Adverse Events with SUBSYS were Consistent with
Those Expected with Fentanyl Treatment
Adverse events associated with SUBSYS include nausea, somnolence, dizziness, vomiting, pyrexia, diarrhea and peripheral edema.
There was a <1% discontinuation rate due to application site irritation, somnolence and constipation.
Sublingual administration minimizes first-pass hepatic effect because the majority of the drug is absorbed directly into systemic circulation.
Adverse Reactions Subsequent to Titration Phase (5%)
SELECTED IMPORTANT SAFETY INFORMATION
- Monitor patients for opioid toxicity who begin therapy with, or increase the dose of, inhibitors of CYP450 3A4, or stop therapy with, or decrease the dose of, inducers of CYP450 3A4.
- Due to the additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death.
- The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.
- MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).
- Mixed agonist/antagonist and partial agonist opioid analgesics may reduce the analgesic effect of SUBSYS and/or precipitate withdrawal symptoms.
- Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
- The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
Use in Specific Populations
- Pregnancy: May cause fetal harm. (8.1)
- Lactation: Not Recommended.
- Renal and Hepatic Impairment: Administer SUBSYS with caution. (8.6)