Trastuzumab products: information for supporting intrathecal risk assessment

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

Trastuzumab 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 trastuzumab 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 (Zercepac®)

Trastuzumab (Zercepac®) powder for concentrate for solution for infusion

Strength

150mg vial

Excipients

L-histidine hydrochloride monohydrate, L-histidine, α, α-trehalose dihydrate, polysorbate 20

Osmolarity

No information

pH

6.0

Endotoxin content

< 12 EU/mL

Amgen (Kanjinti®)

Trastuzumab (Kanjinti®) powder for concentrate for solution for infusion

Strength

150mg vial

Excipients

Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20

Osmolarity

45 – 75 mOsmol/kg

pH

6.0

Endotoxin content

≤ 32 EU/vial

Strength

420mg vial

Excipients

Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20

Osmolarity

45 – 75 mOsmol/kg

pH

6.0

Endotoxin content

≤ 47 EU/vial

Celltrion (Herzuma®)

Trastuzumab (Herzuma®) powder for concentrate for solution for infusion

Strength

150mg vial
420mg vial

Excipients

L-histidine hydrochloride, L-histidine, α,α-trehalose dihydrate, polysorbate 20

Osmolarity

110 – 140 mOsmol/kg

pH

6.0

Endotoxin content

No information

Daiichi Sankyo (Enhertu®)

Trastuzumab deruxtecan (Enhertu®) powder for concentrate for solution for infusion

Strength

100mg vial

Excipients

L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80

Osmolarity

No information

pH

No information

Endotoxin content

< 0.3 EU/mg

Napp (Herzuma®)

Trastuzumab (Herzuma®) powder for concentrate for solution for infusion

Strength

150mg vial
420mg vial

Excipients

L-histidine hydrochloride, L-histidine, α,α-trehalose dihydrate, polysorbate 20

Osmolarity

110 – 140 mOsmol/kg

pH

6.0

Endotoxin content

< 1.0 EU/mL

Organon (Ontruzant®)

Trastuzumab (Ontruzant®) powder for concentrate for solution for infusion

Strength

150mg vial

Excipients

L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20

Osmolarity

No information

pH

6.0

Endotoxin content

< 6.5 EU/mL

Pfizer (Trazimera®)

Trastuzumab (Trazimera®) powder for concentrate for solution for infusion

Strength

150mg vial
420mg vial

Excipients

L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20 (E432)

Osmolarity

No information

pH

6.0

Endotoxin content

≤ 0.32 EU/mg

Roche (Herceptin®) powder for concentrate

Trastuzumab (Herceptin®) powder for concentrate for solution for infusion

Strength

150mg vial

Excipients

L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20

Osmolarity

45 – 75 mOsmol/kg

pH

6.0 (in water for injection)

Endotoxin content

≤ 12 EU/vial

Roche (Herceptin®) solution for injection

Trastuzumab (Herceptin®) solution for injection

Strength

120mg/mL in 5mL vials

Excipients

Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 20, water for injection

Osmolarity

45 – 75 mOsmol/kg

pH

6.0 (in water for injection)

Endotoxin content

≤ 10 EU/vial

Roche (Kadcyla®)

Trastuzumab emtansine (Kadcyla®) powder for concentrate for solution for infusion

Strength

100mg vial
160mg vial

Excipients

Succinic acid, sodium hydroxide, sucrose, polysorbate 20

Osmolarity

No information

pH

No information

Endotoxin content

< 4 EU/mL

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