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WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE
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.
ACTIQ is intended to be used only in the care of cancer patients and
only by oncologists and pain specialists who are knowledgeable of and skilled
in the use of Schedule II opioids to treat cancer pain.
Because life-threatening hypoventilation could occur at any dose in
patients not taking chronic opiates, ACTIQ is contraindicated in the
management of acute or postoperative pain. This product must not be used in
opioid non-tolerant patients.
Patients and their caregivers must be instructed that ACTIQ
contains a medicine in an amount which can be fatal to a child. All units
must be kept out of the reach of children and opened units properly
discarded.
The concomitant use of ACTIQ with strong and moderate cytochrome
P450 3A4 inhibitors may result in an increase in fentanyl plasma
concentrations, and may cause potentially fatal respiratory depression.
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