Summary

• DARZALEX is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation.¹
• DARZALEX can cause severe and/or serious infusion-related reactions (IRR) including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported.¹
• Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision.¹
• Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX infusion. If ocular symptoms occur, interrupt DARZALEX infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX.¹
• For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX.¹
• Following a request from the food and drug association (FDA) in Nov 2021, the Janssen safety management team (SMT) assessed clinical trial and post marketing data, and literature for a potential association between these ocular events in the context of IRRs.² 
  • A total of 38 cases were identified in the Janssen Global Medical Safety database at the time, 36 involving DARZALEX and 2 involving DARZALEX FASPRO for subcutaneous (SC) use. None of the cases were reported from a registrational clinical trial.
  • Following internal review, the Janssen SMT concluded that transient, reversible ocular events had been observed on rare occasions in the context of an IRR in association with DARZALEX administration. 
• Several case reports have been published describing ocular events in patients who received DARZALEX. The reports are included in the References section for your information.^3-12

PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
12 June 2024.