Key Information regarding the safe use of ACTIQ:

• ACTIQ is used to treat breakthrough pain in adult patients with cancer (16 years and older) who are already taking other opioid pain medicines for their constant (around-the-clock) cancer pain.
• ACTIQ is started only after you have been on other opioid pain medicines and your body has gotten used to them (you are opioid tolerant). DO NOT USE ACTIQ if you are not opioid-tolerant.
• You must continue taking your regularly-used around-the-clock opioid medicine while taking ACTIQ.
• You MUST keep ACTIQ in a safe place out of the reach of children. Accidental ingestion by a child is a medical emergency and can result in death. Death has been reported in children who have accidentally taken ACTIQ. If a child accidentally takes ACTIQ, get emergency help right away.
• ACTIQ can cause life threatening breathing problems which can lead to death:
• if it is used by anyone who is not already taking other opioid pain medicines and their body is not used to these medicines (not opioid tolerant)
• if it is not used exactly as prescribed
• Your doctor will prescribe a starting dose of ACTIQ that is different than other fentanyl containing medicines you may have been taking. Do NOT substitute ACTIQ for other fentanyl medicines without talking to your doctor.
• ACTIQ must not be used for the treatment of short-term pain from injuries, surgery, or headaches, including migraines.
• Never give ACTIQ to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death.
• Selling or giving away ACTIQ is against the law.
• Follow dosage instructions carefully:
• Use ACTIQ exactly as prescribed by your doctor. Do NOT use ACTIQ more often than prescribed.
• Do not open the blister package until you are ready to use ACTIQ.
• Use 1 unit of ACTIQ for an episode of breakthrough cancer pain. Consume the unit over 15 minutes.
• If your breakthrough cancer pain is not relieved 15 minutes after you finished the ACTIQ unit, use ONLY 1 more dose of ACTIQ at this time.
• Wait at least 4 more hours before using ACTIQ again for another episode of breakthrough pain.
• Limit your use of ACTIQ to 4 or fewer units per day.
• If you have more than 4 episodes of breakthrough pain per day, talk to your doctor.
• Dispose of any partially used or unused units properly. Never leave unused or partially used ACTIQ units where children or pets can get to them.

An ACTIQ Child Safety Kit (an introductory kit containing important safety and educational material, emergency information, and safe storage container) is available to patients and/or their caregivers. To obtain a Child Safety Kit, please call 1-888-534-3119, or click here to complete an order form.

If you would like to receive additional information about ACTIQ, please call Cephalon, Inc. at 1-800-896-5855.

To view or print the ACTIQ Medication Guide, click here.