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PecFent is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential for abuse of fentanyl. 3 Posology PecFent should be titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions without causing undue (or intolerable) adverse reactions, for two consecutively treated episodes of BTP.
The efficacy of a given dose should be assessed over the ensuing 30 minute period. Patients should be carefully monitored until an effective dose is reached. PecFent is available in two strengths: 100 micrograms/spray and 400 micrograms/spray.
One dose of PecFent may include administration of 1 spray (100 microgram or 400 microgram doses) or 2 sprays (200 microgram or 800 microgram doses) of the same strength (either 100 microgram or 400 microgram strength). Patients should not use more than 4 doses per day.
Patients should wait at least 4 hours after a dose before treating another BTP episode with PecFent.
PecFent can deliver 100, 200, 400 and 800 microgram doses as follows:
Dose required (micrograms) Product strength (micrograms) Amount 100 100 One spray administered into one nostril 200 100 One spray administered into each nostril 400 400 One spray administered into one nostril 800 400 One spray administered into each nostril Initial dose • The initial dose of PecFent to treat episodes of BTP is always 100 micrograms (one spray), even in patients switching from other fentanyl containing products for their BTP.
• Patients must wait at least 4 hours before treating another episode of BTP with PecFent. Method of titration • Patients should be prescribed an initial titration supply of one bottle (2 sprays or 8 sprays) of PecFent 100 micrograms/spray.
• Patients whose initial dose is 100 micrograms and who need to titrate to a higher dose due to a lack of effect can be instructed to use two 100 microgram sprays (one in each nostril) for their next BTP episode. If this dose is not successful, the patient may be prescribed a bottle of PecFent 400 micrograms/spray and instructed to change to one 400 microgram spray for their next episode of pain.
If this dose is not successful, the patient may be instructed to increase to two 400 microgram sprays (one in each nostril). • From treatment initiation, patients should be closely followed and the dose titrated until an effective dose is reached and confirmed for two consecutively treated episodes of BTP.
Summary of the safety profile Typical opioid adverse reactions are to be expected with PecFent. Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be monitored for these. The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Therefore it is not possible to definitively separate the effects of PecFent alone. Tabulated list of adverse reactions The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data)).
Common Uncommon Unknown Infections and infestations Pneumonia Nasopharyngitis Pharyngitis Rhinitis Blood and lymphatic system disorders Neutropenia Immune system disorders Hypersensitivity 10 Common Uncommon Unknown Metabolism and nutrition disorders Dehydration Hyperglycaemia Decreased appetite Increased appetite Psychiatric disorders Disorientation Delirium Hallucination Confusional state Depression Attention deficit/hyperactivity disorder Anxiety Euphoric mood Nervousness Insomnia Drug dependence (addiction) Drug abuse Nervous system disorders Dysgeusia Dizziness Somnolence Headache Loss of consciousness Depressed level of consciousness Convulsion Ageusia Anosmia Memory impairment Parosmia Speech disorder Sedation Lethargy Tremor Ear and labyrinth disorders Vertigo Cardiac disorders Cyanosis Vascular disorders Cardiovascular insufficiency Lymphoedema Hypotension Hot flush Flushing Respiratory, thoracic and mediastinal disorders Epistaxis Rhinorrhoea Nasal discomfort (such as “nasal burning”) Upper airway obstruction Pharyngolaryngeal pain Rhinalgia Nasal mucosal disorder Cough Dyspnoea Sneezing Upper respiratory tract congestion Nasal congestion Intranasal hypoaesthesia Throat irritiation Postnasal drip Nasal dryness Respiratory depression 11 Common Uncommon Unknown Gastrointestinal disorders Vomiting Nausea Constipation Intestinal perforation Peritonitis Oral hypoaesthesia Oral paraesthesia Diarrhoea Retching Abdominal pain Tongue disorder Mouth ulceration Dyspepsia Dry mouth Skin and subcutaneous tissue disorders Pruritus Hyperhydrosis Urticaria Musculoskeletal and connective tissue disorders Arthralgia Muscle twitching Renal and urinary disorders Anuria Dysuria Proteinuria Urinary hesitation Reproductive system and breast disorders Vaginal haemorrhage General disorders and administration site conditions Non-cardiac chest pain Asthenia Chills Face oedema Peripheral oedema Gait disturbance Pyrexia Fatigue Malaise Thirst Withdrawal syndrome* Neonatal withdrawal syndrome Drug tolerance Investigations Platelet count decreased Weight increased Injury, poisoning and procedural complications Fall Intentional drug misuse Medication error * Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl.
Because of the risks, including fatal outcome, associated with accidental exposure, misuse, and abuse, patients and their carers must be advised to keep PecFent in a safe and secure place, not accessible by others. Patients and their carers must be instructed that PecFent contains an active substance in an amount that can be fatal to a child.
In order to minimise the risks of opioid-related adverse reactions and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process. 6 It is important that the long acting opioid treatment used to treat the patient’s persistent pain has been stabilised before PecFent therapy begins.
Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered. A fentanyl dose reduction or discontinuation of fentanyl treatment or treatment review may be indicated.
Respiratory depression There is a risk of clinically significant respiratory depression associated with the use of fentanyl. Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients is reduced.
5). Chronic pulmonary disease In patients with chronic obstructive pulmonary diseases, fentanyl may cause more serious adverse reactions. In these patients, opioids may decrease respiratory drive and increase airway resistance. Increased intracranial pressure PecFent should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Opioids may obscure the clinical course of patients with a head injury and should be used only if clinically warranted. Cardiac disease Fentanyl may produce bradycardia. PecFent should, therefore, be used with caution in patients with previous or pre-existing bradyarrhythmias.
1. Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. Severe respiratory depression or severe obstructive lung conditions. Treatment of acute pain other than breakthrough pain. Patients being treated with medicinal products containing sodium oxybate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in European Union.
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Titration in patients switching between immediate-release fentanyl containing products Substantial differences may exist in the pharmacokinetic profile of immediate-release fentanyl medicinal products, which result in clinically important differences in the rate and extent of absorption of fentanyl.
Therefore, when switching between fentanyl containing medicinal products indicated for treatment of breakthrough pain, including intranasal formulations, it is essential that patients are again titrated with the new medicinal product, and not switched on a dose-for-dose (microgram-for- microgram) basis.
4 Maintenance therapy Once an effective dose has been established during titration, patients should continue to take this dose up to a maximum of 4 doses per day. Dose readjustment Generally, the maintenance dose of PecFent should be increased only where the current dose fails to adequately treat the BTP for several consecutive episodes.
A review of the dose of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours. 4). If adverse reactions are intolerable or persistent, the dose should be reduced or treatment with PecFent replaced by another analgesic.
Treatment duration and goals Before initiating treatment with PecFent, 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.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4). PecFent should not be used longer than necessary.
Discontinuation of therapy PecFent should be discontinued immediately if the patient no longer experiences breakthrough pain episodes. The treatment for persistent backgound pain should be kept as prescribed. If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor as gradual downward opioid titration therapy is necessary in order to avoid the possibility of abrupt withdrawal effects.
8%) over 75 years. There was no indication that older patients tended to titrate to lower doses or experience more adverse reactions. Nevertheless, in view of the importance of renal and hepatic function in the metabolism and clearance of fentanyl, additional care should be exercised in the use of PecFent in the elderly.
No data on the pharmacokinetics of PecFent in elderly patients are available. 4). Paediatric population The safety and efficacy of PecFent in children and adolescents aged below 18 years have not yet been established. No data are available.
Method of administration PecFent is for nasal use only. 5 The bottle should be […]
Description of selected adverse reactions Tolerance Tolerance can develop on repeated use. Drug dependence Repeated use of PecFent can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 12 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Impaired hepatic or renal function In addition, PecFent should be administered with caution to patients with hepatic or renal impairment. The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated; however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment. Careful consideration should be given to patients with hypovolaemia and hypotension. Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Repeated use of PecFent may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of PecFent may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. Patients should be advised to contact their physician if these signs occur. g.
too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Athletes should be informed that treatment with fentanyl could lead to positive doping tests. Serotonin Syndrome Caution is advised when PecFent is coadministered with medicinal products that affect the serotoninergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic medicinal products such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with medicinal products which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
5). , nausea, vomiting, diarrhoea). If serotonin syndrome is suspected, treatment with PecFent should be discontinued. Route of administration PecFent is only intended for nasal use, and must not be administered by any other route. Due to physico-chemical properties of excipients included in the formulation, intravenous or intra-arterial injection must be avoided in particular.
Nasal conditions If the patient experiences recurrent episodes of epistaxis or nasal discomfort while taking PecFent, an alternative method of administration for treatment of breakthrough pain should be considered. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk […]