- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
High grade malignant glioma: Adjunctive treatment
Recurrent glioblastoma multiforme: Adjunctive treatment
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
A maximum of 8 implants (containing a total of 61.6mg of carmustine) are to be placed in the resection cavity, if the size and shape of the cavity allows. Slight overlapping of the implants is acceptable.
Implants broken in half may be used, but implants broken in more than 2 pieces should be discarded according to regulations for cytotoxic drugs.
Oxidised regenerated cellulose may be placed over the implants to secure them to the cavity surface.After placement of the implants, the resection cavity should be irrigated and the dura closed in a watertight fashion.
For intralesional use
Precautions and Warnings
Avoid communication between resection cavity and ventricular system
Staff: Not to be handled by pregnant staff
Monitor for cerebral oedema
Monitor for intracranial hypertension
Monitor for known complications of craniotomy
Development of brain oedema may require the removal of the implants
Oedema or inflammation may occur around resection cavity area
Female: Ensure adequate contraception during treatment
Driving or operating machinery not advisable following treatment
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 hydrocephalous. If a communication exists that is larger than an implant, it should be closed prior to carmustine implantation.
Computer tomography and magnetic resonance imaging may demonstrate enhancement in the brain tissue surrounding the resection cavity after placement of carmustine implants.
This enhancement may represent oedema and inflammation caused by carmustine implant or tumour progression.
Alkylating agents are normally considered unsafe for use in porphyria.
Pregnancy and Lactation
Carmustine is contraindicated during pregnancy.
There are no studies assessing the reproductive toxicity of carmustine, or the use of carmustine in pregnant women. Animal studies have shown carmustine to be mutagenic, embryotoxic and teratogenic.
If an inadvertent pregnancy occurs, the woman should be advised of the possible risk for severe adverse effects in the embryo and foetus.
The effect of concurrent therapies must also be considered.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Carmustine is contraindicated during breastfeeding.
It is not known if carmustine is excreted in human breast milk. Some sources consider it likely based on molecular weight, solubility and lack of ionisation at physiological pH.
The effect of concurrent therapies must also be considered.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Cerebrospinal fluid leaks
Deep vein thrombosis (DVT)
Facial nerve paresis
Grand mal seizure
Urinary tract infections
Visual field defects
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full review Date: July 2013
British National Formulary, 65th Edition (2013) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Summary of Product Characteristics: Gliadel 7.7 mg implant. Archimedes Pharma UK. Revised December 2011.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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