FENTORA Resources

Glossary

Abuse
Frequent or persistent intentional, excessive drug use which causes physical or psychological harm.

Addiction
A chronic disease that is characterized by one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving of a medicine.

Around-the-clock opioid pain medicine
Medicine that works throughout the day. This may also be called long-acting, controlled-release, or sustained-release medicine. An around-the-clock opioid pain medicine is used to treat persistent pain.

Breakthrough pain
Sudden flares of moderate-to-severe pain that "breaks through" your around-the-clock medicine. Breakthrough pain often comes on quickly and in most cases does not last for more than 2 hours.

Breakthrough pain medicine
Medicine used to treat flares of breakthrough pain. Short-acting opioids, including normal-release pain medicines and rapid-onset opioids, are common treatments for breakthrough pain.

Buccal cavity
The area between the cheek and gum. A buccal tablet is designed to be placed in the buccal cavity, where it dissolves.

Constipation
Difficulty with bowel movements because of hardened stools. Constipation is a common side effect of taking opioids and often requires treatment.

Chronic pain
Chronic pain is pain that lasts for more than 3 months. It often has 2 parts: persistent pain and breakthrough pain.

Diversion
Intentional transfer of a drug from a legitimate source (ie, distribution from a manufacturer or storage in hospitals, pharmacies, and healthcare professionals’ offices) and/or from a patient for whom the drug has been prescribed to unauthorized users and/or for illegal sale.

Opioid
Medicine that's part of a class of strong painkillers. While opioids do not take the cause of pain away, they do interfere with and stop pain messages from being sent to the brain. Opioids require a prescription from your healthcare professional. Examples of opioids are morphine, fentanyl, oxycodone, and codeine.

Overdose
Ingestion of more than the normal or recommended amount of something, usually a drug. An overdose may result in serious, harmful symptoms or death, and may be the result of accidental or intentional exposures to a drug.

Persistent pain (constant or around-the-clock pain)
If your pain lasts all day, it is called persistent pain, and your healthcare professional can give you an around-the-clock opioid pain medicine that should work throughout the day.

Physical dependence
This happens when your body has gotten used to having the drug in your system. You will feel sick if you suddenly stop taking a medicine that you are physically dependent upon. This is called withdrawal syndrome. If opioids are used for a long period of time, it is expected that you will become physically dependent on your medicine.

Pseudoaddiction
Drug-seeking behavior that appears similar to addiction but is due to a need for more medication to control pain rather than psychological dependence on a drug.

Pseudotolerance
Similar to tolerance, this is when your body needs more medicine to continue feeling pain relief. More medicine is needed because the original cause of pain has progressed, a new cause is present, or because of increased activity. It is not because your body has adjusted to the medicine.

Short-acting/normal-release pain medicine
A kind of medicine that starts working in about 30 to 40 minutes and usually works for about 2 to 6 hours.

Tolerance
This is when the body gets used to the medicine and its effects. It may mean a stronger amount of medicine is needed to maintain pain relief. It can also be when the body gets used to some of the side effects, such as nausea. This means that over time you will not feel these side effects or the side effects will be less bothersome to you. Tolerance is NOT addiction.

IMPORTANT:

Do not use FENTORA 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 you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep FENTORA in a safe place away from children.

Get emergency help right away if:

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

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

Read this Medication Guide completely before you start using FENTORA, 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. Share this important information with members of your household and other caregivers.

FENTORA is used to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.

The most important information you should know about FENTORA is:

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

  1. Do not use FENTORA 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 using FENTORA. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  3. Use FENTORA exactly as prescribed by your healthcare provider.
    • You must not use more than 2 doses of FENTORA for each episode of breakthrough cancer pain.
    • You must wait at least 4 hours before treating a new episode of breakthrough pain with FENTORA. See the Medication Guide section “How should I use FENTORA?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to use FENTORA the right way.
  4. Do not switch from FENTORA to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of FENTORA is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of FENTORA that may be different than other fentanyl containing medicines you may have been taking.