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