Rituximab products: information for supporting intrathecal risk assessment

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

Rituximab 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 no rituximab 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.

Napp (Truxima®) infusion

Rituximab concentrate for solution for infusion

Strength

10mg/mL in 10mL vials
10mg/mL in 50mL vials

Excipients

Sodium chloride, tri-sodium citrate dihydrate (E331), polysorbate 80 (E433), water for injection

Osmolarity

329 – 387 mOsmol/kg

pH

6.3 – 6.8

Endotoxin content

< 1.0 EU/mL

Pfizer (Ruxience®) infusion

Rituximab concentrate for solution for infusion

Strength

10mg/mL in 10mL vials
10mg/mL in 50mL vials

Excipients

L-histidine, L-histidine hydrochloride monohydrate, disodium edetate, polysorbate 80 (E433), sucrose, water for injection

Osmolarity

237 – 372 mOsmol/kg

pH

5.8 (undiluted)

Endotoxin content

≤ 0.23 EU/mg

Roche (MabThera®) injection

Rituximab solution for subcutaneous injection

Strength

120mg/mL in 11.7mL vials
120mg/mL in 13.4mL vials

Excipients

Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 (E433), water for injection

Osmolarity

300 – 400 mOsmol/kg

pH

5.2 – 5.8

Endotoxin content

≤ 11 EU/mL

Roche (MabThera®) infusion

Rituximab concentrate for solution for infusion

Strength

10mg/mL in 10mL vials
10mg/mL in 50mL vials

Excipients

Sodium citrate (E331), polysorbate 80 (E433), sodium chloride, sodium hydroxide (for pH adjustment) (E524), hydrochloric acid (for pH adjustment) (E507), water for injection

Osmolarity

324 – 396 mOsmol/kg

pH

6.2 – 6.8

Endotoxin content

≤ 1.0 EU/mL

Sandoz (Rixathon®) infusion

Rituximab concentrate for solution for infusion

Strength

10mg/mL in 10mL vials
10mg/mL in 50mL vials

Excipients

Sodium citrate (E331), polysorbate 80 (E433), sodium chloride, sodium hydroxide (for pH adjustment) (E524), hydrochloric acid (for pH adjustment) (E507), water for injection

Osmolarity

≥ 240 mOsmol/kg

pH

6.3 – 6.7

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