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Columvi TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: glofitamab

Brand name

(ARTG)

: COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

Columvi monotherapy with obinutuzumab pretreatment has provisional approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi is not indicated for the treatment of patients with primary central nervous system lymphoma.,The decision to approve this indication has been made on the basis of Complete Response and the Overall Response Rate from an uncontrolled, open label phase I/II study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, concentrated
  • Intravenous
  • Colourless, clear solution supplied in single dose vials

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Do not Shake
  • Shelf lifetime is 30 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 1 pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient glofitamab

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.

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