Instanyl

fentanyl

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This is a summary of the European public assessment report (EPAR) for Instanyl. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Instanyl.

What is Instanyl?

Instanyl is a nasal spray that contains the active substance fentanyl (50, 100 and 200 micrograms per dose). It is available in single-dose containers and in multidose containers.

What is Instanyl used for?

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

The 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 Instanyl used?

Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients. The doctor should keep in mind the potential for Instanyl to be abused.

Before starting treatment with Instanyl, the patient’s long‑term pain should be well controlled by opioid pain killers and they should have no more than four episodes of breakthrough pain a day.

The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief. If there has been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.

The patient should be given Instanyl for a maximum of four episodes of breakthrough pain a day. See the package leaflet for further information.

How does Instanyl work?

The active substance in Instanyl, fentanyl, is an opioid. It is a well-known substance, which has been used to control pain for many years. In Instanyl, fentanyl is contained inside a nasal spray. When the patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the blood vessels in the nose. Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.

How has Instanyl been studied?

Because fentanyl has been in use for many years, the company presented data from scientific literature, as well as from studies that it had carried out. In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo (a dummy treatment) when they experienced breakthrough pain. In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached. The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after ten minutes if there had been insufficient pain relief. Each patient then used the identified dose of Instanyl or placebo to treat breakthrough pain. The main measures of effectiveness for the two studies were the change in pain intensity as measured on a pain scale and the number of patients who responded to treatment after ten minutes. Each patient ranked their pain intensity on an 11-point scale. A patient’s breakthrough pain was considered to have responded to treatment if there was a reduction of at least two points.

A third study involving 139 patients compared Instanyl with fentanyl as a ‘transmucosal’ tablet (absorbed through the lining of the mouth). The main measure of effectiveness was how quickly the patients had pain relief after experiencing breakthrough pain. The patients taking Instanyl were allowed to take a second spray ten minutes after the first dose if there had been insufficient pain relief.

What benefit has Instanyl shown during the studies?

Instanyl was more effective than placebo at treating breakthrough pain in cancer patients. In one of the main studies, the change in pain intensity after ten minutes was between 1.8 and 2.7 points on the pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo. The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.

In the second main study, the change in pain intensity after ten minutes was between 2.0 and 2.7 points after receiving doses of Instanyl compared with 1.3 after receiving placebo. The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.

In the third study, patients who received Instanyl had faster pain relief than patients who received the comparator medicine.

What is the risk associated with Instanyl?

The most common side effects with Instanyl (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating). For the full list of all side effects reported with Instanyl, see the package leaflet.

Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing). It must not be used to treat short-term pain other than breakthrough pain. It must also not be used in patients who have had facial radiotherapy (treatment with radiation) or who have recurrent episodes of epistaxis (nosebleeds). For the full list of restrictions, see the package leaflet.

Why has Instanyl been approved?

The CHMP decided that Instanyl’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Instanyl?

A risk management plan has been developed to ensure that Instanyl is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Instanyl, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that makes Instanyl will also provide educational materials in all Member States to be supplied to patients, doctors and pharmacists, to explain the correct and safe use of the medicine.

Other information about Instanyl

The European Commission granted a marketing authorisation valid throughout the European Union for Instanyl on 20 July 2009.

For more information about treatment with Instanyl, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Instanyl : EPAR - Summary for the public BG = bălgarski 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public ES = español 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public CS = čeština 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public DA = dansk 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public DE = Deutsch 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public ET = eesti keel 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public EL = elliniká 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public EN = English 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public FR = français 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public IT = italiano 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public LV = latviešu valoda 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public LT = lietuvių kalba 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public HU = magyar 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public MT = Malti 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public NL = Nederlands 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public PL = polski 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public PT = português 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public RO = română 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public SK = slovenčina 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public SL = slovenščina 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public FI = suomi 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public SV = svenska 30/07/2009 14/04/2014
Instanyl : EPAR - Summary for the public HR = Hrvatski 30/07/2009 14/04/2014

This EPAR was last updated on 06/06/2016 .

Authorisation details

Product details

Product details for Instanyl
NameInstanyl
Agency product numberEMEA/H/C/000959
Active substance

fentanyl citrate

International non-proprietary name (INN) or common name

fentanyl

Therapeutic area PainCancer
Anatomical therapeutic chemical (ATC) code N02AB03

Publication details

Publication details for Instanyl
Marketing-authorisation holder

Takeda Pharma A/S

Revision16
Date of issue of marketing authorisation valid throughout the European Union20/07/2009

Contact address:

Takeda Pharma A/S
Langebjerg 1
DK-4000 Roskilde
Denmark

Product information

Product information

01/04/2016  Instanyl -EMEA/H/C/000959 -X/0030/G

Name Language First published Last updated
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - Product Information HR = Hrvatski 30/07/2009 06/06/2016

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.


Name Language First published Last updated
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016
Instanyl : EPAR - All Authorised presentations HR = Hrvatski 30/07/2009 06/06/2016

Name Language First published Last updated
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011
Instanyl : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 30/07/2009 11/07/2011

Pharmacotherapeutic group

Analgesics

Therapeutic indication

Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain 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 oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Assessment History

Authorised

This medicine is approved for use in the European Union