About FENTORA

How Should I Use FENTORA?

Use FENTORA exactly as prescribed by your healthcare professional. Do not use FENTORA more often than prescribed.

  • Use 1 dose of FENTORA for an episode of breakthrough cancer pain. When the amount of FENTORA is being adjusted by your healthcare professional, a dose may include more than 1 tablet.
  • If your breakthrough cancer pain is not relieved after 30 minutes, use ONLY 1 more dose of FENTORA at this time.
  • Wait at least 4 more hours before using FENTORA again for another episode of breakthrough cancer pain.
  • Remember you must continue taking your regularly used around-the-clock opioid medicine while taking FENTORA.

Talk to your healthcare professional if your dose of FENTORA does not relieve your breakthrough cancer pain. Your healthcare professional will decide if your dose of FENTORA needs to be changed.

Talk to your healthcare professional 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.

FENTORA comes packaged in a blister card. Do not open the blister until ready to use. Separate one of the blister units from the blister card by tearing apart at the perforations. Bend the blister unit along the line where indicated. Peel back the foil on the blister pack to expose the tablet.

DO NOT push the tablet through the foil on the blister pack because this could damage the tablet.

Once removed from the blister pack, FENTORA must be used right away.

Place a FENTORA tablet in your mouth above a rear molar tooth between the upper cheek and gum and leave in place until the tablet is dissolved. This generally takes between 14 to 25 minutes. After 30 minutes if there is any tablet left, swallow it with a glass of water. If you cannot take the medicine in this manner, tell your healthcare professional who will advise you what to do. Do not split the tablet.

Do not bite, chew or suck FENTORA tablets. If you do so, you will swallow more of the medicine and get less relief for your breakthrough cancer pain.

Do not split the FENTORA tablet. The FENTORA tablet should be used whole.

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.

If you take too much FENTORA or overdose, call 911 for emergency help.

Finding the right dose

FENTORA comes in several dosage strengths. Your healthcare professional will prescribe a starting dose of FENTORA that is different from other fentanyl containing medicines you may have been taking. Do not substitute FENTORA for other fentanyl medicines, including Actiq®, without talking with your healthcare professional.

To start you on FENTORA, your healthcare professional will likely prescribe a low-dosage strength. This initial dose may include more than 1 tablet.

Next, your healthcare professional may gradually increase the dosage strength of FENTORA to find the right dose for you. To help with this process, your healthcare professional may instruct you to use multiple tablets at the same time.

By following your healthcare professional's instructions during this adjustment period, and telling your healthcare professional how you're feeling, you can help your healthcare professional determine a correct dose.

Once your healthcare professional finds the dose of FENTORA that is right for you, you should use ONLY 1 FENTORA tablet per breakthrough cancer pain flare. Remember you must continue taking your regularly used around-the-clock opioid pain medicine while taking FENTORA.

If you still have pain 30 minutes after taking a single dose
Sometimes, a single dose of FENTORA may not control your breakthrough cancer pain because some flares of pain may be more severe.

If your breakthrough cancer pain is not relieved within 30 minutes, your healthcare professional may instruct you to take ONLY 1 additional dose of the same strength for that flare. No more than 2 doses should be used per breakthrough cancer pain flare. You must wait at least 4 hours before taking FENTORA for another flare of breakthrough cancer pain

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.