Subsys

Anesthesia procedures, Induction of anesthesia therapy, Anesthetic premedication therapy + 7 more

Treatment

8 FDA approvals

2 Active Studies for Subsys

What is Subsys

Fentanyl

The Generic name of this drug

Treatment Summary

Fentanyl is a powerful opioid drug that was developed in the 1950s to provide strong and fast-acting pain relief. It is used to treat chronic cancer pain and as an anesthetic. Fentanyl is related to other opioids such as morphine and oxycodone, and it is often used as an adulterant in illegal drugs like heroin. In 2017, over 47,600 opioid overdose deaths were reported in the United States, and 11 Canadians die every day due to opioid overdoses. Fentanyl was approved by the FDA in 1968.

Fentanyl Citrate

is the brand name

image of different drug pills on a surface

Subsys Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Fentanyl Citrate

Fentanyl

1984

322

Approved as Treatment by the FDA

Fentanyl, commonly known as Fentanyl Citrate, is approved by the FDA for 8 uses which include Anesthetic premedication therapy and Pain .

Anesthetic premedication therapy

Used to treat Anesthetic premedication therapy in combination with Droperidol

Pain

Helps manage Cancer Related Pain (Breakthrough Pain)

Cancer Related Pain (Breakthrough Pain)

Helps manage Cancer Related Pain (Breakthrough Pain)

opioid tolerant

Helps manage opioid tolerant

Anesthesia procedures

Used to treat Maintenance of anesthesia therapy in combination with Droperidol

High Risk Surgery

Used to treat High Risk Surgery in combination with Oxygen

Induction of anesthesia therapy

Used to treat Induction of anesthesia therapy in combination with Droperidol

Anesthetics

Used to treat Anesthetics Agent in combination with Oxygen

Effectiveness

How Subsys Affects Patients

Fentanyl is a type of medication that reduces pain by targeting opioid receptors. It works for several hours, and patients may become tolerant of the effects over time. Taking Fentanyl carries a risk of addiction and abuse and it should not be taken with alcohol or benzodiazepines.

How Subsys works in the body

Fentanyl works by binding to opioid receptors on nerve cells. This triggers a reaction that changes G-proteins, which reduces the flow of calcium ions into the cell. This causes the cell to become more negatively charged, which stops it from sending signals.

When to interrupt dosage

The recommended measure of Subsys is contingent upon the diagnosed state, for instance Anesthesia, Conduction, Preanesthetic Medication and General Anesthesia. The extent of dosage is contingent upon the mode of delivery featured in the table beneath.

Condition

Dosage

Administration

Induction of anesthesia therapy

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

General Anesthesia

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Anesthesia procedures

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

High Risk Surgery

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Anesthetics

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Anesthetic premedication therapy

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Pain

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Pain

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Anesthesia, Conduction

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

opioid tolerant

0.025 mg/hour, 0.05 mg/hour, 0.075 mg/hour, , 0.1 mg/hour, 0.0125 mg/hour, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 0.3 mg, 0.012 mg/hour, 0.25 mg/hour, 0.5 mg/hour, 0.75 mg/hour, 0.01 mg/mL, 0.02 mg/mL, 0.025 mg/mL, 0.05 mg/mL, 0.002 mg/mL, 0.003 mg/mL, 0.001 mg/mL, 0.005 mg/mL, 2.55 mg/[USP'U], 5.1 mg/[USP'U], 7.65 mg/[USP'U], 10.2 mg/[USP'U], 1.28 mg/[USP'U], 1.2 mg, 1.6 mg, 0.012 mg, 0.05 mg, 0.075 mg, 0.025 mg, 2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg, 0.0875 mg/hour, 0.04 mg/dose, 0.01 mg/hour, 0.0025 mg/hour, 0.005 mg/hour, 0.0125 mg, 0.04 mg, 0.0375 mg/hour, 0.0625 mg/hour, 0.01 mg, 0.03 mg, 0.1 mg/mL, 0.1 mg/spray, 0.4 mg/spray, 0.2 mg/dose, 0.1 mg/dose, 0.05 mg/dose, 0.037 mg/hour, 0.25 mg/mL

, Transdermal, Patch, extended release, Patch, extended release - Transdermal, Buccal; Oral; Transmucosal, Tablet - Buccal; Oral; Transmucosal, Tablet, Nasal, Spray, Spray - Nasal, Patch, Patch - Transdermal, Oral; Transmucosal, Lozenge, Lozenge - Oral; Transmucosal, Sublingual, Tablet - Sublingual, Injection, solution - Intravenous, Injection, solution, Intravenous, Epidural, Injection, solution - Epidural, Intramuscular; Intravenous, Injection, solution - Intramuscular; Intravenous, Solution, Solution - Epidural; Intramuscular; Intravenous, Liquid - Epidural; Intramuscular; Intravenous, Liquid, Liquid - Intramuscular; Intravenous, Epidural; Intramuscular; Intravenous, Buccal, Film, soluble, Film, soluble - Buccal, Buccal; Sublingual, Tablet - Buccal; Sublingual, Tablet, orally disintegrating, Tablet, orally disintegrating - Sublingual, Spray - Sublingual, Injection, Injection - Intramuscular; Intravenous, Injection - Intravenous, Tablet, effervescent, Tablet, effervescent - Buccal; Sublingual, Transmucosal, Lozenge - Transmucosal, Tablet - Buccal, Solution - Nasal, Film - Buccal, Epidural; Intravenous, Injection, solution - Epidural; Intravenous, Patch, extended release, electrically controlled, Patch, extended release, electrically controlled - Transdermal, Aerosol, spray - Nasal

Warnings

Subsys Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Fentanyl may interact with Pulse Frequency

short opioid analgesia requirement

Do Not Combine

Asthma

Do Not Combine

Pain

Do Not Combine

Asthma

Do Not Combine

Mental Depression

Do Not Combine

opioid non-tolerant patients

Do Not Combine

known or suspected gastrointestinal obstruction

Do Not Combine

Intestinal Pseudo-Obstruction

Do Not Combine

Paralytic Ileus

Do Not Combine

management of acute or intermittent pain

Do Not Combine

Pain

Do Not Combine

respiratory compromise

Do Not Combine

There are 20 known major drug interactions with Subsys.

Common Subsys Drug Interactions

Drug Name

Risk Level

Description

Copanlisib

Major

The metabolism of Copanlisib can be decreased when combined with Fentanyl.

Eluxadoline

Major

The risk or severity of constipation can be increased when Fentanyl is combined with Eluxadoline.

Oliceridine

Major

The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Fentanyl is combined with Oliceridine.

Paclitaxel

Major

The metabolism of Paclitaxel can be decreased when combined with Fentanyl.

Sirolimus

Major

The metabolism of Sirolimus can be decreased when combined with Fentanyl.

Subsys Toxicity & Overdose Risk

Fentanyl has a toxic dose of 2.91mg/kg when given intravenously to rats, and 18mg/kg when given orally to rats and 368mg/kg when given orally to mice. The toxic dose in humans is not known. Symptoms of overdose include trouble breathing, sleepiness, stupor, coma, weak muscles, cold and clammy skin, small pupils, fluid in the lungs, slow heart rate, low blood pressure, blocked airway, unusual snoring, and death. In case of overdose, patients should be given naloxone or nalmefene to counter the effects of the opioid drug

image of a doctor in a lab doing drug, clinical research

Subsys Novel Uses: Which Conditions Have a Clinical Trial Featuring Subsys?

43 active clinical trials are now underway to assess the potential of Subsys in alleviating Pain, Anesthetics and Preanesthetic Medication.

Condition

Clinical Trials

Trial Phases

Pain

0 Actively Recruiting

Anesthetic premedication therapy

0 Actively Recruiting

Anesthesia, Conduction

0 Actively Recruiting

General Anesthesia

1 Actively Recruiting

Phase 4

Induction of anesthesia therapy

0 Actively Recruiting

opioid tolerant

0 Actively Recruiting

Anesthetics

1 Actively Recruiting

Phase 3

High Risk Surgery

0 Actively Recruiting

Anesthesia procedures

0 Actively Recruiting

Pain

0 Actively Recruiting

Subsys Reviews: What are patients saying about Subsys?

3

Patient Review

4/11/2016

Subsys for Breakthrough Cancer Pain in Opioid-Tolerant Patient

I've been using this medication to manage my cancer pain, but lately I've noticed that a disturbingly high percentage of the doses have either had no effect or very little effect. I reached out to the company about this issue but haven't received any response.

2.7

Patient Review

4/21/2016

Subsys for Breakthrough Cancer Pain in Opioid-Tolerant Patient

I've had a lot of problems with the packaging--empty containers or less medication than what's supposed to be there. I reported it to the company but they never called me back. I also reported it to my doctor's office and pharmacist, but it's been difficult to stay ahead of the pain.

2.7

Patient Review

5/8/2016

Subsys for Breakthrough Cancer Pain in Opioid-Tolerant Patient

I am not satisfied with the delivery method of this med. I am finding 6-8 DUDS in each box, plus one fourth to one half the medicine in other containers. I have reported this to the Company and after four weeks, no changes have been made. Extremely frustrated.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about subsys

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Subsys spray?

"Subsys is the first and only sublingual fentanyl cancer pain medicine.

Subsys is a powerful opioid pain reliever that is indicated for treating breakthrough cancer pain in adults who are already taking other opioid pain medications for cancer pain around the clock. Subsys is the first and only sublingual fentanyl cancer pain medicine."

Answered by AI

Can you still buy Subsys?

"Only healthcare professionals who prescribe to outpatients, pharmacies, and distributors who enroll in the TIRF REMS Access program can get SUBSYS."

Answered by AI

Is Subsys FDA approved?

"The efficacy of Subsys was based on a double-blind, placebo-controlled, crossover study in opioid tolerant adults with cancer and breakthrough pain. The subjects received Subsys from 100 mcg per dose to 1600 mcg per dose."

Answered by AI

Who created Subsys?

"When Subsys was first introduced, there were high hopes that it would revolutionize cancer pain treatment. This was personal for Insys' founder, Dr. John Kapoor."

Answered by AI

Clinical Trials for Subsys