Thiotepa products: information for supporting intrathecal risk assessment

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Thiotepa products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Licensed for intrathecal use

Products licensed for intrathecal use are the first line option and should be used wherever suitable.

There are currently no known thiotepa products licensed for intrathecal administration.

Not licensed for intrathecal use, limited information available

Products with partial information that are not licensed for intrathecal administration can still sometimes be used. Refer to the advice in our article and complete a risk assessment to enable you to interpret the details below and choose an appropriate product.

ADIENNE (Tepadina®)

Strength

100mg vial
15mg vial

Excipients

None

Osmolarity

No information

pH

No information

Endotoxin content

No information

Strength

400mg bag

Excipients

Powder: None
Solvent: Sodium chloride, water for injections

Osmolarity

No information

pH

4.5 – 7.0

Endotoxin content

No information

ADVANZ

Strength

100mg vial
15mg vial

Excipients

None

Osmolarity

No information

pH

No information

Endotoxin content

No information

Intrapharm

Thiotepa Riemser

Strength

100mg vial

Excipients

None

Osmolarity

No information

pH

No information

Endotoxin content

< 0.000625 EU/mg

Strength

15mg vial

Excipients

None

Osmolarity

No information

pH

No information

Endotoxin content

< 0.0125 EU/mg

All our intrathecal product resources

Understand what to consider when giving medicines via the intrathecal route and use our material to help inform your risk assessment

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Thiotepa products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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