ABSTRAL  FENTANYL - fentanyl citrate tablet, orally disintegrating 
Sentynl Therapeutics, Inc.

----------

Medication Guide

ABSTRAL® (AB-stral) CII

(fentanyl)

Sublingual tablets

IMPORTANT:
Do not use ABSTRAL® unless you are regularly using another opioid pain medicine around-the-clock, for at least one week or longer, for your cancer pain, and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if 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.
ABSTRAL® is:
  • A strong prescription pain medicine that contains an opioid (narcotic) and is used to manage breakthrough pain in adults with cancer 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 (i.e., you are opioid tolerant). Do not use ABSTRAL® if you are not opioid tolerant.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about ABSTRAL®:

  • 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.
  • Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti- depressant medicines, 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.
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 at least one week or longer, for your cancer pain, and your body is used to these medicines.
  • You have severe asthma, trouble breathing, or other lung problems.
  • You have a bowel blockage or have narrowing of the stomach or intestines.
  • You are allergic to any of the ingredients in ABSTRAL®. See the end of this Medication Guide for a complete list of ingredients in ABSTRAL®.
  • You have short-term pain that you would expect to go away in a few days, such as:
    • Pain after surgery
    • Headache or migraine
    • Dental pain
Before taking ABSTRAL®, tell your healthcare provider if you have a history of:
  • Troubled breathing or lung problems such as asthma, wheezing, or shortness of breath.
  • Head injury or seizures.
  • Slow heart rate or other heart problems.
  • Low blood pressure.
  • Mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)].
  • Problems urinating.
  • Liver, kidney, thyroid problems.
  • Pancreas or gallbladder problems.
  • Abuse of street or prescription drugs, alcohol addiction, or other mental health problems.

Tell your healthcare provider if you are:

When taking ABSTRAL®:
  • Do not change your dose. Take ABSTRAL® exactly as prescribed by your healthcare provider.
  • Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.
  • See the detailed Instructions for Use at the end of this Medication Guide for information about how to use ABSTRAL®.
  • Use ABSTRAL® tablets whole.
  • Do not crush, split, suck, or chew ABSTRAL® tablets, or swallow the tablets whole. You will get less relief for your breakthrough cancer pain.
  • Wait 30 minutes after using ABSTRAL®. If there is any of the ABSTRAL tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.
  • You must not use more than 2 doses of ABSTRAL® for each episode of breakthrough cancer pain.
  • Use 1 dose of ABSTRAL for an episode of breakthrough cancer pain.
  • If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of ABSTRAL®, you can use only 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 use 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 use 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 using
  • 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 begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.
  • Do not stop taking ABSTRAL® without talking to your healthcare provider.
  • After you stop taking ABSTRAL®, or when it is no longer needed, see the section titled “How should I dispose of unused ABSTRAL® tablets when they are no longer needed?” for proper disposal of ABSTRAL®.
  • DO NOT drive or operate heavy machinery, until you know how ABSTRAL affects you. ABSTRAL can make you sleepy, dizzy, or lightheaded.
  • DO NOT drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ABSTRAL® may cause you to overdose and die.
  • 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 medicines containing fentanyl that you may have been taking.

How should I store ABSTRAL®?

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

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 1- 866-822-1483.

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:

Manufactured by:
Pharmaceutics International, Inc. Hunt Valley, MD 21031

Manufactured for:
Sentynl Therapeutics, Inc. Solana Beach, CA 92075

Issued: May 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Copyright © 2017, Sentynl Therapeutics, Inc. All rights reserved.

ABSTRAL® and Sentynl Therapeutics, Inc. are trademarks owned by the Sentynl Therapeutics, Inc.

Revised: 5/2017
Sentynl Therapeutics, Inc.