Indication:Breakthrough pain in patients with Cancer
Instanyl/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 therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
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.
Instanyl patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Patients must be carefully monitored during the titration process.Titration to a higher dose necessitates contact with the health care professional.
The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies
Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.
Instanyl should be discontinued immediately if the patient no longer experience breakthrough pain episodes. The treatment for the persistent background pain should be kept as prescribed.
Instanyl Nasal Spray Summary of Product Characteristics 01/07/2010
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.
Patients should not take more than 4 doses per day. Patients should wait at least 4 hours after a dose before treating another BTP episode with PecFent.
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.
PecFent Summary of Product Characteristics 13/12/2010