Recommended Topic Related To:

Abstral

"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.

Pancreati"...

Abstral

PATIENT INFORMATION

ABSTRAL®
(AB-stral)
(fentanyl) Sublingual tablets 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg

IMPORTANT

Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). Keep ABSTRAL in a safe place away from children. Get emergency medical help right away if:

  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock, takes ABSTRAL

These are medical emergencies that can cause death. If possible, try to remove ABSTRAL from the mouth.

Read this Medication Guide completely before you start taking ABSTRAL, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to share this important information with members of your household and other caregivers.

What is the most important information I should know about ABSTRAL?

ABSTRAL can cause life-threatening breathing problems which can lead to death.

1. Do not take ABSTRAL if you are not opioid tolerant.

2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop taking ABSTRAL. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

3. Take ABSTRAL exactly as prescribed by your healthcare provider.

  • You must not take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
  • You must wait two hours before treating a new episode of breakthrough pain with ABSTRAL. See the Medication Guide section “How should I take ABSTRAL?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to take ABSTRAL the right way.

4. Do not switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of ABSTRAL is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl containing medicines you may have been taking.

5. Do not take ABSTRAL for short-term pain that you would expect to go away in a few days, such as:

6. Never give ABSTRAL to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.

ABSTRAL is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

  • Prevent theft, misuse or abuse. Keep ABSTRAL in a safe place to protect it from being stolen. ABSTRAL can be a target for people who abuse opioid (narcotic) medicines or street drugs.
  • Selling or giving away this medicine is against the law.

7. ABSTRAL is available only through a program called the TIRF (Transmucosal Immediate-Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. To receive ABSTRAL, you must:

  • talk to your healthcare provider
  • understand the benefits and risks of ABSTRAL
  • agree to all of the instructions
  • sign the Patient-Prescriber Agreement form

What is ABSTRAL?

  • ABSTRAL is a prescription medicine that contains the medicine fentanyl.
  • ABSTRAL is used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
  • ABSTRAL is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use ABSTRAL if you are not opioid tolerant.
  • ABSTRAL is a small tablet that is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.
  • You must stay under your healthcare provider's care while taking ABSTRAL.
  • ABSTRAL is only:
    • available through the TIRF REMS Access program
    • given to people who are opioid tolerant

It is not known if ABSTRAL is safe and effective in children under 18 years of age.

Who should not take ABSTRAL?

Do not take ABSTRAL:

  • if you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the- clock for your cancer pain, and your body is used to these medicines.
    • for short-term pain that you would expect to go away in a few days, such as:
    • pain after surgery
    • headache or migraine
    • dental pain
  • if you are allergic to any of the ingredients in ABSTRAL. See the end of this Medication Guide for a complete list of other ingredients in ABSTRAL.

What should I tell my healthcare provider before taking ABSTRAL?

Before taking ABSTRAL, tell your healthcare provider if you:

  • have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • have or had a head injury or brain problem
  • have liver or kidney problems
  • have seizures
  • have a slow heart rate or other heart problems
  • have low blood pressure
  • have mental health problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
  • have a past or present drinking problem (alcoholism), or a family history of drinking problems
  • have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem
  • have any other medical conditions
  • are pregnant or plan to become pregnant. ABSTRAL may cause serious harm to your unborn baby.
  • are breastfeeding or plan to breastfeed. ABSTRAL can pass into your breast milk. It can cause serious harm to your baby. You should not use ABSTRAL while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with ABSTRAL. Sometimes, the doses of certain medicines and ABSTRAL may need to be changed if used together.

  • Do not take any medicine while using ABSTRAL until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using ABSTRAL.
  • Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABSTRAL?

Before you can begin to take ABSTRAL:

  • Your healthcare provider will explain the TIRF REMS Access program to you.
  • You will sign the TIRF REMS Access program Patient-Prescriber Agreement form.
  • ABSTRAL is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your ABSTRAL prescription filled.

Taking ABSTRAL:

  • Take ABSTRAL exactly as prescribed. Do not take ABSTRAL more often than prescribed.
  • If you notice that your tablets are a different shape or color, be sure to check with your pharmacist to make sure you have the right strength of medicine.
  • Do not suck, chew or swallow the tablet.
  • See the detailed Patient Instructions for Use at the end of this Medication Guide for information about how to take ABSTRAL the right way.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
  • You must not use more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain:
    • Take 1 dose for an episode of breakthrough cancer pain.
    • If your breakthrough pain does not get better within 30 minutes after taking the first dose of ABSTRAL, you can take 1 more dose of ABSTRAL as instructed by your healthcare provider.
    • If your breakthrough pain does not get better after the second dose of ABSTRAL, call your healthcare provider for instructions. Do not take another dose of ABSTRAL at this time.
  • Wait at least 2 hours before treating a new episode of breakthrough cancer pain with ABSTRAL:
    • If you only need to take 1 dose of ABSTRAL for an episode of breakthrough pain, you must wait 2 hours from the time of that dose to take a dose of ABSTRAL for a new episode of breakthrough pain
    • If you need to take 2 doses of ABSTRAL for an episode of breakthrough pain, you must wait 2 hours after the second dose to take a dose of ABSTRAL for a new episode of breakthrough pain.
  • It is important for you to keep taking your around-the-clock opioid pain medicine while taking ABSTRAL.
  • Talk to your healthcare provider if your dose of ABSTRAL does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of ABSTRAL needs to be changed.
  • Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around- the-clock opioid pain medicine may need to be adjusted.
  • If you take too much ABSTRAL or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room right away.

What should I avoid while taking ABSTRAL?

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABSTRAL affects you. ABSTRAL can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
  • Do not drink alcohol while using ABSTRAL. It can increase your chance of getting dangerous side effects.

What are the possible side effects of ABSTRAL?

ABSTRAL can cause serious side effects, including:

1. Breathing problems that can become life-threatening. See “What is the most important information I should know about ABSTRAL?”

  • Call your healthcare provider or get emergency medical help right away if you:
    • have trouble breathing
    • have drowsiness with slowed breathing
    • have shallow breathing (little chest movement with breathing)
    • feel faint, very dizzy, confused, or have other unusual symptoms
      These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.

2. Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.

3. Physical dependence. Do not stop taking ABSTRAL or any other opioid, without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.

4. A chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.

The most common side effects of ABSTRAL are:

  • nausea
  • sleepiness
  • headache

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including ABSTRAL and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking ABSTRAL.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ABSTRAL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about your side effects. You may report side effects to FDA at 1-800FDA-1088.

How should I store ABSTRAL?

  • Always keep ABSTRAL in a safe place away from children and from anyone for whom it has not been prescribed. Protect ABSTRAL from theft.
  • Store ABSTRAL at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
  • Keep ABSTRAL in the original blister unit. Do not remove ABSTRAL tablets from their blister packaging for storage in a temporary container, such as a pillbox.

How should I dispose of unopened ABSTRAL tablets when they are no longer needed?

  • Dispose of any unopened ABSTRAL units remaining from a prescription as soon as you no longer need them:
    • remove the tablets from the blister cards and flush them down the toilet.
  • Do not flush the ABSTRAL blister cards, units or cartons down the toilet.
  • If you need help with disposal of ABSTRAL, call Galena Biopharma, Inc.., at 1-888-227-8725 or call your local Drug Enforcement Agency (DEA) office.

General information about ABSTRAL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ABSTRAL only for the purpose for which it was prescribed. Do not give ABSTRAL to other people, even if they have the same symptoms you have. ABSTRAL can harm other people and even cause death. Sharing ABSTRAL is against the law.

This Medication Guide summarizes the most important information about ABSTRAL. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about ABSTRAL that is written for healthcare professionals.

For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1866-822-1483.

What are the ingredients in ABSTRAL?

Active Ingredient: fentanyl citrate

Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.

Patient Instructions for Use

Before you take ABSTRAL, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you take ABSTRAL the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to take ABSTRAL.

When you get an episode of breakthrough pain, take the dose prescribed by your healthcare provider as follows:

  • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle ABSTRAL tablets.
  • ABSTRAL comes in a blister card with 4 blister units. Each blister unit contains an ABSTRAL tablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.
  • When you are ready to take an ABSTRAL tablet, pull apart 1 of the blister units from the blister card by tearing along the dotted lines (perforations) until it is fully separated. (See Figures 1 and 2)

Figure 1 and 2

Separating the blisters - Illustration

  • When the blister unit is fully separated, peel back the foil starting at the unsealed area where indicated. Gently remove the tablet. Do not try to push ABSTRAL tablets through the foil. This will damage the tablet. (See Figures 3 and 4)

Figure 3 and 4

Peel back the foil - Illustration

  • As soon as you remove the ABSTRAL tablet from the blister unit:
    • place it on the floor of your mouth, under your tongue, as far back as you can (See Figures 5, 6, and 7).

Figures 5, 6, and 7

Placing the tablets -  Illustration

    • If more than 1 tablet is required, spread them around the floor of your mouth under your tongue.
    • Let the tablet dissolve completely. ABSTRAL dissolves under your tongue and will be absorbed by your body to help provide relief for your breakthrough cancer pain.
    • Do not suck, chew or swallow the tablet.
    • You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.

Initial REMS approval: 12/2011
Most recent modification: 7/2013

TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF)RISK EVALUATION AND MITIGATION STRATEGY (REMS)

I. GOALS

The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:

  1. Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
  2. Preventing inappropriate conversion between TIRF medicines.
  3. Preventing accidental exposure to children and others for whom it was not prescribed.
  4. Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.

II. REMS ELEMENTS

A. Medication Guide

The product-specific TIRF Medication Guide will be dispensed with each TIRF prescription in accordance with 21 CFR 208.24.

The Medication Guides for TIRF medicines are part of the TIRF REMS Access program and will be available on the TIRF REMS Access website (www.TIRFREMSaccess.com).

B. Elements to Assure Safe Use

1. Healthcare providers who prescribe TIRF medicines for outpatient use are specially certified.

a. TIRF sponsors will ensure that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified.

b. To become certified to prescribe TIRF medicines, prescribers will be required to enroll in the TIRF REMS Access program. Prescribers must complete the following requirements to be enrolled:

i. Review the TIRF REMS Access education materials (TIRF REMS Access Education Program), including the Full Prescribing Information (FPI) for each TIRF medicine, and successfully complete the Knowledge Assessment (Knowledge Assessment).

ii. Complete and sign the Prescriber Enrollment Form. In signing the Prescriber Enrollment Form, each prescriber is required to acknowledge the following:

a) I have reviewed the TIRF REMS Access Education Program, and I have completed the Knowledge Assessment. I understand the responsible use conditions for TIRF medicines and the risks and benefits of chronic opioid therapy.

b) I understand that TIRF medicines can be abused and that this risk should be considered when prescribing or dispensing TIRF medicines in situations where I am concerned about an increased risk of misuse, abuse, or overdose, whether accidental or intentional.

c) I understand that TIRF medicines are indicated only for the management of breakthrough pain in patients with cancer, who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent pain.

d) I understand that TIRF medicines are contraindicated for use in opioid non-tolerant patients, and know that fatal overdose can occur at any dose.

e) I understand that TIRF medicines must not be used to treat any contraindicated conditions described in the FPI, such as acute or postoperative pain, including headache/migraine.

f) I understand that converting patients from one TIRF medicine to a different TIRF medicine must not be done on a microgram-per-microgram basis. I understand that TIRF medicines are not interchangeable with each other, regardless of route of administration, and that conversion may result in fatal overdose, unless conversion is done in accordance with labeled product-specific conversion recommendations (refer to the 'List of TIRF Medicines Available only through the TIRF REMS Access program' in Attachment 1). Note, a branded TIRF medicine and its specific generic product(s) are interchangeable.

g) I understand that the initial starting dose for TIRF medicines for all patients is the lowest dose, unless individual product labels provide product-specific conversion recommendations, and I understand that patients must be titrated individually.

h) I will provide a Medication Guide for the TIRF medicine that I intend to prescribe to my patient or their caregiver and review it with them. If I convert my patient to a different TIRF medicine, the Medication Guide for the new TIRF medicine will be provided to, and reviewed with, my patient or their caregiver.

i) I will complete and sign a TIRF REMS Access Patient-Prescriber Agreement Form with each new patient, before writing the patient's first prescription for a TIRF medicine, and renew the agreement every two (2) years.

j) I will provide a completed, signed copy of the Patient-Prescriber Agreement Form to the patient and retain a copy for my records. I will also provide a completed, signed copy to the TIRF REMS Access program (through the TIRF REMS Access website or by fax) within ten (10) working days.

k) At all follow-up visits, I agree to assess the patient for appropriateness of the dose of the TIRF medicine, and for signs of misuse and abuse.

l) I understand that TIRF medicines are only available through the TIRF REMS Access program. I understand and agree to comply with the TIRF REMS Access program requirements for prescribers.

m) I understand that I must re-enroll in the TIRF REMS Access program and successfully complete the enrollment requirements every two (2) years.

In signing the Patient-Prescriber Agreement Form, the prescriber documents the following:

1) My patient is currently using around-the-clock opioid medication and has been for at least one (1) week.

2) My patient is opioid-tolerant. Patients considered opioid-tolerant are those who are regularly taking at least: 60 mg oral morphine/day; 25 micrograms transdermal fentanyl/hour; 30 mg oral oxycodone/day; 8 mg oral hydromorphone/day; 25 mg oral oxymorphone/day; or an equianalgesic dose of another opioid for one week or longer.

3) I have provided to, and reviewed with, my patient or their caregiver the Medication Guide for the TIRF medicine I intend to prescribe.

4) If I change my patient to a different TIRF medicine, I will provide the Medication Guide for the new TIRF medicine to my patient or my patient's caregiver, and I will review it with them.

5) I understand that if I change my patient to a different TIRF medicine, the initial dose of that TIRF medicine for all patients is the lowest dose, unless individual product labels provide product-specific conversion recommendations.

6) I have counseled my patient or their caregiver about the risks, benefits, and appropriate use of TIRF medicines including communication of the following safety messages:

A. If you stop taking your around-the-clock pain medicine, you must stop taking your TIRF medicine.

B. NEVER share your TIRF medicine.

C. Giving a TIRF medicine to someone for whom it has not been prescribed can result in a fatal overdose.

D. TIRF medicines can be fatal to a child; used and unused dosage units must be safely stored out of the reach of children living in or likely to visit the home and disposed of in accordance with the specific disposal instructions detailed in the product's Medication Guide.

I will ensure that the patient and/or caregiver understand that, in signing the Patient-Prescriber Agreement Form, they document the following:

1) My prescriber has given me a copy of the Medication Guide for the TIRF medicine I have been prescribed, and has reviewed it with me.

2) I understand that before I can take any TIRF medicine, I must be regularly using another opioid pain medicine, around-the-clock, for my constant pain.

3) I understand that if I stop taking my around-the-clock opioid pain medicine for my constant pain, I must stop taking my TIRF medicine.

4) I understand how I should take this TIRF medicine, including how much I can take, and how often I can take it. If my prescriber prescribes a different TIRF medicine for me, I will ensure I understand how to take the new TIRF medicine.

5) I understand that any TIRF medicine can cause serious side effects, including life-threatening breathing problems which can lead to death, especially if I do not take my TIRF medicine exactly as my prescriber has directed me to take it.

6) I agree to contact my prescriber if my TIRF medicine does not relieve my pain. I will not change the dose of my TIRF medicine myself or take it more often than my prescriber has directed.

7) I agree that I will never give my TIRF medicine to anyone else, even if they have the same symptoms, since it may harm them or even cause death.

8) I will store my TIRF medicine in a safe place away from children and teenagers because accidental use by a child, or anyone for whom it was not prescribed, is a medical emergency and can cause death.

9) I have been instructed on how to properly dispose of my partially used or unneeded TIRF medicine remaining from my prescription, and will dispose of my TIRF medicine as soon as I no longer need it.

10) I understand that selling or giving away my TIRF medicine is against the law.

11) I have asked my prescriber all the questions I have about my TIRF medicine. If I have any additional questions or concerns in the future about my treatment with my TIRF medicine, I will contact my prescriber.

12) I have reviewed the “Patient Privacy Notice for the TIRF REMS Access Program” and I agree to its terms and conditions which allow my healthcare providers to share my health information, as defined in that document, with the makers of TIRF medicines (TIRF Sponsors) and their agents and contractors for the limited purpose of managing the TIRF REMS Access program.

c. Prescribers are required to re-enroll every two (2) years. Additionally, prescribers must re-counsel their patients and complete a new Patient-Prescriber Agreement Form every two (2) years.

d. TIRF Sponsors will:

i. Ensure that prescriber enrollment can successfully be completed via the TIRF REMS Access website, or by mailing or faxing the forms.

ii. Ensure that, as part of the enrollment process, the following materials that are part of the TIRF REMS Access program are available to prescribers. These materials are appended:

TIRF REMS Access Prescriber Program Overview

TIRF REMS Access Education Program

Knowledge Assessment

Prescriber Enrollment Form

Patient-Prescriber Agreement Form

TIRF REMS Access Patient and Caregiver Overview

Frequently Asked Questions (FAQs)

TIRF REMS Access Website

iii. Ensure that prescribers have successfully completed the Knowledge Assessment, and ensure that enrollment forms are complete before activating a prescriber's enrollment in the TIRF REMS Access program.

iv. Ensure that prescribers are notified when they are successfully enrolled in the TIRF REMS Access program, and therefore, are certified to prescribe TIRF medicines.

v. Monitor education and enrollment requirements for prescribers and may inactivate non-compliant prescribers. Upon initial activation, prescribers remain active until inactivation occurs or expiration of the enrollment period.

vi. Ensure that prior to the first availability of the TIRF REMS Access program/website, Dear Healthcare Provider Letters will be sent. The target audience for the letters will include pain management specialists (comprised of anesthesiologists, physical medicine and rehabilitation physicians), primary care physicians, oncologists, oncology nurse practitioners who treat breakthrough pain in patients with cancer, and other appropriately licensed healthcare professionals who prescribe TIRF medicines. The letter will include information on the risks associated with the use of TIRF medicines and will explain to healthcare providers that if they wish to treat patients using TIRF medicines, they must enroll in the TIRF REMS Access program. The letters will be available on the TIRF REMS Access website for 1 year from the date of the mailing.

The Dear Healthcare Provider Letter is part of the TIRF REMS Access program and is appended.

2. TIRF medicines will only be dispensed by pharmacies that are specially certified.

a. TIRF Sponsors will ensure that TIRF medicines will only be dispensed by certified pharmacies. To become certified to dispense TIRF medicines, each pharmacy must be enrolled in the TIRF REMS Access program.

b. Each pharmacy will be required to designate an authorized pharmacy representative (chain pharmacy) or authorized pharmacist (outpatient and inpatient pharmacies) to complete enrollment on behalf of the pharmacy(s).

c. There are different enrollment requirements for :

  • outpatient pharmacies (e.g., retail, mail order, institutional outpatient pharmacies that dispense for outpatient use), including chain pharmacies, but excluding closed system pharmacies (see definition below).
  • closed system pharmacies For the purposes of this REMS, a closed system pharmacy is defined as an outpatient pharmacy that uses a pharmacy management system that does not support the process of electronically transmitting the validation and claim information currently required by the TIRF REMS Access program. For example, some pharmacies that are part of integrated healthcare delivery systems may qualify as closed system pharmacies.
  • inpatient pharmacies (e.g., hospitals, in-hospital hospices, and long-term care facilities that dispense for inpatient use)

d) Outpatient Pharmacies:

The authorized pharmacist/pharmacy representative must complete the following requirements to enroll their outpatient pharmacy:

i. Review the TIRF REMS Access Education Program (TIRF REMS Access Education Program) and successfully complete the Knowledge Assessment.

ii. Ensure the pharmacy enables its pharmacy management system to support communication with the TIRF REMS Access program system, using established telecommunication standards, and runs the standardized validation test transaction to validate the system enhancements.

iii. Complete and sign the Outpatient Pharmacy Enrollment Form or the Chain Pharmacy Enrollment Form for groups of associated pharmacies. In signing the Outpatient Pharmacy Enrollment Form or Chain Pharmacy Enrollment Form, the authorized pharmacist is required to acknowledge the following:

a) I have reviewed the TIRF REMS Access Education Program, and I have completed the Knowledge Assessment. I understand the risks and benefits associated with TIRF medicines and the requirements of the TIRF REMS Access program for pharmacies.

b) I will ensure that all pharmacy staff who participate in dispensing TIRF medicines are educated on the risks associated with TIRF medicines and the requirements of the TIRF REMS Access program, as described in the TIRF REMS Access Education Program. This training should be documented and is subject to audit.

c) I understand that converting patients from one TIRF medicine to a different TIRF medicine must not be done on a microgram-per-microgram basis. I understand that TIRF medicines are not interchangeable with each other, regardless of route of administration, and that conversion may result in fatal overdose, unless conversion is done in accordance with labeled product-specific conversion recommendations (refer to the 'List of TIRF Medicines available only through the TIRF REMS Access Program' in Attachment 1). Note, a branded TIRF medicine and its specific generic product(s) are interchangeable.

d) I understand that TIRF medicines are contraindicated for use in opioid non-tolerant patients.

e) I understand that the initial starting dose of TIRF medicines for all patients is the lowest dose, unless individual product labels provide product-specific conversion recommendations, and I understand that patients must be titrated individually.

f) I understand the importance of discussing the risks and benefits of TIRF medicines with patients and their caregivers, and in particular the importance of taking the drug as prescribed, not sharing with others, and proper disposal.

g) I understand that the product-specific Medication Guide must be given to the patient or their caregiver each time a TIRF medicine is dispensed.

h) I understand that TIRF medicines will not be dispensed without verifying through our pharmacy management system that the prescriber and pharmacy are enrolled and active, and that the patient has not been inactivated in the program.

i) I understand that ALL TIRF medicine prescriptions, regardless of the method of payment, must be processed through our pharmacy management system.

j) I understand that all dispensing locations must be enrolled in the TIRF REMS Access program to dispense TIRF medicines.

k) I understand that TIRF medicines can only be obtained from wholesalers/distributors that are enrolled in the TIRF REMS Access program.

l) I understand that our pharmacy will not sell, loan or transfer any TIRF medicine inventory to any other pharmacy, institution, distributor, or prescriber.

m) I understand that our pharmacy must re-enroll in the TIRF REMS Access program and successfully complete the enrollment requirements every two (2) years.

n) I understand that TIRF medicines are only available through the TIRF REMS Access program. I understand that the pharmacy must comply with the TIRF REMS Access program requirements for outpatient pharmacies.

e. Closed System Pharmacies:

The authorized pharmacist/pharmacy representative must complete the following requirements to enroll their closed system pharmacy:

i. Review the TIRF REMS Access Education Program (TIRF REMS Access Education Program) and successfully complete the Knowledge Assessment.

ii. Complete and sign the Closed System Pharmacy Enrollment Form. In signing the Closed System Pharmacy Enrollment Form, the authorized closed system pharmacy representative is required to acknowledge the following:

a) I have reviewed the TIRF REMS Access Education Program, and I have completed the Knowledge Assessment. I understand the risks and benefits associated with TIRF medicines and the requirements of the TIRF REMS Access program for pharmacies.

b) I will ensure that all pharmacy staff who participate in dispensing TIRF medicines are educated on the risks associated with TIRF medicines and the requirements of the TIRF REMS Access program, as described in the TIRF REMS Access Education Program. This training should be documented and is subject to audit.

c) I understand that converting patients from one TIRF medicine to a different TIRF medicine must not be done on a microgram-per-microgram basis. I understand that TIRF medicines are not interchangeable with each other, regardless of route of administration, and that conversion may result in fatal overdose, unless conversion is done in accordance with labeled product-specific conversion recommendations (refer to the 'List of TIRF Medicines available only through the TIRF REMS Access Program' in Attachment 1). Note, a branded TIRF medicine and its specific generic product(s) are interchangeable.

d) I understand that TIRF medicines are contraindicated for use in opioid non-tolerant patients.

e) I understand that the initial starting dose for TIRF medicines for all patients is the lowest dose, unless individual product labels provide product-specific conversion recommendations, and I understand that patients must be titrated individually.

f) I understand the importance of discussing the risks and benefits of TIRF medicines with patients and their caregivers, and in particular the importance of taking the drug as prescribed, not sharing with others, and proper disposal.

g) I understand that the product-specific Medication Guide must be given to the patient or their caregiver each time a TIRF medicine is dispensed.

h) I understand that a TIRF medicine will not be dispensed without obtaining a TIRF REMS Access prescription authorization number issued by the TIRF REMS Access program prior to dispensing the prescription. A TIRF REMS Access prescription authorization number verifies that the prescriber and pharmacy are enrolled and active, and that the patient has not been inactivated from the program.

i) I understand that all dispensing locations must be enrolled in the TIRF REMS Access program to dispense TIRF medicines

j) I understand that TIRF medicines can only be obtained from wholesalers/distributors that are enrolled in the TIRF REMS Access program.

k) I understand that our pharmacy will not sell, loan or transfer any TIRF inventory to any other pharmacy, institution, distributor, or prescriber.

l) I understand that our pharmacy must re-enroll in the TIRF REMS Access program every two (2) years.

m) I understand that TIRF medicines are only available through the TIRF REMS Access program. I understand that the pharmacy must comply with the TIRF REMS Access program requirements for outpatient closed system pharmacies.

f. Inpatient Pharmacies:

The authorized pharmacist must complete the following requirements to successfully enroll their inpatient pharmacy:

i. Review the TIRF REMS Access Education Program (TIRF REMS Access Education Program) and successfully complete the pharmacy Knowledge Assessment.

ii. Complete and sign the Inpatient Pharmacy Enrollment Form. In signing the Inpatient Pharmacy Enrollment Form, the authorized pharmacist is required to acknowledge the following:

a) I have reviewed the TIRF REMS Access Education Program, and I have completed the Knowledge Assessment. I understand the benefits and risks associated with TIRF medicines and the requirements of the TIRF REMS Access program for pharmacies.

b) I will ensure that our inpatient pharmacists are educated on the risks associated with TIRF medicines and the requirements of the TIRF REMS Access program, as described in the TIRF REMS Access Education Program.

c) I understand that converting patients from one TIRF medicine to a different TIRF medicine must not be done on a microgram-per-microgram basis. I understand that TIRF medicines are not interchangeable with each other, regardless of route of administration, and that conversion may result in fatal overdose, unless conversion is done in accordance with labeled product-specific conversion recommendations (refer to the 'List of TIRF Medicines available only through the TIRF REMS Access Program' in Attachment 1). Note, a branded TIRF medicine and its specific generic product(s) are interchangeable.

d) I understand that TIRF medicines are contraindicated for use in opioid non-tolerant patients.

e) I understand that the initial starting dose for TIRF medicines for all patients is the lowest dose, unless individual product labels provide product-specific conversion recommendations, and I understand that patients must be titrated individually.

f) I understand that pharmacies within or associated with the healthcare facility that dispense to outpatients must be separately enrolled in and comply with the TIRF REMS Access program to dispense TIRF medicines to outpatients, as described in section B.2.d, above.

g) I understand that our inpatient pharmacy must not dispense TIRF medicines for outpatient use.

h) I understand that a prescriber who wants to discharge a patient with a TIRF medicine prescription, intended to be dispensed by an outpatient pharmacy, will be required to enroll in the TIRF REMS Access program, as described in section B.1 of this REMS.

i) I will establish, or oversee the establishment of, a system, order sets, protocols and/or other measures to help ensure appropriate patient selection and compliance with the requirements of the TIRF REMS Access program.

j) I understand that our pharmacy will not sell, loan or transfer any TIRF inventory to any other pharmacy, institution, distributor, or prescriber.

k) I understand that TIRF medicines can only be obtained from wholesalers/distributors that are enrolled in the TIRF REMS Access program.

l) I understand that our pharmacy must re-enroll in the TIRF REMS Access program every two (2) years.

m) I understand that TIRF medicines are available only through the TIRF REMS Access program. I understand and agree to comply with the TIRF REMS Access program requirements for inpatient pharmacies.

g. Pharmacies (authorized pharmacist) are required to re-enroll every two (2) years.

h. TIRF Sponsors will:

i. Ensure that pharmacy enrollment can successfully be completed via the TIRF REMS Access website, by mailing or faxing the forms.

ii. Ensure that, as part of the enrollment process, the following materials that are part of the TIRF REMS Access program are available to pharmacies. These materials are appended:

  • The TIRF REMS Access Program Overview (Outpatient Pharmacy, Chain Pharmacy or Inpatient Pharmacy, as applicable)
  • TIRF REMS Access Education Program
  • Knowledge Assessment
  • Pharmacy Enrollment Form (Outpatient, Chain, Closed System, or Inpatient, as applicable)
  • Frequently Asked Questions (FAQs)
  • TIRF REMS Access Website

iii. Ensure that all enrollment forms are complete, and that the authorized pharmacist has successfully completed the Knowledge Assessment before activating a pharmacy's enrollment in the TIRF REMS Access program.

iv. For outpatient pharmacies (including chain pharmacies) only, TIRF Sponsors will also ensure that the configurations to the pharmacy management system have been validated before enrolling a pharmacy in the TIRF REMS Access program.

v. For closed system pharmacies only, TIRF Sponsors will ensure that, prior to authorizing a pharmacy's enrollment as a closed system pharmacy, the pharmacy meets the requirements of being deemed a 'closed system' pharmacy (see II.B.2.c)

vi. Ensure that pharmacies are notified when they are successfully enrolled in the TIRF REMS Access program, and therefore, certified to dispense TIRF medicines.

vii. Monitor education and enrollment requirements for pharmacies and inactivate noncompliant pharmacies. Upon initial activation of enrollment, pharmacies remain active until a corrective action of inactivation occurs or expiration of the enrollment period.

viii. Ensure that prior to first availability of the TIRF REMS Access program/website, Dear Pharmacy Letters will be sent (one for inpatient pharmacies and one for outpatient pharmacies). The target audience for the letter will include outpatient and inpatient pharmacies that dispense Schedule II drugs and may be involved in dispensing TIRF medicines. The letter will include information on the risks associated with the use of TIRF medicines and the requirements of the TIRF REMS Access program. The letter will be available on the TIRF REMS Access website for 1 year from the date of the mailing.

The Dear Pharmacy Letters (Outpatient and Inpatient) are part of the TIRF REMS Access program. These materials are appended.

3. TIRF medicines will only be dispensed for outpatient use with evidence or other documentation of safe-use conditions.

a. TIRF Sponsors will ensure that TIRF medicines will only be dispensed for outpatient use if there is documentation in the TIRF REMS Access program system that the dispensing pharmacy and prescriber are enrolled and active, and the patient is not inactive in the TIRF REMS Access program.

b. Patients are passively enrolled in the TIRF REMS Access program when their first TIRF medicine prescription is processed at the pharmacy. Patients may continue to receive TIRF medicines while passively enrolled, for up to ten working days, as described in section II.C.5. Prescribers and outpatient pharmacies (including closed system outpatient pharmacies) are enrolled, as previously described in sections B.1 and B.2, respectively.

c. For outpatient pharmacies: Prior to dispensing TIRF medicines, enrolled outpatient pharmacies will electronically verify documentation of the required enrollments by processing the TIRF prescription through their pharmacy management system.

i. If the required enrollments are verified, a unique authorization code will be issued to allow processing and dispensing of the prescription to the patient.

ii. If one or more of the required enrollments cannot be verified, the TIRF REMS Access program system will reject the prescription (prior to a claim being forwarded to the payer) and the pharmacy will receive a rejection notice.

d. For closed system pharmacies: prior to dispensing TIRF medicines, enrolled closed system pharmacies will verify documentation of the required enrollments by contacting the TIRF REMS Access program at 1-866-822-1483, or via fax, and providing the required information from the TIRF prescription.

i. If the required enrollments are verified, the TIRF REMS Access program will provide a unique authorization code to allow processing and dispensing of the prescription to the patient.

ii. If one or more of the required enrollments cannot be verified, a rejection reason, and information regarding how to resolve the rejection, will be provided.

e. Following initial activation, patients remain active until a trigger for inactivation occurs. Triggers for patient inactivation include:

i. The patient has not filled a prescription for more than six (6) months.

ii. The patient receives prescriptions for TIRF medicines from multiple prescribers within an overlapping time frame that is suggestive of misuse, abuse, or addiction.

f. If an active patient transfers from an enrolled prescriber to a non-enrolled or inactive prescriber, the TIRF REMS Access program cannot fill the prescription for TIRF medicines until the new prescriber is active in the TIRF REMS Access program.

g. A patient may have more than one current prescriber (e.g., pain management specialist, primary care physician) provided that prescriptions for TIRF medicines are not for the same or overlapping period of treatment.

h. Documentation and verification of safe-use conditions are not required for prescriptions ordered within an inpatient healthcare setting and given to an inpatient.

C. Implementation System

1. TIRF Sponsors will ensure that wholesalers/distributors who distribute TIRF medicines are enrolled in the TIRF REMS Access program. The wholesaler/distributor enrollment process is comprised of the following steps that must be completed by the distributor's authorized representative, prior to receiving TIRF medicine inventory for distribution:

a. Review the distributor TIRF REMS Access program materials

b. Complete and sign the Distributor Enrollment Form and send it to the TIRF Sponsors (by fax or mail). In signing the Distributor Enrollment Form, each wholesaler/distributor is required to indicate they understand that TIRF medicines are available only through the TIRF REMS Access program and acknowledges that they must comply with the following program requirements:

i. The Wholesaler/Distributor will ensure that relevant staff are trained on the TIRF REMS Access program procedures and will follow the requirements of the TIRF REMS Access program.

ii. The Wholesaler/Distributor will ensure that TIRF medicines are only distributed to pharmacies whose enrollment has been validated in the TIRF REMS Access program.

iii. The Wholesaler/Distributor will provide complete, unblinded and unblocked data (i.e. EDI 867 transmission) to the TIRF REMS Access program including information on shipments to enrolled pharmacies.

iv. The Wholesaler/Distributor will cooperate with periodic audits or non-compliance investigations to ensure that TIRF medicines are distributed in accordance with the program requirements.

c. TIRF Sponsors will ensure that all forms are complete prior to enrolling a distributor in the TIRF REMS Access program.

d. TIRF Sponsors will notify distributors when they are enrolled in the TIRF REMS Access program and, therefore, able to distribute TIRF medicines.

e. Upon initial activation, distributors remain active until an action of inactivation occurs, expiration of the enrollment period, or failure to comply with the pharmacy enrollment verification obligations. If a previously active distributor becomes inactive, the distributor may become active again by completing the distributor enrollment process in its entirety.

f. Distributors will be re-educated and re-enrolled in the TIRF REMS Access program every two (2) years.

g. The following distributor materials are part of the TIRF REMS Access program. These materials are appended:

  • Dear Distributor Letter
  • Distributor Enrollment Form
  • Frequently Asked Questions

2. TIRF Sponsors will maintain a database of all enrolled entities (prescribers, pharmacies, patients, and distributors) and their status (i.e. active or inactive), and will monitor and evaluate implementation of the TIRF REMS Access program requirements.

3. For outpatient pharmacies, TIRF Sponsors will develop a TIRF REMS Access program system that uses existing pharmacy management systems that allow for the transmission of TIRF REMS Access information using established telecommunication standards. The TIRF REMS Access program system will incorporate an open framework that allows a variety of distributors, systems vendors, pharmacies, and prescribers to participate, and that is flexible enough to support the expansion or modification of the TIRF REMS Access program requirements, if deemed necessary in the future.

4. For closed system pharmacies, TIRF Sponsors will develop a system to allow enrollment and verification of safe use conditions through a telephone system and/or fax. TIRF Sponsors will monitor distribution data and prescription data to ensure that only actively enrolled distributors are distributing, actively enrolled pharmacies are dispensing, and actively enrolled prescribers for outpatient use are prescribing TIRF medicines. Additionally, TIRF Sponsors will monitor to ensure that, when dispensing in an outpatient setting, TIRF medicines are only being dispensed to actively enrolled patients of actively enrolled prescribers. Corrective action or inactivation will be instituted by TIRF Sponsors if non-compliance is found.

5. TIRF Sponsors will monitor prescribers' compliance with the requirement to complete a Patient-Prescriber Agreement Form with each TIRF patient, and to submit it to the TIRF REMS Access program within ten (10) working days. A maximum of three prescriptions are allowed within 10 working days from when the patient has their first prescription filled. No further prescriptions will be dispensed after the 10 working day window until a completed Patient-Prescriber Agreement Form is received. This will be accomplished by reconciling the Patient-Prescriber Agreements submitted to the TIRF REMS Access program with patient enrollment data captured through the pharmacy management system for outpatient pharmacies or through the call center for closed system pharmacies.

6. TIRF Sponsors will monitor and evaluate all enrolled outpatient pharmacies (including closed system pharmacies), distributors, and the TIRF REMS Access program vendors to validate the necessary system upgrades and ensure the program is implemented as directed.

7. TIRF Sponsors will evaluate enrolled inpatient pharmacies' compliance with the TIRF REMS Access program requirements through surveys.

8. TIRF Sponsors will maintain a call center to support patients, prescribers, pharmacies, and distributors in interfacing with the TIRF REMS Access program.

9. TIRF Sponsors will ensure that all materials listed in or appended to the TIRF REMS Access program will be available through the TIRF REMS Access program website www.TIRFREMSaccess.com or by calling the TIRF REMS Access call center at 1-866822-1483.

10. TIRF Sponsors will notify pharmacies, prescribers, and distributors of forthcoming enrollment expiration and the need to re-enroll in the TIRF REMS Access program. Notifications for patients will be sent to the patient's prescriber.

11. If there are substantive changes to the TIRF REMS Access program, TIRF Sponsors will update all affected materials and notify pharmacies, prescribers, and distributors of the changes, as applicable. Notifications for patients will be sent to the patient's prescriber. Substantive changes to the TIRF REMS Access program are defined as:

a. Significant changes to the operation of the TIRF REMS Access program.

b. Changes to the Prescribing Information and Medication Guide that affect the risk-benefit profile of TIRF medicines.

12. Based on monitoring and evaluation of the REMS Elements to Assure Safe Use, TIRF Sponsors will take reasonable steps to improve implementation of these elements and to maintain compliance with the TIRF REMS Access program requirements, as applicable.

III. TIMETABLE FOR SUBMISSION OF ASSESSMENTS

TIRF NDA Sponsors will submit REMS Assessments to the FDA at 6 and 12 months from the date of the initial REMS approval, and annually thereafter. To facilitate inclusion of as much information as possible, while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment. TIRF NDA Sponsors will submit each assessment so that it will be received by the FDA on or before the due date.

Attachment 1:

List of TIRF Medicines Available Only through the TIRF REMS Access Program

  • ABSTRAL® (fentanyl) sublingual tablets
  • ACTIQ® (fentanyl citrate) oral transmucosal lozenge
  • FENTORA® (fentanyl citrate) buccal tablet
  • LAZANDA® (fentanyl) nasal spray
  • ONSOLIS® (fentanyl buccal soluble film)
  • SUBSYS™ (fentanyl sublingual spray)
  • Approved generic equivalents of these products are also covered under this program.

The TIRF REMS Access Program – An Overview for Prescribers

The Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program An Overview for Prescribers

What is the TIRF REMS Access Program?

The TIRF REMS (Risk Evaluation and Mitigation Strategy) Access program is designed to ensure informed risk-benefit decisions before initiating treatment and, while patients are on treatment to ensure appropriate use of TIRF medicines (refer to the 'List of TIRF Medicines Available Only through the TIRF REMS Access Program' in Attachment 1.). Because of the risk for misuse, abuse, addiction, overdose, and serious complications due to medication errors, TIRF medicines are available only through a restricted distribution program required by the Food and Drug Administration (FDA).

To prescribe TIRF medicines, you will need to enroll in the TIRF REMS Access program. Under the TIRF REMS Access program, only prescribers, pharmacies, distributors and patients enrolled in the program are able to prescribe, dispense, distribute, or receive TIRF medicines in an outpatient setting.

TIRF medicines which have previously been available under individual REMS programs have been transitioned to the shared TIRF REMS Access program.

For inpatient administration (e.g. hospitals, in-hospital hospices, and long-term care facilities that prescribe for inpatient use), of TIRF medicines, patient and prescriber enrollment in the TIRF REMS Access program is not required. Only the inpatient pharmacy and distributors are required to be enrolled to be able to order and dispense TIRF medicines for inpatient use. Inpatient pharmacies may not dispense TIRF medicines for outpatient use.

TIRF REMS Access Program Enrollment:

To reduce the risks of inappropriate patient selection and ensure appropriate dosing and administration of TIRF medicines, you will need to be enrolled in the TIRF REMS Access program. Enrollment requires you to complete the TIRF REMS Access Education Program and Knowledge Assessment. The TIRF REMS Access Education Program and Knowledge Assessment are available online at the TIRF REMS Access program website (www.TIRFREMSaccess.com) or by contacting the TIRF REMS Access program call center at 1-866-822-1483 to request materials. When you enroll, you will be required to acknowledge your understanding of the appropriate use of TIRF medicines and agree to adhere to the TIRF REMS Access program requirements. Without this enrollment, you will not be eligible to prescribe TIRF medicines for outpatient use. Outpatient prescriptions written by prescribers who are not enrolled, or for patients who are not enrolled, will not be authorized by the TIRF REMS Access program and will not be dispensed to the patient.

If you are already enrolled in an individual REMS program for at least one TIRF medicine, you will be automatically transitioned to the shared TIRF REMS Access program. Your enrollment in the shared TIRF REMS Access program allows prescribing of all TIRF medicines that are covered under the TIRF REMS Access program. You can use your existing secure username and password to access the TIRF REMS website at www.TIRFREMSaccess.com and prescribe all TIRF medicines. The TIRF REMS Access Education Program is also available on the shared TIRF REMS Access website (www.TIRFREMSaccess.com). Alternatively, you can request this information by calling 1-866-822-1483.

The TIRF REMS Access Program – An Overview for Prescribers

Overview of the TIRF REMS Access Program for Prescribing to Outpatients: Steps for Enrollment and Program Requirements

Prescriber Education & Enrollment (Outpatient Use)

All enrollment activities can be completed at www.TIRFREMSaccess.com

Enrollment Options:

Option 1: If you are already enrolled in at least one individual REMS Program

  • Beginning mm/dd/yyyy, your enrollment information will be automatically entered into the new shared TIRF REMS Access program. Your enrollment in the shared TIRF REMS Access program allows prescribing of all TIRF medicines that are covered under the TIRF REMS Access program. The website for the shared TIRF REMS Access program can be accessed at www.TIRFREMSaccess.com.
  • You can use your existing secure user ID and password from any one of your individual REMS programs to access the TIRF REMS Access website at www.TIRFREMSaccess.com and prescribe all TIRF medicines.
    • The user ID and password you use to initially log on will become your permanent user ID and password for the shared TIRF REMS Access program.
  • The TIRF REMS Access Education Program is available on the shared TIRF REMS Access website or by calling 1-866-822-1483. We recommend that you review the TIRF REMS Access Education Program for information on all the products that are available under the TIRF REMS Access program.
  • You will be required to re-enroll in the shared TIRF REMS Access program two (2) years after your last enrollment in an individual REMS program if you wish to continue prescribing these products. You will be notified by the TIRF REMS Access program in advance of the need to re-enroll.
  • Patients that have already signed a Patient-Prescriber Agreement Form on file will not have to sign another form until their two year enrollment is due.

Option 2: If you do not have an existing enrollment in any individual REMS program

  • Access the TIRF REMS Access program at www.TIRFREMSaccess.com to create an account.
  • Review the TIRF REMS Access Education Program materials available at www.TIRFREMSaccess.com including the Full Prescribing Information for each product covered in this program, and successfully complete the Knowledge Assessment.
  • Enroll in the TIRF REMS Access program by completing the Prescriber Enrollment Form and re-enroll every two (2) years. You will be notified by the TIRF REMS Access program in advance of the need to re-enroll.
  • If you are unable to enroll online, please call the TIRF REMS program call center at 1866-822-1483 for further assistance.

Patient Program Requirements:

Patient Education -All Prescribers Who Prescribe to Outpatients

  • Identify appropriate patients based on the guidance provided in the TIRF REMS Access Education program and the product-specific Full Prescribing Information.
  • The TIRF REMS Access Program – An Overview for Prescribers
  • Counsel the patient about the benefits and risks of TIRF medicines and together review the appropriate product-specific Medication Guide. A Patient and Caregiver Overview is available on the TIRF REMS Access program website.
  • Encourage the patient to ask questions.
  • Complete the TIRF REMS Access Program Patient-Prescriber Agreement Form, for each new patient, which must be signed by both you and your patient (not required for inpatients).
  • Submit the signed Patient-Prescriber Agreement Form to the TIRF REMS Access program through the TIRF REMS Access program website at www.TIRFREMSaccess.com. Submissions can also be made via fax at 1-866-8221487.
  • The signed Patient-Prescriber Agreement Form must be submitted within 10 working days. A maximum of three prescriptions are allowed within 10 working days from when the patient has their first prescription filled. No further prescriptions will be dispensed after the 10 working day window until a completed PPAF is received.

Prescribing

  • Write a prescription for the appropriate TIRF medicine.
  • Help each patient find pharmacies which are enrolled in the TIRF REMS Access program. A list of enrolled pharmacies can be found on www.TIRFREMSaccess.com, or by calling 1-866-822-1483.
  • Inform patients that they can also find a participating pharmacy by calling the TIRF REMS Access program at 1-866-822-1483.

Monitoring

  • Promptly report suspected adverse events including misuse, abuse, addiction and overdoses directly to the TIRF REMS Access program at 1-866-822-1483. You also may report adverse event information to the FDA MedWatch Reporting System by telephone at 1-800-FDA-1088 or by mail using Form 3500, available at www.fda.gov/medwatch.
  • Respond to requests for additional information from the TIRF REMS program.

If you have any questions or require additional information or further copies of any TIRF REMS documents, please either visit www.TIRFREMSaccess.com, or call the TIRF REMS Access program at 1-866-822-1483.

The TIRF REMS Access Program – An Overview for Prescribers

Attachment 1:

List of TIRF Medicines Available Only through the TIRF REMS Access Program

  • ABSTRAL® (fentanyl) sublingual tablets
  • ACTIQ® (fentanyl citrate) oral transmucosal lozenge
  • FENTORA® (fentanyl citrate) buccal tablet
  • LAZANDA® (fentanyl) nasal spray
  • ONSOLIS® (fentanyl buccal soluble film)
  • SUBSYS™ (fentanyl sublingual spray)
  • Approved generic equivalents of these products are also covered under this program.

Last reviewed on RxList: 8/7/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Abstral - User Reviews

Abstral User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Abstral sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.