin syndrome: discontinue Durogesic. Refer to SmPC for full details of special warnings & precautions.

SIDE EFFECTS: Very common: somnolence, dizziness, headache, nausea, vomiting, constipation. 
Common: hypersensitivity, anorexia, insomnia, anxiety, depression, hallucination, confusional state, tremor, paraesthesia, vertigo, hypertension, dyspnoea, diarrhoea, dry mouth, muscle spasms, palpitations, tachycardia, abdominal pain, dyspepsia, hyperhydrosis, pruritus, rash, erythema, urinary retention, feeling cold, fatigue, malaise, peripheral oedema, asthenia. Other side effects: anaphylactic shock/reaction, androgen deficiency, delirium, dependence, respiratory depression, respiratory distress, ileus, convulsions, drug withdrawal syndrome, depressed level/loss of consciousness, drug tolerance. Refer to SmPC for other side effects.

PREGNANCY: No adequate data. Neonatal withdrawal syndrome reported with chronic maternal use during pregnancy. Should not be used in pregnancy unless clearly necessary. Not recommended for use during childbirth.

LACTATION: Do not use during breast-feeding. Discontinue breast-feeding during treatment and for at least 72 hours after removal of patch.

INTERACTIONS: Special care and observation when used with CNS depressants (including alcohol, benzodiazepines, sedatives/hypnotics, opioids, general anaesthetics, phenothiazines, tranquilisers, sedating antihistamines, CNS depressant narcotic drugs) and skeletal muscle relaxants as respiratory depression, hypotension, profound sedation, coma or death may occur. Monoamine Oxidase Inhibitors (MAOI): do not use within 14 days after discontinuation of MAOIs. Risk of serotonin syndrome (potentially life-threatening) when used with Selective Serotonin Re-uptake Inhibitor (SSRI), Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or MAOI. Buprenorphine, nalbuphine or pentazocine; not recommended. Cytochrome P450 3A4 (CYP3A4) inhibitors: not recommended without close monitoring. Cytochrome P450 3A4 (CYP3A4) inducers: monitor and possibly increase Durogesic® dose until stable drug effects are achieved. Refer to SmPC for full details of interactions.

LEGAL CATEGORY: CD (Sch 2) POM

FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Prescribing information last revised: August 2023