You can try again. Combination therapy: Consider administering oral methylprednisolone at ≤20 mg (or equivalent intermediate- or long-acting corticosteroid) beginning the day after each daratumumab infusion. Proposed INN: List 101", "Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma", "Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab", "Daratumumab Approved for Multiple Myeloma in US", https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100115/darzalex-daratumumab%7Ctitle=Darzalex, "Janssen's Single-Agent Darzalex (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM)", "FDA approves Darzalex for newly diagnosed, transplant-ineligible multiple myeloma", "An overview of Darzalex and why it is authorised in the EU", "Infectious complications and NK cell depletion following daratumumab treatment of Multiple Myeloma", "Resolving the daratumumab interference with blood compatibility testing", "Daratumumab Interferes with Flow Cytometric Evaluation of Multiple Myeloma", "The Good, the Bad and the Unknown of CD38 in the Metabolic Microenvironment and Immune Cell Functionality of Solid Tumors", "CD38 and Anti-CD38 Monoclonal Antibodies in AL Amyloidosis: Targeting Plasma Cells and beyond", International Journal of Molecular Sciences, "Daratumumab - Janssen Biotech - AdisInsight", "Therapeutic Opportunities with Pharmacological Inhibition of CD38 with Isatuximab", "Resistance Mechanisms Towards CD38-Directed Antibody Therapy in Multiple Myeloma", "Daratumumab Continues To Show Promise For Relapsed/Refractory Myeloma Patients (ASH 2012)", "Daratumumab, lenalidomide, and dexamethasone for multiple myeloma", "Daratumumab, bortezomib, and dexamethasone for multiple myeloma", https://en.wikipedia.org/w/index.php?title=Daratumumab&oldid=980082769, Antineoplastic and immunomodulating drugs, Chemicals that do not have a ChemSpider ID assigned, Drugboxes which contain changes to verified fields, Drugboxes which contain changes to watched fields, Wikipedia articles in need of updating from August 2020, All Wikipedia articles in need of updating, Creative Commons Attribution-ShareAlike License, This page was last edited on 24 September 2020, at 14:11. Solution, Subcutaneous [preservative free]: Darzalex Faspro: Daratumumab 1,800 mg and hyaluronidase-fihj 30,000 units per 15 mL (15 mL). Monitor for signs/symptoms of hypersensitivity (systemic and local reactions).

Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up. Treatment of relapsed or refractory multiple myeloma (in combination with dexamethasone and pomalidomide) in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor. If the diluted solution is refrigerated prior to use, allow to come to room temperature before administration. Grade 3 (severe) infusion reaction: Once symptoms resolve, consider resuming the daratumumab infusion at no more than 50% of the rate at which the reaction occurred. Avoid combination.

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Consider therapy modification, Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. • Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat. Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching. Prior to implementing the accelerated infusion rate, patients should demonstrate tolerability to a 500 mL infusion. If not used, discard after 4 hours. If no major systemic administration-related reaction occurs following the first 4 daratumumab/hyaluronidase doses, consider discontinuing these additional inhaled post-medications. Management: Patients receiving estrogens (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Avoid combination, Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Following daratumumab therapy interruption for autologous stem cell transplant (ASCT), the incidence of infusion reaction was ~11% when reinitiating daratumumab (at the infusion rate/dilution used prior to transplant); symptoms/severity were consistent with week 2 incidences prior to ASCT.

Monitor therapy, Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. [27][needs update], Interference with blood compatibility testing, "International Nonproprietary Names for Pharmaceutical Substances (INN). [25] A 2015 study compared monotherapy 8 and 16 mg/kg at monthly to weekly intervals. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In patients with a history of chronic obstructive pulmonary disease, also consider short- and long-acting bronchodilators and inhaled corticosteroids. The addition of montelukast and famotidine to the premedication regimen has also been reported (Barr 2018; Hofmeister 2016). The following premedication regimen has also been reported (Hofmeister 2016): First infusion: Acetaminophen 325 mg orally, diphenhydramine 25 mg orally or IV, dexamethasone 20 mg IV, montelukast 10 mg orally, and famotidine 20 mg IV. The binding of anti-CD38 monoclonal antibody to natural killer (NK) cells mimics the normal CD38-CD31 interaction on the NK cell surface. Keep up. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. The only antigen system affected that is associated with common, clinically significant antibodies is Kell, making crossmatch testing with K-negative RBCs a reasonable alternative when urgent transfusion is indicated. Daratumumab and hyaluronidase-fihj is a form of daratumumab that is given as a subcutaneous injection. Consider therapy modification, Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Daratumumab 15 mL was given over three to five minutes, alternating between left and right abdominal sites. [10], In the European Union it is indicated as monotherapy for the treatment of adults with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Try choosing a different name, Sorry! [17] Daratumumab binds to CD38, causing cells to apoptose via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity or antibody-dependent cellular phagocytosis. Week 1 infusion (500 mL [split-dose infusion; 8 mg/kg on days 1 and 2] or 1,000 mL volume [single-dose infusion; 16 mg/kg on day 1]): Infuse at 50 mL/hour for the first hour. Avoid combination, Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. If dexamethasone or prednisone is administered the day after the daratumumab/hyaluronidase dose as part of background combination chemotherapy regimen, additional post-dose corticosteroid therapy may not be necessary. Based on the mechanism of action, in utero exposure to daratumumab/hyaluronidase may cause fetal harm. If no infusion reactions occur, may increase the rate by 50 mL/hour every hour (maximum rate: 200 mL/hour). Monotherapy: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after each daratumumab administration. Administer in a facility with immediate access to resuscitative measures (eg, glucocorticoids, epinephrine, bronchodilators, oxygen).

Data from another small phase II study also support the use of single agent daratumumab in the treatment of relapsed light chain amyloidosis in patients who had received at least 1 prior treatment regimen [Sanchorawala 2020]. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants.



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