Topotecan products: information for supporting intrathecal risk assessment

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

Topotecan 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 topotecan 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 concentrate

Topotecan Accord concentrate for solution for infusion

Strength

1mg/mL 1mL and 4mL vials

Excipients

Tartaric acid (E334), hydrochloric acid (for pH adjustment) (E507), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

100 – 40 mOsmol/L

pH

1.5 – 2.5

Endotoxin content

No information

Accord powder for concentrate

Topotecan Accord powder for concentrate for solution for infusion

Strength

1mg vials
4mg vials

Excipients

Mannitol (E421), tartaric acid (E334), sodium hydroxide, hydrochloric acid (E507)

Osmolarity

No information

pH

No information

Endotoxin content

No information

Medac

Topotecan Medac concentrate for solution for infusion

Strength

1mg/mL in 1mg, 2mg or 4mg vials

Excipients

Water for injection, hydrochloric acid for pH adjustment, sodium hydroxide for pH adjustment

Osmolarity

No information

pH

No information

Endotoxin content

No information

Pfizer

Topotecan Hospira concentrate for solution for infusion

Strength

1mg/mL in 4mL vials

Excipients

Tartaric acid (E334), hydrochloric acid (for pH adjustment) (E507), sodium hydroxide (for pH adjustment), water for injection

Osmolarity

No information

pH

No information

Endotoxin content

No information

Sandoz

Topotecan Sandoz concentrate for solution for infusion

Strength

1mg/mL in 1mg, 2mg or 4mg vials

Excipients

Tartaric acid, diluted hydrochloric acid, water for injection

Osmolarity

No information

pH

2.0 – 2.5

Endotoxin content

No information

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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