Mylan-fentaNYL Matrix Patch (Transdermal)

Addiction, Abuse, and Misuse; Risk Evaluation and Mitigation Strategy (REMS); Life-threatening Respiratory Depression; Accidental Exposure; Neonatal Opioid Withdrawal Syndrome; Cytochrome P450 3A4 Interaction; Risk of Increased Fentanyl Absorption with Application of External Heat; and Risks From Concomitant Use of Benzodiazepines or Other CNS DepressantsFentanyl exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for these behaviors or conditions.To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.Accidental exposure to fentanyl, especially in children, can result in fatal overdose of fentanyl.Prolonged use of fentanyl during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Exposure of the fentanyl application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the fentanyl application site and surrounding area to direct external heat sources.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatmen..