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DARZALEX® SC development

DARZALEX® SC was developed to reduce patient and provider burden without compromising safety and efficacy

Adapted with permission. © Halozyme, Inc. 2018. All rights reserved. © Janssen Pharmaceuticals, Inc.

Related content

DARZALEX® SC home

DARZALEX® SC handling and administration
Handling and administration demonstration & information 

DARZALEX® SC studies
Overview of the DARZALEX® SC PAVO, COLUMBA and PLEIADES studies 

DARZALEX® SC support materials
A range of materials, including a practical guide, in-clinic poster and patient materials

DARZALEX® SC MOA

DARZALEX® SC contains recombinant human hyaluronidase PH20 (rHuPH20; ENHANZE® drug delivery technology), an enzyme that disrupts the extracellular matrix to open the subcutaneous space, allowing access to the lymphatic and capillary vessels. The mechanism permits DARZALEX® SC to be absorbed quickly into the systemic circulation.[1][2][3]

DARZALEX® SC dose selection

The DARZALEX® SC 1,800 mg flat dose was selected based on the phase 1b PAVO study[4][5]

DARZALEX® SC provides:[1]

* Compared with DARZALEX® IV.

Quick downloads

SC Checklist beginning of treatment

Includes a first use checklist of Darzalex® SC.

Darzalex® SC Practical Guide

Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more

Glossary

IRR: infusion-related reaction 

IV: intravenous 

MOA: mode of action

rHuPH20: recombinant human hyaluronidase PH20

SC: subcutaneous

Para visualizar o IECRCM de Darzalex, veja aqui.

Referências

RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4(4):427–440.
Wasserman RL. Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies. Immunotherapy. 2014;6(5):553–567.
Chari A et al. Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Pavo, an Open-Label, Multicenter, Dose Escalation Phase 1b Study. Oral presentation at the 59th American Society of Hematology annual meeting & exposition; December 9–12, 2017; Atlanta, GA. Abstract 838.
Usmani SZ, et al. Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients With Relapsed or Refractory Multiple Myeloma: COLUMBA Update. Poster presented at the 61st American Society of Hematology annual meeting; December 7–10, 2019; Orlando, FL. Poster 1865.
CP-287862 - Março 2022