Etoposide products: information for supporting intrathecal risk assessment

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

Etoposide 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 etoposide 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.

Accord

Strength

20mg/mL in 5mL vial
20mg/mL in 10mL vial
20mg/mL in 12.5mL vial
20mg/mL in 20mL vial
20mg/ml in 25mL vial
20mg/mL in 50mL vial

Excipients

Citric acid, anhydrous, benzyl alcohol (30 mg/ml), polysorbate 80, macrogol 300, ethanol, anhydrous (240.64 mg/ml)

Osmolarity

No information

pH

3.0 – 4.0

Endotoxin content

≤ 1.3 EU/mg

Actavis

Strength

20mg/ml in 5mL vial

Excipients

Macrogol 400, polysorbate 80, ethanol (anhydrous), citric acid, anhydrous (for pH adjustment)

Osmolarity

> 2000 mOsmol/L

pH

3.0 – 4.0

Endotoxin content

No information

Bristol-Myers Squibb (Etopophos®)

Strength

100mg vial

Excipients

Dextran 40, Sodium citrate

Osmolarity

No information

pH

No information

Endotoxin content

No information

Fresenius

Strength

20mg/mL in 5mL vial
20mg/mL in 10mL vial
20mg/mL in 25mL vial
20mg/mL in 50mL vial

Excipients

Macrogol 300, polysorbate 80, benzyl alcohol (30mg/mL), ethanol (241.4 mg/mL), citric acid (anhydrous)

Osmolarity

No information

pH

No information

Endotoxin content

≤ 2.0 EU/mg

Medac

Strength

20mg/mL in 5mL vial
20mg/mL in 25mL vial
20mg/mLin 50mL vial

Excipients

Macrogol 300, polysorbate 80, ethanol, citric acid (anhydrous)

Osmolarity

No information

pH

No information

Endotoxin content

No information

Neon (Etopophos®)

Strength

100mg vial

Excipients

Dextran 40, Sodium citrate

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.47 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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Etoposide products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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