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ACTIQ (oral transmucosal fentanyl citrate) is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid.
ACTIQ is contraindicated in opioid non-tolerant patients. ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine and dental pain. Life-threatening respiratory depression and
death could occur at any dose in opioid non-tolerant patients. Patients considered opioid tolerant are those who are taking around-the clock medicine consisting of at least 60 mg of oral morphine daily, at least 25mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at
least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. ACTIQ is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of ACTIQ.
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ACTIQ can cause life-threatening breathing problems which can lead to death:
1. Do not use ACTIQ if you are not opioid tolerant.
2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using ACTIQ. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
3. Use ACTIQ exactly as prescribed by your healthcare provider.
• You must not use more than 1 unit of ACTIQ at a time and no more than 2 units of ACTIQ during each episode of breakthrough
• You must wait at least 4 hours before treating a new episode of breakthrough pain. See the Medication Guide section “How should I use ACTIQ?” and the Patient Instructions for Use at the end of this Medication Guide about how to use ACTIQ the right way.
4. Do not switch from ACTIQ to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of ACTIQ is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ACTIQ that may be different than other fentanyl containing medicines you may have been taking.
5. Do not use ACTIQ for short-term pain that you would expect to go away in a few days, such as:
• pain after a surgery
• headache or a migraine
• dental pain