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If you would like to order a Child Safety Kit, please complete the following questionnaire and registration form.

Child Safety Kit Website Educational Messaging
1. Which product are you currently taking for Cancer breakthrough pain?
a)
b)
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d)
2. When did you first receive your initial prescription of Actiq® (oral transmucosal fentanyl citrate) or OTFC?
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b)
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3. Have you ever received a Child Safety Kit (previously known as Welcome Kit) before?
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b)
4. I understand that Actiq is to be used only 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. Examples of these medications include but are not limited to morphine (MSIR®, Roxanol™); morphine sustained release (MSContin®, OraMorph®); oxycodone (OxyIR®, OxyFast®); oxycodone sustained release (OxyContin®); hydromorphone (Dilaudid®); fentanyl patch (Duragesic®); oral fentanyl (Oral Transmucosal Fentanyl Citrate, Fentora™); and combination products (Percocet®, Vicodin®, Lortab™).
a)
b)
5. I understand the following: Actiq must not be used for short-term pain from injuries or surgery. 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), and if is not used exactly as prescribed. If you have not been using these types of medicines, consult your doctor to verify that Actiq is safe for you to use. It is very important that you not give Actiq to other people, even if they have the same symptoms you have. Actiq can harm other people and even cause death.
a)
b)
6. I understand that I must keep Actiq in a safe and secure place, out of the reach of children.
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b)
7. I understand the following: Actiq should be properly used and stored. Each Actiq unit is sealed in its own blister package. I should not open the blister package until I am ready to use Actiq. Once I start using an Actiq unit, I should completely finish the Actiq unit over a 15-minute period unless I begin to feel dizzy, sick to my stomach or very sleepy. If these symptoms occur, I should remove the Actiq unit from my mouth. I should dispose of any remaining medicine right away by rinsing the handle under hot tap water until the medicine is completely gone, or place the unit in the temporary storage bottle (Skeeper) found in the Child Safety Kit until I am able to rinse the unit under hot tap water. Once the blister package is opened, the unit is no longer child resistant, and must be kept out of the reach of children.
a)
b)
8. Do any children or grandchildren live in or visit you in your home?
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b)
9. I understand the following: Actiq should be stored in a locked medicine cabinet, safe, locked cabinet or the Actiq Child Safety Kit. I further understand that it is not safe to leave Actiq in its box or packaging without special storage conditions. I should keep Actiq and other medicines in a safe and secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes Actiq, I should get emergency help right away. It is very important that I use the items in the Actiq Child Safety Kit to protect the children who live in or visit my home. I should use the child resistant lock that I received in the Child Safety Kit.
a)
b)
10. I understand that when I am finished with the Actiq Unit, it should be properly disposed of by placing it under hot tap water and then in the trash, using the safety container from the Child Safety Kit or cutting the medicine off so that it falls into the toilet. Actiq should not be disposed of by throwing it in the trash.
a)
b)
11. I understand that if I am no longer using Actiq and need to dispose of Actiq units that I can call 1-800-896-5855 for disposal listed in the Actiq Medication Guide for assistance with disposal of the medication.
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b)
12. What dosage strength are you currently using?
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b)
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f)
13. Patient Attestation

I understand and agree that all information I have provided is true and accurate. Cephalon Inc. may verify the accuracy of the information I have provided. I certify and attest that my physician has written a prescription for Actiq for my personal use or for the use of the individual for whom I am requesting this kit. I will not share, sell or give away Actiq to others even if they have the same symptoms as I have. Actiq can harm other people and even cause death. Sharing, selling, or giving away Actiq is against the law. I will protect my medicine from misuse, abuse and diversion (theft) in my home. I am responsible for protecting Actiq from access by children and from loss or theft. If a child accidentally takes Actiq, I will get emergency help right away. I will always keep Actiq in a secure place. I further attest that the Actiq Child Safety Kit that I receive will be used correctly to protect children living in and visiting my home from accidental ingestion of Actiq.
a)
b)
 
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WARNING: IMPORTANCE OF PROPER PATIENT SELECTION, DOSING, and POTENTIAL FOR ABUSE

Reports of serious adverse events, including deaths in patients treated with ACTIQ® have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. 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 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

ACTIQ is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.

Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.

ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine.

When prescribing, do not convert patients on a mcg per mcg basis to ACTIQ from other fentanyl products.

When dispensing, do not substitute an ACTIQ prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of ACTIQ compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of ACTIQ for any other fentanyl product may result in fatal overdose.

Special care must be used when dosing ACTIQ. If the breakthrough pain episode is not relieved 15 minutes after completion of the ACTIQ unit, patients may take ONLY ONE additional dose using the same strength and then must wait at least 4 hours before taking another dose [see Dosage and Administration (2.2)].

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.

Patients and their caregivers must be instructed that ACTIQ contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested ACTIQ. All units must be kept out of the reach of children and opened units properly discarded [see Warnings And Precautions (5.3), Patient Counseling Information (17.5, 17.6), and How Supplied/Storage And Handling (16.2)].

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.

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 [see Drug Interactions (7)].
 
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