Step ii recommends adding an opioid for mild to moderate pain. Abstral, actiq, fentora, lazanda, subsys, and fentanyl citrate lozenges generic actiq. Medication guide subsys sub sis fentanyl sublingual spray. They are fda approved for breakthrough cancer pain in patients. Initial claim for 100 mcg for abstral, fentora, lazanda, subsys or 200 mcg for actiq or onsolis disposition of edit denial. With the back side of the foil package facing you, cut along arrows with scissors see figure a. Share your location or enter your city or zip code to find studies near you. Subsys fentanyl sublingual spray is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to aroundtheclock opioid therapy for their underlying persistent cancer pain. Burke in support of certain findings in proposed order authorizing debtors to sell certain assets to btcp pharma, llc related documents546 filed by insys therapeutics, inc. Clinical pharmacogenetics implementation consortium guideline cpic for cyp2d6 and cyp2c19 genotypes and dosing of tricyclic. Dosage and administration patients must require and use. References xinsys therapeutics, subsys package insert. Rxinformerhow offlabel prescribing drives a claim off course.
Limitations of use as part of the transmucosal immediaterelease fentanyl tirf rems access program, subsys may be. Repeat step above to open the other side of the package. Analgesics narcotic short acting texas health and human services. Onsolis criteria version 1 last updated 02092010 approved. Norco hydrocodone bitartrate and acetaminophen tablets, usp.
Policy history date action april 2012 renal patients may require lower doses. Oct 27, 2014 information on the package insert, subsys s black box warning reads as follows. Clinical pharmacogenetics implementation consortium cpic guidelines for codeine therapy in the context of cytochrome p450 2d6. Dailymed alfentanil alfentanil hydrochloride injection. Nasal decongestive agents may lead to lower peak plasma concentrations of intranasal formulations. Fentanyl transmucosal immediaterelease monograph pharmacy. Aug 31, 2018 use the connection where two wires will insert into one voice coil connector and then route the other end of the wire to opposite connector, shown in fig 33 and fig 34. Oral and nasal fentanyl products wellmark blue cross.
Subsys has a boxed warning regarding the risk of fatal respiratory depression in patients treated with subsys, including following use in opioid nontolerant patients and improper dosing. Dosage and administration patients must require and. Ferrance suggested this medication have the same edits as the other formulations of. Product information for onsolis, abstral, fentora, lazanda, subsys, and. Offlabel uses include noncancer pain and painful procedures in children 810. The end of the unit printed with actiq and the strength number of the unit 200, 400, 600, 800, 1200, or 1600 is the medicine end that is to be. Jan 28, 2021 subsys exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. All opioid analgesics therapy both preferred and nonpreferred agents that. With sublingual administration of a newly developed 30. Abstral, actiq, fentora, lazanda, subsys, and fentanyl citrate lozenges generic actiq are rapidacting opioid analgesics indicated for the management of breakthrough cancer pain in patients who are already receiving and have developed tolerance to aroundthe. As explained in the last wa rning, subsys is one of a handful of medications for which prescription and use are tightly regulat ed and monitored by the fdas tirf rems access program. Transmucosal immediaterelease fentanyl tirf clinical edit. Abstral, actiq, fentora, lazanda, subsys, and fentanyl citrate lozenges generic actiq are indicated for the management of breakthrough cancer pain in patients who are already receiving and have developed tolerance to aroundtheclock opioid therapy for their underlying persistent cancer pain.
Subsys package insert, chandler, az, insys therapeutics, inc november 2019. Comparison of fentanyl oral and nasal formulations palliative. Remove the subsys spray unit from the blister package by cutting the dashed line with a pair of scissors. Description opioid analgesics exert their analgesic effect through opiate receptors distributed in tissues throughout the body. Once opened, use the entire onsolis film right away. Patients must remain on aroundtheclock opioids when taking subsys. Nucynta er tapentadol extendedrelease tablets, cii. Otfc lozenge and fsl spray over other oral opioids include avoidance of. Subsys may be dispensed only to patients enrolled in the tirf rems access program 1. Pharmacokinetic properties of a sufentanil sublingual tablet. Opioid analgesic risk evaluation and mitigation strategy rems. Subsys package insert, phoenix, az, insys therapeutics, inc december, 2014.
Subsys is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of schedule ii opioids to treat cancer pain. Offlabel uses include noncancer pain and painful procedures in children. Epps stated that there was no package insert available online at this time and other fentanyl products had precautions and drugdrug interactions not found on subsys package insert sent from the company. When you are ready to use actiq, cut open the package using scissors. Singledose pharmacokinetics of fentanyl sublingual spray and. Do not open the blister package until you are ready to use it. Tirf rems stands for transmucosal immediate release fentanyl. Edit 682 clinical edit default approval period default approval period. Norco hydrocodone bitartrate and acetaminophen tablets. The dextranomer component consists of microspheres of dextran chains crosslinked into a threedimensional network. This package installs the software card reader driver to enable the following device. Subsys exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. From the 100 mcg initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single subsys dose per breakthrough cancer pain episode with tolerable side effects.
Patients considered opioid tolerant are those who are. This is a document written for patients that provides information about how to safely use the drug. Products such as actiq fentanyl lollipop, fentora and subsys are exclusively indicated for use in breakthrough cancer pain. Fentanyl powder was added as a line extension to the commercially availablefentanyl. Assess each patients risk prior to prescribing subsys, and monitor all patients regularly for the development of these behaviors and conditions see warnings and precautions. Pamedical necessity unitedhealthcare commerical plans. Medication guide subsys sub sis fentanyl sublingual. Open the blister package with scissors immediately prior to product use. Quantity limit or maximum morphine louisiana department of health. Abstral, actiq, fentora, onsolis, lazanda and subsys. The substitution of subsys for any other fentanyl product may.
Subsys fda prescribing information, side effects and uses. Subsys is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Butalbital, acetaminophen, caffeine and codeine package insert. At doses of 8 to 40 mcgkg for surgical procedures lasting up to 30 minutes, alfentanil provides analgesic protection against hemodynamic responses to surgical stress with recovery times generally comparable to those seen with equipotent fentanyl dosages. This policy includes both brand and generic versions if available for the drug. Assess patients risk before prescribing and monitor regularly for these behaviors and conditions. Diprivan injectable emulsion is a single access parenteral product single. This emedtv web selection contains an explanation of the effects of this painkiller, covers dosing information, lists potential side effects, and more. Fentanyl is a potent and highly addictive opioid that has a history of being prescribed offlabel in workers comp. Search for clinical trials by condition, keyword or trial number. Considerations in selecting rapidonset opioids for the management of breakthrough pain. Patient information for sublocade buprenorphine extended.
Fentanyl powder fentanyl citrate rationale for inclusion in. Onsolis, and subsys 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg. Patients are considered opioid tolerant if they are taking at least. This should be considered when prescribing or dispensing subsys in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Fentanyl powder can be compounded into the same immediate release dosage forms provided that the requested dose is not commercially availableand does not exceed the fda approved maximum strength for the equivalent commercially available product. Sublocade buprenorphine extendedrelease injection, for subcutaneous use ciii is a prescription medicine used to treat adults with moderate to severe addiction dependence to opioid drugs prescription or illegal who have received an oral transmucosal used under the tongue or inside the cheek buprenorphinecontaining medicine at a dose that controls withdrawal symptoms for at least. Timeline of selected fda activities and significant events.
Medication guide or patient package insert ppi communication plan for health care providers. Desirable product attributes for treatment of moderatetosevere acute pain in many medically supervised settings are rapid onset. Both the dextranomer and sodium hyaluronate are made up of biosynthesized polysaccharides of nonanimal origin. Fentanyl powder can be compounded into the same immediate release dosage forms provided that the requested dose is not commercially available and does not exceed the fda approved maximum strength for the equivalent commercially available product. Adverse effects data are obtained from package inserts and are not meant to. The patient should place the actiq unit in his or her mouth between the cheek and lower gum, occasionally moving the drug matrix from one side to the other using the handle.
Transmucosal fentanyl formulations are available via a variety of nontraditional routes e. Norco hydrocodone bitartrate and acetaminophen tablets, usp cii. Peel back the blister backing, and remove the actiq unit see figures a and b. Adverse events associated with the use of subsys may include, but are not limited to, the following. Regenerative medicine steps to accelerate development.
Oral and nasal fentanyl products wellmark blue cross and. Subsys sublingual fentanyl spray subsys fep clinical rationale rationale for inclusion in pa program background subsys has one indication, the management of breakthrough cancer pain in patients with. Subsys is a narcotic drug licensed for treating breakthrough cancer pain. Subsys sublingual fentanyl spray rationale for inclusion in. Realtek card reader driver for windows 10 64bit, 8. Alfentanil is an opioid analgesic with a rapid onset of action. Louisiana feeforservice medicaid shortacting narcotic. Pharmacokinetic properties of a sufentanil sublingual. Rems stands for risk evaluation and mitigation strategy and is intended to manage known or potential problems for drugs that present an especially important risk. Individually titrate subsys to a dose that provides adequate analgesia and minimizes adverse reactions. Patient is already receiving around the clock opioid therapy for underlying persistent cancer pain b. Because of the risk for misuse, abuse, addiction, and overdose, subsys is.
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