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Effentora is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP 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 guidance of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse of fentanyl. Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain, and to dispose of any fentanyl product prescribed for BTP when switching to Effentora.
The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose. Posology Dose titration Effentora should be individually titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions.
In clinical studies, the effective dose of Effentora for BTP was not predictable from the daily maintenance dose of opioid. Patients should be carefully monitored until an effective dose is reached. Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms).
Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio. If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
However, in these patients, a starting dose higher than 100 micrograms may be considered. Method of titration During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
If treatment of a BTP episode requires more than one tablet, an increase in dose to the next higher available strength should be considered to treat the next BTP episode. During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule: 4 • If the initial 100 micrograms tablet is not efficacious, the patient can be instructed to treat the next episode of BTP with two 100 micrograms tablets.
It is recommended that one tablet should be placed in each side of the mouth. If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 200 micrograms tablet of Effentora.
Summary of the safety profile Typical opioid adverse reactions are to be expected with Effentora. 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 closely monitored for these. The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Therefore it is not possible to definitively separate the effects of Effentora alone. Tabulated list of adverse reactions The following adverse reactions have been reported with Effentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience.
6) Drug tolerance Investigations Weight decreased Platelet count decreased Heart rate increased Haematocrit decreased Haemoglobin decreased Injury, poisoning and procedural complications Fall * See section Description of selected adverse reactions Description of selected adverse reactions Tolerance Tolerance can develop on repeated use.
Drug dependence Repeated use of Effentora can lead to drug dependence, even at therapeutic doses. 4). Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl.
9). 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 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Because of the risks, including fatal outcome, associated with accidental exposure, misuse, and abuse, patients and their carers must be advised to keep Effentora in a safe and secure place, not accessible by others. Accidental use in children Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child.
Therefore they must keep all tablets out of the sight and reach of children. Monitoring In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Maintenance opioid treatment It is important that the maintenance opioid treatment used to treat the patient’s persistent pain has been stabilised before Effentora therapy begins and that the patient continues to be treated with the maintenance opioid treatment whilst taking Effentora.
The product must not be given to patients without maintenance opioid therapy as there is an increased risk of respiratory depression and death. Respiratory depression As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
, use in patients without maintenance opioid therapy) and/or improper dosing have resulted in fatal outcome with Effentora as well as with other fentanyl products. 1. Chronic obstructive pulmonary disease Particular caution should be used when titrating Effentora in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Effentora may further decrease respiratory drive to the point of respiratory failure.
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 of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
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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• If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
It is recommended that two tablets should be placed in each side of the mouth. If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 400 micrograms tablet of Effentora.
• For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used. Doses above 800 micrograms were not evaluated in clinical studies. No more than two tablets should be used to treat any individual BTP episode, except when titrating using up to four tablets as described above.
Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration. Maintenance therapy Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength.
Breakthrough pain episodes may vary in intensity and the required Effentora dose might increase over time due to progression of the underlying cancer disease. In these cases, a second tablet of the same strength may be used. If a second tablet of Effentora was required for several consecutive times, the usual maintenance dose is to be readjusted (see below).
Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy. Dose readjustment The maintenance dose of Effentora should be increased when a patient requires more than one tablet per BTP episode for several consecutive BTP episodes.
For dose-readjustment the same principles apply as outlined for dose titration (see above). Dose readjustment of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
4). Treatment duration and goals Before initiating treatment with Effentora, 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). Effentora should not be used longer than necessary.
Discontinuation of therapy Effentora should be discontinued immediately if the patient no longer experiences breakthrough pain episodes. The treatment for the persistent background pain should be kept as prescribed. If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
4). Patients with xerostomia Patients experiencing xerostomia are advised to drink water to moisten […]
5). 7 Risks of concomitant administration with benzodiazepines or related drugs Concomitant use of opioids, including Effentora, with benzodiazepines or related drugs may result in profound sedation, respiratory depression, coma, and death.
Because of these risks, concomitant prescribing of opioids and benzodiazepines or related drugs should be made only in patients for whom alternative treatment options are inadequate. If a decision is made to prescribe Effentora concomitantly with benzodiazepines or related drugs, the lowest effective dosages and minimum durations of concomitant use should be chosen.
5). Increased intracranial pressure, impaired consciousness Effentora 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 a patient with a head injury and should be used only if clinically warranted. Bradyarrhythmias Fentanyl may produce bradycardia. Fentanyl should be used with caution in patients with previous or pre-existing bradyarrythmias.
Hepatic or renal impairment In addition, Effentora 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.
After administration of Effentora, impaired hepatic and renal function may both increase the bioavailability of swallowed fentanyl and decrease its systemic clearance, which could lead to increased and prolonged opioid effects. 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. Serotonin Syndrome Caution is advised when Effentora is co-administered with drugs that affect the serotoninergic neurotransmitter systems. The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
This may occur within the recommended dose. , nausea, vomiting, diarrhoea). If serotonin syndrome is suspected, treatment with Effentora should be discontinued. Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical dependence and psychological dependence may develop upon repeated administration of opioids.
Fentanyl can be abused in a manner similar to other opioids and all patients treated with opioids require monitoring for signs of abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with opioids; however, these patients will require additional monitoring for signs of misuse, abuse, or addiction.
Repeated use of Effentora may […]