Precautions
You can ask your pharmacist or healthcare provider for information about Actiq that is written for healthcare professionals. For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1-866-822-1483. What are the ingredients of Actiq?
How do I get more information about Actiq?
The Actiq unit should be consumed over 15 minutes. Patients should be prescribed an initial titration supply of six 200 mcg Actiq units, thus limiting the number of units in the home during titration. Patients should use up all units before increasing to a higher dose to prevent confusion and possible overdose.
How long should Actiq be taken during titration?
Actiq contains fentanyl, a Schedule II controlled substance. As an opioid, Actiq exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ( 9 )]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Actiq.
Is Actiq a controlled substance?
As an opioid, Actiq exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence ( 9 )]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Actiq. Addiction can occur at recommended dosages and if the drug is misused or abused.
What are the risks of Actiq?
How much does Actiq cost?
What is Actiq coupon?
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What is Actiq used for?
Actiq 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.
What are the priorities of Actiq?
In case of overdose, priorities are: removal of the Actiq unit, if still in the mouth, the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
How much morphine is needed for Actiq?
Breakthrough cancer pain was defined as a transient flare of moderate-to-severe pain occurring in cancer patients experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications including at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for a week or longer.
What is Actiq lozenge?
Actiq (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. Actiq is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed.
How long after Actiq unit can you take another dose?
In cases where the breakthrough pain episode is not relieved after 15 minutes after completion of the Actiq unit (30 minutes after the start of the unit), patients may take ONLY ONE additional dose using the same strength for that episode. Thus patients should take a maximum of two doses of Actiq for any episode of breakthrough pain.
How old are people on Actiq?
Of the 257 patients in clinical studies of Actiq in breakthrough cancer pain, 61 (24%) were 65 years of age and older, while 15 (6%) were 75 years of age and older. Those patients over the age of 65 years were titrated to a mean dose that was about 200 mcg less than the mean dose titrated to by younger patients. No difference was noted in the safety profile of the group over 65 years of age as compared to younger patients in Actiq clinical trials.
How many strengths are there in Actiq?
Actiq is supplied in six dosage strengths. Each unit is individually wrapped in a child-resistant, protective blister package. These blister packages are packed 30 per shelf carton for use when patients have been titrated to the appropriate dose.
How to use Actiq?
Open the blister package with scissors immediately prior to product use. The patient should place the ACTIQ unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle. The ACTIQ unit should be sucked, not chewed. A unit dose of ACTIQ, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when consumed as directed [see Clinical Pharmacology (12.3)]. The ACTIQ unit should be consumed over a 15-minute period. Longer or shorter consumption times may produce less efficacy than reported in ACTIQ clinical trials. If signs of excessive opioid effects appear before the unit is consumed, remove the drug matrix from the patient’s mouth immediately and decrease future doses.
What is Actiq used for?
ACTIQ is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tol-erant to around-the-clock opioid therapy for their underlying persistent cancer pain.Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking ACTIQ.Limitations of Use
What is the warning for ActIQ?
FULL PRESCRIBING INFORMATION WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION ; RISKS FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS; and NEONATAL OPIOID WITHDRAWAL SYNDROME Life-Threatening Respiratory Depression Serious, life-threatening and/or fatal respiratory depression has occurred in patients treated with ACTIQ, including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, especially during initiation of ACTIQ or following a dose increase [see Warnings and Precautions (5.1)]. The substitution of ACTIQ for any other fentanyl product may result in fatal overdose [see Warnings and Precautions (5.1)]. Due to the risk of respiratory depression, ACTIQ is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients [see Contraindications (4)]. Accidental Ingestion Accidental ingestion of even one dose of ACTIQ, especially by children, can result in a fatal overdose of fentanyl [see Warnings and Precautions (5.2)]. Death has been reported in children who have accidentally ingested ACTIQ. ACTIQ must be kept out of reach of children [see Patient Counseling Information and How Supplied/ Storage and Handling (16)]. Cytochrome P450 3A4 Interaction The concomitant use of ACTIQ with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving ACTIQ and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.3), Drug Interactions (7), Clinical Pharmacology (12.3)]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.4), Drug Interactions (7)].
What year was Actiq approved?
See full prescribing information for ACTIQ. ACTIQ®(fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968 WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS; and NEONATAL OPIOID WITHDRAWAL SYNDROME
When to discontinue Actiq?
When opioid therapy is no longer required, consider discontinuing ACTIQ along with a gradual downward tapering (titration) of other opioids to minimize possible withdrawal effects. In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, ACTIQ therapy can usually be discontinued immediately.
Can you use Actiq for fentanyl?
When prescribing, do not convert a patient to ACTIQ from any other fentanyl product on a mcg per mcg basis as ACTIQ and other fentanyl products are not equivalent on a microgram per microgram basis. ACTIQ is not a generic version of other transmucosal immediate release fentanyl (TIRF) formulations. When dispensing, do not substitute an ACTIQ prescription for any other TIRF formulation under any circumstances. Other TIRF formulations and ACTIQ are not equivalent. Substantial differences exist in the pharmacokinetic profile of ACTIQ compared to other fentanyl products including other TIRF formulations that result in clinically important differences in the rate and extent of absorption of fentanyl. As a result of these differences, the substitution of ACTIQ for any other fentanyl product may result in a fatal overdose. There are no safe conversion directions available for patients on any other fentanyl products. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) Therefore, for opioid tolerant patients, the initial dose of ACTIQ should always be 200 mcg. Each patient should be individually titrated to provide adequate analgesia while minimizing side effects [see Dosage and Administration (2.4)].
Can ActIQ be used with benzodiazepines?
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of ACTIQ with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/ hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions (7)]. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2), Warnings and Precautions (5.1)]. Advise both patients and caregivers about the risks of respiratory depression and sedation when ACTIQ is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions (7) and Patient Counseling Information (17)].
How much does Actiq cost?
The cost for Actiq oral transmucosal lozenge 200 mcg is around $2,511 for a supply of 30 lozenge, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
What is Actiq coupon?
Actiq Coupons and Rebates. Actiq offers may be in the form of a printable coupon, rebate, savings card, trial offer, or free samples. Some offers may be printed right from a website, others require registration, completing a questionnaire, or obtaining a sample from the doctor's office.
