Oral Transmucosal Fentanyl Citrate, CII 600 mcg

ACTIQ contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an
abuse liability similar to other opioid analgesics. ACTIQ can be abused in a manner similar to
other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing
ACTIQ in situations where the physician or pharmacist is concerned about an increased risk of
misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone,
hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of
fatal overdose due to respiratory depression.
ACTIQ® is indicated only for the management of breakthrough cancer pain in patients with
malignancies who are already receiving and who are tolerant to opioid therapy for their
underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at
least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone
daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or
longer.