Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10110 |
| Trade Name | Dose Form | Strength | Identifier |
| Darzalex | Concentrate for infusion | 100 mg/5mL | |
| Sponsor | Application date | Registration situation | Classification |
| Janssen-Cilag (New Zealand) Ltd P O Box 62185 Sylvia Park Auckland 1644 | 9/2/2017 | Consent given Approval date: 30/11/2017 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Daratumumab 20 mg/mL | Samsung Biologics Co Ltd 300, Songdo bio-daero Yeonsu-gu Incheon 21987 South Korea | |
| Janssen Sciences Ireland UC Barnahely Ringaskiddy County Cork Ireland | ||
| Biogen Inc 5000 Davis Drive Research Triangle Park North Carolina 27709 United States of America | ||
| Excipient | ||
| Glacial acetic acid | ||
| Mannitol | ||
| Polysorbate 20 | ||
| Sodium acetate trihydrate | ||
| Sodium chloride | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
| Janssen Biologics BV Einsteinweg 101 Leiden 2333 CB Netherlands | |
| Janssen Biotech Inc 200 Great Valley Parkway Malvern Pennsylvania 19355 United States of America | |
| Janssen Sciences Ireland UC Barnahely Ringaskiddy County Cork Ireland | |
| PharmAssist Inc. 392 State Highway 8 South New Berlin New York 13843 United States of America | |
| PPD Development Ireland Ltd Building C, Garrycastle Business & Technology Park Athlone Co. Westmeath Ireland | |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Helmut-Vetter-Str. 10 Ravensburg Baden Wurttemberg 88213 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 Germany | |
| Manufacture of Final Dose Form | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Secondary Packaging | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
| Contract Pharmaceutical Services of Australia Pty Ltd 5 Eden Park Drive North Ryde NSW 2113 Australia | |
| DHL Supply Chain (Australia) Pty Limited 52 Huntingwood Drive Huntingwood NSW 2148 Australia | |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| NZ Site of Product Release | Janssen-Cilag (New Zealand) Ltd 507 Mt Wellington Highway AUCKLAND 1060 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, | 5 mL | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. followed by 15 hours (including infusion time) at room temperature (15 to 25 deg C) |
Indications
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
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/4/2023 | CMN 24(5) | Indications/dosage - G1; Contraindications, warnings and precautions - G1; Data sheet - G1; Administrative fee (CMN) | Granted 23/11/2023 | 2/5/2023 | |
| 9/2/2017 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 30/11/2017 | 15/2/2017 | Y |
