Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gliadel 7.7mg Implant
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Carmustine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
GLIADEL Implants are a way to deliver the anticancer substance carmustine directly to the site of the brain tumour after the tumour has been removed by surgery. Carmustine belongs to a group of anticancer substances that act by slowing the growth of cancer cells in brain. GLIADEL Implants can be used in combination with radiation for the treatment of brain tumours. GLIADEL Implants have been shown to prolong survival in patients with brain tumours. 2.
What you need to know before you take it
e GLIADEL Implants
Do not use GLIADEL Implants if you are allergic to carmustine or Polifeprosan 20. Warnings and precautions Following surgery to remove the brain tumour and insert the GLIADEL Implants, your doctor or surgeon will monitor you closely for known complications. In some cases your surgeon may need to re-operate (due to complications or recurrence of the tumour). Complications include:
- Convulsions (seizures)
- Infections in the brain (infections within the skull)
- Swelling of the brain due to accumulation of fluid
- Brain fluid leak
- Wound healing problems
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Your doctor will monitor you closely in case you are taking steroids due to swelling or high fluid pressure in the brain. Prior to inserting the implants your surgeon may need to close a canal in your brain to avoid the implants passing through it which could cause an accumulation of fluids within the skull. After insertion of Gliadel Implants, medical imaging may detect swelling of the brain due to accumulation of fluid and inflammation caused by Gliadel Implants or tumour progression. Other medicines and GLIADEL Implants Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine. GLIADEL Implants have not been studied in pregnant women. The active ingredient, carmustine, has been shown to adversely affect the development of unborn babies. GLIADEL Implants should not be used if you are pregnant or breast-feeding. Women of childbearing potential are advised to use effective contraception for 6 months after receiving GLIADEL implants. Men who have a female partner of childbearing potential should use contraception for 90 days after receiving GLIADEL implants. Driving and using machines Driving is not advisable after treatment. You must check with your doctor before driving or operating any tools or machines. 3.
How to take it
GLIADEL Implants are for use in adults only Your surgeon or pharmacist will ensure that the product is available for your surgery. After the surgeon removes your brain tumour, he or she inserts up to eight implants into the space the tumour once occupied. Your surgeon will decide how many implants to place into the cavity created by the removal of your brain tumour. The implants are placed in such a manner that they cover as much of the cavity as possible. After your surgery, the implants slowly dissolve over a 2 to 3 week period releasing carmustine directly to the surrounding cells. If you have any further questions on the use of this product, ask your surgeon. 4.
Possible side effects
Like all medicines, GLIADEL Implants can cause side effects, although not everybody gets them. If you experience any of the following side effects as a new event, or if a side effect that you have worsens, tell your doctor immediately or go to the casualty department at your nearest hospital.
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The most common adverse events observed during trials in either newly-diagnosed malignant glioma (brain tumour) (120 patients) or recurrent diagnosed malignant glioma (110 patients) are presented below. The following four categories of side effects are possibly related to treatment with GLIADEL Implants. 1. Seizures were very common. Most of them had a mild to moderate intensity and occurred within 5 days of the surgical treatment. 2. Brain swelling was very common. The development of brain swelling could necessitate a new surgical intervention either to remove the implants or the remnants of the implants. 3. Mild to severe wound healing problems were very common. 4. Infections in the brain (infections within the skull) such as meningitis and abscess(es) (localised collections of pus) were common. The following side effects were seen in the patients during the trials. They were similar to those encountered by patients who have surgery for their brain cancer without the insertion of GLIADEL Implants. Very common: may affect more than 1 in 10 people
- Psychiatric disorders Depression
- Nervous system disorders Weakness, especially on one side of the body; convulsion (fits); confusion; headache; swelling of the brain; somnolence (drowsiness); problems with speech
- Vascular disorders Vein inflammation
- Gastrointestinal disorders (stomach and intestinal related disorders) Nausea (feeling sick); vomiting; constipation
- Skin and subcutaneous (tissue under the skin) disorders Rash; hair loss
- Renal (kidney) and urinary disorders Infection of the urinary tract
- General disorders and administration site conditions A worsening of your condition; infection; headache; feeling of weakness; fever or pain; abnormal (slow) healing of the surgical wound Gliadel, February 2026
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Common: may affect up to 1 in 10 people
- Blood and lymphatic (immune) system disorders Reduction in red blood cells which can make the skin pale and cause weakness and breathlessness; reduction in blood platelets which increases the risk of bleeding; increase in white blood cells
- Endocrine disorders (hormonal disorders) Diabetes mellitus (abnormally high sugar level in blood)
- Metabolism and nutrition disorders Peripheral oedema (excess fluid in the arms and legs); low blood levels of sodium which can cause tiredness and confusion; muscle twitching, fits or coma; high blood sugar levels; low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
- Psychiatric disorders Changes in your personality; excessive anxiety; abnormal thinking; hallucinations; insomnia (little or poor sleep)
- Nervous system disorders Amnesia (loss of memory); an increase in the blood pressure in the skull due to abnormal build up of fluid; paralysis of the face; lack of coordination; diminished sensitivity to stimulation; abnormal burning or prickling sensation; problems with walking; dizziness; epileptic seizures (fits); tremor (small shaking movements); meningitis (inflammation of the brain); abscess (localised collection of pus); loss of consciousness
- Eye disorders Blurred or abnormal vision; swelling of the eye lining; eye pain
- Vascular disorders Bleeding; high or low blood pressure
- Respiratory disorders (lung related disorders) Lung infection or pneumonia which causes breathlessness, cough and raised temperature
- Gastrointestinal disorders (stomach and intestinal related disorders) Yeast infection of the mouth; diarrhoea; constipation; faecal incontinence (uncontrolled bowel movements); difficulty in swallowing; bleeding in the stomach or in bowels
- Skin and subcutaneous (tissue under the skin) disorders Rash
- Muscle, skeletal and soft tissue related disorders General infection
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- Renal (kidney) and urinary disorders Urinary infections; urinary incontinence
- General disorders and administration site conditions Abdominal, back and chest pain; swelling of the face; abscess (localised collection of pus); accidental injury; allergic reaction; neck pain and infection in the blood stream Uncommon side effects (between 1 and 10 patients in every 1000) Injury, poisoning and procedural complications Pneumocephalus (air accumulation at the implant site) Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
GLIADEL Implants
Keep this medicine out of the sight and reach of children. Store in a freezer at or below -20°C. Unopened outer sachets may be kept at a temperature of not more than 22°C for a maximum of six hours. The product may be refrozen only once if the sachets have been unopened and kept for a maximum of 6 hours at a temperature of not more than 22°C. After the refreezing, the product should be used within 30 days. Do not use GLIADEL Implants after the expiry date which is stated on the outer carton and/or the sachet. The expiry date refers to the last day of that month. Your surgeon or hospital pharmacist will check the expiry date before implants are used. 6.
Contents of the pack and other information
What GLIADEL Implants contain –
The active substance is carmustine. Each implant contains 7.7 mg of carmustine.
–
The other ingredient is polifeprosan 20.
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What GLIADEL Implants look like and contents of the pack GLIADEL Implants are available in boxes containing eight implantable wafers. These wafers are off-white to pale yellow flat discoid implants. Each wafer is individually packaged in an aluminium foil laminate sachet.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Manufacturer 1 (Importer)
Clinigen Healthcare Ltd. Pitcairn House First Avenue Burton-on-Trent Staffordshire, DE14 2WW United Kingdom
ALMAC PHARMA SERVICES (IRELAND) LIMITED Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD Ireland Tel: +353 42 932 0718 Fax: +353 42 932 0718
Manufacturer 2 (Importer) Orion GMP Consulting Limited Unit 4, W8 Centre Church Lane Manorhamilton Leitrim, F91 H2YA Ireland Manufacturer 3 (Importer) Clinigen Clinical Supplies Management GmbH Am Kronberger Hang 3 65824 Schwalbach am Taunus Germany This leaflet was last revised in 02/2026 ——————————————————————————————————————–The following information is intended for medical or healthcare professionals only
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Frequently asked questions about Gliadel 7.7mg Implant
What is the active substance in Gliadel 7.7mg Implant?
The active substance in Gliadel 7.7mg Implant is carmustine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gliadel 7.7mg Implant, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gliadel 7.7mg Implant without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: carmustine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
GLIADEL Implant is indicated for the treatment of adult patients with newly-diagnosed high-grade malignant glioma as an adjunct to surgery and radiation.
GLIADEL Implant is indicated as an adjunct to surgery for the treatment of adult patients with recurrent histologically proved glioblastoma multiforme and for whom surgical resection is indicated.
4.2. Posology and method of administration
Posology
For intralesional use only.
Each GLIADEL Implant contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight implants are placed in the tumour resection cavity.
Paediatric population
The safety and efficacy of GLIADEL Implant in children under 18 years of age have not been established. No data are available.
Method of administration
It is recommended that a maximum of eight implants be placed if the size and shape of the resection cavity allows it. Implants broken in half may be used, but implants broken in more than two pieces should be discarded in the dedicated biohazard waste containers (see section 6.6).
It is recommended that the placement of the implants should be directly from the product's inner sterile packaging into the resection cavity. Oxidised regenerated cellulose may be placed over the implants to secure them to the cavity surface (see section 6.6).
4.3. Contraindications
Hypersensitivity to the active substance carmustine or to any of the excipients of GLIADEL Implant.
4.4. Special warnings and precautions for use
Patients undergoing craniotomy for glioblastoma and implantation of GLIADEL Implant should be monitored closely in view of known complications of craniotomy which includes convulsions, intracranial infections, abnormal wound healing, brain oedema and pneumocephalus (see section 4.8). Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL Implant, including one case leading to brain herniation. Careful monitoring of GLIADEL Implant-treated patients for cerebral oedema/intracranial hypertension with consequent steroid use is warranted (see section 4.8). CSF leak was more common in GLIADEL Implant-treated patients. Attention to a water-tight dural closure and local wound care is indicated (see section 4.8).
Changes of wall of cerebral blood vessels located close to Gliadel wafer, including cases of aneurysms leading to cerebral bleeding several months after Gliadel wafer implantation, have been described. Gliadel wafers implantation adjacent to large cerebral vessels should be avoided.
Development of brain oedema with mass effect (due to tumour recurrence, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Implant or its remnants.
Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the implants from migrating into the ventricular system and possibly causing obstructive hydrocephalus. If a communication larger than the diameter of the implant exists, it should be closed prior to GLIADEL Implant implantation.
Computed tomography and magnetic resonance imaging may demonstrate enhancement in the brain tissue surrounding the resection cavity after placement of GLIADEL Implants. This enhancement may represent oedema and inflammation caused by GLIADEL Implants or tumour progression.
Women of child-bearing potential should use effective contraception for at least 6 months after receiving GLIADEL Implant.
Male patients with female partners of child-bearing potential should be advised to use effective contraception for at least 90 days after receiving GLIADEL Implant.
4.5. Interaction with other medicinal products and other forms of interaction
Interactions of GLIADEL Implant with other drugs or chemotherapy have not been formally evaluated.
4.6. Fertility, pregnancy and lactation
Pregnancy:
There are no studies of GLIADEL Implant in pregnant women and no studies assessing the reproductive toxicity of GLIADEL Implant.
Carmustine, the active component of GLIADEL Implant, when administered systemically, can have genotoxic effects and can adversely affect foetal development (see section 5.3). GLIADEL Implant, therefore, is not recommended during pregnancy and in women of childbearing potential not using contraception. Women of child-bearing potential should use effective contraception for at least 6 months after receiving GLIADEL Implant.
Male patients with female partners of child-bearing potential should be advised to use effective contraception for at least 90 days after receiving GLIADEL Implant. If the use of GLIADEL Implant during pregnancy is still considered necessary, the patient should be informed of the potential risk to the foetus. In case of patients getting pregnant after receiving GLIADEL Implant, genetic advice should be sought.
Breastfeeding:
It is not known if GLIADEL Implant components are excreted in human milk. Since some drugs are excreted in human milk and because of the potential risk of serious adverse reactions of carmustine in nursing infants, breast-feeding is contra-indicated.
Fertility:
No impairment of fertility studies have been conducted with GLIADEL Implants.
4.7. Effects on ability to drive and use machines
GLIADEL Implant has no influence on the ability to drive and use machines. However, craniotomy and GLIADEL Implant may cause nervous system and vision abnormalities. Therefore patient should be warned of the potential effect of these events on the ability to drive or to use machines.
4.8. Undesirable effects
The spectrum of undesirable effects observed in patients with newly-diagnosed high-grade malignant glioma and recurrent malignant gliomas was generally consistent with that encountered in patients undergoing craniotomy for malignant gliomas.
Very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100) adverse reactions reported in patients receiving GLIADEL Implant during the clinical trials are listed below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Primary Surgery
The following data are the most frequently occurring adverse reactions observed in 5% or more of the 120 newly-diagnosed malignant glioma patients receiving GLIADEL Implant during the trial.
Common Adverse Reactions Observed in ≥ 5% of Patients Receiving GLIADEL Implant at Initial Surgery
System Organ Class
Adverse reactions
Endocrine disorders
common
Diabetes mellitus
Psychiatric disorders
very common
Depression
common
Personality disorder, anxiety, thinking abnormal, hallucinations, insomnia
Nervous system disorders
very common
Hemiplegia, convulsion, confusion, brain oedema, aphasia, somnolence, speech disorder
common
Amnesia, intracranial pressure increased, personality disorder, anxiety, facial paralysis, neuropathy, ataxia, hypoesthesia, paresthesia, thinking abnormal, abnormal gait, dizziness, grand mal convulsion, hallucinations, insomnia, tremor
Eye disorders
common
Conjunctival oedema, abnormal vision, visual field defect
Vascular disorders
very common
Thrombophlebitis
common
Haemorrhage
Respiratory, thoracic and mediastinal disorders
common
Pulmonary embolism
Infections and infestations
common
Pneumonia
Gastrointestinal disorders
very common
Nausea, vomiting, constipation
common
Diarrhoea
Skin and subcutaneous tissue disorders
very common
Rash, alopecia
Renal and urinary disorders
common
Urinary tract infection, urinary incontinence
General disorders and administration site conditions
very common
Aggravation reaction, headache, asthenia, infection, fever, pain, healing abnormal
common
Abdominal pain, back pain, face oedema, chest pain, abscess, accidental injury, peripheral oedema
Intracranial hypertension was present in more GLIADEL Implant-treated patients than in Placebo patients (9.2% vs. 1.7%). It was typically observed late, at the time of tumour recurrence, and was unlikely to be associated with GLIADEL Implant use (see section 4.4).
CSF leak was more common in GLIADEL Implant-treated patients than in placebo patients. However intracranial infections and other healing abnormalities were not increased (see section 4.4).
Surgery for Recurrent Disease
The following post-operative adverse reactions were observed in 4% or more of the 110 patients receiving GLIADEL Implant at recurrent surgery in a controlled clinical trial. Except for nervous system effects, where there is a possibility that the placebo implants could have been responsible, only reactions more common in the GLIADEL Implant group are listed. These adverse reactions were either not present pre-operatively or worsened post-operatively during the follow-up period. The follow-up period was up to 71 months.
Common Adverse Reactions in ≥4% of Patients Receiving GLIADEL Implant at Recurrent Surgery
System Organ Class
Adverse reactions
Blood and lymphatic system disorders
common
Anaemia
Metabolism and nutrition disorders
common
Hyponatraemia
Nervous system disorders
very common
Convulsion, hemiplegia, headache, somnolence, confusion
common
Aphasia, stupor, brain oedema, intracranial pressure increased, meningitis or abscess
Vascular disorders
common
Thrombophlebitis,
Respiratory, thoracic and mediastinal disorders
common
Pulmonary embolism
Infections and infestations
common
Pneumonia, oral candidias
Gastrointestinal disorders
common
Nausea, vomiting,
Skin and subcutaneous tissue disorders
common
Rash
Renal and urinary disorders
very common
Urinary tract infection
General disorders and administration site conditions
very common
Fever, healing abnormal
common
Infection, pain
The following adverse reactions, not listed in the table above, were reported in patients treated with GLIADEL Implant in all studies. The reactions listed were either not present pre-operatively or worsened post-operatively. Whether GLIADEL Implant caused these events cannot be determined.
Adverse Reactions in Patients Receiving GLIADEL Implant
System Organ Class
Adverse reactions
Blood and lymphatic system disorders
common
Thrombocytopenia, leukocytosis
Metabolism and nutrition disorders
common
Hyponatraemia, hyperglycaemia, hypokalaemia
Nervous system disorders
common
Hydrocephalus, ataxia, dizziness, hemiplegia, coma, amnesia, diplopia,
uncommon
Cerebral haemorrhage, cerebral infarct
Psychiatric disorders
common
Depression, abnormal thinking, insomnia, paranoid reaction
Eye Disorders
common
Visual defect, eye pain
Cardiac and vascular disorders
common
Hypertension, hypotension
Respiratory, thoracic and mediastinal disorders
common
Infection, aspiration pneumonia
Gastrointestinal disorders
common
Diarrhoea, constipation, dysphagia, gastrointestinal haemorrhage, faecal incontinence
Skin and subcutaneous tissue disorders
common
Rash
Musculoskeletal and connective tissue disorders
common
Infection
Renal and urinary disorders
common
Urinary incontinence
General disorders and administration site conditions
common
Peripheral oedema, neck pain, accidental injury, back pain, allergic reaction, asthenia, chest pain, sepsis
Injury, poisoning and procedural complications
uncommon
pneumocephalus
Cases of air accumulation at the implant site, sometimes associated with neurological symptoms (hemiplegia, aphasia, seizures) have been reported with Gliadel.
The following four categories of adverse reactions are possibly related to treatment with GLIADEL Implant.
Seizures:
In the initial surgery trial, the incidence of seizures within the first 5 days after implantation was 2.5% in the GLIADEL Implant group.
In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in patients receiving GLIADEL Implant. 12/22 (54%) of patients treated with GLIADEL Implant experienced the first new or worsened seizure within the first five post-operative days. The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with GLIADEL Implant.
Brain Oedema:
Development of brain oedema with mass effect (due to tumour recurrence, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Implant or its remnants (see section 4.4).
Healing Abnormalities:
The following healing abnormalities have been reported in clinical trials of GLIADEL Implant: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak.
In the initial surgery trial, cerebrospinal fluid leaks occurred in 5% of GLIADEL Implant recipients. During surgery, a water-tight dural closure should be obtained to minimise the risk of cerebrospinal fluid leak (see section 4.4)
Intracranial Infection:
In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with GLIADEL Implant.
In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with GLIADEL Implant.
In a published clinical study, cyst formation after GLIADEL Implant treatment has been reported. This reaction occurred in 10% of the patients observed in the study, however, the formation of cysts is possible after resection of a malignant glioma.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
Not applicable.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- CARMUSTINA WAYMADE 100 mg prescriptionCARMUSTINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Carmustine ZentivaCarmustinum · injection / infusion
- Carmustine medacCarmustinum · injection / infusion
- Carmustine AccordCarmustinum · injection / infusion
- Carmustine WaymadeCarmustinum · injection / infusion
- Carmustine AccordpharmaCarmustinum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Gliadel 7.7mg Implant. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.