Indication:Breakthrough pain in patients with Cancer
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 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 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.
Effentora should be individually titrated to an âeffectiveâ dose that provides adequate analgesia and minimises undesirable effects. 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.
Effentora Summary of Product Characteristics last updated on the eMC: 05/02/2010