Effentora

fentanyl

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Effentora?

Effentora is a medicine that contains the active substance fentanyl. It is available as round, white ‘buccal tablets’ (tablets that dissolve in the mouth). The tablets contain 100, 200, 400, 600 or 800 micrograms of fentanyl.

What is Effentora used for?

Effentora is used to treat ‘breakthrough’ pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain. Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.

This medicine can only be obtained by ‘special’ prescription. This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.

How is Effentora used?

Treatment with Effentora should be started by and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.

Effentora is taken at the start of a breakthrough pain episode. The tablets should be removed from the packaging immediately before being placed between the gum and the cheek. Alternatively, the tablets can be placed under the tongue. The tablets usually dissolve in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream. After 30 minutes, any pieces of tablet remaining can be swallowed with a glass of water. The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole. Patients should not eat or drink anything while the tablet is in the mouth.

When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects. The patient should be monitored carefully while the dose is increased. Once the appropriate dose for the patient has been found, the patient should take this dose as a single tablet. If this dose stops controlling the pain well enough, the doctor will need to work out a new individual dose. Doses of Effentora above 800 micrograms have not been tested. There must be a gap of at least four hours between treating each episode of pain.

Patients should not possess or use any other medicines containing fentanyl for the treatment of breakthrough cancer pain at the same time as using Effentora. They should only have the necessary strengths of Effentora tablets available at any one time, to prevent confusion and possible overdose. See the Package Leaflet for further information.

How does Effentora work?

The active substance in Effentora, fentanyl, is an opioid. It is a well-known substance, which has been used to control pain for many years. In Effentora, it is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain.

How has Effentora been studied?

Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.

The ability of Effentora to treat breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids. In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet). The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet. Each patient ranked their pain intensity on an 11-point scale.

What benefit has Effentora shown during the studies?

Effentora was more effective than placebo in reducing pain in both studies. In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo. In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.

What is the risk associated with Effentora?

The most common side effects with Effentora (seen in more than 1 patient in 10) are dizziness, headache, nausea (feeling sick), vomiting, and reactions at the site of application including bleeding, pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots. Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use. The most serious of these are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure). Patients should be closely monitored for these side effects. For the full list of all side effects reported with Effentora, see the Package Leaflet.

Effentora should not be used in people who may be hypersensitive (allergic) to fentanyl or any of the other ingredients. It must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have a severe disease involving obstruction of the lungs. It must not be used to treat short-term pain other than breakthrough pain, such as pain after an operation, headache or migraine.

Why has Effentora been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Effentora’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Which measures are being taken to ensure the safe use of Effentora?

The company that makes Effentora will provide educational materials in each European Union (EU) Member State to make sure that patients and doctors are aware of how the medicine should be used safely, the risks of accidental exposure to fentanyl and how to dispose of Effentora.

Other information about Effentora:

The European Commission granted a marketing authorisation valid throughout the EU for Effentora to Cephalon Europe on 4 April 2008. The marketing authorisation is valid for five years, after which it can be renewed.

This EPAR was last updated on 02/12/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

22/11/2011  Effentora -EMEA/H/C/000833 -II/0014

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Analgesics

Therapeutic indication

Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.

BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.

Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents