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Darzalex SC 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: daratumumab

Pack: Darzalex SC 1.8 g/15 mL injection, 15 mL vial

Brand name

(ARTG)

: DARZALEX SC daratumumab 1800 mg/15 mL solution for injection 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)

DARZALEX SC is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. For use in combination with: bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. For use in combination with: bortezomib, melphalan and prednisone, or lenalidomide and dexamethasone. with relapsed or refractory multiple myeloma who have received: - at least one prior therapy. For use in combination with: bortezomib and dexamethasone, or lenalidomide and dexamethasone, or carfilzomib and dexamethasone, or pomalidomide and dexamethasone (after at least one prior therapy including lenalidomide and a proteasome inhibitor (PI)). - at least three prior lines of therapy including a PI and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as: monotherapy. DARZALEX SC in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain AL amyloidosis.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • Colourless to yellow, clear to opalescent, preservative-free solution

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from direct sunlight
  • Do not Shake
  • Shelf lifetime is 24 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

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on December, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient daratumumab

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

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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