Severe, life-threatening, or fatal respiratory depression has happened in patients treated with ACTIQ, including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, particularly during initiation of ACTIQ or following a dose increase. The change of ACTIQ for any other fentanyl product may cause fatal overdose from ACTIQ drug addition.
Because of the risk of depression, ACTIQ is contraindicated in managing acute or postoperative pain, including headache/migraine and opioid non-tolerant patients.
Accidental ingestion of even one dosage of ACTIQ, especially by children, can result in a fatal overdose of fentanyl
Fatalities have been recognized in children who have accidentally ingested ACTIQ. ACTIQ must be kept out of reach of children
Cytochrome P450 3A4 Interaction
The concomitant use of ACTIQ with all cytochrome P450 3A4 inhibitors may increase fentanyl plasma concentrations, which could increase or prolong severe reactions and possibly cause fatal respiratory depression. Moreover, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may cause a rise in fentanyl plasma concentration.
Risks from Concomitant Usage with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other (CNS)central nervous system depressants, including alcohol, may result in extensive sedation, respiratory depression, coma, and death
- Stop concomitant presc of ACTIQ and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Restrict dosages and timelines to the minimum required.
- Monitor patients for signs and symptoms of respiratory depression and sedation.
Risk of Medication Errors
Significant differences exist in the pharmacokinetic profile of ACTIQ compared to other fentanyl products that result in clinically vital differences in the extent of absorption of fentanyl, and that could result in lethal overdose
- When prescribing, do not alter patients on an mcg per mcg basis from any other fentanyl products to ACTIQ
- When dispensing, do not change an ACTIQ prescription for other fentanyl products.
Addiction, Abuse, and Misuse
ACTIQ exposes users to the risks of opioid addiction, misuse, and abuse, leading to overdose and death. Assess each patient’s risk before prescribing ACTIQ, and check all patients regularly for the development of these behaviors and conditions
Risk Evaluation and Mitigation Strategy (REMS) Access Program
Because of the potential risk for abuse, misuse, addiction, and overdose, ACTIQ is accessible only through a restricted program required by the (FDA) Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS).
Neonatal Opioid Withdrawal Syndrome
Extended usage of ACTIQ during pregnancy can cause neonatal opioid withdrawal syndrome, which may be life-threatening if not noted and treated, and requires management according to protocols developed by neonatology professionals. If opioid use is needed for an extended period in an expectant woman, direct the patient of the possible risk of neonatal opioid withdrawal syndrome and make sure that proper treatment will be available.