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What is SUBSYS?

Pharmacokinetics Profile

SUBSYS Achieved a Greater Rate and Extent of Absorption than Actiq

Fentanyl Plasma Concentration of SUBSYS Compared to Actiq

In a study that compared the relative bioavailability of SUBSYS and Actiq in 21 healthy adult subjects, the rate and extent of fentanyl absorption were considerably greater with SUBSYS (34% greater maximum plasma concentration [Cmax] and 38% greater systemic exposure [AUCinf]).

SUBSYS Pharmacokinetics Profile

At 5 minutes
SUBSYS blood levels were approximately that of Actiq at 15 minutes.

SUBSYS Pharmacokinetics Profile

At 10 minutes
SUBSYS blood levels were approximately that of Actiq at 60 minutes.

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SUBSYS Achieved a Mean Absolute Bioavailability

Fentanyl Plasma Concentration of SUBSYS Compared to Actiq

SUBSYS achieved roughly 50% more bioavailability than Actiq.

* Absolute bioavailability is calculated as a percentage of IV, which is 100%.

Fentanyl pharmacokenetic profile and bioavailability depend on the fraction of the dose that is absorbed through the sublingual mucosa and the fraction swallowed from the gastrointestinal tract. Monitor patients with Grade 1 mucositis closely for signs of respiratory and central nervous system depression particularly during initiation of therapy with SUBSYS. The use of SUBSYS should be avoided in patients with Grade 2 and more severe mucositis unless the benefits are expected to outweigh the risk of respiratory depression.

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SELECTED IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • When prescribing, DO NOT convert a patient to SUBSYS from any other fentanyl product on a mcg per mcg basis as SUBSYS and other fentanyl products are not equivalent on a microgram per microgram basis. SUBSYS is NOT a generic version of other transmucosal immediate-release fentanyl (TIRF) formulations. When dispensing, DO NOT substitute a SUBSYS prescription for any other TIRF formulation under any circumstances. Other TIRF formulations and SUBSYS are not equivalent. Substantial differences exist in the pharmacokinetic profile of SUBSYS 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 SUBSYS for any other fentanyl product may result in a fatal overdose.
  • Patients and their caregivers must be instructed that SUBSYS contains a medicine in an amount that can be fatal to a child. Death has been reported in children who have accidentally ingested transmucosal immediate–release fentanyl products. While all units should be disposed of immediately after use, partially consumed units represent a special risk to children. In the event that a unit is not completely consumed it must be properly disposed of as soon as possible
  • Concomitant use of SUBSYS with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythmycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.5)], particularly when an inhibitor is added after a stable dose of SUBSYS is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in SUBSYS-treated patients may increase fentanyl plasma concentrations and prolong opioid adverse reactions. When using SUBSYS with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in SUBSYS-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of SUBSYS until stable drug effects are achieved [see Drug Interactions (7)].
  • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of SUBSYS 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.
  • Patients taking SUBSYS must be warned that opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Warn patients taking SUBSYS of these dangers and counsel them accordingly.
Breakthrough Cancer Pain Relief
Breakthrough Cancer Pain Relief