Gliolan® indication

Gliolan® is indicated in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).

Gliolan® SPC
England, Scotland, Wales (GB) Gliolan® SPC
Northern Ireland (NI)
Gliolan® prescribing information

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk

Adverse events should also be reported to medac drug safety at: Photonamic-PhV@spm2-safety.com

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NICE recommended

NICE guidance 2018, recommends that Gliolan® should be used in initial surgery to assist with brain tumour removal.

Click the link below to view the guidance.

NICE guidance

Techniques for resection of glioma: If a person has a radiologically enhancing suspected high-grade glioma and the multidisciplinary team thinks that surgical resection of all enhancing tumour is possible, offer 5-aminolevulinic acid (5-ALA)-guided resection as an adjunct to maximise resection at initial surgery.

NICE quality standard

Brain tumours (primary) and brain metastases in over 16s.

NICE quality standards describe high-priority areas for quality improvement in a defined care or service area. They draw on existing NICE guidance that provides a comprehensive set of recommendations designed to support the measurement of improvement.

Quality statement 3 focuses on “adults with radiologically enhancing suspected high-grade gliomas that are suitable for resection of all enhancing tumour.” It states these patients should have 5-aminolevulinic acid (5-ALA)-guided resection (Gliolan®).

Click the link below to view the guidance.

NICE guidance

medac Pharma is available to support hospital Trusts with any aspects of these recommendations to help improve the standard of care for patients with suspected high grade gliomas.

About Gliolan®

Gliolan® is taken orally by the patient prior to surgery. In combination with a specialist surgical microscope and blue light source, Gliolan® fluoresces the malignant part of the tumour enabling the surgeon to make a distinction between malignant and normal tissue.

Gliolan® can be used by neurosurgical units with the necessary microscopic equipment and staffed by experienced, authorised neurosurgeons in line with European Medicines Agency (EMA) regulations.

Using Gliolan® requires special training. For information on this click below.

Tumour convetional light

Tumour appearance under conventional light
Tumour in blue light

WIth Gliolan®, tumour tissue appears red under blue light

Gliolan® training

Clinical experience

Efficacy

The result of a randomised controlled multicentre phase III trial (evidence level I) showed that by using Gliolan®, neurosurgeons achieved 64% complete resections compared to only 38% among the control group.1

 

Progression free survival

Six months after tumour resection, 20.5% of those patients who had been administered Gliolan® and just 11% of patients who received standard surgery showed no signs of progression.

Reference
1. https://www.ema.europa.eu/en/documents/scientific-discussion/gliolan-epar-scientific-discussion_en.pdf

Mode of action

The active substance in Gliolan®, 5-aminolevulinic acid (5-ALA) is absorbed by cells in the body where it is changed by enzymes into fluorescent molecules protoporphyrin IX (PPIX). Due to their different enzymes, malignant glioma cells seem to absorb and accumulate higher levels of 5-ALA than normal tissue and change it more rapidly into PPIX. When illuminated under a blue light of specific wavelength, the PPIX in the malignant tissue glows an intense red, while the normal brain tissue appears blue, enabling surgeons to distinguish between malignant and normal tissue.

Instructions for use

  • The pharmaceutical form is a powder for oral solution
  • The recommended dosage is 20mg 5-aminolevulinic acid hydrochloride per kg body weight
  • The solution should be administered orally three hours (range 2-4 hours) before induction of anaesthesia

Dosage scale

The interactive scale below is a guide to the correct dosage of Gliolan® and drinking solution that should be administered, depending on your patient’s bodyweight.

Patient‘s bodyweight (kg) Amount of Gliolan® to be administered (mg) Volume of a freshly prepared drinking solution to be administered orally (ml)
55 1100 37
56 1120 37
57 1140 38
58 1160 39
59 1180 39
60 1200 40
61 1220 41
62 1240 41
63 1260  42
64 1280 43
65 1300 43
66 1320 44
67 1340 45
68 1360 45
69 1380 46
70 1400 47
71 1420 47
72 1440 48
73 1460 49
74 1480 49
75 1500 50
76 1520 51
77 1540 51
78 1560 52
79 1580 53
80 1600 53
81 1620 54
82 1640 55
83 1660 55
84 1680 56
85 1700 57
86 1720 57
87 1740 58
88 1760 59
89 1780 59
90 1800 60
91 1820 61
92 1840 61
93 1860 62
94 1880 63
95 1900 63
96 1920 64
97 1940 65
98 1960 65
99 1980 66
100 2000 67

 

Gliolan® training

Before using Gliolan®, neurosurgeons must attend a training course to inform them how to use the medicine safely and effectively during
surgery as required by the EMA. These are held in the following UK locations:

  • Addenbrooke’s Hospital, Cambridge
    (Mr Stephen Price & Mr Thomas Santarius)
  • King’s College Hospital, London
    (Prof Keyoumars Ashkan & Mr Ranj Bhangoo)
  • Queen Elizabeth Hospital, Birmingham
    (Prof Colin Watts & Mr Ismail Ughratdar)
  • Salford Royal Hospital, Salford
    (Miss Konstantina Karabatsou & Mr Pietro D’urso)

English speaking courses are also available in Europe.
Courses consist of lectures as well as a sit in during a live fluorescence guided surgery. Participants will receive a handout and an official
certificate. The training follows the regulation of European Medicines Agency (EMA) for the safe and effective use of gliolan.

Upcoming training courses

Current restrictions have temporarily stopped Gliolan® training courses in hospitals. However, there are virtual courses available so that Neurosurgeons can get authorisation to use Gliolan® under exceptional COVID-19 flexibilities. There are 10 spaces available on each course.

Course dates

There are currently no courses available. Once new course dates are confirmed, they will be listed here. If you would like to register your interest in attending a course, please fill in your details and we will notify you when courses are available.

Register Interest

Patient support

To view the patient guide, click below.

If you would like to request hard copies of this guide, please complete the online form.

Order Guides

 

Ordering Gliolan®

Gliolan® is available from Alloga
Tel: +44 (0)1773 441 702

Alloga product code:
Gliolan® 1.5g (1 x 1) USP8861 – GB customers
Gliolan® 1.5g (1 x 1) USP8866 – NI customers

Order form GBOrder form NI

Note: In order to ensure compliance with restrictions from the European Medicine’s Agency (EMA) that the neurosurgeon must have attended a Gliolan® training course, a Gliolan® form has to be completed and submitted with the pharmacy purchase order to info@medacpharma.co.uk

The information provided on the Gliolan® form must include the name of the qualified neurosurgeon who has successfully completed a Gliolan® training course, and a procurement pharmacy signature. This does not need to be a pharmacist.

 

News and events

NICE publish new Quality Standard in brain tumours (primary) and brain metastases in adults to help improve quality of care provided to brain tumour patients
11 Jan 2022

NICE publish new Quality Standard in brain tumours (primary) and brain metastases in adults to help improve quality of care provided to brain tumour patients

The new Quality Standard for brain tumours and metastases in adults published by NICE on the 7th of December is... read more

BBC Two Documentary, Surgeons: At the Edge of Life
11 Jan 2022

BBC Two Documentary, Surgeons: At the Edge of Life

BBC Two documentary Surgeons: At the Edge of Life, Series 4, Episode 4 (Aired on 2nd December 2021) showed brain... read more

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Stirling University Innovation Park,
Stirling,
FK9 4NF

Tel:  +44 (0)1786 458086

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For enquiries about Gliolan®, please contact the Medicines Information Department at medac Pharma.

Tel:  +44 (0)1786 458086

Our normal enquiry service is available from 9am to 5pm Monday to Friday. However, we do offer an emergency service outside these hours for urgent enquiries.

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A pdf version of the order form will be emailed to the address supplied for you to complete. This can be completed digitally and emailed back or you can print out to complete and email/fax it to us.

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Product order form NI

Product order form NI

Order format

Printable Elements

A pdf version of the order form will be emailed to the address supplied for you to complete. This can be completed digitally and emailed back or you can print out to complete and email/fax it to us.

Online Elements

£

Address
Address
Town/City
County
Postcode
Patient Guide Request

Patient Guide Request