Cytarabine products: information for supporting intrathecal risk assessment

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

Cytarabine 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.

Accord

Strength

20 mg/mL in 2mL vial
20 mg/mL in 5mL vial

Hospira

Strength

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

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

100 mg/mL in 1mL vial
100 mg/mL in 5mL vial
100 mg/mL in 10mL vial
100 mg/mL in 20mL vial
100 mg/mL in 40mL vial
100 mg/mL in 50mL vial

Excipients

Macrogol 400, trometamol (for pH adjustment), water for injection

Osmolarity

No information

pH

7.0 – 9.5

Endotoxin content

≤ 0.07 EU/mg

Fresenius

Strength

100 mg/mL in 1mL vial
100 mg/mL in 5mL vial
100 mg/mL in 10mL vial
100 mg/mL in 20mL vial

Excipients

Hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

250 – 400 mOsmol/L

pH

7.0 – 9.5

Endotoxin content

No information

Hospira

Strength

100 mg/mL in 1mL vial
100 mg/mL in 5mL vial
100 mg/mL in 10mL vial
100 mg/mL in 20mL vial

Excipients

Water for injection, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment)
SmPC (04/2021): Cytarabine 100 mg/ml Injection should not be administered by the intrathecal route due to the slight hypertonicity of this formulation.

Osmolarity

No information

pH

No information

Endotoxin content

No information

Pfizer

Strength

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

Excipients

Hydrochloric acid, sodium hydroxide, nitrogen, water for injection, sodium chloride

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.07 EU/mg

No information available

Products with very little or no information are rarely used for intrathecal administration.

There are currently no known additional cytarabine products.

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