Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DARATUMUMAB
SOHO INDUSTRI PHARMASI - Indonesia
DARATUMUMAB
20 MG/ML
KONSENTRAT INJEKSI
DUS, 1 VIAL @ 20 ML (400 MG)
CILAG CHEMIE - Switzerland
2019-03-20
PI DARZALEX (daratumumab) (CCDS 21Dec18 v.07+TD 28Sep18+deletion RRMM) 1 DARZALEX™ Daratumumab. Concentrate for solution for infusion DOSAGE FORMS AND STRENGTHS Daratumumab is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. DARZALEX is available as a colorless to yellow preservative free liquid concentrate for intravenous infusion after dilution. Each mL contains 20 mg daratumumab. 5 mL vial: Each single-use vial contains 100 mg of daratumumab. 20 mL vial: Each single-use vial contains 400 mg of daratumumab. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS DARZALEX is indicated as monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent. POSOLOGY AND METHOD OF ADMINISTRATION DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Posology Pre- and post-infusion medications should be administered to reduce the risk of infusion-related reactions (IRRs) with daratumumab. See below “Recommended concomitant medications”, “Management of infusion-related reactions” and _Warnings and Precautions_. _Dose _ Standard dosing for monotherapy (4-week cycle regimen): The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1. TABLE 1: STANDARD DARZALEX DOSING SCHEDULE FOR MONOTHERAPY (4-WEEK CYCLE DOSING REGIMEN) WEEKS SCHEDULE Weeks 1 to 8 weekly (total of 8 doses) Weeks 9 to 24 a every two weeks (total of 8 doses) Week 25 onwards until disease progression b every four weeks a First dose of the every-2 week-dosing schedule is given at Week 9 b First dose of the every-4 week-dosing schedule is given at Week 25 Baca dokumen lengkapnya