Darzalex 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
Brand name
(ARTG)
: DARZALEX daratumumab 400 mg/20 mL concentrated solution for infusion vialDownload 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 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 multiple myeloma who have received:,- at least one prior therapy. For use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as:,? monotherapy.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, concentrated
- Intravenous
- DARZALEX is a colourless to yellow liquid concentrate
Storage conditions
(ARTG)
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Do not Freeze
- See Product information for shelf life
- 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
- 1 vial pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on September, 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
